WO2021255464A1

WO2021255464A1 - Nutraceutical composition

Info

Publication number: WO2021255464A1
Application number: PCT/GB2021/051542
Authority: WO
Inventors: Norman Hahn
Original assignee: Norman Hahn
Priority date: 2020-06-17
Filing date: 2021-06-17
Publication date: 2021-12-23

Abstract

The invention relates to nutraceutical compositions useful in the treatment or prevention of diseases and/or disorders. In particular, the nutraceutical compositions contribute to strengthening of the immune system, resulting in the prevention and treatment of many diseases. A nutraceutical composition of the present invention comprises: C3 curcumin; Vitamin C; Chlorella, or an extract thereof, Spirulina, or an extract thereof; and Boswellia resin, or an extract thereof. An alternative nutraceutical composition of the present invention comprises: Coenzyme Q10; Spirulina, or an extract thereof; Moringa leaf, or an extract thereof; and Astaxanthin. The compositions may be used in the treatment or prevention of diseases such as chronic fatigue syndrome, immunodeficiency disorders, and viruses, in particular both acute COVID-19 infection and the COVID-19 sequelae or post viral fatigue known as long COVID. Furthermore, the compositions of the present inventions may be used in combination, or as a combination therapy in the treatment of different stages of a disease.

Description

NUTRACEUTICAL COMPOSITION

The invention relates to a nutraceutical composition useful in the treatment or prevention of diseases and/or disorders. The composition may be used in the treatment or prevention of diseases such as chronic fatigue syndrome, immunodeficiency disorders, and viruses, in particular COVID-19, and may be used for improving the immune system. In particular, the composition contributes to strengthening of the immune system, resulting in the prevention of many diseases, as well as their effective treatment. The composition is effective in both ameliorating the acute symptoms of COVID-19 as well as the symptoms of the COVID-19 sequelae or post viral fatigue known as long COVID, such as chronic fatigue, muscle and joint pain.

Background It is widely known that nutrition is important in the treatment of many diseases, including boosting the immune system, with many traditional remedies using native plant materials. This has resulted in the analysis of the content of these plant materials in order to determine the chemical constituents that provide these properties and the mechanism of action of these compounds.

Fruits and vegetables represent a vast source of phytochemicals, many of which have already been studied extensively for their potential to treat and prevent various diseases. The benefit of using phytochemicals from such fruit and vegetables is that they present a reduced risk of causing side effects, whilst also providing a potential source of vitamins, minerals, and fibre if the fruit or vegetable itself, or a portion of it, is also consumed.

Numerous studies have also been performed on entire fruit or vegetable plant matter, or extracts therefrom. However, such studies are much more difficult to perform because the modern pharmacological approach is not designed to study effects produced by such complex mixtures of compounds. Owing to these problems and the non-toxic and edible properties of these products, studies have therefore largely focussed on a model which relies on ingestion by a patient followed by monitoring of the effects.

Although individual chemicals have been identified as potential treatments and/or preventative agents for various diseases, drawbacks such as low bioavailability or lack of efficacy in vivo have limited their medical use. Additionally, difficulties in obtaining and administering the chemicals have prevented wide-spread application. The present invention is the result of extensive research by the inventor to identify a particular combination of natural ingredients which has been found to significantly strengthen the immune system when administered, which contributes to an overall effect of ameliorating and/or preventing diseases.

The present invention provides a combination of naturally derived products, or their extracts, which results in an easily administered product and having benefits in the treatment of diseases such as chronic fatigue syndrome, immunodeficiency disorders, and/or viruses, in particular COVID-19. This composition has the potential to overcome deficits of each individual component, that have hitherto limited the efficacy of the components individually, resulting in a more effective treatment. This composition may also be used in the prevention of diseases, such as those mentioned above, particularly chronic fatigue syndrome, immunodeficiency disorders, and/or viruses such as COVID-19, over a long time scale if required, as each of the natural products which forms the composition is safe for human consumption over a prolonged period of time. The composition may also be used in ameliorating the symptoms of diseases, particularly those that are in an advanced state, including as part of palliative treatment.

This composition may also be used in the treatment of the sequelae of a disease, for example a post viral fatigue such as the post viral fatigue symptoms of COVID-19, known as long COVID.

The present invention results from the surprising finding of a synergistic interaction between particular natural products, or extracts therefrom, which result in therapeutic effects of the composition which exceed additive effects associated with the use of the natural products individually. This synergistic interaction is believed to improve one or more of bioavailability, activity or selectivity of the active ingredients of the components of the composition. Another particular benefit of the present invention is an increase in convenience associated with multiple ingredients being available in a single composition which can also improve patient compliance. Summary of Invention

In one aspect, the invention provides a nutraceutical composition comprising C3 curcumin; Vitamin C; Boswellia resin, or an extract thereof; spirulina, or an extract thereof; and chlorella, or an extract thereof. The composition may also include one or more, preferably all, of; moringa leaf; quercetin; Vitamin D3; Vitamin K2; one or more zinc-containing compound, preferably zinc picolinate; Astragalus, or an extract thereof, and/or one or more astragaloside; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; and turmeric. Preferably, the composition further comprises astaxanthin.

In one embodiment, the composition consists essentially of, C3 curcumin; Vitamin C; Boswellia resin, or an extract thereof; spirulina, or an extract thereof; chlorella, or an extract thereof; moringa leaf; quercetin; Vitamin D3; Vitamin K2; zinc picolinate; Astragalus, or an extract thereof; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; and turmeric.

In one embodiment, the composition consists essentially of, C3 curcumin; Vitamin C; Boswellia resin, or an extract thereof; spirulina, or an extract thereof; chlorella, or an extract thereof; moringa leaf; quercetin; Vitamin D3; Vitamin K2; zinc picolinate; Astragalus, or an extract thereof; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; turmeric; and astaxanthin.

In one embodiment, the composition comprises, on a dry weight basis, 1 to 8 wt.% C3 curcumin; 20 to 90 wt.% Vitamin C; 1.0 to 15 wt.% Boswellia resin, or an extract thereof; 5 to 20 wt.% spirulina, or an extract thereof; and 5 to 20 wt.% chlorella, or an extract thereof. The composition may also include, on a dry weight basis, include one or more, preferably all, of; 5 to 50 wt.% moringa leaf; 0.5 to 5.0 wt.% quercetin; 0.0001 to 1.0 wt.% Vitamin D3; 0.0001 to 0.2 wt.% Vitamin K2; 0.01 to 5.0 wt.% one or more zinc-containing compound, preferably zinc picolinate; 1.0 to 7.0 wt.% Astragalus, or an extract thereof, and/or one or more astragaloside; 0.00001 to 0.2 wt.% a selenium-containing compound; 0.0001 to 0.2 wt.% Vitamin B12; 0.1 to 10 wt.% ginger, or an extract thereof; 1 to 8 wt.% turmeric. Preferably, the composition further comprises 1 to 10 wt.% astaxanthin. In one embodiment, on a dry weight basis, the composition consists essentially of: 1 to 8 wt.% C3 curcumin; 20 to 90 wt.% Vitamin C; 1.0 to 15 wt.% Boswellia resin, or an extract thereof; 5 to 20 wt.% spirulina, or an extract thereof; 5 to 20 wt.% chlorella, or an extract thereof; 5 to 50 wt.% moringa leaf; 0.5 to 5.0 wt.% quercetin; 0.0001 to 1.0 wt.% Vitamin D3; 0.0001 to 0.2 wt.% Vitamin K2; 0.01 to 5.0 wt.% zinc picolinate; 1.0 to 7.0 wt.% Astragalus, or an extract thereof; 0.00001 to 0.2 wt.% a selenium-containing compound; 0.0001 to 0.2 wt.% Vitamin B12; 0.1 to 10 wt.% ginger, or an extract thereof; and 1 to 8 wt.% turmeric.

In one embodiment, on a dry weight basis, the composition consists essentially of: 1 to 8 wt.% C3 curcumin; 20 to 90 wt.% Vitamin C; 1.0 to 15 wt.% Boswellia resin, or an extract thereof; 5 to 20 wt.% spirulina, or an extract thereof; 5 to 20 wt.% chlorella, or an extract thereof; 5 to 50 wt.% moringa leaf; 0.5 to 5.0 wt.% quercetin; 0.0001 to 1.0 wt.% Vitamin D3; 0.0001 to 0.2 wt.% Vitamin K2; 0.01 to 5.0 wt.% zinc picolinate; 1.0 to 7.0 wt.% Astragalus, or an extract thereof; 0.00001 to 0.2 wt.% a selenium-containing compound; 0.0001 to 0.2 wt.% Vitamin B12; 0.1 to 10 wt.% ginger, or an extract thereof; 1 to 8 wt.% turmeric; and 1 to 10 wt.% astaxanthin.

In another aspect, there is provided a nutraceutical composition comprising: 1) coenzyme Q10; 2) spirulina, or an extract thereof; 3) moringa leaf, or an extract thereof; and 4) astaxanthin. The composition may also include one or more of, preferably all of, 5) C3 curcumin, or an extract thereof: 6) ginger, or an extract thereof; 7) chlorella, or an extract thereof; 8) reishi, or an extract thereof; 9) dandelion, or an extract thereof; 10) scouring rush, or an extract thereof; and 11) greater nettle, and/or an extract thereof. In one embodiment, the composition comprises, on a dry weight basis, 1) 0.1 to 10 wt.% coenzyme Q10; 2) 10 to 20 wt.%, spirulina, or an extract thereof; 3) 5 to 50 wt.%, moringa leaf, or an extract thereof; and 4) 0.01 to 1 wt.% astaxanthin. The composition may also include 5) 0.1 to 10 wt.% C3 curcumin, or an extract thereof: 6) 0.1 to 5 wt.% ginger, or an extract thereof; 7) 10 to 20 wt.%, chlorella, or an extract thereof; 8) reishi, or an extract thereof; 9) dandelion, or an extract thereof; 10) scouring rush, or an extract thereof; and 11) greater nettle, and/or an extract thereof.

In one embodiment, the composition comprises, on a dry weight basis, 0.1 to 20 wt.% coenzyme Q10; 5 to 20 wt.%, spirulina, or an extract thereof; 5 to 50 wt.%, moringa leaf, or an extract thereof; and 0.01 to 10 wt.% astaxanthin. The composition may also include on a dry weight basis, one or more of, preferably all of: 0.1 to 20 wt.% C3 curcumin, or an extract thereof: 0.1 to 10 wt.% ginger, or an extract thereof; 5 to 20 wt.%, chlorella, or an extract thereof; 0.01 to 5 wt.% reishi, or an extract thereof; 5 to 20 wt.% dandelion, or an extract thereof; 5 to 20 wt.% scouring rush, or an extract thereof; and 5 to 20 wt.% greater nettle, or an extract thereof.

In one embodiment, on a dry weight basis, the composition consists essentially of, 0.1 to 20 wt.% coenzyme Q10; 5 to 20 wt.%, spirulina, or an extract thereof; 5 to 50 wt.%, moringa leaf, or an extract thereof; 0.01 to 10 wt.% astaxanthin; 0.1 to 20 wt.% C3 curcumin, or an extract thereof: 0.1 to 10 wt.% ginger, or an extract thereof; 5 to 20 wt.%, chlorella, or an extract thereof; 0.01 to 5 wt.% reishi, or an extract thereof; 5 to 20 wt.% dandelion, or an extract thereof; 5 to 20 wt.% scouring rush, or an extract thereof; and 5 to 20 wt.% greater nettle, or an extract thereof. In one aspect there is provided a nutraceutical composition comprising: C3 curcumin; moringa leaf, or an extract thereof; spirulina, or an extract thereof; chlorella, or an extract thereof; and ginger, or an extract thereof. The composition may also include astaxanthin.

In one embodiment, the composition comprises, on a dry weight basis: 0.1 to 20 wt.% C3 curcumin; 5 to 50 wt.% moringa leaf, or an extract thereof; 5 to 20 wt.% spirulina, or an extract thereof; 5 to 20 wt.% chlorella, or an extract thereof; and 0.1 to 10 wt.% ginger, or an extract thereof. The composition may also include, on a dry weight basis 1 to 10 wt.% astaxanthin. In an alternative aspect, there is provided a nutraceutical composition comprising: i) C3 curcumin: ii) Vitamin C; and iii) Boswellia resin, or an extract thereof. The composition may also include iv) grape seed, or an extract thereof, v) quercetin, vi) Vitamin D3, vii) Vitamin K2; viii) a zinc-containing compound, preferably zinc gluconate; ix) Astragalus, or an extract thereof, and/or one or more astragaloside, preferably Astragalus root, or an extract thereof, and/or one or more astragaloside; x) a selenium-containing compound, preferably L-selenium methionine; xi) Vitamin B12, preferably comprising methylcobalamin; xii) Vitamin A acetate; xiii) glutathione; and/or xiv) potassium sorbate. The composition may further include xv) broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof; xvi) ginger, or an extract thereof; xvii) bitter melon, or an extract thereof, and/or cucumber, or an extract thereof, xviii) spirulina or an extract thereof, xix) co-enzyme Q10, xx) chlorella, or an extract thereof, xxi) reishi, or an extract thereof, xxii) dandelion, or an extract thereof, xxiii) scouring rush, or an extract thereof, xxiv) greater nettle, or an extract thereof, and/or xxv) astaxanthin. Preferably the composition additionally includes at least v) quercetin. The composition may also include xviii) one or more sweeteners, preferably comprising stevia, or an extract thereof; and/or xix) one or more flavours. The composition may also include, or the composition may be provided in combination with, a glyceride oil and/or fat. The composition may comprise a liposome-based vehicle and may be administered as a liposome composition.

