WO2021074706A1 - Food product with immunomodulator effect - Google Patents

Food product with immunomodulator effect Download PDF

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Publication number
WO2021074706A1
WO2021074706A1 PCT/IB2020/056982 IB2020056982W WO2021074706A1 WO 2021074706 A1 WO2021074706 A1 WO 2021074706A1 IB 2020056982 W IB2020056982 W IB 2020056982W WO 2021074706 A1 WO2021074706 A1 WO 2021074706A1
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WO
WIPO (PCT)
Prior art keywords
weight
total composition
composition
vitamin
omega
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PCT/IB2020/056982
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Spanish (es)
French (fr)
Inventor
Alejandro Mauricio Vargas Upegui
Original Assignee
Alsec Alimentos Secos S.A.S
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Application filed by Alsec Alimentos Secos S.A.S filed Critical Alsec Alimentos Secos S.A.S
Priority to PCT/IB2020/056982 priority Critical patent/WO2021074706A1/en
Publication of WO2021074706A1 publication Critical patent/WO2021074706A1/en
Priority to CONC2021/0008245A priority patent/CO2021008245A2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants

Definitions

  • the present invention is in the field of biotechnology that can be used in the food industry and medicine for the prevention and treatment of diseases associated with immunodeficiencies and respiratory viral infections, especially Covid 19 coronarivus disease, infection generated by SARS-CoV-2.
  • the fields, especially of interest are the field of foods, supplements or nutraceuticals to strengthen the immune system of living beings, especially human beings.
  • the invention WO2012 / 091945 refers to the use of nutritional compositions that include substances such as lactoferrin from a non-human source to reinforce resistance to diseases or conditions. It also describes a method that includes administering to a human a nutritional composition comprising a fat or lipid source, a protein source, and lactoferrin produced from a non-human source. The method helps increase resistance to a disease or condition, such as a viral respiratory tract infection in a human caused by a bacterial or viral pathogen.
  • a disease or condition such as a viral respiratory tract infection in a human caused by a bacterial or viral pathogen.
  • the protein source included in the nutritional composition comprises bovine milk proteins including, milk protein powder, milk protein concentrates, milk protein isolates, nonfat milk solids, nonfat milk, nonfat milk powder, whey protein, protein isolates from Whey, whey protein concentrates, sweet whey, sour whey, casein, acid casein, caseinate (for example, sodium caseinate, sodium calcium caseinate, calcium caseinate) and any combination thereof, wherein they are combined with probiotics such such as oligosaccharides, polysaccharides, and other prebiotics that contain fructose, xylose, soy, galactose, glucose, and mannose.
  • probiotics such as oligosaccharides, polysaccharides, and other prebiotics that contain fructose, xylose, soy, galactose, glucose, and mannose.
  • prebiotics can include lactulose, lactosucrose, raffinose, gluco-oligosaccharide, inulin, polydextrose, polydextrose, galactooligo saccharide, fructo-oligosaccharide, isomalto-oligosaccharide, soy oligosaccharides, lactosucosa, chair xigosaccharides, chair xigosa -oligosaccharides, aribino-oligosaccharides, sialyl-oligosaccharides, fuco-oligosaccharides and gentio-oligosaccharides.
  • patent WO2016 / 138911 refers to a composition for use in the prevention and / or mitigation of symptoms of acute respiratory tract infections in immunocompromised people, particularly adults where the composition it comprises 2'-fucosylactose (2'-FL) and lacto-N-neotretraose (LNnT) and / or lacto-N-tetraose (LNT).
  • This invention takes advantage of the abundance of bifidobacteria in the intestinal tract of the person that is increased by the dose of 2'-FL and LNnT and / or LNT.
  • This nutritional composition contains probiotics, a source of protein, lipids and digestible carbohydrates in powder, liquid or solid form.
  • Protein sources can include milk protein, soy protein, rice protein, oat protein, or mixtures thereof, it can have substances such as lactoferrin, nucleotides, and nucleosides. It may also contain medium chain (MCT) and long chain (LCT) triglycerides. Some of the sources of long chain triglycerides are rapeseed oil, sunflower seed oil, palm oil, soybean oil, milk fat, corn oil; oils high in oleic acid and soy lecithin. Fractionated coconut oils are a suitable source of medium chain triglycerides. In general, lipids provide 35% to 50% of the energy of the nutritional composition. Lipids can include polyunsaturated fatty acids such as omega-6 and omega-3 fatty acids.
  • patent document US2006 / 0280840 reports a nutritional formulation rich in proteins for multiple nutritional needs that includes components to improve health and the human immune system that comprises a mixture of proteins, among which is the protein soy, egg white whey protein, casein and nonfat milk powder and optionally one or more amaranth, quinoa, millet, rice and / or other proteins of plant origin combined with flaxseed flour powder and fructose, safflower oil, natural and artificial flavor, guar gum, cellulose gum, lecithin, sodium chloride, xanthan, acesulfame-K, sucralose, silicon dioxide, vitamin palmitate (vitamin A), ascorbic acid (vitamin D) , dicalcium phosphate, cholecalciferol (vitamin D), vitamin E acetate, phytomenadione (vitamin K1), vitamin B1, also known as thiamine or thiamine mononitrate, thiamine or aneurin, niacin or nic
  • kits, compositions and methods that comprise a nutritional composition
  • the kit comprises a first external coating that encapsulates a first filling composition that comprises vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, iron, iodine, magnesium, zinc, copper, a source of omega-3 fatty acids and one or more pharmaceutically acceptable vehicles; and a second outer coating that encapsulates a second filler composition comprising a laxative and one or more pharmaceutically acceptable carriers and wherein the first filler composition comprises at least 1100 IU of vitamin A, at least 60 mg of vitamin C, at least 1000 IU of vitamin D, at least 20 IU of vitamin E, at least 1.6 mg of vitamin B1, at least 1.8 mg of vitamin B2, at least 15 mg of vitamin B3, at least 1 mg of vitamin B9, at least 25 pg of vitamin B12, at least 90 mg of iron, at least 150 pg of iodine
  • Patent WO2011 / 150395 reports preparations and compositions that comprise an isolated lactoferrin and a nutritional mixture and that do not include an inorganic source of a biologically effective amount of iron.
  • preparations and compositions are provided comprising an isolated lactoferrin and a nutritional mixture comprising at least folic acid and vitamin B6 in amounts sufficient to supplement the daily dietary requirements of an adult, including pregnant women, infants or children, wherein the nutritional mix further comprises one or more vitamins selected from folic acid, vitamin B6, vitamin B12, biotin, thiamine, riboflavin, niacin, vitamin B5, vitamin A, vitamin C, vitamin D and vitamin E and one or more selected minerals from calcium , Chromium, Chloride, Copper, Iodide, Fluoride, Magnesium, Manganese, Molybdenum, Potassium, Phosphorus, Selenium, Sodium and Zinc.
