WO2020160617A1 - A membrane protein expression and distribution modulating composition and method of use thereof - Google Patents
A membrane protein expression and distribution modulating composition and method of use thereof Download PDFInfo
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- WO2020160617A1 WO2020160617A1 PCT/AU2020/050092 AU2020050092W WO2020160617A1 WO 2020160617 A1 WO2020160617 A1 WO 2020160617A1 AU 2020050092 W AU2020050092 W AU 2020050092W WO 2020160617 A1 WO2020160617 A1 WO 2020160617A1
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- sulphoraphane
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Classifications
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Definitions
- the present disclosure relates to a membrane protein expression and distribution modulating composition and a method of use thereof.
- compositions that will mitigate an effect of ageing when administered in a therapeutically effective dose to a subject in need thereof and a method of using such a composition.
- Dysfunctional protein production accumulates in multicellular organisms, such as humans, with the passage of time. Such dysfunction is associated with deleterious effects that are typically termed“ageing”. These deleterious effects, including a deterioration of cell function, lead to an increase of ageing-related pathologies and inevitably accelerate mortality. Increasing relevant protein production to physiologic levels may delay onset of ageing-related negative health effects and contribute to economic benefits, i.e., a reduction in healthcare costs.
- the present disclosure in one aspect sets forth a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y- aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with a reduction in Klotho protein production and/or distribution of a subject.
- GABA y- aminobutyric acid
- the present disclosure in another aspect sets forth a method of modulating Klotho protein production and/or distribution, the method including administering to a subject in need thereof a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega- 3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
- a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega- 3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
- the present disclosure is directed to a composition that mitigates an effect of insufficient Klotho protein perse and/or reduced Klotho protein activity in one or more cell of a multicellular organism, such as humans, that may arise with the passage of time.
- the present disclosure also relates to a method of use of the composition.
- a composition for mitigating ageing-related pathologies of a subject includes a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with reduced Klotho protein production and/or distribution of the subject.
- GABA y-aminobutyric acid
- a Cordyceps sinensis extract zinc
- a Centaurea cyanus extract cholecalciferol, ergocalciferol, magnesium, and resveratrol
- the amount of actin, green tea extract, sulphoraphane, g-aminobutyric acid (GABA), omega-3 fatty acid, a Cordyceps sinensis extract, zinc, Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol will depend on a preferred route of administration, the rate and expected duration of release of the composition, and the nature of the condition, disease or disorder to be treated or prevented.
- each of the actin, green tea extract, sulphoraphane, g-aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol may be present in an amount of 20 - 80 mg.
- each of the actin, green tea extract, sulphoraphane, y- aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol may be present in an amount of 40 mg.
- composition herein disclosed may be delivered to a subject in need thereof by any one of several routes.
- the composition may be delivered via buccal, infusion (e.g., a bolus infusion), inhalation, intracranial injection, enteral, intradermal, intramuscular, intranasal, intraocular, intraperitoneally, intravenously, orally, rectal, rectal, subcutaneously, sublingual, topically, transdermal, vaginal, or any combination thereof.
- the composition may be formulated for enteral administration.
- composition herein disclosed may be formulated for delayed release (also termed sustained or slow release, timed release, delayed release, or controlled release).
- delayed release also termed sustained or slow release, timed release, delayed release, or controlled release.
- Such compositions may generally be prepared using well known technology and administered by, for example, oral, rectal, intradermal, or subcutaneous implantation, or by implantation at the desired target site in a delayed release manner.
- Delayed-release formulations may contain the compound dispersed in a carrier matrix and/or contained within a reservoir surrounded by a rate controlling barrier.
- a particularly preferred embodiment of the composition may be formulated in an enteric coating layer.
- the enteric coating layer may include one or more of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and water-based polymer solutions or dispersions of acrylates.
- composition disclosed herein may be formulated with a buffering agent to protect the compound from low pH of the gastric environment and/or an enteric coating.