In one embodiment, the composition comprises, on a dry weight basis, i) 1 to 8 wt.% C3 curcumin; ii) 40 to 80 wt.% Vitamin C; iii) 0.2 to 4.0 wt.% grape seed, or an extract thereof; and iv) 1.0 to 15 wt.% Boswellia resin, or an extract thereof. The composition may also include, on a dry weight basis, v) 0.5 to 5.0 wt.% quercetin, vi) 0.01 to 1.0 wt.% Vitamin D3, vii) 0.01 to 0.2 wt.% Vitamin K2; viii) 0.1 to 5.0 wt.% zinc-containing compound; ix) 1.0 to 7.0 wt.% Astragalus, or an extract thereof, and/or one or more astragaloside; x) 0.01 to 0.2 wt.% selenium-containing compound; xi) 0.01 to 0.2 wt.% Vitamin B12; xii) 0.01 to 0.2 wt.% Vitamin A acetate; xiii) 0.5 to 5.0 wt.% glutathione; and/or xiv) 0.5 to 5.0 wt.% potassium sorbate. The composition may further include xv) 5.0 to 13 wt.% broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof; xvi) 3.0 to 10 wt.% ginger, or an extract thereof; and/or xvii) 16 to 50 wt.% bitter melon, or an extract thereof, and/or cucumber, or an extract thereof. In another aspect, there is provided a method of preparing the aforementioned nutraceutical composition, wherein the components are combined to form an admixture, thereby forming the nutraceutical composition.

In yet another aspect, there is provided a food product or beverage comprising the aforementioned nutraceutical composition.

In a still further aspect, there is provided the aforementioned composition for use in therapy. Further provided is a composition for use in the treatment of a disease or disorder selected from chronic fatigue syndrome, immunodeficiency disorders, and/or viruses.

Additionally, there is provided a nutraceutical composition for use in therapy or for the treatment of any one of the above diseases, wherein the composition is administered to a subject at a dose of from 3 to 20 grams per day for 5 to 10 days.

Also provided are methods of treating a subject, comprising administering an effective amount of the aforementioned nutraceutical composition to a subject in need thereof, and in particular to a subject diagnosed with a disease or disorder, including but not limited to chronic fatigue syndrome, immunodeficiency disorders, and viruses. In some embodiments the disease or disorder is COVID-19 and/or the COVID-19 sequelae or post viral fatigue known as long COVID.

Also provided are uses of the nutraceutical composition described herein for the preparation of a medicament for use in therapy, or in particular for use in the treatment or prevention of a disease or disorder, including but not limited to chronic fatigue syndrome, immunodeficiency disorders, and/or viruses. In preferred embodiments the disease or disorder is COVID-19 and/or the COVID-19 sequelae or post viral fatigue known as long COVID.

Further provided is a method of improving the immune system, wherein the aforementioned nutraceutical composition is administered at a dose of 3 to 5 grams per day. Also provided is the use of the aforementioned nutraceutical composition for improving the immune system of a subject.

In another aspect, there is provided a method of preparing the aforementioned nutraceutical composition, wherein the components are combined to form an admixture, thereby forming the nutraceutical composition.

In yet another aspect, there is provided a food product or beverage comprising the aforementioned nutraceutical composition. In a still further aspect, there is provided the aforementioned composition for use in therapy.

Further provided is the aforementioned composition for use in the treatment of the sequalae of a disease, such as post viral fatigue the COVID-19 sequelae or post viral fatigue known as long COVID.

Further provided is a aforementioned composition for use in the treatment of an acute phase of a disease, such as symptomatic COVID-19, in combination with another aforementioned composition for use in the treatment of the sequalae of a disease such as post viral fatigue the COVID-19 sequelae or post viral fatigue known as long COVID. In one embodiment, a first nutraceutical composition comprising: C3 curcumin; Vitamin C; Chlorella, or an extract thereof; Spirulina, or an extract thereof; and Boswellia resin, or an extract thereof is used in the treatment of an acute phase of a disease, such as symptomatic COVID-19, and a second nutraceutical composition comprising: Coenzyme Q10; Spirulina, or an extract thereof; Moringa leaf, or an extract thereof; and astaxanthin is used in the treatment of the sequalae of a disease such as post viral fatigue the COVID-19 sequelae or post viral fatigue known as long COVID.

Further provided by the present invention is a kit of parts comprising: i. a first nutraceutical composition comprising: C3 curcumin; Vitamin C; Chlorella, or an extract thereof; Spirulina, or an extract thereof; and Boswellia resin, or an extract thereof: ii. a second nutraceutical composition comprising: Coenzyme Q10; Spirulina, or an extract thereof; Moringa leaf, or an extract thereof; and astaxanthin: and iii. instructions for use, providing the first nutraceutical composition for the treatment of an acute phase of a disease, and the second nutraceutical composition for the treatment of the sequalae of a disease. Further provided by the present invention is a kit of parts comprising: a first nutraceutical composition comprising: C3 curcumin; Vitamin C; Boswellia resin, or an extract thereof; spirulina, or an extract thereof; chlorella, or an extract thereof; moringa leaf; quercetin; Vitamin D3; Vitamin K2; one or more zinc-containing compound, preferably zinc picolinate; Astragalus, or an extract thereof, and/or one or more astragaloside; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; and turmeric; preferably, further comprising astaxanthin: preferably wherein these components are present in the wt.% as described above; preferably wherein the nutraceutical composition consists essentially of these components: ii. a second nutraceutical composition comprising: coenzyme Q10; spirulina, or an extract thereof; moringa leaf, or an extract thereof; astaxanthin; C3 curcumin, or an extract thereof: ginger, or an extract thereof; chlorella, or an extract thereof; reishi, or an extract thereof; dandelion, or an extract thereof; scouring rush, or an extract thereof; and greater nettle, and/or an extract thereof: preferably wherein these components are present in the wt.% as described above; preferably wherein the nutraceutical composition consists essentially of these components: and iii. instructions for use, providing the first nutraceutical composition for the treatment of an acute phase of a disease, and the second nutraceutical composition for the treatment of the sequalae of a disease.

Detailed Description The nutraceutical compositions of the invention as described herein contain particular combinations of ingredients that have been found to confer beneficial effects. As described hereinbefore, these ingredients may variously be selected from: i) C3 curcumin; ii) Vitamin C; and iii) Boswellia resin, or an extract thereof, iv) grape seed, or an extract thereof, v) quercetin, vi) Vitamin D3, vii) Vitamin K2; viii) a zinc-containing compound; ix) Astragalus, or an extract thereof, and/or one or more astragaloside; x) a selenium-containing compound; xi) Vitamin B12; xii) Vitamin A acetate; xiii) glutathione; and/or xiv) potassium sorbate. The composition may further include xv) broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof; xvi) ginger, or an extract thereof; and/or xvii) bitter melon, or an extract thereof, and/or cucumber, or an extract thereof, xviii) spirulina or an extract thereof, xix) co-enzyme Q10, xx) chlorella, or an extract thereof, xxi) reishi, or an extract thereof, xxii) dandelion, or an extract thereof, xxiii) scouring rush, or an extract thereof, xxiv) greater nettle, or an extract thereof, and/or xxv) astaxanthin, as well as other optional ingredients. These ingredients may be derived from combinations of fruit, vegetables, seeds, leaves, resins and other parts of a plant. When referring to these fruit, vegetables, seeds, leaves, resins and other parts of a plant, the term ‘plant matter’ or ‘plant material’ may also be used.

As will be appreciated, the ingredients discussed herein may be derived and/or extracted from their natural sources. Many of these ingredients are derived from plant or fungi, whilst others, for example, vitamins and minerals, may be produced synthetically. All of the ingredients described herein are also commercially available.

The term ‘edible’ is used to refer to plant matter which is fit to be eaten by humans. These may be considered safe to eat by an official organisation, such as the Food and Drug Administration (FDA) of the United States or the European Food Safety Authority (EFSA) of the European Union, or is authorised for human consumption, for example on the EU Novel food catalogue. As will be appreciated, selenium is an essential micronutrient for animals, but elemental selenium is not bioavailable and is toxic in large doses. The terms “selenium” and “selenium-containing compound” when used herein therefore refer to a bioavailable organic or inorganic selenium compound. Examples of bioavailable inorganic selenium containing compounds include selenium salts such as sodium selenite and sodium selenate. Examples of bioavailable organic selenium containing compounds include selenium containing amino acids such as selenocysteine, Se-methyl-selenocysteine, or L-selenium methionine. Preferably, the selenium compound useful in the present invention is L-selenium methionine. The composition may comprise further optional additional ingredients. These include any combination of one or more antioxidants, antifungals, antivirals, antidepressants and anti-inflammatories, of which the skilled person is familiar.

Additional, optional ingredients that may be included in the composition, in any combination, include moringa leaf, or an extract thereof, black pepper, or an extract thereof, green tea leaf, or an extract thereof, pomegranate seed or an extract thereof, tomato or an extract thereof, cinnamon, pumpkin seed or an extract thereof, omega 5, magnesium oxide, calcium carbonate, omega 3, vitamin E, vitamin Bi, vitamin B₃, vitamin Be, blueberry or an extract thereof, saffron or an extract thereof, beet or an extract thereof, kale or an extract thereof, asparagus or an extract thereof, mannitol, clove or an extract thereof, wheatgrass or a juice or extract thereof, iodine, biotin, caffeine, serrapeptase, melatonin, centella asiatica or an extract thereof, silica, oat ( Avena Sativa) or an extract thereof, sweet wormwood ( Artemisia annua) or an artemisinin-containing derivative thereof, desert wormwood ( Artemisia herba-alba) or an artemisinin-containing derivative thereof, selenium, saw palmetto or an extract thereof, skullcap ( Scutellaria Baicalensis) root or an extract thereof, horsetail or an extract thereof, acerola cherry or an extract thereof, acai berry or an extract thereof, and/or turkey tail mushroom or an extract thereof. These ingredients have been found in some instances to enhance the effects of the nutraceutical composition of the invention, for example by increasing bioavailability of the components and/or by providing further active ingredients. Preferred optional ingredients that may be incorporated into the nutraceutical composition may differ depending upon whether a specific disease or disorder is being treated. Each of these optional ingredients may suitably be present in an amount of from 0 to 5 wt.% of the composition on a dry weight basis. In embodiments, each of these optional ingredients is present in an intended single dosage volume of the composition in an amount of from 0 to 200 % of the reference daily intake (RDI) for that ingredient.

It has been found that the particular combination of components of the nutraceutical composition according to the present invention, which individually have been shown to have beneficial effects in the treatment of various diseases, results in a synergistic interaction giving benefits that are beyond merely additive, based on the effects of the various components individually. It has been found that the particular combination of components of the nutraceutical composition according to the present invention has been found to have beneficial effects in the treatment of both the acute symptoms of COVID-19 and the COVID-19 sequelae or post viral fatigue known as long COVID.

In the treatment of many diseases, known pharmaceutical drugs used have many side- effects, some of which can be serious. One advantage of the present invention is that there are little or no side-effects from taking the composition, with successful treatment of symptoms when used in the treatment of a disease.

The nutraceutical composition of the present invention may be obtained from entirely natural products which are widely consumed and therefore may present fewer adverse effects than other medications. Each of the components of the nutraceutical composition is described below, in turn. C3 Curcumin

Turmeric, Curcuma tonga, is a plant of the ginger family, Zingiberaceae, whose rhizomes are frequently dried and used as a spice in cooking. In this document, ‘turmeric’ is used to refer to these plant rhizomes or the dried spice originating from these rhizomes as opposed to the plant itself, which will be referred to as the ‘turmeric plant’.

The turmeric plant is native of south-east Asia and turmeric has been used in Asia for centuries for its purported health benefits for many years. Research has shown that turmeric has antibacterial, antiviral, antifungal, antioxidant, and anticancer activities and also has a potential to reduce the risk of various malignant diseases, arthritis, Alzheimer’s disease, and other chronic illnesses including rheumatoid arthritis.

Turmeric contains curcuminoids which make up approximately 1 to 6 wt.% of turmeric by dry weight. Most extracts prepared from turmeric contain three major compounds: curcumin (typically 50 to 95 wt.% of an extract), demethoxycurcumin (typically 4 to 40 wt.% of an extract), and bisdemethoxycurcumin (typically 1 to 25 wt.% of an extract). The combination of these three compounds is referred to as “C3 curcumin”. Most commonly, the extracts prepared from turmeric contain 60 to 85 wt.% curcumin, 10 to 27 wt.% demethoxycurcumin, and 2 to 15 wt.% bisdemethoxycurcumin. Curcumin is the major phenolic extract in turmeric and both curcumin and C3 curcumin are widely studied. It should be noted that in literature, C3 curcumin is often referred to generically as curcumin. In the present application, “curcumin” is used to refer to the specific compounds by chemical name, whilst “C3 curcumin” is used to refer to aforementioned combination of compounds. In embodiments, C3 curcumin comprises greater than 95 wt.% curcuminoids.

Curcumin has been shown to have powerful antioxidant effects, protecting against oxidative stress and stimulating activities of antioxidant enzymes.

In some embodiments of the present invention, C3 curcumin may be in the form of an extract obtained by the extraction of turmeric. Extraction may be performed by any of the methods discussed below. In some embodiments, turmeric may be used as the source of C3 curcumin. In one embodiment, Bioperine® may be used as the source of curcumin and piperine. In embodiments, on a dry weight basis, 0.1 to 20 wt.%, C3 curcumin and/or an extract thereof may be included in the nutraceutical composition. In embodiments, 1 to 15 wt.%, preferably 1 to 10 wt.%, more preferably 1 to 8 wt.%, even more preferably 3 to 6 wt.%, most preferably 4 to 5 wt.% curcumin and/or an extract thereof may be included in the nutraceutical composition.

In embodiments, on a dry weight basis, 1 to 8 wt.%, turmeric may additionally be included in the nutraceutical composition.

C3 curcumin is commercially available, for example from the company Sabinsa (East Windsor, US) in the form of Curcumin C3 Complex®. C3 curcumin is often sold in combination with a form of piperine, as sold by Sabinsa (East Wndsor, US).