  • Patent US2020 / 0000860 shows emulsion compositions containing 1-10% probiotics and 2-10% lactoferrin so that the total of both is 10%, or in the range of 10% to 15%, and they contain no less than 2% mucoadhesive protein, such as lactoferrin. It also provides powders that are they prepare by spray drying the emulsions, which contain lactoferrin and probiotics. In the provided powders the mucoadhesive protein, such as lactoferrin, interacts through chemical or physical interaction or associates with surface proteins on the probiotic microorganism.
  • the mucoadhesive protein interacts or associates with surface proteins on the probiotic microorganism to encapsulate the probiotic microorganism, thereby increasing the stability of the microorganism. Powders and emulsions do not require refrigeration and have a shelf life of up to one year or more.
  • ALSEC carried out preliminary in silico studies, that is, simulations with molecular software to predict the effect inhibitory of bioactive molecules present in plant extracts and milk proteins against the SARS-CoV-2 virus.
  • retroviral drugs ie Nelfinavir.
  • the present invention reports a novel and promising formulation of a nutritional supplement or food product that is composed of a balanced mixture of proteins, vegetable oils, vitamins and minerals and as bio-ingredients: lactoferrin, probiotics, omega 3 and 6 and oils, for example cannabis extract, which are directly related to strengthening the immune system, where said formulation, composition or food product strengthens and / or regulates the immune system of consumers with a diet rich in antioxidants, vitamins, minerals and other bioactive compounds such as probiotics, lactoferrin, omega 3, omega 6 and omega 9, also allowing to activate the inhibition mechanism in cells to prevent the entry and replication of viruses such as SARS-CoV2 (COVID-19), among others.
  • lactoferrin lactoferrin
  • probiotics for example cannabis extract
  • omega 3 and 6 and oils for example cannabis extract
  • compositions or food, nutraceutical or dietary supplement products of the present invention stimulate the production of fundamental proteins for the proper development and functioning of the immune system, resulting in a rapid response to infection and significantly reducing severity. of the symptoms associated with the virus with the additional result of mitigating the contagion of the virus (s) in the population with the highest risk of exposure.
  • the present invention refers to a product, which is a composition or formulation or dietary supplement for the food and pharmacological industry for the prevention and risk reduction of diseases associated with immunodeficiencies and viral infections caused by viruses such as coronavirus Sars -Covid 2 (Covid-19) where the components of the composition or formulation or product according to the present invention are lactoferrin between 3.00% and 4.00% by weight of the total composition, cannabidiol (CBD) in a proportion of 0.05 % to 1.00% by weight of the total composition, high oleic sunflower oil between 12.00% by weight, corn oil between 8.00% and 9.00% by weight, sunflower oil between 5.00% and 6.11% by weight, flaxseed between 3.00% and 4.00% by weight, fish oil between 0.20% and 0.30%, fructooligosaccharides -FOS between 16.00% and 17.00% by weight, calcium caseinate between 15.00% and 16.00% by weight, sodium between 1.9
  • CBD cannabidiol
  • maltodextrin between 15.00% and 16.00% by weight, modified starch between 12.00% and 13.00% by weight; soy lecithin between 0.40 and 0.60% by weight; dextrose between 0.50% and 1.00% by weight, polydextrose between 1.00% and 1.50% by weight, distilled monoglycerides between 0.50% and 1.00% by weight, dipotassium phosphate between 0.50% and 0.70% by weight; silicon dioxide between 0.30% and 0.40% by weight, titanium dioxide between 0.020% and 0.022% by weight, tocopherols (gamma, delta, alpha and beta) between 0.090% and 0.150% by weight, ascorbic acid between 0.090% and 0.150 % by weight, carrageenan between 0.050% and 0.070% by weight, diacetyl tartaric monodiglyceride acid ester between 0.040% and 0.060% by weight and probiotics (Lactobacillus acidophilus, Lactobacillus rhamnosu, Lacto
  • Figure 1 shows the result of the cell viability test carried out with a composition or final product according to the examples provided in the present invention.
  • Figure 2 shows the result of the antiviral activity measured by MTT of a composition or final product according to the examples provided in the present invention.
  • Figure 3 shows the result of a cell viability assay measured by MTT for live cells exposed to different concentrations of CBD.
  • Figure 4 shows the result of an antiviral activity assay measured by MTT for cells when the SARS-CoV-2 virus was used.
  • Figure 5 shows a plating assay showing the plaques formed by SARS-CoV-2 obtained from the supernatant of the control of the virus without treatment and of the treatment with CBD (6 uM) of the antiviral assay.
  • a food product which is a food composition or formulation or nutraceutical product with an immunomodulatory effect where the selection of its components is based on scientific foundations and computer modeling, where the product or Food products of the invention have supplementation effects directed at specific dietary nutrients to alter and improve aspects of immune function offering an immunoregulatory activity due to the participation of nutrients or their products in communication within and between leukocytes.
  • Food products, compositions or formulations according to the present invention have effects on the immune system, that is, they have immunomodulatory properties against viral infections, among which are include but are not limited to COVID-19, where the product or formulation can be a nutritional supplement that is composed of a balanced mixture of proteins, vegetable oils, vitamins, minerals and as bio-ingredients: lactoferrin, probiotics, omega 3, omega 6 and omega 9 and optionally, oils for example, cannabidiol (CBD), all of which are directly related to strengthening the immune system.
  • COVID-19 where the product or formulation can be a nutritional supplement that is composed of a balanced mixture of proteins, vegetable oils, vitamins, minerals and as bio-ingredients: lactoferrin, probiotics, omega 3, omega 6 and omega 9 and optionally, oils for example, cannabidiol (CBD), all of which are directly related to strengthening the immune system.
  • CBD cannabidiol
  • the formulations or food compositions of the invention have applications in different classes of products. Indeed, according to the invention, the possibility is contemplated that the food composition or formulation is part of a food product that is defined as any food that, through chemical and / or physical industrial processes of treatment, handling, conservation and packaging, results in an optimal product for human consumption. Also, the composition or food formulation can be part of a food supplement, which is defined as a formulation that is taken by mouth and that can contain one or more additional food ingredients (such as vitamins, minerals, herbs, amino acids and enzymes among others).
  • the food composition or formulation can be part of a dietary supplement which can be defined as any substance that can be ingested to improve health or well-being and that include vitamins, minerals and herbal extracts and with common forms of pills or capsules.