- the composition may, when administer orally, buccally, or sublingually, may be formulated with a flavouring agent, e.g., in a liquid, solid or semi-solid formulation.
- Preferred embodiments may include one or more pharmaceutically acceptable dispersant, excipient, pH-buffering compound, and pigment.
- Preferred embodiments will include at least one excipient that is biocompatible and may also be biodegradable; preferably the formulation provides a relatively constant level of active component release.
- the excipient facilitates absorption. In yet a further particularly preferred embodiment, the excipient enhances solubility.
- the composition may be a tablet formulation.
- the composition may be a powder formulation.
- the powder formulation may be in a capsule.
- the composition may be a liquid formulation.
- the composition may be formulated for parenteral administration.
- the composition may be formulated for subcutaneous administration.
- the composition may be formulated for intramuscular administration.
- the composition may be formulated for intravenous administration.
- the composition may be formulated for intradermal administration.
- the composition may be formulated for transdermal administration.
- composition disclosed herein will be administered for a sufficient amount of time to selectively modulate Klotho protein production and/or distribution.
- modulation may be associated with transcription of the Klotho gene, i.e., HTFC3, maturation of a Klotho mRNA transcript, transport of a mature Klotho mRNA transcript into the cytoplasm, docking of a mature Klotho mRNA transcript with one or more ribosome, translation of a mature Klotho transcript, post-translational modification of a Klotho protein, transport of a Klotho protein to a membrane location, docking of a mature Klotho protein in a organelle and/or cell membrane, insertion of a mature Klotho protein as an integral membrane protein, and a reduction in Klotho degradation.
- Klotho as a transmembrane protein related to b-glucuronidases.
- a reduction in Klotho protein, potentially production, concentration, and or distribution may ameliorate at least one symptom associated with a number of pathologies.
- pathologies may include age-related loss of pulmonary function, Alzheimer's disease, angina, aortic aneurysm, arrhythmia, arteriosclerosis, asthma, atherosclerosis, atopic dermatitis, brain aneurysm, bronchiectasis, cardiac diastolic dysfunction, a cancer, cardiac fibrosis, cardiac stress resistance, cardiomyopathy, carotid artery disease, cataracts, chronic obstructive pulmonary disease, chronic renal failure, congestive heart failure, coronary artery disease, coronary thrombosis, cutaneous lupus, cutaneous lymphomas, cystic fibrosis, dementia, diabetes, diabetic ulcer, diseases and disorders related to photosensitivity or photoaging, dysesthesia, eczema, eczematous eruptions, emphysema,
- composition will be administered for a time sufficient and in an amount sufficient that selectively ameliorates at least one symptom associated with insufficient Klotho production and/or distribution as a functional integral protein in an organelle and/or cell membrane.
- a method for modulating Klotho protein production and/or distribution includes administering to a subject in need thereof a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
- the method may include a treatment course no longer than (a) one month, or (b) no longer than two months, or (c) no longer than three months.
- each treatment course is no longer than (a) five days, (b) seven days, (c) ten days, (d) fourteen days, or (e) twenty-one days.
- the composition is administered every second day or every third day of each treatment course.
- the composition is administered once daily during each treatment course.
- the composition is administered twice daily during each treatment course. Suitable interval periods between treatments will be known to a person skilled in the art.
- the subject may be a multicellular animal.
- the multicellular animal is a human.
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Abstract
Dysfunctional protein production is associated with the development of morbidities related to tissue damage that accumulates with age and a need exists for a composition that will mitigate an effect of ageing when administered in a therapeutically effective dose to a subject in need thereof and a method of using such a composition. Provided is a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, γ-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with a reduction in Klotho protein production and/or distribution of a subject and a method of use thereof.
Description
A MEMBRANE PROTEIN EXPRESSION AND DISTRIBUTION MODULATING COMPOSITION AND METHOD OF USE THEREOF
Field of Invention
The present disclosure relates to a membrane protein expression and distribution modulating composition and a method of use thereof.