It is known from literature that C3 curcumin is not absorbed well into the body. The combination of C3 curcumin and black pepper extract has been to especially improve the bioavailability of the C3 curcumin upon ingestion by improving absorption of curcumin. Therefore, the combination of C3 curcumin and black pepper extract and/or piperine is preferred. A particularly suitable weight ratio of C3 curcumin to black pepper extract and/or piperine for use in the composition of the present invention is from 90:10 to 99:1, for example 95:5. Alternatively, provision of the composition as a liposomal formulation, discussed in more detail below, can also be an effective means for increasing the bioavailability of C3 curcumin, and is therefore preferred.

Vitamin C

Vitamin C, also known as ascorbic acid and ascorbate, is a vitamin found in various foods including citrus fruits, kiwifruit, guava, broccoli, Brussels sprouts, bell peppers and strawberries.

Vitamin C has numerous benefits and has been extensively researched. For example, it is a powerful antioxidant, is involved in the repair of tissue and the enzymatic production of certain neurotransmitters, is required for the functioning of several enzymes and is important for immune system function. A correlation between the intake of Vitamin C and the functioning of a normal immune system has been observed by The European Food Safety Authority. There is also evidence that regular administration of Vitamin C may reduce the duration of viral infections. Vitamin C distributes readily in high concentrations into immune cells, has antimicrobial and natural killer cell activities, promotes lymphocyte proliferation, and is consumed quickly during infections. These effects indicate that it plays a prominent role in immune system regulation. Recently, Vitamin C has been researched as a treatment for COVID-19, with preliminary results suggesting that this resulted in reduced duration and severity of symptoms.

Vitamin C is included on the World Health Organization's List of Essential Medicines, which contains the medications considered to be the safest and most effective which meet the most important needs of a health system. The recommended Vitamin C intake by adults is currently 45 mg/day or 300 mg/week by the World Health Organization, 90 mg/day (males) and 75 mg/day (females) by United States National Academy of Sciences and 110 mg/day (males) and 95 mg/day (females) by European Food Safety Authority. In embodiments, 20 to 90 wt.%, preferably 30 to 85 wt.%, more preferably 40 to 80 wt.%, even more preferably 50 to 70 wt.%, most preferably 55 to 65 wt.% Vitamin C and/or an extract thereof may be included in the nutraceutical composition.

Vitamin C is widely available as an inexpensive over-the-counter nutrient.

Grape Seed

Grape seeds obtained from grapes ( Vitis vinifera, Vitis labrusca and Vitis rotundifolia) are known to contain many phenolic compounds. These include flavonoids and polyphenols, which are known to be antioxidants. Grape seed oil, obtained by extracting grape seeds as discussed in detail below, has been shown to possess potent cardioprotective, hepatoprotective, antidiabetic, anti-mutagenic, anti-inflammatory, chemopreventive and anticancer properties. These effects may, at least in part, be due to the free-radical scavenging ability of these antioxidants. The total phenol content may be linked to the antioxidant effect and can be measured using the Folin-Ciocalteu reaction. Results are typically expressed as gallic acid equivalents (GAE).

Proanthocyanidins are the principal polyphenols in grape seeds, and can be considered to be polymeric flavanols. The basic structural building blocks of flavanols are the 2- phenyl-3, 4-dihydro-2/-/-chromen-3-ol skeleton, which are linked together by C-C bonds to form proanthocyanidins. Proanthocyanidins are typically formed from various combinations of three flavanol monomer units: catechin, epicatechin and epicatechin 3- O-gallate (also known as epigallocatechin), which include additional hydroxyl moieties, with epicatechin 3-O-gallate also containing a gallate moiety.

In some embodiments, the grape seed, or an extract thereof, of the nutraceutical composition of the present invention comprises or consists essentially of at least one proanthocyanidin. In further embodiments, the proanthocyanidin comprises catechin and/or epicatechin and/or epicatechin 3-O-gallate.

In embodiments, 0.05 to 10 wt.%, preferably 0.1 to 6 wt.%, more preferably 0.2 to 4 wt.%, even more preferably 0.5 to 2 wt.%, most preferably 1 to 1.5 wt.% grape seed, or an extract thereof, may be included in the nutraceutical composition, on a dry weight basis.

Grape seed extract is available commercially, for example Grape Seed Extract capsules by Naravis® (Winter Springs, US) which contains 95 % proanthocyanidins and Grape Seed Extract powder by Bulk Powders™ (Colchester, UK). Boswellia

Boswellia is a genus of trees known for its fragrant resin. Boswellia species are moderate-sized flowering plants native to tropical regions of Africa and Asia. The four main species of Boswellia are Boswellia sacra (also known as Boswellia carterii and Boswellia bhaw-dajiana ), Boswellia irereana, Boswellia papyrifera, and Boswellia serrata. Traditional frankincense is obtained from the resin of Boswellia serrata.

Preferably, the resin, or an extract thereof, of Boswellia used in the present invention is obtained from Boswellia sarrata and Boswellia carterii , more preferably Boswellia carterii. Boswellia resin, and extracts thereof, is used in many religious and cultural ceremonies and in traditional medicines for the treatment of many diseases, including arthritis ringworm and fevers (antipyretic). In modern medicine, it is believed to act as an antiarthritic, anti-inflammatory, antihyperlipidemic, antiatherosclerotic, analgesic and hepatoprotective.

Boswellia resin comprises monoterpenes, diterpenes, triterpenes, tetracyclic triterpenic acids and four major pentacyclic triterpenic acids (also known as boswellic acids). The four main pentacyclic acids are b-boswellic acid, acetyl- -boswellic acid, H-keto-b- boswellic acid and acetyl-11-keto^-boswellic acid and are responsible for inhibition of pro-inflammatory enzymes. Out of these four boswellic acids, acetyl-11-keto^-boswellic acid is the most potent inhibitor of 5-lipoxygenase, an enzyme responsible for inflammation. In addition, and in contrast to non-steroidal anti-inflammatory drugs, these pentacyclic acids have been shown to significantly reduce glycosaminoglycan degradation

In some embodiments, the Boswellia resin, or an extract thereof, of the nutraceutical composition of the present invention comprises or consists essentially of at least one pentacyclic acids. In further embodiments, the Boswellia resin, or an extract thereof, comprises b-boswellic acid, acetyl^-boswellic acid, 11-keto^-boswellic acid and/or acetyl-11-keto^-boswellic acid.

In embodiments, 0.1 to 25 wt.%, preferably 0.5 to 20 wt.%, more preferably 1 to 15 wt.%, even more preferably 3 to 12 wt.%, most preferably 5 to 10 wt.% Boswellia resin, or an extract thereof, may be included in the nutraceutical composition, on a dry weight basis.

Boswellia resin, or an extract thereof is available commercially, for example Boswellia Resin by Viridian™ (Daventry, UK) and Boswellia Resin Extract by Solgar® (Leonia, US). Quercetin

Quercetin, a flavonoid, is a natural pigment present in many fruits, vegetables, and grains and acts as an antioxidant. Thus, it is believed to help reduce inflammation, allergy symptoms and blood pressure. Quercetin has also demonstrated antiviral properties, for example in the treatment of influenza A, Ebola and Zika. In embodiments, 0.1 to 10 wt.%, preferably 0.3 to 8 wt.%, more preferably 0.5 to 5 wt.%, even more preferably 0.8 to 3 wt.%, most preferably 1 to 2 wt.% quercetin, may be included in the nutraceutical composition, on a dry weight basis.

Quercetin is widely available commercially.

Soirulina Spirulina is a biomass of cyanobacteria (blue-green algae) that can be consumed by humans and animals. The three species are Arthrospira platensis , Arthrospira fusiformis , and Arthrospira maxima.

Spirulina is a nutrient rich dietary supplement and is a rich source of essential nutrients, particularly protein, B vitamins (thiamin, riboflavin, and niacin), and dietary minerals, such as iron and manganese. Spirulina has been studied as a potential nutritsonai supplement for adults and children affected by HIV.

In embodiments, 5 to 20 wt.%, preferably 10 to 20 wt. %, more preferably 12 to 18 wt.%, even more preferably 14 to 16 wt.%, for example 15 wt.%, spirulina, or an extract thereof, may be included in the nutraceutical composition, on a dry weight basis.

In embodiments the w/w ratio of spirulina, or an extract thereof to chlorella, or an extract thereof in the composition may be from 1 :2 to 2:1, more preferably from 1 :1.5 to 1.5:1, even more preferably from 1:1.2 to 1.2:1 , for example 1 :1.

Coenzyme Q10

Coenzyme Q10, also known as ubiquinone, is a coenzyme family that is ubiquitous in animals and most bacteria. Coenzyme Q10 is an essential component of the electron transport chain as well as acting as a free-radical-scavenging antioxidant.

Coenzyme Q10 has been investigated for use in the treatment of heart disease, migraine headaches, statin myopathy, cancer, dental disease, chronic kidney disease, Alzheimer's disease, high cholesterol and amyotrophic lateral sclerosis. In embodiments, 0.1 to 20 wt.%, coenzyme Q10, may be included in the nutraceutical composition, on a dry weight basis. In embodiments, 0.1 to 10 wt.%, preferably 1 to 8 wt.%, more preferably 2 to 5 wt.%, even more preferably 3.5 to 4.5 wt.%, coenzyme Q10, may be included in the nutraceutical composition, on a dry weight basis.

Chlorella

Chlorella is a genus of single-celled green algae. Their chloroplasts contain the green photosynthetic pigments chlorophyll-a and -b.

Chlorella has been used as an inexpensive protein supplement to the human diet and has been investigated for its health benefits, such as weight control, cancer prevention, and immune system support.

In embodiments, 5 to 20 wt.%, preferably 10 to 20 wt. %, more preferably 12 to 18 wt.%, even more preferably 14 to 16 wt.%, for example 15 wt.%, chlorella, or an extract thereof, may be included in the nutraceutical composition, on a dry weight basis.

In embodiments the w/w ratio of chlorella, or an extract thereof to spirulina, or an extract thereof in the composition may be from 1 :2 to 2:1, more preferably from 1 :1.5 to 1.5:1, even more preferably from 1:1.2 to 1.2:1 , for example 1 :1.

Morinqa Leaf

Moringa leaf, is the leaf of the plant Moringa oleifera, which is a small native tree of the sub-Himalayan regions of North West India. The other terms used for Moringa are Horseradish tree, Mulangay, Mlonge, Benzolive, Drumstick tree, Sajna, Kelor, Saijihan and Marango. All plant parts of Moringa oleifera are traditionally used for different purposes, but leaves are generally the most used.

Several bioactive compounds have been recognized in the leaves of Moringa oleifera and extracts therefrom. They can be grouped as vitamins, carotenoids, polyphenol, phenolic acids, flavonoids, alkaloids, glucosinolates, isothiocyanates, tannins, saponins and oxalates and phytates. In particular, moringa leaf and moringa leaf extract have been found to contain uncommon sugar-modified glucosinolates compounds containing sugar and ramose.

Compounds found in moringa leaf and extracts of moringa leaf that are considered to contribute towards anti-cancer properties, in addition to other effects, include 4-(a-L- rhamnosyloxyjbenzyl isothiocyanate, niazimicin, glycerol-1 -(9-octadecanoate), 3-0-(6'-0- oleoyl-beta-D-glucopyranosyl), b-sitosterol and -sitosterol-3-0- -D-glucopyranoside. These have been reported to be anti-tumour and/or anti-cancer promoters. In particular, 4-(a-L-rhamnosyloxy)benzyl isothiocyanate, niazimicin and -sitosterol-3-0- -D- glucopyranoside have demonstrated strong anti-tumour properties.

4-(a-L-rhamnosyloxy)-benzyl glucosinolate (glucomoringin, also named 4-0-(a-L- rhamnopyranosyloxy)-benzyl glucosinolate), which is metabolised to 4-(a-L- rhamnosyloxy)benzyl isothiocyanate by the myrosinase enzymes in a similar fashion to that described for the glycosinolates in broccoli sprout and broccoli sprout extracts, has been reported to be the dominant alkaloid in moringa leaf and moringa leaf extracts. In embodiments, the moringa leaf, or extract thereof, comprises or consists essentially of 4-(a-L-rhamnosyloxy) benzyl isothiocyanate, niazimicin and/or -sitosterol-3-0- -D- glucopyranoside, or a precursor thereof.

In embodiments, 5 to 50 wt.%, preferably 10 to 40 wt.%, more preferably 17 to 25 wt.%, even more preferably 19 to 24 wt.%, most preferably 20 to 23 wt.% moringa leaf, or an extract thereof, may be included in the nutraceutical composition, on a dry weight basis.

Moringa leaf is commercially available, for instance from Rambam-Medicine (Israel), from Health Solution Prime (US) in the form of capsules.

Astaxanthin

Astaxanthin is a keto-carotenoid. Like many carotenoids, astaxanthin is a lipid-soluble pigment. It has a red colour due to the extended chain of conjugated double bonds at the centre of the compound. This chain of conjugated double bonds is responsible for the antioxidant function of astaxanthin.

Astaxanthin is produced naturally in the freshwater microalgae Haematococcus pluvialis and the yeast fungus Xanthophyllomyces dendrorhous (also known as Phaffia). Aquatic animals that feed on the algae, such as salmon, red trout, red sea bream, and crustaceans subsequently reflect a natural red astaxanthin pigmentation to various degrees.

Astaxanthin has been investigated for use in treating Alzheimer's disease, Parkinson's disease, stroke, high cholesterol, liver diseases, age-related macular degeneration, and preventing cancer. Also, astaxanthin is believed to prevent sunburn, to improve sleep, and ameliorate carpal tunnel syndrome, dyspepsia, male infertility, symptoms of menopause, and rheumatoid arthritis. In embodiments, 0.01 to 10 wt.%, preferably 0.01 to 5 wt.%, astaxanthin, may be included in the nutraceutical composition, on a dry weight basis.

In embodiments, _0.01 to 1 wt.%, preferably 0.05 to 0.5 wt.%, more preferably 0.15 to 0.4 wt.%, even more preferably 0.2 to 0.3 wt.%, astaxanthin, may be included in the nutraceutical composition, on a dry weight basis.

Other Ingredients

The composition may comprise further optional additional ingredients. These include any combination of one or more antioxidants, antifungals, antivirals, antidepressants and anti-inflammatories. Compounds falling under these categories would be known to the skilled person.