  • the food composition or formulation can be part of a nutraceutical product that is defined as any food or food ingredient that exerts beneficial action in health and disease prevention and also the formulation of the present invention can be part of functional foods that can be defined as those that in addition to their usual nutritional effects and have biological compounds (nutrients or non-nutrients) with a positive selective effect on one or more functions of the body and that present beneficial effects on health, improving it or reducing the risk of suffering from diseases.
  • the present invention also considers any other presentation of the composition or formulation as a food product, such as edible gums, edible energy bars, healthy snacks, cookies and bakery products, among others.
  • the food product or composition or formulation with immunomodulatory effect comprises bioactive molecules present in extracts of plants such as cannabis, especially with cannabidiol; dairy proteins such as lactoferrin and calcium caseinate; vitamins A, B6, B9, B12, C, D3 and E; minerals of magnesium, copper, zinc, selenium and probiotics, where all these components have evidence of being nutritional promoters with immunological benefits or being compounds with the ability to fight viral infections.
  • CBD cannabidol
  • lactoferrin is a multifunctional glycoprotein considered as a substance of innate immunity, since it stimulates or inhibits various humoral and cellular components involved in the prevention and resolution of microbial and viral infections.
  • the invention also comprises the process for the production of the composition or formulation or food product in the form of nanoparticles, wherein the process has the following stages:
  • Dosage includes the weighing stages where for micronutrients, such as vitamins and minerals, more care must be taken in weighing them since more precision equipment is required.
  • micronutrients such as vitamins and minerals
  • macronutrients such as proteins, carbohydrates and oils
  • these can be weighed in conventional weighing systems, always keeping in mind the accuracy of the quantities, which depend on the regulations that exist in the country where the product is to be marketed and the functionality of the the components as reported to obtain a nutritional benefit.
  • Mixing After having a nutritional balance between the ingredients (micronutrients and macronutrients), a mixture is made between them, for example: encapsulating agents, vegetable and animal oils, milk proteins, emulsifiers (mono and diglycerides), pH regulators and acidity, antioxidants, natural sweeteners, vitamins and minerals, probiotics, natural flavorings, in this order or in a defined order when standardizing and validating the mixing process.
  • encapsulating agents for example: encapsulating agents, vegetable and animal oils, milk proteins, emulsifiers (mono and diglycerides), pH regulators and acidity, antioxidants, natural sweeteners, vitamins and minerals, probiotics, natural flavorings, in this order or in a defined order when standardizing and validating the mixing process.
  • Final packaging that refers to the finished product after mixing, packed for commercialization.
  • the present invention provides a composition, formulation or product for application in the prevention and / or relief of symptoms of respiratory tract infections in immunologically compromised persons.
  • the present invention further provides a method for preventing respiratory tract infection and / or symptoms of said disease, wherein the method comprises administering an effective amount of the composition, formulation or product of the present invention.
  • the composition or formulation has an immunomodulatory effect thanks to the selection of the components of said composition.
  • the composition may be in any suitable form, such as, for example, a nutritional composition, a dietary supplement, a beverage, a food or a pharmaceutical composition wherein said pharmaceutical composition may be a galenic form such as a tablet, capsule, lozenge or a powder in a sachet or liquid, wherein the composition may be with pharmaceutically acceptable excipients or carriers.
  • the food product with immunomodulatory effect according to the present invention may be in the form of a nutritional composition in powder per serving or in powder in certain amounts of servings, a dietary supplement in powder per serving or in powder in certain amounts of servings, or the above in liquid presentation, a food or a pharmaceutical composition.
  • the food product with immunomodulatory effect according to the present invention when it is a pharmaceutical formulation has the form that is selected from a tablet, capsule, lozenge, a powder in one portion or in several portions and a portion in liquid presentation; wherein the formulation comprises pharmaceutically acceptable excipients or carriers.
  • the composition comprises lactoferrin between 3.00% and 4.00% by weight of the total composition, cannabidiol (CBD) in a proportion from 0.05% to 1.00% by weight of the total composition, high oleic sunflower oil in a percentage of 12.00% by weight of the total composition, corn oil between 8.00% and 9.00% by weight of the total composition, oil sunflower between 5.00% and 6.11% by weight of the total composition, linseed oil between 3.00% and 4.00% by weight of the total composition, fish oil between 0.20% and 0.30%, fructooligosaccharides -FOS between 16.00 % and 17.00% by weight of the total composition, calcium caseinate between 15.00% and 16.00% by weight of the total composition, sodium caseinate between 1.97% and 2.50% by weight of the total composition, maltodextrin between a 15.00% and 16.00% by weight of the total composition, modified
  • composition or formulation or dietary supplement according to the present invention also comprises pH regulators, such as, for example, potassium citrate between 0.040% and 0.050% by weight of the total composition.
  • pH regulators such as, for example, potassium citrate between 0.040% and 0.050% by weight of the total composition.
  • composition or formulation or dietary compound according to the present invention also comprises natural or artificial flavors and flavorings, such as, for example, vanilla, in a percentage of 1.70% by weight.
  • the composition or formulation or dietary supplement may further comprise omega 3, omega 6 and omega 9 alone or in combination in a proportion of 0.05% to 1.00% by weight of the composition, wherein the A source of omega 3 can be vegetable oil and / or fish oil (DHA- docosahexaenoic acid; and EPA- eicosapentaenoic acid), and it also contains a source of omega 6 and omega 9 from vegetable oil.
  • omega 3 can be vegetable oil and / or fish oil (DHA- docosahexaenoic acid; and EPA- eicosapentaenoic acid)
  • omega 6 and omega 9 from vegetable oil.
  • composition or formulation or dietary supplement according to the present invention also comprises a mixture of vitamins and minerals that is between 2.50% and 3.50% by weight; where said mixture can comprise vitamin A between 446 and 604 mcg, vitamin D3 between 170 and 230 IU, vitamin E between 5.1 and 6.9 mg, vitamin B6 between 0.77 and 1.04 mg, folic acid between 119 and 161 mcg, vitamin B12 between 1.53 and 2.1 mcg, vitamin C between 28.1 and 38.0 mg, copper between 510 and 690 mcg, magnesium between 170 and 230 mg, selenium between 26.8 and 36.2 mcg and zinc between 4.51 and 6.10 mg.
  • vitamins and minerals that is between 2.50% and 3.50% by weight; where said mixture can comprise vitamin A between 446 and 604 mcg, vitamin D3 between 170 and 230 IU, vitamin E between 5.1 and 6.9 mg, vitamin B6 between 0.77 and 1.04 mg, folic acid between 119 and 161 mcg, vitamin B12
  • the lactoferrin that is part of the composition can be lactoferrin from any known commercially available food grade source.
  • the probiotics can be Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans, or mixtures thereof.
  • High oleic sunflower oils, corn oil, sunflower oil and linseed oil can be commercially available and food grade.