Background of Invention
As animals, including humans, age, a reduction in the production of important proteins leads to accumulated damage in the tissues. Such damage is thought to be associated with age-related dysfunction of the cells. Indeed, dysfunctional protein production is associated with the development of morbidities within the ageing populations world-wide.
Given the afore-mentioned dysfunction and morbidities within the ageing populations around the world, a need exists for a composition that will mitigate an effect of ageing when administered in a therapeutically effective dose to a subject in need thereof and a method of using such a composition.
Summary
Dysfunctional protein production accumulates in multicellular organisms, such as humans, with the passage of time. Such dysfunction is associated with deleterious effects that are typically termed“ageing”. These deleterious effects, including a deterioration of cell function, lead to an increase of ageing-related pathologies and inevitably accelerate mortality. Increasing relevant protein production to physiologic levels may delay onset of ageing-related negative health effects and contribute to economic benefits, i.e., a reduction in healthcare costs.
The present disclosure in one aspect sets forth a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y- aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with a reduction in Klotho protein production and/or distribution of a subject.
The present disclosure in another aspect sets forth a method of modulating Klotho protein production and/or distribution, the method including administering to a subject in need thereof a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-
3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
The reference to any prior art in this specification is not and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge in Australia or in any other country.
It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed, unless otherwise stated. In the present specification and claims, the word“comprising” and its derivatives including“comprises” and“comprise” include each of the stated integers but does not exclude the inclusion of one or more integers. The claims as filed with this application are hereby incorporated by reference in the description.
Detailed Description
The present disclosure is directed to a composition that mitigates an effect of insufficient Klotho protein perse and/or reduced Klotho protein activity in one or more cell of a multicellular organism, such as humans, that may arise with the passage of time. The present disclosure also relates to a method of use of the composition.
In a preferred embodiment, a composition for mitigating ageing-related pathologies of a subject includes a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with reduced Klotho protein production and/or distribution of the subject. A skilled person will appreciate that the reduction in this context is expressed relative to a healthy subject. Without wishing to be bound by theory, a therapeutically effective dose refers to an amount of a composition administered to a subject, either as a single dose or as part of a series of doses, which is effective to produce a desired therapeutic effect.
It will be appreciated that the amount of actin, green tea extract, sulphoraphane, g-aminobutyric acid (GABA), omega-3 fatty acid, a Cordyceps sinensis extract, zinc, Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol will depend on a preferred route of administration, the rate and expected duration of release of the composition, and the nature of the condition, disease or disorder to be treated or prevented. In a preferred embodiment, each of the actin, green tea extract,
sulphoraphane, g-aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol may be present in an amount of 20 - 80 mg. In a further preferred embodiment, each of the actin, green tea extract, sulphoraphane, y- aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol may be present in an amount of 40 mg.
A person skilled in the art will appreciate that the composition herein disclosed may be delivered to a subject in need thereof by any one of several routes. By way of non-limiting example, the composition may be delivered via buccal, infusion (e.g., a bolus infusion), inhalation, intracranial injection, enteral, intradermal, intramuscular, intranasal, intraocular, intraperitoneally, intravenously, orally, rectal, rectal, subcutaneously, sublingual, topically, transdermal, vaginal, or any combination thereof. Preferably, the composition may be formulated for enteral administration.
It will be appreciated that the composition herein disclosed may be formulated for delayed release (also termed sustained or slow release, timed release, delayed release, or controlled release). Such compositions may generally be prepared using well known technology and administered by, for example, oral, rectal, intradermal, or subcutaneous implantation, or by implantation at the desired target site in a delayed release manner. Delayed-release formulations may contain the compound dispersed in a carrier matrix and/or contained within a reservoir surrounded by a rate controlling barrier.
A particularly preferred embodiment of the composition may be formulated in an enteric coating layer. In a preferred embodiment, the enteric coating layer may include one or more of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and water-based polymer solutions or dispersions of acrylates.