In embodiments, the composition comprises one or more of Vitamin D3, Vitamin K2, a zinc-containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate. The composition may additionally or alternatively include broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof, ginger, or an extract thereof, and/or bitter melon, or an extract thereof, and/or cucumber, or an extract thereof. Preferably, the composition also comprises quercetin.

Preferably the zinc-containing compound is zinc gluconate, or zinc picolinate. Astragalus, or an extract thereof, and/or one or more astragaloside is Astragalus root, or an extract thereof, and/or one or more astragaloside, the selenium-containing compound is L-selenium methionine and/or Vitamin B12 comprises methylcobalamin.

In embodiments, the composition may comprise one or more of these ingredients in the following amounts: 0.0005 to 1.0 wt.% Vitamin D3; 0.0001 to 0.2 wt.% Vitamin K2; 0.05 to 5.0 wt.% zinc-containing compound; 1.0 to 7.0 wt.% Astragalus, or an extract thereof, and/or one or more astragaloside; 0.0001 to 0.2 wt.% selenium-containing compound; 0.0001 to 0.2 wt.% Vitamin B12; 0.001 to 0.2 wt.% Vitamin A acetate; 0.5 to 5.0 wt.% glutathione; 0.5 to 5.0 wt.% potassium sorbate; 2.5 to 8.5 wt.% broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof; 1.5 to 5 wt.% ginger, or an extract thereof; and/or 8 to 25 wt.% bitter melon, or an extract thereof, and/or cucumber, or an extract thereof. Preferably the composition also comprises 0.5 to 5.0 wt.% quercetin. In embodiments, the composition may comprise one or more of these ingredients in the following amounts: 0.01 to 5 wt.% reishi, or an extract thereof, 0.1 to 10 wt.% ginger, 0.5 to 10 wt.% dandelion, 5 to 20 wt. % scouring rush or 5 to 15 wt.% greater nettle.

Preferably, the composition comprises C3 Curcumin, Vitamin C, grape seed, or an extract thereof, Boswellia resin, or an extract thereof, quercetin, Vitamin D3, Vitamin K2, zinc gluconate, Astragalus root, or an extract thereof, and/or one or more astragaloside, L-selenium methionine, Vitamin B12 comprising methylcobalamin, Vitamin A acetate, glutathione, and potassium sorbate. In embodiments, the composition may further comprise any combination of moringa leaf, or an extract thereof, black pepper, or an extract thereof, green tea leaf, or an extract thereof, pomegranate seed or an extract thereof, tomato or an extract thereof, cinnamon, pumpkin seed or an extract thereof, omega 5, magnesium oxide, calcium carbonate, omega 3, vitamin E, vitamin Bi, vitamin B₃, vitamin B₆, blueberry or an extract thereof, saffron or an extract thereof, beet or an extract thereof, kale or an extract thereof, asparagus or an extract thereof, mannitol, clove or an extract thereof, wheatgrass or a juice or extract thereof, iodine, biotin, caffeine, serrapeptase, melatonin, centella asiatica or an extract thereof, silica, oat ( Avena Sativa) or an extract thereof, sweet wormwood ( Artemisia annua) or an artemisinin-containing derivative thereof, desert wormwood ( Artemisia herba-alba) or an artemisinin-containing derivative thereof, selenium, saw palmetto or an extract thereof, skullcap ( Scutellaria Baicalensis) root or an extract thereof, horsetail or an extract thereof, acerola cherry or an extract thereof, acai berry or an extract thereof, and/or turkey tail mushroom or an extract thereof. Each of these optional ingredients may be present in an amount of from 0 to 5 wt.% of the composition on a dry weight basis. In embodiments, each of these optional ingredients is present in an intended single dosage volume of the composition in an amount of from 0 to 200 % of the reference daily intake (RDI) for that ingredient. Without being bound by theory, ingredients with antioxidant properties are believed to promote immune system health, increase white blood cells count and may kill virus- infected cells. Thus, the inclusion of these ingredients in a composition for treating viral infections and immunodeficiency disorders is preferred. Physical Form of the Components

The components of the nutraceutical composition may be in any physical form, provided that the component may be provided in an admixture suitable for human consumption. For example, each component may be in the form of processed plant material, juice obtained from the plant material or an oil obtained from the plant material or any combination of these. “Processed plant material” referred to herein is intended to refer to plant material that has undergone treatment so as to be fit for human consumption and suitable for incorporating into an admixture of the components to form the composition. Such processing may include washing, blending, liquidising, air drying, oven drying, microwave drying, lyophilising, powdering, grinding, ball milling, and extracting the plant material.

An extract used as a component of the composition, which is obtained by extracting the relevant plant material, may be in the form of an oil, a powder, an alcoholic extract with or without the alcohol removed, an aqueous extract with or without the water removed or other form of extract with or without the solvent removed. If non-edible solvents are used, these must be removed before use or be present at levels safe for human consumption. An extract in the form of an oil or powder may originate from an extract obtained using an extraction solvent with the extraction solvent subsequently removed, and optionally with any solvents extracted from the plant material during extraction also removed.

The amounts of each ingredient in the composition are described on a dry weight basis. This means that no solvent has been added to the ingredient when determining the mass. If the ingredient is naturally a liquid e.g. a juice, this means that no additional solvent has been added and the mass is the mass of the ingredient in its natural form. If the ingredient is an extract, the dry weight mass of the ingredient refers to the mass once the extraction solvent has been removed.

The above only applies when determining the amount of the ingredient present in the formulation on a dry weight basis and is not intended to limit the form in which the ingredient is added to the composition. For example, the ingredient may be incorporated into the composition in another form (e.g. including extraction solvent).

Powder

All, a selection of, or one of any of the components of the composition may be in the form of a powder. The powder of one or more of these ingredients may be formed by any method available in the art, such as by air-drying, oven-drying, microwave-drying or freeze-drying (lyophilisation) the plant matter and optionally grinding to obtain a powder. Grinding may be performed using conventional apparatus, such as a mortar and pestle or an electric mill.

Alternatively, the powder may be formed by first extracting the plant matter followed by removing the solvent(s) used for extraction and optionally any solvent(s) removed from the plant matter during extraction and optionally grinding the resultant solid so as to form a powder.

Powders are typically stable during storage, easy to transport, easy to combine and easy to administer to a subject. For these reasons, it is preferred that the components are in powder form and it is particularly preferred that the nutraceutical composition is a powder. Such a powder may then be incorporated into a food product and/or a beverage, in addition to other optional components, and ingested.

Nanoparticles

In embodiments, all, a selection of, or one of any of the components of the compositions disclosed herein, including C3 curcumin, Vitamin C; Boswellia resin, or an extract thereof, grape seed, or an extract thereof, quercetin, Vitamin D3, Vitamin K2; a zinc- containing compound; Astragalus, or an extract thereof, astragaloside; a selenium- containing compound; Vitamin B12; Vitamin A acetate; glutathione; potassium sorbate. broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, Brussels spout, or an extract thereof; ginger, or an extract thereof; bitter melon, or an extract thereof, cucumber, or an extract thereof, spirulina or an extract thereof, co enzyme Q10, chlorella, or an extract thereof, reishi, or an extract thereof, dandelion, or an extract thereof, scouring rush, or an extract thereof, greater nettle, or an extract thereof, moringa leaf, or an extract thereof, Chinese milk-vetch, or an extract thereof, and/or astaxanthin may be present in the form of nanoparticles. Nanoparticles are typically defined as particles of matter having an average particle size diameter of from 1 to 100 nanometres (nm). However, the composition of the present invention is not necessarily limited in these embodiments to requiring an average particle size diameter of from 1 to 100 nm and such compositions may comprise larger particles, as discussed below, in addition to nanoparticles.

In embodiments, all, a selection of, or one of any of the components of the composition, including C3 curcumin, Vitamin C; Boswellia resin, or an extract thereof, grape seed, or an extract thereof, quercetin, Vitamin D3, Vitamin K2; a zinc-containing compound; Astragalus, or an extract thereof, astragaloside; a selenium-containing compound; Vitamin B12; Vitamin A acetate; glutathione; potassium sorbate. broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, Brussels spout, or an extract thereof; ginger, or an extract thereof; bitter melon, or an extract thereof, cucumber, or an extract thereof, spirulina or an extract thereof, co-enzyme Q10, chlorella, or an extract thereof, reishi, or an extract thereof, dandelion, or an extract thereof, scouring rush, or an extract thereof, greater nettle, or an extract thereof, moringa leaf, or an extract thereof, Chinese milk-vetch, or an extract thereof, and/or astaxanthin, may be in the form of particulate having an average diameter size of less than 10,000 nm, preferably of less than 1,000 nm, more preferably of less than 500 nm, most preferably of less than 100 nm. In other embodiments, the composition may be in the form of particulate having an average diameter size from 10 to 10,000 nm, preferably from 10 to 1 ,000 nm, more preferably fromlOO to 1 ,000 nm, most preferably from 100 to 500 nm.

As will be appreciated, the particle size distribution (PSD) of one or more of the above discussed ingredients may not be uniform. The particle size distribution may be unimodal or multimodal, preferably unimodal. Without being limited to a particular theory, it would be appreciated that methods of nanoparticle formation known in the art would produce a Gaussian PSD as evidenced by Nirmalya B. et al, J. Phys. Chem. C 2016, 120, 8, 4612- 4622 and Gao C. et al, Nanoscale, 2012, 4, 9, 2875-2878. Measuring the PSD of nanoparticles may be achieved by methods known in the art, such as those disclosed in Caputo F. etal, J Control Release, 2019, 299, 10, 31-43. In embodiments, all, a selection of, or one of any of the components of the composition, including C3 curcumin, Vitamin C; Boswellia resin, or an extract thereof, grape seed, or an extract thereof, quercetin, Vitamin D3, Vitamin K2; a zinc-containing compound; Astragalus, or an extract thereof, astragaloside; a selenium-containing compound; Vitamin B12; Vitamin A acetate; glutathione; potassium sorbate. broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, Brussels spout, or an extract thereof; ginger, or an extract thereof; bitter melon, or an extract thereof, cucumber, or an extract thereof, spirulina or an extract thereof, co-enzyme Q10, chlorella, or an extract thereof, reishi, or an extract thereof, dandelion, or an extract thereof, scouring rush, or an extract thereof, greater nettle, or an extract thereof, moringa leaf, or an extract thereof, Chinese milk-vetch, or an extract thereof, and/or astaxanthin, may be in the form of particulate wherein at least 10 %, or at least 25 %, of the particles have an average particle size diameter of from 1 to 10,000 nm, preferably wherein at least 10 %, or at least 25 %, of the particles have an average particle size diameter of from 10 to 1 ,000 nm, more preferably wherein at least 10 %, or at least 25 %, of the particles have an average particle size diameter of from 100 to 1,000 nm, most preferably wherein at least 10 %, or at least 25 %, of the particles have an average particle size diameter of from 100 to 500 nm.

The nanoparticles and/or larger particles of one or more of these ingredients may be formed by any method available in the art, such as grinding, ball milling, or by disintegration mechanically in combination with chemical oxidation or enzymatic treatment to promote breakup or hydrolysis using acid. Known methods of forming fine particles from biomass are described in Mayer-Laigle, C et al., Bioengineering, 2018, 5(3), 50 and Dufresne, A et al., Mater. Today, 2013, 16, 6, 220-227.

Alternatively, the nanoparticle and/or larger particle may be formed by first extracting the plant matter followed by removing the solvent(s) used for extraction and optionally any solvent(s) removed from the plant matter during extraction and grinding or ball milling the resultant solid so as to form particles of the desired average diameter.

Provision of any of the nutraceutical components as nanoparticles may allow for increased permeation of the particles through phospholipid bilayers. This may advantageously allow for active ingredients to enter into cells prior to absorption by the digestive system. A proposed mechanism of nanoparticle entry directly into cells via the phospholipid bilayer is discussed in Contini, C et al., J. Exp. Nanosci, 2018, 13, 1 , 62-81. Absorption of the nutraceutical component directly into cells, bypassing the digestive system allows the body to quickly and efficiently use the active ingredients, and may reduce any side effects of the nutraceutical component. Collagen is often used as a drug delivery system, allowing for absorption of active ingredients such as small molecule drugs through the skin. Embodiments comprising nanoparticles advantageously allow for active ingredients to be absorbed through the skin, either in combination with, or in the absence of collagen. Extraction

Fresh or dried samples may be used for extraction, however dried samples are preferred due to the typically long transport times between picking and extraction. The dried sample is preferably a powder, which may be formed as described above, as for efficient extraction, the solvent must make contact with the target compounds. A particle size smaller than 0.5 mm is preferred for efficient extraction, with a particularly preferred particle size range of from 0.5 to 1000 nm.

Extraction of the plant matter to form an extract may be performed by numerous methods, the selection of which depends upon the compounds to be extracted. These include sonification, heating under reflux, soxhlet extraction or maceration or percolation of fresh green plants or dried powdered plant material in water and/or organic solvent systems. Other extraction techniques include solid-phase micro-extraction, supercritical- fluid extraction, pressurized-liquid extraction, microwave-assisted extraction, solid-phase extraction, and surfactant-mediated techniques, which are beneficial as they may reduce organic solvent consumption and sample degradation, eliminate additional sample clean up and concentration steps and improve extraction efficiency, selectivity, and kinetics of extraction. However, these methods may require more sophisticated and/or expensive equipment to perform.

Extraction of plant matter may be performed using any solvent, including water, methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride or supercritical carbon dioxide. The selection of solvent system largely depends on the specific nature of the compound in the plant matter being targeted. Different solvent systems are available to extract the compound from natural products. The extraction of hydrophilic compounds preferably uses polar solvents such as methanol, ethanol or ethyl-acetate. For extraction of more lipophilic compounds, dichloromethane or a mixture of dichloromethane/methanol in ratio of 1 :1 is preferably used. In some instances, extraction may be performed using hexane.