  • composition or formulation or dietary supplement is made by mixing, this process is a unit operation highly used in food processing, in which a homogeneous distribution of raw materials is obtained by mechanical means.
  • Different equipment designs are used such as: turning mixers that can be a horizontal cylinder, double cone, oblique cone, V cone or Y cone; ribbon mixer where said metallic ribbons are rotatable in a helical way; vertical screw mixers that consists of the screw turning longitudinally on its axis and the turbo mixer, in which the product is removed by the lower blade allowing the product to be thrown towards the chopper, crushing and thus eliminating the lumps in the mixture of powders.
  • the particle size is the factor of greatest influence to obtain a uniform mixture of the powdered products and prevent segregation from occurring, as the particle size of each raw material increases, more time is required to obtain a completely uniform mixing, of such that the coefficient of variation between the samples of each lot is lower.
  • the proportion of each raw material is identified to select in which part of the process they are added, the component that is in the smallest proportion makes it difficult to incorporate into the homogeneity of the mixture and the one with the highest proportion generates ease, which allows pre-dispersing the minority components, therefore, in one aspect of the invention, it is preferred to pre-mix the components that are in a lower proportion and then mix them with the components that are in a higher proportion within the percentage composition or product. final.
  • the mixing time and the components to be incorporated are precisely controlled, if it is exceeded, the uniformity of the mixture is broken and separation or segregation of the ingredients begins to occur.
  • samples of the mixture are taken at different times and in the mixing stages; Each sample is analyzed to validate the composition or concentration of the components, the standard deviation of each batch measured for each time is taken into account, the operation of the mixer and mixing efficiency are evaluated to calculate the optimal mixing time, given that homogeneity of the product depends on this factor.
  • SARS-CoV2 is transmitted through respiratory droplets, with the potential for aerosolization and spread by contact.
  • ACE2 angiotensin II converting enzyme
  • Modulation of ACE2 levels in these input tissues may be a plausible strategy to decrease susceptibility to disease. Given the current serious and rapidly evolving epidemiological situation, all possible therapeutic opportunities and avenues should be considered.
  • the present study is crucial for the future analysis of the effects of the composition or formulation or dietary supplement according to the present invention and the participation of medicinal cannabidiol (CBD) in the composition of the invention as an ideal product for prevention and treatment of diseases associated with respiratory infections, especially with SARS-Covid 2 (COVID-19).
  • CBD cannabidiol
  • the present example illustrates an embodiment of the product or composition according to the present invention where a batch of the components is made according to the following characteristics.
  • a 180 kg batch of product is taken for which the following amounts by weight were used according to the percentage ranges indicated in the present invention for the composition or final product:
  • the in vitro antiviral activity of natural compounds was quantified on SARS-COV-2, which was carried out by means of a cell viability test carried out with the composition or final product (called Immunut) and according to With figure 1, it showed that concentrations of 500ug / ml_ or lower reached levels of cell viability higher than 80%, in some cases they reached 100% cell viability, which means that these concentrations have very low or no cytotoxicity. Therefore, the non-cytotoxic concentrations that can be evaluated to determine the AAV (Antiviral Activity) of the Immunut product (composition according to the present invention), are the concentrations equal to or less than 500ug / MI.
  • the antiviral activity assay measured by MTT was carried out (based on the color change that occurs when the substance 3- 4,5-dimethylthiazol-2-yl-2.5-diphenyltetrazolium bromide is reduced by the action of mitochondrial enzymes) of the Immunut product (product according to the present invention) and according to figure 2, it showed that the concentration of 500ug / ml_ reached the highest percentage of antiviral activity, with an average of 46% -85%, followed by the concentration of 250ug / ml_ and 125ug / ml_, with a mean antiviral activity of 33% and 35%, respectively. No statistically significant difference was observed between these concentrations and the Chloroquine inhibition positive control, which showed a mean inhibition of 73%.
  • the antiviral activity assay measured by MTT and using the SARS-CoV-2 virus with an MOI of 0.1 M can be seen in figure 4; It is observed that the CBD compound at the concentration of 6uM reached the highest antiviral activity with an average of 27.4%, followed by the concentration of 3uM with an average of 12%; no statistically significant difference was observed between these concentrations and the positive control of inhibition of viral replication used in this experiment or Chloroquine, which showed a mean inhibition of 73%; the other concentrations did not have a significant antiviral effect. Percentage of antiviral activity calculated from the MTT cell viability assay.
  • Graph 4 shows the percentage of AAV of the CBD compound in the different concentrations when the SARS-CoV-2 virus was used at an MOI of 0.1. The graph shows the mean of each measurement and the standard deviation. 2 experiments were performed with 4 replicates each.
  • CLQ Chloroquine, positive control for inhibition of viral replication.
  • the virus titer was determined by plating assay. It can be seen that the viral titer in the presence of the treatment was on average 8.25x10 3 PFU / mL, while, in the virus control without treatment, the viral titer was on average 1.08x10 5 PFU / mL, which which means a 92.4% reduction in viral particles infectious diseases of SARS-CoV-2 by the compound CBD.
  • Figure 5 shows the plating test in which the plaques formed by SARS-CoV-2 obtained from the supernatant of the untreated virus control and from the treatment with CBD (6uM) of the antiviral assay are shown. Undiluted conditions and dilutions from 10 1 to 10 4 are observed. The result is expressed in plaque forming units (PFU) / ml_. CC: uninfected cell control.
  • PFU plaque forming units
  • composition or formulation or product of the present invention has desired and promising activity for the prevention or mitigation of symptoms caused by respiratory viral diseases related to Coronarivus caused by the virus SARS-Cov-2 (Covid 19) thanks to its components and especially with the presence of Cannabidiol CBD and lactoferrin.

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Abstract

The invention relates to a dietary supplement or composition having an immunomodulating effect, characterised in that it comprises lactoferrin, cannabidiol (CBD), high oleic sunflower oil, corn oil, sunflower oil, linseed oil, fish oil, fructooligosaccharides (FOS), calcium caseinate, sodium caseinate, maltodextrine, modified starch, soy lecithin, dextrose, polydextrose, monoglycerides, dipotassium phosphate, silicon dioxide, titanium dioxide, tocopherols, ascorbic acid, carrageenan, diacetyl tartaric acid ester of mono- and diglyceride, and probiotics. The supplement or composition can also contain vitamins and minerals, omega 3, omega 6, pH regulators, sweeteners and flavourings. It is intended for the food and pharmacological industry for the prevention and treatment of viral infections caused by viruses such as coronavirus SARS-CoV-2, and can take the form of a nutritional composition or a pharmaceutical formulation.