A skilled person will appreciate that the composition disclosed herein may be formulated with a buffering agent to protect the compound from low pH of the gastric environment and/or an enteric coating. Furthermore, the composition may, when administer orally, buccally, or sublingually, may be formulated with a flavouring agent, e.g., in a liquid, solid or semi-solid formulation. Preferred embodiments may include one or more pharmaceutically acceptable dispersant, excipient, pH-buffering
compound, and pigment. Preferred embodiments will include at least one excipient that is biocompatible and may also be biodegradable; preferably the formulation provides a relatively constant level of active component release.
In a particularly preferred embodiment, the excipient facilitates absorption. In yet a further particularly preferred embodiment, the excipient enhances solubility.
In a further preferred embodiment, the composition may be a tablet formulation.
In a further preferred embodiment, the composition may be a powder formulation. In a particularly preferred embodiment, the powder formulation may be in a capsule.
In a further preferred embodiment, the composition may be a liquid formulation. Preferably, the composition may be formulated for parenteral administration. In a particularly preferred embodiment, the composition may be formulated for subcutaneous administration. In a further particularly preferred embodiment, the composition may be formulated for intramuscular administration. In a further particularly preferred embodiment, the composition may be formulated for intravenous administration. In a further particularly preferred embodiment, the composition may be formulated for intradermal administration. In a further particularly preferred embodiment, the composition may be formulated for transdermal administration.
A skilled person will appreciate that the composition disclosed herein will be administered for a sufficient amount of time to selectively modulate Klotho protein production and/or distribution. Such modulation may be associated with transcription of the Klotho gene, i.e., HTFC3, maturation of a Klotho mRNA transcript, transport of a mature Klotho mRNA transcript into the cytoplasm, docking of a mature Klotho mRNA transcript with one or more ribosome, translation of a mature Klotho transcript, post-translational modification of a Klotho protein, transport of a Klotho protein to a membrane location, docking of a mature Klotho protein in a organelle and/or cell membrane, insertion of a mature Klotho protein as an integral membrane protein, and a reduction in Klotho degradation. A person skilled in the art will recognise Klotho as a transmembrane protein related to b-glucuronidases.
A skilled person will also appreciated that a reduction in Klotho protein, potentially production, concentration, and or distribution, may ameliorate at least one symptom associated with a number of pathologies. Such pathologies may include age-related loss of pulmonary function, Alzheimer's disease, angina, aortic aneurysm, arrhythmia, arteriosclerosis, asthma, atherosclerosis, atopic dermatitis, brain
aneurysm, bronchiectasis, cardiac diastolic dysfunction, a cancer, cardiac fibrosis, cardiac stress resistance, cardiomyopathy, carotid artery disease, cataracts, chronic obstructive pulmonary disease, chronic renal failure, congestive heart failure, coronary artery disease, coronary thrombosis, cutaneous lupus, cutaneous lymphomas, cystic fibrosis, dementia, diabetes, diabetic ulcer, diseases and disorders related to photosensitivity or photoaging, dysesthesia, eczema, eczematous eruptions, emphysema, endocarditis, eosinophilic dermatosis, fibrohistocytic proliferations of skin, frailty, glaucoma, hearing loss, herniated intervertebral disc, Huntington's disease, hypercholesterolemia, hyperlipidemia, hyperpigmentation, hypertension, hypertension, immunobullous dermatosis, impaired angiogenesis, impaired endothelium-dependent vasodilation, inflammatory bowel disease, klotho-associated vitamin D metabolic abnormalities, kyphosis, liver fibrosis, macular degeneration, metabolic syndrome, mild cognitive impairment, mitral valve prolapse, motor neuron dysfunction, muscle fatigue, myocardial infarction, nevi, rashes, obesity, oral mucositis, oral submucosa fibrosis, osteoarthritis, osteoarthritis, osteoporosis, osteoporosis, pathologies associated with the cardiovascular system through endothelium-derived NO production, pancreatic fibrosis, Parkinson's disease, pathologies associated with cellular calcium homeostasis, pathologies associated with perturbed TRPV5, i.e., transient receptor potential cation channel subfamily v member 5, pathologies of the skin, pemphigoid, pemphigus, peripheral vascular disease, presbyopia, pruritis, psoriasis, pulmonary fibrosis, pulmonary fibrosis, reactive neutrophilic dermatosis, renal disease, renal failure, rhytides, sarcopenia, skin conditions, skin wound healing, stroke, urticaria, and vision loss.