Commonly, methanol, ethanol or a mixture of an alcohol and water is used for soxhlet extraction or extraction by sonification or maceration.

Extracts obtained from this extraction may contain a complex mixture of many plant metabolites. Further isolation of compounds may be performed in order to separate individual compounds or classes of compounds by further chemical extraction, chromatography or other methods known to the skilled person.

Further details on extraction methods may be found in N. Azwanida, A Review of the Extraction Methods Use in Medicinal Plants, Principle, Strength and Limitation , Med. Aromat. Plants, 2015, 4(3).

In embodiments, one or more of the components are extracts of the relevant plant material, with preferably all of the components being extracts of the relevant plant material. In more preferred embodiments, these extracts are powders. In one embodiment, the method includes a step of extracting the fruit, vegetable, leaf, seed, resin or other plant material to form the desired extract or extracts prior to combining the components. In embodiments, the method may include the step of extracting the relevant plant materials to obtain C3 curcumin, grape seed extract and Boswellia resin extract. Vitamin C may be obtained by extracting the relevant plant materials and/or through synthetic pathways. The method may further include the step of extracting the relevant plant materials to obtain quercetin and/or Astragalus root extract. Other components may be obtained by extracting the relevant plant materials and/or through synthetic pathways

Glyceride Oil and Fat

The composition may comprise, or be provided in combination with, a glyceride oil and/or fat prior to consumption. Without being bound by any particular theory, the inclusion of a glyceride oil and/or fat in the composition, or ingesting glyceride oil or fat alongside the composition, may aid in the absorption of at least some of the active compounds in the composition and may aid in their transmission into the bloodstream and into the different organs of the body.

In particular, the combination of C3 curcumin and a glyceride oil and/or fat is known to result in beneficial absorption of the C3 curcumin and improve bioavailability. In particular, flaxseed oil is preferred for this purpose. The combination of C3 curcumin, Bioperine (the trade name for an extract obtained from black pepper and which contains 95 % piperine) and flaxseed oil is known to be particularly beneficial in improving the bioavailability of C3 curcumin. This is commercially available in the form of tablets, capsules or caplets. For example, Physician Naturals Mega Potency Super C3 Curcum with Flax Seed Oil & Bioperine® containing 1000 mg C3 curcumin, 100 mg flaxseed oil and 5 mg Bioperine.

In one embodiment, the composition is consumed with a glyceride oil and/or a fat. This may be achieved by combining the composition with a glyceride oil and/or fat prior to consumption or by consuming the composition followed by the glyceride oil and/or fat, or vice versa. The interval between consumption of the composition and the glyceride oil and/or fat is not particularly limited, but may be from 1 to 15 minutes, preferably from 1 to 10 minutes and more preferably from 1 to 5 minutes and most preferably from 1 to 2 minutes.

In one embodiment, the glyceride oil and/or a fat is combined with the composition, to form a mixture, following which it may be consumed. The glyceride oil and/or fat may be present in any amount in the mixture. In embodiments, the weight ratio of the composition to the glyceride oil and/or fat is from 1 :30 to 30:1. In other embodiments, 0.1 to 10 wt.%, preferably 1 to 8 wt.%, more preferably 1 to 4 wt.%, even more preferably 1 to 3 wt.%, most preferably 2 to 3 wt.% glyceride oil and/or fat may be included in the nutraceutical composition.

The term “fat” generally designates a solid at room temperature (i.e. at 20 °C) and “oil” a liquid. Most fats and glyceride oils consist of triglycerides, esters of glycerol and free fatty acids, with different triglycerides differing in their fatty acid compositions. Other constituents which may be present in fats and glyceride oils (generally less than 3 wt.%) are an unsaponifiable fraction and a number of acyl lipids such as free fatty acids and monoglycerides and diglycerides, formed from only one or two fatty acid molecules. Preferably the glyceride oil is a triglyceride oil. Preferably the fat is a triglyceride. The glyceride oil and/or fat may be present in order to aid with administration of the composition, for instance by providing a medium to combine the components or to dissolve some or all of the components. Alternatively or additionally, the glyceride oil and/or fat may impart additional properties to the composition. For instance, the glyceride oil and/or fat may improve pharmacokinetics of the composition, aid in absorption of one or more of the active ingredients and/or improve the bioavailability of one or more of the components by other means.

In some embodiments, the glyceride oil and/or fat acts as a solvent or medium for combining the other components. In one embodiment, the final composition is an oil, which may include a glyceride oil and/or a fat.

The glyceride oil and/or fat may be any edible glyceride oil and/or fat. The glyceride oil and/or fat comprises glycerides (mono-, di- and/or tri-glycerides) as the major component and may be a natural glyceride oil and/or fat selected from one or more of a vegetable oil, an animal oil, a marine oil, a mineral oil, a vegetable fat or an animal fat, or may be a synthetic oil. Natural oils or fats may be extracted from natural sources, and typically, it is necessary for natural oils or fats to undergo refining before their use, which can vary depending on the particular oil or fat and the associated level and nature of any contamination following extraction.

Vegetable oils include all plant, nut and seed oils. Examples of suitable vegetable oils which may be of use in the present invention include: agai oil, almond oil, beech oil, brazil nut oil, canola oil, cashew oil, coconut oil, colza oil, corn oil, cottonseed oil, flaxseed oil, grapefruit seed oil, grape seed oil, hazelnut oil, hemp oil, lemon oil, macadamia oil, mustard oil, olive oil, orange oil, palm oil, peanut oil, pecan oil, pine nut oil, pistachio oil, poppyseed oil, pumpkinseed oil, rapeseed oil, rice bran oil, safflower oil, sesame oil, soybean oil, sunflower oil, walnut oil and wheat germ oil.

Suitable marine oils include oils derived from the tissues of oily fish or crustaceans (e.g. krill), such as fish oil, which includes cod liver oil, shark liver oil. Examples of suitable animal fats include duck fat, goose fat, pig fat (lard), tallow, suet, dripping and butter.

In embodiments, the glyceride oil and/or fat is flaxseed oil and/or fish oil. More preferably, the glyceride oil and/or fat is flaxseed oil.

In preferred embodiments in which the composition is administered as a liposomal formulation (in which the composition is combined with a liposome-based vehicle), as discussed further below, the oil is preferably a vegetable oil, more preferably comprising sunflower oil.

The composition may comprise, on a dry weight basis, 3 to 20 g of the composition and 0.5 to 10 g of glyceride oil and/or fat. In one embodiment, 3 to 20 g of the composition is combined with 0.5 to 10 g of glyceride oil and/or fat in order to form a mixture which may then be consumed. In embodiments, the weight ratio of the composition to the glyceride oil and/or fat is from 1:30 to 30:1.

Reference herein to a mass of a composition / mass of the formulation refers to the combined mass of C3 curcumin, Vitamin C, grape seed, or an extract thereof and Boswellia resin, or an extract thereof, only. Additional optional ingredients that are present may thus increase the actual mass of the composition, particularly if the composition is formulated with solid or liquid diluents (e.g. water solvent of glyceride oil and/or fat), for example.

Combination

As discussed above, each of the ingredients of the composition of the present invention has demonstrated various health benefits, in particular in improving the immune system. It has been found however that the composition of the present invention is much more effective than the additive contribution of each of the individual components, indicating a surprising synergistic interaction between the components that is beyond merely an additive effect. It is therefore believed that the interaction of the particular components of the composition improves at least one of bioavailability, activity or selectivity of the active ingredient of the components of the composition. Providing the multiple ingredients in a single composition also increases convenience and therefore patient compliance.

In one aspect, the composition of the present invention comprises C3 curcumin; Vitamin C; Boswellia resin, or an extract thereof; spirulina, or an extract thereof; and chlorella, or an extract thereof. In preferred embodiments, the composition further comprises one or more of, preferably all of: moringa leaf; quercetin; Vitamin D3; Vitamin K2; one or more zinc-containing compound, preferably zinc picolinate; Astragalus, or an extract thereof, and/or one or more astragaloside; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; and turmeric. More preferably, the composition further comprises astaxanthin. In another aspect, the composition of the present invention comprises coenzyme Q10; spirulina, or an extract thereof; moringa leaf, or an extract thereof; and astaxanthin. In preferred embodiments, the composition may also include one or more of, preferably all of: C3 curcumin, or an extract thereof: ginger, or an extract thereof; chlorella, or an extract thereof; reishi, or an extract thereof; dandelion, or an extract thereof; scouring rush, or an extract thereof; and greater nettle, or an extract thereof.

As will be appreciated, in preferred embodiments of these two aspects, the formulations may both include common ingredients, including those selected from: C3 curcumin; moringa leaf, or an extract thereof; spirulina, or an extract thereof; chlorella, or an extract thereof; and ginger, or an extract thereof. Those ingredients which typically differ between the compositions (i.e. those which are preferably present in one but not both of the compositions according to these two aspects), include: Boswellia resin, or an extract thereof, coenzyme Q10, quercetin; Vitamin D3; Vitamin K2; one or more zinc-containing compound, preferably zinc picolinate; Astragalus, or an extract thereof, astragaloside; a selenium-containing compound; Vitamin B12; turmeric; astaxanthin; reishi, or an extract thereof; dandelion, or an extract thereof; scouring rush, or an extract thereof; and greater nettle, or an extract thereof. These ingredients are believed to be important in optimizing each composition for either the treatment of an acute phase of a disease or the sequelae of a disease, such that both compositions are particularly suitable for use as part of a combination therapy.

In an alternative aspect, the composition of the present invention comprises C3 curcumin, Vitamin C, grape seed, or an extract thereof, and Boswellia resin, or an extract thereof. In preferred embodiments, the composition further comprises quercetin. In embodiments, the composition comprises one or more of Vitamin D3, Vitamin K2, a zinc- containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, a selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate. The composition may additionally or alternatively include broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof, ginger, or an extract thereof, and/or bitter melon, or an extract thereof, and/or cucumber, or an extract thereof.

Preferably, the composition comprises C3 Curcumin, Vitamin C, grape seed, or an extract thereof, Chlorella, or an extract thereof, Spirulina, or an extract thereof, Boswellia resin, or an extract thereof, quercetin, Vitamin D3, Vitamin K2, zinc gluconate, Astragalus root, or an extract thereof, and/or one or more astragaloside, L-selenium methionine, Vitamin B12 comprising methylcobalamin, Vitamin A acetate, glutathione, and potassium sorbate. In one embodiment, the composition comprises bitter melon, or an extract thereof, and no cucumber, or extract thereof. In an alternative embodiment, the composition comprises cucumber, or an extract thereof, and no bitter melon, or an extract thereof. These embodiments may be used in the treatment of all diseases or disorders discussed in this application. In some embodiments, the composition comprises both bitter melon, or an extract thereof, and cucumber, or an extract thereof. In one embodiment the composition comprises broccoli sprouts, or an extract thereof, and/or broccoli seed, or an extract thereof and no Brussel sprouts, or extract thereof. In an alternative embodiment, the composition comprises Brussel sprouts, or an extract thereof, and no broccoli sprouts, or an extract thereof, and/or broccoli seed, or an extract thereof. These embodiments may be used in the treatment of all diseases or disorders discussed herein. In some embodiments, the composition comprises both broccoli sprouts, or an extract thereof, and/or broccoli seed, or an extract thereof and Brussel sprouts, or extract thereof.

In one embodiment the composition comprises coenzyme Q10, spirulina, or an extract thereof, moringa leaf, or an extract thereof; and astaxanthin. In a further embodiment the composition further comprises C3 curcumin, or an extract thereof, ginger, or an extract thereof, chlorella, or an extract thereof, reishi, or an extract thereof, dandelion, or an extract thereof, scouring rush, or an extract thereof, and greater nettle, and/or an extract thereof.

The composition may further comprise any combination of moringa leaf, or an extract thereof, black pepper, or an extract thereof, green tea leaf, or an extract thereof, pomegranate seed or an extract thereof, tomato or an extract thereof, cinnamon, pumpkin seed or an extract thereof, omega 5, magnesium oxide, calcium carbonate, omega 3, vitamin E, vitamin Bi, vitamin B₃, vitamin B₆, blueberry or an extract thereof, saffron or an extract thereof, beet or an extract thereof, kale or an extract thereof, asparagus or an extract thereof, mannitol, clove or an extract thereof, wheatgrass or a juice or extract thereof, iodine, biotin, caffeine, serrapeptase, melatonin, centella asiatica or an extract thereof, silica, oat ( Avena Sativa) or an extract thereof, sweet wormwood ( Artemisia annua) or an artemisinin-containing derivative thereof, desert wormwood ( Artemisia herba-alba) or an artemisinin-containing derivative thereof, selenium, saw palmetto or an extract thereof, skullcap ( Scutellaria Baicalensis) root or an extract thereof, horsetail or an extract thereof, acerola cherry or an extract thereof, acai berry or an extract thereof, and/or turkey tail mushroom or an extract thereof.

In another aspect, the present invention provides a nutraceutical composition comprising a combination of compounds which may be derived from the plant materials/extracts discussed hereinbefore. In one embodiment, this composition comprises at least one curcuminoid, Vitamin C (ascorbic acid and/or ascorbate), at least one proanthocyanidin, at least one pentacyclic triterpenic acid. Preferably, the curcuminoid comprises curcumin, the proanthocyanidin comprises catechin and/or epicatechin and/or epicatechin 3-0- gallate.and the pentacyclic triterpenic acid comprises b-boswellic acid, acetyl- -boswellic acid, 11-keto- -boswellic acid and/or acetyl-11-keto- -boswellic acid.

In a preferred embodiment, the composition comprises curcumin, at least one of catechin and/or epicatechin and/or epicatechin 3-0-gallate, Vitamin C (ascorbic acid and/or ascorbate), and at least one of b-boswellic acid, acetyl^-boswellic acid, H-keto-b- boswellic acid and/or acetyl-11 -keto^-boswellic acid.

It is not required that the source of such compounds are the plant materials/extracts described herein, although this may be the case in preferred embodiments, provided that they are theoretically obtainable from these plant materials/extracts. For instance, such compounds may be synthesised under laboratory conditions and/or obtained from alternative plant materials.