Description

PRODUCTO ALIMENTICIO CON EFECTO INMUNOMODULADOR FOOD PRODUCT WITH IMMUNOMODULATING EFFECT
CAMPO TÉCNICO TECHNICAL FIELD
[001] La presente invención se encuentra en el campo de la biotecnología que puede ser empleada en la industria alimenticia y medicina para la prevención y tratamiento de enfermedades asociadas con inmunodeficiencias e infecciones virales respiratorias, especialmente la enfermedad por coronarivus Covid 19, infección generada por el SARS-CoV-2. Los campos, especialmente de interés son el campo de alimentos, suplementos o nutracéuticos para reforzar el sistema inmunitario de seres vivos, en especial de seres humanos. [001] The present invention is in the field of biotechnology that can be used in the food industry and medicine for the prevention and treatment of diseases associated with immunodeficiencies and respiratory viral infections, especially Covid 19 coronarivus disease, infection generated by SARS-CoV-2. The fields, especially of interest are the field of foods, supplements or nutraceuticals to strengthen the immune system of living beings, especially human beings.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
[002] Existen formulaciones alimenticias y farmacéuticas capaces de fortalecer el sistema inmune a fin de poder luchar contra microorganismos gracias a que dichas formulaciones tienen actividad antagonista contra bacterias, virus y otros patógenos promoviendo la digestión de componentes alimenticios, ayudando a la producción de sustancias necesarias para el cuerpo y estimulan la inmunidad local. [002] There are food and pharmaceutical formulations capable of strengthening the immune system in order to be able to fight against microorganisms thanks to the fact that said formulations have antagonistic activity against bacteria, viruses and other pathogens, promoting the digestion of food components, helping the production of necessary substances for the body and stimulate local immunity.
[003] En el estado del arte se conoce la invención WO2012/091945 que hace referencia al uso de composiciones nutricionales que incluyen sustancias tales como lactoferrina de una fuente no humana para reforzar la resistencia a enfermedades o afecciones. También describe un método que incluye administrar a un ser humano una composición nutricional que comprende una fuente de grasa o lípidos, una fuente de proteína y lactoferrina producida por una fuente no humana. El método ayuda a aumentar la resistencia a una enfermedad o afección, tal como infección viral del tracto respiratorio en un ser humano causado por un patógeno bacteriano o viral. La fuente de proteína incluida en la composición nutricional comprende proteínas de leche bovina que incluyen, proteína de leche en polvo, concentrados de proteína de leche, aislados de proteína de leche, sólidos de leche sin grasa, leche sin grasa, leche en polvo sin grasa, proteína de suero, aislados de proteína de suero, proteína de suero concentrados, suero dulce, suero ácido, caseína, caseína ácida, caseinato (por ejemplo, caseinato de sodio, caseinato de calcio sódico, caseinato de calcio) y cualquier combinación de los mismos, en donde se combinan con probióticos tales como oligosacáridos, polisacáridos y otros prebióticos que contienen fructosa, xilosa, soya, galactosa, glucosa y mañosa. Más específicamente, los prebióticos pueden incluir lactulosa, lactosucrosa, rafinosa, gluco-oligosacárido, inulina, polidextrosa, polidextrosa, galactooligo sacárido, fructo-oligosacárido, isomalto-oligosacárido, oligosacáridos de soya, lactosucosa, xilo-silla, xilo-silla oligosacáridos, mano-oligosacáridos, aribino-oligosacáridos, sialil-oligosacáridos, fuco-oligosacáridos y gentio-oligosacáridos. In the state of the art, the invention WO2012 / 091945 is known which refers to the use of nutritional compositions that include substances such as lactoferrin from a non-human source to reinforce resistance to diseases or conditions. It also describes a method that includes administering to a human a nutritional composition comprising a fat or lipid source, a protein source, and lactoferrin produced from a non-human source. The method helps increase resistance to a disease or condition, such as a viral respiratory tract infection in a human caused by a bacterial or viral pathogen. The protein source included in the nutritional composition comprises bovine milk proteins including, milk protein powder, milk protein concentrates, milk protein isolates, nonfat milk solids, nonfat milk, nonfat milk powder, whey protein, protein isolates from Whey, whey protein concentrates, sweet whey, sour whey, casein, acid casein, caseinate (for example, sodium caseinate, sodium calcium caseinate, calcium caseinate) and any combination thereof, wherein they are combined with probiotics such such as oligosaccharides, polysaccharides, and other prebiotics that contain fructose, xylose, soy, galactose, glucose, and mannose. More specifically, prebiotics can include lactulose, lactosucrose, raffinose, gluco-oligosaccharide, inulin, polydextrose, polydextrose, galactooligo saccharide, fructo-oligosaccharide, isomalto-oligosaccharide, soy oligosaccharides, lactosucosa, chair xigosaccharides, chair xigosa -oligosaccharides, aribino-oligosaccharides, sialyl-oligosaccharides, fuco-oligosaccharides and gentio-oligosaccharides.
[004] Otra tecnología relacionada con este campo es la patente WO2016/138911 que se refiere a una composición para el uso en la prevención y/o mitigación de síntomas de infecciones agudas del tracto respiratorio en personas inmuno comprometidas, particularmente adultos en donde la composición comprende 2’- fucosillactosa (2’-FL) y lacto-N-neotretraosa (LNnT) y/o lacto-N-tetraosa (LNT). Esta invención aprovecha la abundancia de bifidobacteria en el tracto intestinal de la persona que se incrementa por la dosis de 2’-FL y LNnT y/o LNT. Esta composición nutricional contiene probióticos, una fuente de proteína, lípidos y carbohidratos digestibles en forma de polvo, líquido o sólido. Las fuentes de proteína pueden incluir proteínas de leche, proteína de soya, proteína de arroz, proteína de avena, o mezclas de las mismas, puede tener sustancias tales como lactoferrina, nucleótidos y nucleósidos. Puede contener además triglicéridos de cadena media (MCT) y de cadena larga (LCT). Algunas de las fuentes de triglicéridos de cadena larga son aceite de colza, aceite de semilla de girasol, el aceite de palma, el aceite de soja, grasa de leche, aceite de maíz; aceites con alto contenido de ácido oleico y la lecitina de soya. Los aceites de coco fraccionados son una fuente adecuada de triglicéridos de cadena media. En general, los lípidos proporcionan del 35% al 50% de la energía de la composición nutricional. Los lípidos pueden incluir ácidos grasos poliinsaturados como los ácidos grasos omega-6 y omega-3. [004] Another technology related to this field is patent WO2016 / 138911 which refers to a composition for use in the prevention and / or mitigation of symptoms of acute respiratory tract infections in immunocompromised people, particularly adults where the composition it comprises 2'-fucosylactose (2'-FL) and lacto-N-neotretraose (LNnT) and / or lacto-N-tetraose (LNT). This invention takes advantage of the abundance of bifidobacteria in the intestinal tract of the person that is increased by the dose of 2'-FL and LNnT and / or LNT. This nutritional composition contains probiotics, a source of protein, lipids and digestible carbohydrates in powder, liquid or solid form. Protein sources can include milk protein, soy protein, rice protein, oat protein, or mixtures thereof, it can have substances such as lactoferrin, nucleotides, and nucleosides. It may also contain medium chain (MCT) and long chain (LCT) triglycerides. Some of the sources of long chain triglycerides are rapeseed oil, sunflower seed oil, palm oil, soybean oil, milk fat, corn oil; oils high in oleic acid and soy lecithin. Fractionated coconut oils are a suitable source of medium chain triglycerides. In general, lipids provide 35% to 50% of the energy of the nutritional composition. Lipids can include polyunsaturated fatty acids such as omega-6 and omega-3 fatty acids.