As described herein it will be appreciated that the composition will be administered for a time sufficient and in an amount sufficient that selectively ameliorates at least one symptom associated with insufficient Klotho production and/or distribution as a functional integral protein in an organelle and/or cell membrane.
In another embodiment, a method for modulating Klotho protein production and/or distribution, the method includes administering to a subject in need thereof a composition including a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
In preferred embodiments of the method disclosed herein, the method may include a treatment course no longer than (a) one month, or (b) no longer than two months, or (c) no longer than three months. In further preferred embodiments, each treatment course is no longer than (a) five days, (b) seven days, (c) ten days, (d) fourteen days, or (e) twenty-one days. In further preferred embodiments, the composition is administered every second day or every third day of each treatment course. In another specific embodiment, the composition is administered once daily during each treatment course. In another preferred embodiment, the composition is administered twice daily during each treatment course. Suitable interval periods between treatments will be known to a person skilled in the art.
In a preferred embodiment, the subject may be a multicellular animal. Preferably, the multicellular animal is a human.
The features described with respect to one embodiment may be applied to other embodiments, or combined with, or interchanged with, the features of other embodiments without departing from the scope of the present invention.
Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.
Claims
1 . A composition comprising a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol, the composition formulated to mitigate a condition associated with a reduction in Klotho protein production and/or distribution of a subject.
2. The composition of claim 1 , wherein each of the actin, green tea extract, sulphoraphane, g-aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol is present in an amount of 20 - 80 mg.
3. The composition of either claim 1 or claim 2, wherein each of the actin, green tea extract, sulphoraphane, g-aminobutyric acid (GABA), an omega-3 fatty acid, the Cordyceps sinensis extract, zinc, the Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol is present in an amount of 40 mg.
4. The composition of any one of claims 1 to 3, formulated for enteral administration.
5. The composition of claim 4, formulated for delayed release.
6. The composition of claim 5, formulated in an enteric coating layer.
7. The composition of claim 6, wherein the enteric coating layer includes one or more of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and water-based polymer solutions or dispersions of acrylates.
8. The composition of any one of claims 1 to 7, further comprising one or more pharmaceutically acceptable dispersant, excipient, pH-buffering compound, and pigment.
9. The composition of claim 8, wherein the excipient facilitates absorption.
10. The composition of claim 8, wherein the excipient enhances solubility.
1 1 . The composition of any one of claims 1 to 10, wherein the composition is a tablet formulation.
12. The composition of any one of claims 1 to 10, wherein the composition is a powder formulation.
13. The composition of claim 12, wherein the powder formulation is in a capsule.
14. The composition of any one of claims 1 to 10, wherein the composition is a liquid formulation.
15. The composition of any one of claims 1 to 10 and 13, formulated for parenteral administration.
16. The composition of claim 15, formulated for subcutaneous administration.
17. The composition of claim 15, formulated for intramuscular administration.
18. The composition of claim 15, formulated for intravenous administration.
19. The composition of claim 15, formulated for intradermal administration.
20. The composition of claim 15, formulated for transdermal administration.
21 . A method of modulating Klotho protein production and/or distribution, the method comprising administering to a subject in need thereof a composition comprising a therapeutically effective dose of each of actin, a green tea extract, sulphoraphane, y-aminobutyric acid (GABA), an omega-3 fatty acid, a Cordyceps
sinensis extract, zinc, a Centaurea cyanus extract, cholecalciferol, ergocalciferol, magnesium, and resveratrol.
22. The method of claim 21 , wherein the subject is a human.
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