The compositions of the invention may be prepared by combining the components. The components of the nutraceutical compositions may be combined separately in any order or in any combination so as to form the nutraceutical composition.

In embodiments, the composition may be prepared by combining C3 curcumin, Vitamin C, grape seed, or an extract thereof and Boswellia resin, or an extract thereof. Additionally, quercetin may be combined with the above ingredients. Alternatively, or additionally, Vitamin D3, Vitamin K2, a zinc-containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, a selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate may be combined with the above ingredients. Any other ingredients may be combined with the above ingredients as desired. The components of the nutraceutical composition may be combined separately in any order or in combination in any combination so as to form the nutraceutical composition.

In one embodiment, wherein at least one of the components are in the form of an extract, the method includes a step of extracting the fruit, vegetable, leaf, seed, resin or other plant material to form the desired extract or extracts prior to combining the components. In preferred embodiments, the nutraceutical composition is formed by combining C3 curcumin, Vitamin C, grape seed extract, and Boswellia resin extract. Additionally, quercetin may also be combined with the above ingredients. Alternatively, or additionally, Vitamin D3, Vitamin K2, a zinc-containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, a selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate may be combined with the above ingredients. In this instance, the method may include a step of extracting one or more of these components from the relevant plant materials prior to combining them. In embodiments, the method may include the step of extracting the relevant plant materials to obtain C3 curcumin, grape seed extract and Boswellia resin extract. Vitamin C may be obtained by extracting the relevant plant materials and/or through synthetic pathways. The method may further include the step of extracting the relevant plant materials to obtain quercetin and/or Astragalus root extract. In embodiments, a formulation may be formed by combining C3 curcumin, Vitamin C, grape seed, or an extract thereof and Boswellia resin, or an extract thereof with a liquid pharmaceutical vehicle. Additionally, quercetin may be combined with the above ingredients in the formulation. Alternatively, or additionally, Vitamin D3, Vitamin K2, a zinc-containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, a selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate may be combined with the above ingredients in the formulation Any other ingredients may be combined with the above ingredients as desired. In embodiments, the formulation comprises 10 to 20 grams, preferably 12 to 18 grams, more preferably 14 to 18 grams of composition per 100 ml_ of formulation.

Liposome Formulation Liposomes are spherical vesicles having at least one lipid bilayer surrounding an aqueous interior. These can be used to at least partially encapsulate one or more components of the composition prior to administration. Such liposomes may also be referred to as a liposome-based vehicle’. As liposomes are formed under aqueous conditions, a liquid pharmaceutical vehicle which comprises water is combined with the composition described above prior to liposome formation. In embodiments, the composition may be administered as a formulation in which one or more of Vitamin C, grape seed, or an extract thereof and Boswellia resin, or an extract thereof are encapsulated within liposomes. Other ingredients may also be encapsulated within the liposomes; these ingredients may be selected from one or more of quercetin, Vitamin D3, Vitamin K2, a zinc-containing compound, Astragalus, or an extract thereof, and/or one or more astragaloside, a selenium-containing compound, Vitamin B12, Vitamin A acetate, glutathione, and potassium sorbate. Ingredients not included in the liposome may be added to the formulation after liposome formation.

In embodiments, C3 curcumin, Vitamin C and grape seed, or an extract thereof are encapsulated within liposomes, and Boswellia resin, or an extract thereof, is added to the formulation following liposome formation. The formation of liposomes including the composition of the present invention for administration may be performed by any method known in the art, as demonstrated in Akbarzadeh, Abolfazl et al. “Liposome: classification, preparation, and applications”, Nanoscale research letters, 2013, 8(1): 102. In embodiments, one or more of C3 curcumin, Vitamin C, grape seed, or an extract thereof, and Boswellia resin, or an extract thereof, are dissolved or suspended in water and lipids, preferably phospholipids, are added. The mixture is homogenised, for example by mixing, then sonicated to form the desired composition. Other ingredients may also be included inside the liposome and are dissolved or suspended in water with the ingredients listed above prior to sonication.

The advantages of liposomes as a delivery system for the composition according to the present invention include improved and more controlled pharmacokinetics and pharmacodynamics. The administration of the composition in the form of a liposome composition may improve the bioavailability of the composition, or components of the composition, as the composition and/or components thereof may not be absorbed by the body when administered orally or may only be absorbed in small amounts.

Liposomes can also be used to administer large doses of ingredients, whist reducing the toxicity of such a dose. Although the ingredients of the present composition are considered non-toxic, large doses beyond those ordinarily administered may result in side-effects. Such effects may be mitigated by administering these ingredients as a liposomal composition, in which the ingredient is contained within the liposome. In addition, liposomes may reduce, or slow, excretion of the compounds once absorbed into the blood stream, any may be used to slowly release the composition over a period of time, resulting in increased circulation times. This can allow for a more constant level of the composition to be maintained in the body and thus for more effective treatment. Liposomes can also allow compounds to more readily cross the cell wall, which may result in greater intracellular concentrations and activity. This may be particularly beneficial in the treatment of viral infections, such as COVID-19.

Optionally, the liposomal composition may comprise an oil. This may be selected from a glyceride oil, as defined above, preferably a vegetable oil, most preferably sunflower oil.

Administration

Prior to consumption, the composition, the mixture comprising the composition and the glyceride oil and/or fat, or a formulation comprising a liquid pharmaceutical vehicle, optionally comprising a liposome-based vehicle, may be mixed with other edible components in order to produce a food product or beverage containing the composition. Such a food product or beverage may be any food product or beverage, preferably a yoghurt, fruit juice or other water-based drink free-from or containing conventional preservatives. Therefore, in a method of preparing a food product, the components are combined with a yoghurt, fruit juice or an alternative water-based drink.

Fruit juice is a liquid made from the extraction or pressing of the natural liquid contained in fruit and vegetables and may contain additional ingredients. Fruit juice may be selected from one or more of orange juice, apple juice, cranberry juice, tomato juice, mango juice, carrot juice, grape juice and pineapple juice.

Yoghurt is a food product produced by bacterial fermentation of milk. Yoghurt may be natural yoghurt or flavoured yoghurt. Any milk may be used, including milk from cows, water buffalo, goats, ewes, mares, camels and yaks. Preferably cow’s milk is used. Yoghurt may also include dairy free yoghurt which may be made using coconut milk, raw coconut, coconut cream, soy milk, peanut milk, cashew milk, and/or almond milk.

Other water-based drinks include drinks made from concentrate and carbonated drinks.

The composition of the present invention may be administered once per day, twice per day, or 3 or more times per day. Preferably the composition is administered once per day. The composition is preferably administered on an empty stomach, and more preferably, the composition is administered at least half an hour before a meal or two hours after a meal in order to ensure that the person consuming the composition has an empty stomach.

The masses referred to in the doses or dosage regimes for the administration of the nutraceutical composition below refer to the combined mass of C3 curcumin, Vitamin C, grape seed, or an extract thereof, and Boswellia resin, or an extract thereof, only. If additional optional components are present, their masses are additional to the masses defined herein below and are not included within these masses.

The composition of the present invention may be administered at a low dose for improving the immune system, maintaining health and/or preventing disease, whilst it can be administered at a higher dose for treating one or more diseases. In this context, ‘improving’ the immune system refers to strengthening the immune system such that it protects the subject against a pathogenic disease more effectively. This may prevent the individual from exhibiting symptoms of the disease, may make the symptoms milder than they otherwise would have been and/or may reduce the time a subject takes to recover from a disease.

The dosage refers to the amount of composition administered to a subject in one day. In embodiments, the low dose for improving the immune system, maintaining health and/or preventing disease is 2 to 6 g of the composition, preferably from 3 to 5 g of the composition per day. The composition can be administered for as many days as desired, preferably more than 7 days. Preferably, in order to maintain an improved immune system, the composition is taken every day. The dose for treating one or more diseases may be from 2 to 30 g of the composition, preferably from 3 to 20 g of the composition per day, with the specific dose dependent on the condition being treated. In the treatment of chronic fatigue syndrome, immunodeficiency disorders, the dose administered to the subject is dependent on the severity of the symptoms. In embodiments, the composition is administered at a dose of from 3 to 20 g per day, preferably 3 to 10 g per day, more preferably 3 to 5 g per day. The composition is administered as long as necessary in order to overcome the disease. In embodiments, the disease will be managed using the composition and the subject will not be cured of the disease. In these embodiments, the composition should be taken indefinitely in order to manage the disease.

In the treatment of chronic fatigue syndrome, in some embodiments, a high dose of the composition may be taken over the course of a 2 to 6 month period (e.g. 3 months), for example where a dose of 10 to 20 g or 15 to 20 g of the composition is administered per day over that time. Preferably, in such embodiments, the patient is started with a lower dose and built up to the higher dose over the course of 1 to 7 days, with an incremental increase in dose over that time. Also preferably the patient is stepped down from the high dose to a lower dose before the treatment ceases altogether, or a low dose is maintained if necessary to manage the disease. Immunodeficiency disorders result in partial or full impairment of the immune system. Immunodeficiency disorders include both congenital (primary) and acquired (secondary) disorders. Congenital disorders include T and B cell immunodeficiencies, primary antibody deficiencies, immune dysregulation, congenital defects of phagocyte number and/or function, defects in the innate immune system, autoinflammatory disorders and complement system deficiencies. Examples include Wiscott-Aldrich syndrome, severe combined immunodeficiency disease (SCID), DiGeorge syndrome, Ataxia-telangectasia, chronic granulomatous disease, transient hypogammaglobulinemia of infancy, agammaglobulinemia, and selective IgA deficiency. Acquired disorders result from external factors including chronic infections such as HIV (which may develop into AIDs), malnutrition, or medical treatment such as chemotherapy.

Viruses (e.g. human viruses) may be treated using the composition of the present invention, particularly viruses targeting the respiratory system. Examples of such viruses that may be treated in accordance with the present invention include viruses of the following genii: influenza virus (types A, B, C or D), Alphacoronavirus, Betacoronavirus, Enterovirus, Erythrovirus, Mastadenovirus and Orthopneumovirus. A specific example of an Alphacoronavirus that may be treated by the present invention is COVID-19.

In embodiments involving the treatment of a virus, the dose administered to the subject is dependent on the severity of the symptoms. In the present application, these symptoms are divided into three categories: mild symptoms, moderate symptoms and severe symptoms. The symptoms of these three categories are defined according to the NHS and/or the World Health Organisation (WHO) definitions for the disease of interest. In embodiments, the composition or formulation according to the present invention is administered to a subject suffering from mild symptoms at a dose of from 3 to 5 grams per day, to a subject suffering from moderate symptoms at a dose of from 6 to 10 grams per day, and to a subject suffering from severe symptoms at a dose of 12 to 20 grams per day. This may also be referred to as a ‘single’ dose for the treatment of mild symptoms, a ‘double’ dose for the treatment of moderate symptoms, and a ‘quadruple’ dose for the treatment of severe symptoms. Preferably, the composition is administered for 5 to 10 days. The dosage regime is not limited and may be adapted to suit the individual subject.

The novel Alphacoronavirus, COVID-19, has infected millions worldwide in 2020. A study published on Feb 24, 2020 in The Journal of the American Medical Association suggested that COVID-19 appears to get more dangerous with age, which could be related to the weakened immune defence system. Thus, administering the composition according to the present invention acts to strengthen the immune system, aiding in the treatment and recovery rate of patients suffering from COVID-19. A study published on October 23, 2020 in the Journal of Medical Virology suggested that severe or even mild COVID-19 infection can lead to a debilitating and lengthy post viral fatigue known as long COVID. Persistent symptoms of long COVID include fatigue, headaches, shortness of breath, anosmia (loss of smell), muscle weakness, low fever and cognitive dysfunction (brain fog). There is thus a need not only for treatment options able to ameliorate the acute symptoms of COVID-19, but also the symptoms of the long term sequalae.

In embodiments involving the treatment of COVID-19, the symptoms are divided into three categories with the following definitions: mild symptoms, in which the subject experiences respiratory symptoms such as a dry cough, a fever and/or loss of taste or smell; moderate symptoms, in which the subject experiences a persistent cough (coughing a lot for more than an hour, or 3 or more coughing episodes in 24 hours) and/or shortness of breath without physical exertion but without the need for hospitalisation, in addition to the mild symptoms; and severe symptoms, which require hospitalisation, oxygen support and/or a respirator in addition to mild and moderate symptoms. In this embodiment, the composition or formulation comprising the composition is administered to a subject suffering from mild COVID-19 symptoms at a dose of from 3 to 5 grams per day, to a subject suffering from moderate COVID-19 symptoms at a dose of from 6 to 10 grams per day, and to a subject suffering from severe COVID-19 symptoms at a dose of 12 to 20 grams per day.

In embodiments involving the treatment of the sequalae of a disease, a combination of nutraceutical compositions of the invention may be used. For example, a first composition may be more suited to treatment of the acute phase of the disease, and a second composition more suited to the sequalae of the disease, as such the combination of compositions may be administered as is appropriate to the patient’s symptoms. In embodiments wherein the disease is COVID-19, a first composition may be administered during the acute phase where acute symptoms are suffered, and a second composition administered during the sequalae where the symptoms of post viral fatigue are suffered. In preferred embodiments, a combination therapy is provided involving use of a first nutraceutical composition for the acute phase of the disease, comprising:

C3 curcumin;

Vitamin C; grape seed, or an extract thereof; and Boswellia resin, or an extract thereof; or, a first nutraceutical composition comprising

C3 curcumin; Vitamin C;

Chlorella, or an extract thereof,

Spirulina, or an extract thereof; and Boswellia resin, or an extract thereof; together with a second composition for the sequalae of the disease, comprising: coenzyme Q10; spirulina, or an extract thereof, moringa leaf, or an extract thereof; and astaxanthin.

The dosage described above is the dosage per day. If the composition is consumed once per day, the entire dosage is consumed. If the composition is consumed twice per day, the dosage is divided in half and one half is consumed in the first administration and the other half is consumed in the second administration.