[005] Por su parte, el documento de patente US2006/0280840 reporta una formulación nutricional rica en proteínas para múltiples necesidades alimenticias que incluye componentes para mejorar la salud y el sistema inmunológico humano que comprende una mezcla de proteínas, entre las cuales está la proteína de soya, proteína de suero de clara de huevo, caseína y leche en polvo sin grasa y, opcionalmente, una o más proteínas de amaranto, quinua, mijo, arroz y/u otras proteínas de origen vegetal combinadas con polvo de harina de linaza y fructosa, aceite de cártamo, sabor natural y artificial, goma guar, goma de celulosa, lecitina, cloruro de sodio, xantano, acesulfamo-K, sucralosa, dióxido de silicio, palmitato de vitamina (vitamina A), ácido ascórbico (vitamina D), fosfato dicálcico, colecalciferol (vitamina D), acetato de vitamina E, fitomenadiona (vitamina K1), vitamina B1 , también conocida como mononitrato de tiamina o tiamina, tiamina o aneurina, niacina o ácido nicotínico, vitamina B2, también conocida como riboflavina, vitamina B3 conocida como niacinamida, también conocido como niacina, o ácido nicotínico, ácido pantoténico o pantotenato de calcio, también conocido como vitamina B5, vitamina B6 también conocido como piridoxina HCI, vitamina B9, también conocido como ácido fólico o ácido fólico, vitamina B12, lecitina, cianocobalamina, pantotenato de calcio y, yoduro de potasio, óxido de magnesio, fosfato de di magnesio, óxido de zinc, quelato de aminoácidos de selenio, gluconato de cobre, sulfato de manganeso, quelato de aminoácidos de cromo, quelato de aminoácidos de molibdeno, dicha formulación se proporciona en forma de polvo seco o líquido. [005] For its part, patent document US2006 / 0280840 reports a nutritional formulation rich in proteins for multiple nutritional needs that includes components to improve health and the human immune system that comprises a mixture of proteins, among which is the protein soy, egg white whey protein, casein and nonfat milk powder and optionally one or more amaranth, quinoa, millet, rice and / or other proteins of plant origin combined with flaxseed flour powder and fructose, safflower oil, natural and artificial flavor, guar gum, cellulose gum, lecithin, sodium chloride, xanthan, acesulfame-K, sucralose, silicon dioxide, vitamin palmitate (vitamin A), ascorbic acid (vitamin D) , dicalcium phosphate, cholecalciferol (vitamin D), vitamin E acetate, phytomenadione (vitamin K1), vitamin B1, also known as thiamine or thiamine mononitrate, thiamine or aneurin, niacin or nicotinic acid, vitamin B 2, also known as riboflavin, vitamin B3 known as niacinamide, also known as niacin, or nicotinic acid, pantothenic acid or calcium pantothenate, also known as vitamin B5, vitamin B6 also known as pyridoxine HCI, vitamin B9, also known as acid folic or folic acid, vitamin B12, lecithin, cyanocobalamin, calcium pantothenate, potassium iodide, magnesium oxide, dimagnesium phosphate, zinc oxide, selenium amino acid chelate, copper gluconate, manganese sulfate, chelate of chromium amino acids, molybdenum amino acid chelate, said formulation is provided in dry powder or liquid form.
[006] La patente US2017/0202802 reporta kits, composiciones y métodos que comprenden una composición nutricional en donde el kit comprende un primer revestimiento externo que encapsula una primera composición de relleno que comprende vitamina A, vitamina C, vitamina D, vitamina E, vitamina B1 , vitamina B2, vitamina B3, vitamina B6, vitamina B9, vitamina B12, hierro, yodo, magnesio, zinc, cobre, una fuente de ácidos grasos omega-3 y uno o más vehículos farmacéuticamente aceptables; y un segundo recubrimiento externo que encapsula una segunda composición de relleno que comprende un laxante y uno o más vehículos farmacéuticamente aceptables y en donde la primera composición de relleno comprende al menos 1100 Ul de vitamina A, al menos 60 mg de vitamina C, al menos 1000 Ul de vitamina D, al menos 20 Ul de vitamina E, al menos 1 ,6 mg de vitamina B1 , al menos 1 ,8 mg de vitamina B2, al menos 15 mg de vitamina B3, al menos 1 mg de vitamina B9, al menos 25 pg de vitamina B12, al menos 90 mg de hierro, al menos 150 pg de yodo, al menos 20 mg de magnesio, al menos 25 mg de zinc, al menos 2 mg de cobre y al menos 400 mg de la fuente de ácidos grasos omega-3. [006] Patent US2017 / 0202802 reports kits, compositions and methods that comprise a nutritional composition wherein the kit comprises a first external coating that encapsulates a first filling composition that comprises vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, iron, iodine, magnesium, zinc, copper, a source of omega-3 fatty acids and one or more pharmaceutically acceptable vehicles; and a second outer coating that encapsulates a second filler composition comprising a laxative and one or more pharmaceutically acceptable carriers and wherein the first filler composition comprises at least 1100 IU of vitamin A, at least 60 mg of vitamin C, at least 1000 IU of vitamin D, at least 20 IU of vitamin E, at least 1.6 mg of vitamin B1, at least 1.8 mg of vitamin B2, at least 15 mg of vitamin B3, at least 1 mg of vitamin B9, at least 25 pg of vitamin B12, at least 90 mg of iron, at least 150 pg of iodine, at least 20 mg of magnesium, at least 25 mg of zinc, at least 2 mg of copper, and at least 400 mg from source of omega-3 fatty acids.