The composition is intended for oral administration, however administration via other pathways is also envisaged.

The composition can be provided as a tablet, aqueous or oil suspension, dispersible powder or granule, emulsion, in the form of a liposomal composition (as described hereinbefore), hard or soft capsule, syrup, elixir, or beverage. These compositions can be prepared according to any method known in the art for the manufacture of pharmaceutically acceptable compositions and such compositions may contain one or more of the following agents: sweeteners, flavouring agents, colouring agents and preservatives. The sweeteners and flavouring agents will increase the palatability of the preparation. In embodiments, stevia, a low-calorie sugar substitute that does not contain sucrose, is used as a sweetener. Other natural sweeteners that may be used include xylitol, or the like. In embodiments, fruit (e.g. mango) flavouring, or the like, is used as the flavouring agent. Tablets further containing pharmaceutically acceptable excipients suitable for tablet manufacture are acceptable. Pharmaceutically acceptable vehicles such as excipients are compatible with the other ingredients of the formulation (as well as non-injurious to the patient). Such excipients include inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; granulating and disintegrating agents, such as corn starch or alginic acid; binding agents such as starch, gelatin or acacia; and lubricating agents such as magnesium stearate, stearic acid or talc. Tablets can be uncoated or can be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period of time. For example, a time delay material such as glyceryl monostearate or glyceryl distearate alone or with a wax can be employed.

The composition may be in the form of a formulation. Formulations for oral use can be presented as hard gelatin capsules wherein the ingredients are mixed with an inert solid diluent, for example calcium carbonate, calcium phosphate or kaolin, or as soft gelatin capsules wherein the ingredients are mixed with water or an oil medium, such as flaxseed oil, fish oil, peanut oil, liquid paraffin, olive oil or any other oil listed above or elsewhere. Aqueous suspensions can contain the ingredients in admixture with excipients suitable for the manufacture of aqueous suspensions. Such excipients include suspending agents, dispersing or wetting agents, one or more preservatives, one or more colouring agents, one or more flavouring agents and one or more sweetening agents such as sucrose or saccharin. Oil suspensions can be formulated by suspending the active ingredient in an oil. The oil may be selected from an oil listed above or any combination of these oils, for example a vegetable oil such as flaxseed oil, arachis oil, olive oil, sesame oil or coconut oil, a mineral oil such as liquid paraffin, an animal oil such as fish oil or any combination of these oils. Preferably the oil is flaxseed oil and/or fish oil. The oil suspension can contain a thickening agent, such as beeswax, hard paraffin or cetyl alcohol. Sweetening agents, such as those set forth above, and flavouring agents can be added to provide a palatable oral preparation. These compositions can be preserved by an added antioxidant such as ascorbic acid. Dispersible powders and granules of the embodiments suitable for preparation of an aqueous suspension by the addition of water provide the active ingredient in admixture with a dispersing or wetting agent, a suspending agent, and one or more preservatives. Additional excipients, for example sweetening, flavouring and colouring agents, can also be present

Syrups and elixirs can be formulated with sweetening agents, such as glycerol, sorbitol or sucrose. Such formulations can also contain a demulcent, a preservative, a flavouring or a colouring agent.

The composition can also be in the form of an oil-in-water emulsion. The oily phase may be selected from an oil listed above or any combination of these oils, for example a vegetable oil such as flaxseed oil, arachis oil, olive oil, a mineral oil such as liquid paraffin, an animal oil such as fish oil or any combination of these oils. Preferably the oil is flaxseed oil and/or fish oil. Suitable emulsifying agents include naturally-occurring gums such as gum acacia and gum tragacanth, naturally occurring phosphatides, such as soybean lecithin, esters or partial esters derived from fatty acids and hexitol anhydrides, such as sorbitan mono-oleate, and condensation products of these partial esters with ethylene oxide, such as polyoxyethylene sorbitan mono-oleate. The emulsions can also contain sweetening and flavouring agents.

Preferably, the composition is formulated with a pharmaceutically acceptable vehicle (also referred to as a pharmaceutical vehicle). As used herein, the term "pharmaceutically acceptable" means approved by a regulatory agency such as that of the Federal or a state government or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in humans. The term "vehicle" refers to a diluent, adjuvant, excipient, or carrier with which a composition according to the present invention is administered. Such pharmaceutical vehicles can be liquids, such as water and oils, including those of animal, vegetable or synthetic origin, such as flaxseed oil, peanut oil, soybean oil, mineral oil, sesame oil, fish oil and the like, preferably being flaxseed oil and/or fish oil. The pharmaceutical vehicles can be saline, gum acacia, gelatin, starch paste, talc, keratin, colloidal silica, urea, and the like. The vehicle may also be liposome based, as described hereinbefore. In addition, auxiliary, stabilizing, thickening, lubricating and colouring agents may be used. When administered to a patient, the compositions of the embodiments and pharmaceutically acceptable vehicles are preferably sterile. Saline solutions and aqueous dextrose and glycerol solutions can also be employed as liquid vehicles. Suitable pharmaceutical vehicles also include excipients such as starch, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, dried skim milk, glycerol, propylene, glycol, water, ethanol and the like. The present composition, if desired, can also contain minor amounts of wetting or emulsifying agents, or pH buffering agents.

The term “formulation” is used to describe the combination of the composition with one or more liquid pharmaceutically acceptable vehicles. The formulation may comprise additional components. The composition may be dissolved or suspended in or otherwise combined with the liquid pharmaceutical vehicle. Preferably, the formulation comprises the composition and a liquid pharmaceutical vehicle comprising water. In embodiments, the liquid pharmaceutical vehicle may be aqueous. Thus, the formulation may comprise the composition and an aqueous liquid pharmaceutically acceptable vehicle.

The present compositions can take the form of solutions, suspensions, emulsion, tablets, pills, pellets, capsules, capsules containing liquids, powders, sustained-release formulations and transdermal patches, suppositories, emulsions, aerosols, sprays, or any other form suitable for use.

The compositions are preferably formulated for oral delivery, for example in the form of tablets, lozenges, aqueous or oily suspensions, granules, powders, emulsions, capsules, syrups, or elixirs. Compounds and compositions described herein for oral delivery can also be formulated in foods and food mixes. Orally administered compositions can contain one or more optional agents, for example, sweetening agents such as fructose, aspartame or saccharin; flavouring agents such as peppermint, oil of wintergreen, or cherry; colouring agents; and preserving agents, to provide a pharmaceutically palatable preparation. Oral compositions can include standard vehicles such as mannitol, lactose, starch, magnesium stearate, sodium saccharine, cellulose, magnesium carbonate, etc. Such vehicles are preferably of pharmaceutical grade. In embodiments where administration as rectal administration or intravenous administration is envisaged, the composition may be in the form of a suppository, with traditional binders and vehicles such as triglycerides, or a solution suitable for injection, such as a sterile injectable aqueous or oleaginous suspension. For intravenous administration, the composition may be in the form of a liposomal formulation, which can be formed as discussed hereinabove. This suspension can be formulated according to methods well known in the art using suitable dispersing or wetting agents and suspending agents. The sterile injectable preparation can also be a sterile injectable solution or suspension in a non-toxic parenterally-acceptable diluent or solvent, such as a solution in 1 ,3-butanediol. Suitable diluents include, for example, water, Ringer's solution and isotonic sodium chloride solution. In addition, sterile fixed oils can be employed conventionally as a solvent or suspending medium. For this purpose, any bland fixed oil can be employed including synthetic mono or diglycerides. In addition, fatty acids such as oleic acid can likewise be used in the preparation of injectable preparations.

In embodiments, the composition is administered in the form of patches which are applied to the skin of the subject.

In preferred embodiments, the composition is administered orally as a liposomal formulation comprising: the composition, a liquid pharmaceutical vehicle comprising water and a liposome-based vehicle, wherein one or more of C3 curcumin, Vitamin C, grape seed, or an extract thereof, and Boswellia resin, or an extract thereof, are encapsulated within the liposome-based vehicle. Preferably, composition is provided to a subject as a ready-made formulation. The formulation may be further diluted and combined with additional ingredients, foods and/or beverages prior to consumption.

In some embodiments, the composition described herein can be in the form of nutraceutical packs including, but not limited to, functional foods, beverages, bars, dietary supplements, capsules or powder form comprising one or more containers filled with the composition of the present invention. Optionally associated with such products can be a notice in the form prescribed by a governmental agency regulating the manufacture, use or sale of pharmaceuticals or biological products, which notice reflects approval by the agency of manufacture, use or sale for human administration. The administration of the composition may further include the identification of a subject in need of administration of the composition. The term identification is not intended to be limiting and includes in each instance a belief by the subject that the composition will benefit the subject, self-identification, and identification by third party using various techniques.

As used herein, the term "treatment" or "treating" refers to an amelioration of a disease or disorder, or at least one discernible symptom thereof. The term "treatment" or "treating" refers to inhibiting or reducing the progression of a disease or disorder, either physically, e.g., stabilization of a discernible symptom, or physiologically, e.g., stabilization of a physical parameter, or both.

In certain embodiments, the compositions are provided to a subject, such as a human, as a preventative measure against such diseases. As used herein, "prevention" or "preventing" refers to a reduction of the risk of acquiring a given disease or disorder alone or in combination with other clinical condition.

The terms “patient” and “subject” are used synonymously herein. Preferably, the subject or patient is a human subject or patient. The subject may be an adult or a child. The present invention provides a nutraceutical composition, or a formulation thereof, for use in therapy. Also provided is the use of a nutraceutical composition, or a formulation thereof, according to the present invention in the preparation of a medicament for use in therapy. Additionally, there is provided the use of a nutraceutical composition according to the present invention for manufacture of a medicament for use in therapy.

The present invention also provides a method of treatment of a human subject in need thereof, said method comprising administering an effective amount of the nutraceutical composition of the invention to the subject. There is provided a method of improving the immune system, the method comprising administering the nutraceutical composition, or a formulation thereof, to a subject at a dose of 3 to 5 grams per day. There is also provided the use of the nutraceutical composition, a formulation thereof, for improving the immune system. As described above, the composition of the present invention may be used to treat or prevent diseases selected from chronic fatigue syndrome, immunodeficiency disorders, and/or viruses. The administration of the composition of the present invention may beneficially affect the immune system and may be used to improve the immune system. The administration of the composition of the present invention may be used for maintaining health, in the maintenance of hair health and/or to manage the symptoms of a disease and improve the patient’s quality of life. The composition of the present invention may be used to treat diseases outside of this specified list, with the preventative effects and ability to treat diseases or disorders envisaged to extend beyond these specific diseases.

Without being bound by theory, it is believed that the composition of the present invention acts to neutralise free radicals, inhibits destructive enzymes, stimulates beneficial enzymes and/or aids in the removal of toxins from the body. Therefore, the composition of the present invention may prevent connective tissue breakdown caused by destructive enzymes.

In embodiments, the nutraceutical composition of the present invention may be used to manage the symptoms of a disease and improve the patient’s quality of life. In such embodiments, the disease may be incurable. The present invention is further described by way of the following Examples, which are provided for illustrative purposes and are not in any way intended to limit the scope of the invention as claimed. Examples

Example 1

A composition according to the present invention was obtained by combining 175 mg of C3 curcumin powder, 2500 mg Vitamin C, 35 mg grape seed extract, 75 mg quercetin, 0.0375 mg Vitamin D3, 0.025 mg Vitamin K2, 10 mg zinc gluconate, 150 mg Astragalus root extract, 0.02 mg Vitamin B12, 0.25 mg Vitamin A acetate, 75 mg glutathione, 50 mg potassium sorbate, and 1000 mg mango flavour. The composition was combined with 25 ml_ of water, homogenised, and sonicated with phospholipids in order to form liposomes. Finally, 50 mg Boswellia resin extract was added to the liposomal formulation. The resulting formulation was suitable for consumption as a single dose of the composition of the invention.

Example 2

A composition according to the present invention was obtained by combining 700 mg of C3 curcumin powder, 10,000 mg Vitamin C, 140 mg grape seed extract, 300 mg quercetin, 0.14 mg Vitamin D3, 0.1 mg Vitamin K2, 40 mg zinc gluconate, 600 mg Astragalus root extract, 0.09 mg L-selenium methionine, 0.08 mg Vitamin B12, 1 mg Vitamin A acetate, 300 mg glutathione, 200 mg Boswellia resin extract 200 mg potassium sorbate, 300 mg stevia, and flavour (mango). The composition was combined with 100 ml_ of water before being homogenised, and sonicated with phospholipids in order to form liposomes. Example 3

A composition according to the present invention was obtained by combining Vitamin C (L-ascorbic acid) (10,500 mg), horseradish-tree (moringa oleifera) (leaf), curcumin turmeric (curcuma longa) (1 ,230 mg), olibanum (Boswellia thurifera) (resin), ginger (zingiber officinale) (root), spirulina (arthrospira paltensis) (seaweed), chlorella (chlorella vulgaris) (seaweed), quercetin (525 mg), Chinese milk-vetch (astragalus membranaceus) (root), zinc (zinc picolinate) (63 mg), selenium (150 pg), vitamin B12 (methylcobalamin) (348 pg), vitamin D3 (cholecalciferol) (198 pg), vitamin K2 (129 pg) and astaxanthin (84 mg) in a 3:1 (v:v) mixture of water and ethanol (30 ml).

Example 4

A composition according to the present invention was obtained by combining coenzyme Q10 (1,200 mg), spirulina (arthrospira paltensis) (seaweed), chlorella (chlorella vulgaris) (seaweed), curcumin (1 ,230 mg), horseradish-tree (moringa oleifera) (leaf), reishi (Ganoderma lucidum) (mushroom), ginger (zingiber officinale) (root), scouring rush (equisetum hyemale) (leaf), greater nettle (urtica doica) (leaf) and astaxanthin (84 mg) in a 3:1 (v:v) mixture of water and ethanol (30 ml). Example 5

A study was conducted where a nutraceutical composition according to Example 3 was given to patients suffering from acute COVID-19 infection. The nutraceutical composition was given at a dosage of from 2 to 6 ml per day until cessation of symptoms. Qualitative testimonials were given by some patients (N = 51) describing the results of their treatment with the nutraceutical composition of Example 3.

The patients were an approximately even spread of males and females with ages ranging from 20 to 90 (average age of those reported = 51.3). The following symptoms were reported by the patients: fever* (N = 39), severe weakness (N = 22), low oxygen saturation** (N = 21), coughing (N = 18), shortness of breath or difficulty breathing (N = 17), pain in the head or body (N = 11), anosmia (N = 4), and nausea and/or an inability to eat (N = 3). *Fever is defined herein as a body temperature of higher than 37.5 °C. Of those reported numerically, the average patient body temperature prior to treatment was 38.6 °C.

**Low oxygen saturation is defined herein as an oxygen saturation lower than 95 %. Of those reported numerically, the average patient oxygen saturation prior to treatment was 87.1 %. Over the course of treatment all of the patients reported substantial or total alleviation of their symptoms. Of those where the speed of recovery was reported, patients tended to experience alleviation of their symptoms over a time period ranging from 1 to 7 days, depending on the severity of the infection and symptoms. Patients reported alleviation of symptoms an average of 1.6 days after beginning treatment.

Example 6

A study was conducted where a nutraceutical composition according to Example 4 was given to male and female patients suffering from the long term sequalae of COVID-19 infection, or ‘Long COVID’. The nutraceutical composition was given at a dosage of from 2 to 6 ml per day as required. Qualitative testimonials were given by some patients (N = 15) describing the results of their treatment with the nutraceutical composition according to Example 4.

The following symptoms were reported by the patients: severe weakness (N = 13), shortness of breath or difficulty breathing (N = 4), pain in the head or body (N = 3), anosmia (N = 2), and coughing (N = 1). Patients reported suffering from symptoms of long COVID for a time period ranging from 1 week to 10 months, and an average of 3.8 months after the acute infection.

Over the course of treatment all of the patients reported improvement of their symptoms over a time period ranging from 1 day to 2 weeks. Patients reported substantial alleviation of their symptoms an average of 3.9 days after beginning treatment.

Example 7

A study was conducted where a nutraceutical composition according to Example 2 was given to male and female patients suffering from acute COVID-19 infection. The nutraceutical composition was given at a dosage of from 2 to 6 ml per day until cessation of symptoms. Qualitative testimonials were given by some patients (N = 10) describing the results of their treatment with the nutraceutical composition according to Example 2.

The following symptoms were reported by the patients: severe weakness (N = 7), fever (N = 5), pain in the head or body (N = 4), shortness of breath or difficulty breathing (N = 3), coughing (N = 2), nausea and/or an inability to eat (N = 2), anosmia (N = 2), and low oxygen saturation (N = 1).

Over the course of treatment all of the patients reported significant or total alleviation of their symptoms. Of those where the speed of recovery was reported, patients tended to experience alleviation of their symptoms over a time period ranging from 2 to 3 days, depending on the severity of the infection and symptoms. Patients reported alleviation of their symptoms an average of 2.3 days after beginning treatment.

Claims

Claims:

1. A nutraceutical composition comprising:

C3 curcumin; Vitamin C;

Chlorella, or an extract thereof,

Spirulina, or an extract thereof; and Boswellia resin, or an extract thereof.

2. A nutraceutical composition comprising:

Coenzyme Q10;

Spirulina, or an extract thereof;

Moringa leaf, or an extract thereof; and Astaxanthin.

3. The composition according to Claim 1 comprising, on a dry weight basis:

1 to 8 wt.% C3 curcumin;

40 to 90 wt.% Vitamin C;

5 to 20 wt.% Chlorella, or an extract thereof, 5 to 20 wt.% Spirulina, or an extract thereof; and

1.0 to 15 wt.% Boswellia resin, or an extract thereof.

4. The composition according to Claim 2 comprising, on a dry weight basis:

0.1 to 20 wt.% Coenzyme Q10; 5 to 20 wt.% Spirulina, or an extract thereof;

5 to 50 wt.% Moringa leaf, or an extract thereof; and 0.01 to 10 wt.% Astaxanthin.

5. The composition according to any one of the preceding claims wherein the composition further comprises: quercetin.

6. The composition according to any one of the preceding claims wherein the composition further comprises one or more of: Vitamin D3; Vitamin K2; a zinc-containing compound, preferably gluconate;

Astragalus, or an extract thereof, and/or one or more astragaloside, preferably Astragalus root, or an extract thereof, and/or one or more astragaloside; a selenium-containing compound, preferably L-selenium methionine;

Vitamin B12, preferably comprising methylcobalamin;

Vitamin A acetate; glutathione; potassium sorbate, broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof; ginger, or an extract thereof; and/or bitter melon, or an extract thereof, and/or cucumber, or an extract thereof.

7. The composition according to any one of the preceding claims, wherein the composition further comprises, on a dry weight basis:

0.5 to 5.0 wt.% quercetin.

8. The composition according to any one of the preceding claims, wherein the composition further comprises, on a dry weight basis, one or more of:

0.0005 to 1.0 wt.% Vitamin D3;

0.0001 to 0.2 wt.% Vitamin K2;

0.05 to 5.0 wt.% zinc-containing compound, preferably zinc gluconate or zinc picolinate; 1.0 to 7.0 wt.% Astragalus, or an extract thereof, and/or one or more astragaloside, preferably Astralagus root, or an extract thereof, and/or one or more astragaloside;

0.0001 to 0.2 wt.% selenium-containing compound, preferably L-selenium methionine; 0.0001 to 0.2 wt.% Vitamin B12, preferably comprising methylcobalamin;

0.001 to 0.2 wt.% Vitamin A acetate;

0.5 to 5.0 wt.% glutathione;

0.5 to 5.0 wt.% potassium sorbate;

2.5 to 8.5 wt.% broccoli sprout, or an extract thereof, and/or broccoli seed, or an extract thereof, and/or Brussels spout, or an extract thereof;

1.5 to 5 wt.% ginger, or an extract thereof; and/or

8 to 25 wt.% bitter melon, or an extract thereof, and/or cucumber, or an extract thereof. preferably wherein the composition further comprises 0.5 to 5.0 wt.% quercetin.

9. The composition according to Claim 1, wherein the composition further comprises one or more of, preferably all of: moringa leaf; quercetin; Vitamin D3; Vitamin K2; one or more zinc-containing compound, preferably zinc picolinate; Astragalus, or an extract thereof, and/or one or more astragaloside; a selenium-containing compound; Vitamin B12; ginger, or an extract thereof; and turmeric: preferably wherein the composition further comprises astaxanthin.

10. The composition according to Claim 3, wherein the composition further comprises, on a dry weight basis, one or more of, preferably all of: 5 to 50 wt.% moringa leaf; 0.5 to 5.0 wt.% quercetin; 0.0001 to 1.0 wt.% Vitamin D3; 0.0001 to 0.2 wt.% Vitamin K2; 0.01 to 5.0 wt.% one or more zinc-containing compound, preferably zinc picolinate; 1.0 to 7.0 wt.% Astragalus, or an extract thereof, and/or one or more astragaloside; 0.00001 to 0.2 wt.% a selenium-containing compound; 0.0001 to 0.2 wt.% Vitamin B12; 0.1 to 10 wt.% ginger, or an extract thereof; and 1 to 8 wt.% turmeric: preferably wherein the composition further comprises 1 to 10 wt.% astaxanthin.

11. The composition according to Claim 2, wherein the composition further comprises one or more of, preferably all of: C3 curcumin, or an extract thereof; ginger, or an extract thereof; chlorella, or an extract thereof; reishi, or an extract thereof; dandelion, or an extract thereof; scouring rush, or an extract thereof; and greater nettle, or an extract thereof.

12. The composition according to Claim 4, wherein the composition further comprises, on a dry weight basis, one or more of, preferably all of: 0.1 to 20 wt.% C3 curcumin, or an extract thereof: 0.1 to 10 wt.% ginger, or an extract thereof; 5 to 20 wt.%, chlorella, or an extract thereof; 0.01 to 5 wt.% reishi, or an extract thereof; 5 to 20 wt.% dandelion, or an extract thereof; 5 to 20 wt.% scouring rush, or an extract thereof; and 5 to 20 wt.% greater nettle, or an extract thereof.

13. The composition according to any one of Claims 1 to 12, wherein one or more, preferably all, of the listed components is in the form of particles having an average diameter size of from 10 to 10,000 nm, preferably from 100 to 1 ,000 nm, more preferably from 100 to 500 nm.

14. The composition according to any one of the preceding claims, wherein the composition further comprises one or more of: i) one or more sweeteners, preferably comprising stevia, or an extract thereof; and/or ii) one or more flavours.

15. The composition according to any one of the preceding claims, wherein the C3 curcumin comprises greater than 95 wt.% curcuminoids, preferably wherein the curcuminoids comprise 50 to 95 wt.% curcumin, 4 to 40 wt.% demethoxycurcumin, and 1 to 25 wt.% bisdemethoxycurcumin.

16. The composition according to Claim 1 , or any of the preceeding claims dependent thereon, wherein the Boswellia resin, or an extract thereof, comprises or consists essentially of at least one pentacyclic triterpenic acid, preferably b-boswellic acid, acetyl- b-boswellic acid, 11-keto^-boswellic acid and/or acetyl-11-keto^-boswellic acid.

17. The composition according to any one of the preceding claims, wherein the composition is consumed with a glyceride oil and/or fat, preferably in a weight ratio of from 1:30 to 30:1 of composition to glyceride oil and/or fat, preferably wherein the fat is flaxseed oil and/or fish oil.

18. A formulation comprising the composition according to any one of Claims 1 to 17 and a liquid pharmaceutical vehicle, preferably wherein the liquid pharmaceutical vehicle comprises water.

19. The formulation according to Claim 18, wherein the formulation further comprises a liposome-based vehicle wherein the listed components are encapsulated within the liposome-based vehicle.

20. A method of preparing a nutraceutical composition according to any of Claims 1 to 19, wherein the listed components, are combined to form an admixture, optionally wherein at least one of spirulina, moringa leaf, chlorella, Boswellia resin, astragalus, astragalus root, ginger, broccoli sprout, broccoli seed, bitter melon, cucumber, when present is/are provided in the form of one or more extracts, the method further comprising extracting the fruit, vegetable, leaf, seed, resin or other plant material to form at least one extract prior to the combining step.

21. A method of preparing a formulation according to Claim 18 or Claim 19, wherein the listed components are combined with the liquid pharmaceutical vehicle.

22. A food product or beverage comprising the nutraceutical composition of any of Claims 1 to 17 or the formulation of Claims 18 or 19.

23. A method of preparing a food product or beverage according to Claim 22, wherein the listed components are combined with one or more food or beverage components.

24. A nutraceutical composition comprising C3 curcumin, Vitamin C, or an extract thereof, and Boswellia resin, or an extract thereof, obtainable, preferably obtained, by the method of Claim 20, optionally wherein the composition comprises at least one curcuminoid, at least one proanthocyanidin and at least one pentacyclic triterpenic acid, preferably wherein the composition comprises curcumin, at least one of catechin, epicatechin and epicatechin 3-O-gallate, and at least one of b-boswellic acid, acetyl-b- boswellic acid, 11-keto^-boswellic acid and/or acetyl-11-keto^-boswellic acid.

25. A nutraceutical composition according to any of Claims 1 to 17, and 24, or a formulation according to Claim 18 or Claim 19, for use in therapy.

26. A nutraceutical composition according to any of Claims 1 to 17, and 24, or a formulation according to Claim 17 or Claim 19, for use in the treatment of chronic fatigue syndrome, immunodeficiency disorders, and/or viruses.

27. A nutraceutical composition according to any of Claims 1 to 17, and 24, or a formulation according to Claim 18 or Claim 19, for use in the treatment of COVI D-19.

28. A nutraceutical composition or a formulation for use according to any one of Claims 25 to 27, wherein the composition or formulation is administered to a subject at a dose of from 3 to 20 grams per day for 5 to 10 days.

29. A nutraceutical composition or a formulation for use according to any one of Claims 25 to 27, wherein the composition or formulation is administered to a subject suffering from mild COVID-19 symptoms at a dose of from 3 to 5 grams per day for 5 to 10 days, and/or wherein the composition or formulation is administered to a subject suffering from moderate COVID-19 symptoms at a dose of from 6 to 10 grams per day for 5 to 10 days, and/or wherein the composition or formulation is administered to a subject suffering from severe COVID-19 symptoms at a dose of 12 to 20 grams per day for 5 to 10 days.

30. A nutraceutical composition according to Claim 1, or any of the preceeding claims dependent thereon, or a formulation according to Claim 18 or Claim 19, when dependent on Claim 1, in combination with a second nutraceutical composition according to Claim 2, preferably in combination with a second nutraceutical composition according to Claim 2 or any of the preceeding claims dependent thereon, for use as defined in Claims 25 to 28.

31. The combination of nutraceutical compositions or formulations for use according to Claim 30, wherein at least one of the nutraceutical compositions or formulations is administered to a subject at a dose of from 3 to 20 grams per day for 5 to 10 days.

32. A non-therapeutic method of improving the immune system wherein the nutraceutical composition according to Claims 1 to 17, and 24, or the formulation according to Claim 18 or Claim 19, is administered at a dose of 3 to 5 grams per day.

33. Non-therapeutic use of the nutraceutical composition according to Claims 1 to 17, and 24, or the formulation according to Claim 18 or Claim 19 for improving the immune system of a subject.

34. A kit of parts comprising: i. a first nutraceutical composition according to Claim 1 , preferably according to Claim 1 or any of the preceeding claims dependent thereon: ii. a second nutraceutical composition comprising: according to Claim 2, preferably according to Claim 2 or any of the preceeding claims dependent thereon: and iii. instructions for use, providing the first nutraceutical composition for the treatment of an acute phase of a disease, and the second nutraceutical composition for the treatment of the sequalae of a disease.