[007] La patente WO2011/150395 reporta preparaciones y composiciones que comprenden una lactoferrina aislada y una mezcla nutricional y que no incluye una fuente inorgánica de una cantidad biológicamente efectiva de hierro. En realizaciones particulares, se proporcionan preparaciones y composiciones que comprenden una lactoferrina aislada y una mezcla nutricional que comprende al menos ácido fólico y vitamina B6 en cantidades suficientes para suplementar los requerimientos dietarios diarios de un adulto, incluido mujeres embarazadas, bebés o niños, en donde la mezcla nutricional comprende además una o más vitaminas seleccionadas de ácido fólico, vitamina B6, vitamina B12, biotina, tiamina, riboflavina, niacina, vitamina B5, vitamina A, vitamina C, vitamina D y vitamina E y uno o más minerales seleccionados de calcio, cromo, cloruro, cobre, yoduro, fluoruro, magnesio, manganeso, molibdeno, potasio, fósforo, selenio, sodio y zinc. [007] Patent WO2011 / 150395 reports preparations and compositions that comprise an isolated lactoferrin and a nutritional mixture and that do not include an inorganic source of a biologically effective amount of iron. In particular embodiments, preparations and compositions are provided comprising an isolated lactoferrin and a nutritional mixture comprising at least folic acid and vitamin B6 in amounts sufficient to supplement the daily dietary requirements of an adult, including pregnant women, infants or children, wherein the nutritional mix further comprises one or more vitamins selected from folic acid, vitamin B6, vitamin B12, biotin, thiamine, riboflavin, niacin, vitamin B5, vitamin A, vitamin C, vitamin D and vitamin E and one or more selected minerals from calcium , Chromium, Chloride, Copper, Iodide, Fluoride, Magnesium, Manganese, Molybdenum, Potassium, Phosphorus, Selenium, Sodium and Zinc.
[008] La patente US2020/0000860 muestra composiciones de emulsión que contienen 1-10% de probióticos y 2-10% de lactoferrina de modo que el total de ambas es 10%, o en el rango de 10% a 15%, y contienen no menos del 2% de proteína mucoadhesiva, como la lactoferrina. También proporciona polvos que se preparan secando por pulverización las emulsiones, que contienen la lactoferrina y los probióticos. En los polvos proporcionados la proteína mucoadhesiva, como la lactoferrina, interactúa a través de una interacción química o física o se asocia con proteínas de superficie en el microorganismo probiótico. La proteína mucoadhesiva interactúa o se asocia con proteínas de superficie en el microorganismo probiótico para encapsular el microorganismo probiótico, por lo que aumenta la estabilidad del microorganismo. Los polvos y las emulsiones no requieren refrigeración y tienen una vida útil de hasta un año o más. [008] Patent US2020 / 0000860 shows emulsion compositions containing 1-10% probiotics and 2-10% lactoferrin so that the total of both is 10%, or in the range of 10% to 15%, and they contain no less than 2% mucoadhesive protein, such as lactoferrin. It also provides powders that are they prepare by spray drying the emulsions, which contain lactoferrin and probiotics. In the provided powders the mucoadhesive protein, such as lactoferrin, interacts through chemical or physical interaction or associates with surface proteins on the probiotic microorganism. The mucoadhesive protein interacts or associates with surface proteins on the probiotic microorganism to encapsulate the probiotic microorganism, thereby increasing the stability of the microorganism. Powders and emulsions do not require refrigeration and have a shelf life of up to one year or more.
[009] En este sentido, es claro que existe una necesidad no satisfecha aún para productos alimenticios que reporten algún efecto en el sistema inmune o sean inmunomoduladores ante las infecciones bacteriales y/o virales entre las cuales se incluye la COVID-19 que está afectando la población mundial. También, es claro que se requiere de una formulación o producto alimenticio o nutracéutico que logre generar una “barrera inmunitaria” para que los virus, especialmente de la clase de coronavirus, en especial la causada por el SARS-CoV-2 (COVID-19), no tenga acceso ni control al interior de las células de tal modo que no sobreviva y no pueda causar enfermedades en seres vitos, especialmente seres humanos. [009] In this sense, it is clear that there is a need not yet satisfied for food products that report some effect on the immune system or are immunomodulatory against bacterial and / or viral infections, including COVID-19 that is affecting The world population. Also, it is clear that a formulation or food or nutraceutical product is required to generate an "immune barrier" for viruses, especially of the coronavirus class, especially that caused by SARS-CoV-2 (COVID-19 ), does not have access or control to the interior of the cells in such a way that it does not survive and cannot cause disease in vital beings, especially human beings.
[010] En el caso del mecanismo de replicación del COVID-19, se sabe que tiene una proteína llamada 'ACE2’, esta permite abrir la puerta para entrar en las células humanas a través de un mecanismo llave-cerradura para que el coronavirus pueda penetrar y duplicarse en su interior. La maquinaria celular humana utiliza el ARN vírico como propio, continuando la fabricación de proteínas virales como si fueran humanas. A partir de ahí, el material genético vírico y los mismos virus se van multiplicando hasta acabar con las membranas de la célula en cuestión y disponerse a infectar otras células cercanas. [010] In the case of the replication mechanism of COVID-19, it is known that it has a protein called 'ACE2', this allows to open the door to enter human cells through a key-lock mechanism so that the coronavirus can penetrate and duplicate within it. The human cellular machinery uses viral RNA as its own, continuing to manufacture viral proteins as if they were human. From there, the viral genetic material and the viruses themselves multiply until they destroy the membranes of the cell in question and prepare to infect other nearby cells.
[011] Para alcanzar este objetivo, ALSEC realizó de manera preliminar estudios in silico, es decir, simulaciones con software molecular para la predicción del efecto inhibitorio de moléculas bioactivas presentes en extractos de plantas y proteínas lácteas contra el virus SARS-CoV-2. Los resultados demostraron que las moléculas evaluadas tienen capacidad inhibitoria en comparación con medicamentos retrovirales disponibles comercialmente (i.e. Nelfinavir). Posterior a estos estudios, se comienza a evaluar en un modelo in vitro en animales (por ejemplo, en monos) el efecto combinado o no de la aplicación de dichos biocompuestos frente a virus como el SARS-CoV-2 (COVID-19) y otros, en tejidos de riñón sobre la citotoxicidad y capacidad de inhibición. [011] To achieve this objective, ALSEC carried out preliminary in silico studies, that is, simulations with molecular software to predict the effect inhibitory of bioactive molecules present in plant extracts and milk proteins against the SARS-CoV-2 virus. The results demonstrated that the tested molecules have inhibitory capacity compared to commercially available retroviral drugs (ie Nelfinavir). After these studies, the combined effect or not of the application of said biocomposites against viruses such as SARS-CoV-2 (COVID-19) and others, in kidney tissues on cytotoxicity and inhibition capacity.
[012] En este sentido, la presente invención reporta una novedosa y promisoria formulación de un suplemento nutricional o producto alimenticio que está compuesto por una mezcla balanceada de proteínas, aceites vegetales, vitaminas y minerales y como bioingredientes: lactoferrina, probióticos, omega 3 y 6 y aceites, por ejemplo extracto de cannabis, que están directamente relacionados con el fortalecimiento del sistema inmune, en donde dicha formulación, composición o producto alimenticio fortalece y/o regula el sistema inmunológico de los consumidores con una dieta rica en antioxidantes, vitaminas, minerales y otros compuestos bioactivos como probióticos, lactoferrina, omega 3, omega 6 y omega 9, permitiendo además, activar el mecanismo de inhibición en las células para evitar el ingreso y replicación de virus tales como el SARS-CoV2 (COVID-19), entre otros. [012] In this sense, the present invention reports a novel and promising formulation of a nutritional supplement or food product that is composed of a balanced mixture of proteins, vegetable oils, vitamins and minerals and as bio-ingredients: lactoferrin, probiotics, omega 3 and 6 and oils, for example cannabis extract, which are directly related to strengthening the immune system, where said formulation, composition or food product strengthens and / or regulates the immune system of consumers with a diet rich in antioxidants, vitamins, minerals and other bioactive compounds such as probiotics, lactoferrin, omega 3, omega 6 and omega 9, also allowing to activate the inhibition mechanism in cells to prevent the entry and replication of viruses such as SARS-CoV2 (COVID-19), among others.
[013] Las formulaciones, composiciones o productos alimenticios, nutracéuticos o suplemento dietario de la presente invención estimulan la producción de proteínas fundamentales para el buen desarrollo y funcionamiento del sistema inmunológico traduciéndose en una respuesta rápida frente a una infección y disminuyendo de manera significativa la gravedad de la sintomatología asociada al virus con el resultado adicional de mitigar el contagio del o de los virus en la población con mayor riesgo de exposición. [013] The formulations, compositions or food, nutraceutical or dietary supplement products of the present invention stimulate the production of fundamental proteins for the proper development and functioning of the immune system, resulting in a rapid response to infection and significantly reducing severity. of the symptoms associated with the virus with the additional result of mitigating the contagion of the virus (s) in the population with the highest risk of exposure.
RESUMEN DE LA INVENCIÓN [014] La presente invención hace referencia a un producto, el cual es una composición o formulación o suplemento dietario para la industria alimenticia y farmacológica para la prevención y reducción de riesgo de enfermedades asociadas con inmunodeficiencias e infecciones virales causadas por virus tales como coronavirus Sars-Covid 2 (Covid-19) en donde los componentes de la composición o formulación o producto de acuerdo con la presente invención, son lactoferrina entre 3.00% y 4.00% en peso de la composición total, cannabidiol (CBD) en una proporción de 0.05% a 1.00% en peso de la composición total, aceite de girasol alto oleico entre 12.00% en peso, aceite de maíz entre un 8.00% y 9.00% en peso, aceite de girasol entre un 5.00% y 6.11% en peso, aceite de linaza entre un 3.00% y 4.00% en peso, aceite de pescado entre un 0.20% y 0.30%, fructooligosacáridos -FOS entre un 16.00% y 17.00% en peso, caseinato de calcio entre un 15.00% y 16.00% en peso, caseinato de sodio entre un 1.97% y 2.50% en peso, maltodextrina entre un 15.00% y 16.00% en peso, almidón modificado entre un 12.00% y 13.00% en peso; lecitina de soya entre un 0.40 y 0.60% en peso; dextrosa entre un 0.50% y 1.00% en peso, polidextrosa entre un 1.00% y 1.50% en peso, monoglicéridos destilados entre 0.50% y 1.00% en peso, fosfato dipotásico entre 0.50% y 0.70% en peso; dióxido de silicio entre 0.30% y 0.40% en peso, dióxido de titanio entre 0.020% y 0.022% en peso, tocoferoles (gamma, delta, alfa y beta) entre 0.090% y 0.150% en peso, ácido ascórbico entre 0.090% y 0.150% en peso, carragenano entre un 0.050% y 0.070% en peso, éster de ácido de monodiglicérido diacetil tartárico entre 0.040% y 0.060% en peso y probióticos (Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans) entre un 0.050 y 0.090% en peso. SUMMARY OF THE INVENTION [014] The present invention refers to a product, which is a composition or formulation or dietary supplement for the food and pharmacological industry for the prevention and risk reduction of diseases associated with immunodeficiencies and viral infections caused by viruses such as coronavirus Sars -Covid 2 (Covid-19) where the components of the composition or formulation or product according to the present invention are lactoferrin between 3.00% and 4.00% by weight of the total composition, cannabidiol (CBD) in a proportion of 0.05 % to 1.00% by weight of the total composition, high oleic sunflower oil between 12.00% by weight, corn oil between 8.00% and 9.00% by weight, sunflower oil between 5.00% and 6.11% by weight, flaxseed between 3.00% and 4.00% by weight, fish oil between 0.20% and 0.30%, fructooligosaccharides -FOS between 16.00% and 17.00% by weight, calcium caseinate between 15.00% and 16.00% by weight, sodium between 1.97% and 2. 50% by weight, maltodextrin between 15.00% and 16.00% by weight, modified starch between 12.00% and 13.00% by weight; soy lecithin between 0.40 and 0.60% by weight; dextrose between 0.50% and 1.00% by weight, polydextrose between 1.00% and 1.50% by weight, distilled monoglycerides between 0.50% and 1.00% by weight, dipotassium phosphate between 0.50% and 0.70% by weight; silicon dioxide between 0.30% and 0.40% by weight, titanium dioxide between 0.020% and 0.022% by weight, tocopherols (gamma, delta, alpha and beta) between 0.090% and 0.150% by weight, ascorbic acid between 0.090% and 0.150 % by weight, carrageenan between 0.050% and 0.070% by weight, diacetyl tartaric monodiglyceride acid ester between 0.040% and 0.060% by weight and probiotics (Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacillus lactis, Bacillus cousins) 0.050 and 0.090% by weight.
DESCRIPCIÓN DE LAS FIGURAS [015] La figura 1 muestra el resultado del ensayo de viabilidad celular realizado con una composición o producto final de acuerdo con los ejemplos proporcionados en la presente invención. DESCRIPTION OF THE FIGURES [015] Figure 1 shows the result of the cell viability test carried out with a composition or final product according to the examples provided in the present invention.
[016] La figura 2 muestra el resultado de la actividad antiviral medido por MTT de una composición o producto final de acuerdo con los ejemplos proporcionados en la presente invención. [016] Figure 2 shows the result of the antiviral activity measured by MTT of a composition or final product according to the examples provided in the present invention.
[017] La figura 3 muestra el resultado de un ensayo de viabilidad celular medida por MTT para células vivas expuestas a diferentes concentraciones de CBD. [017] Figure 3 shows the result of a cell viability assay measured by MTT for live cells exposed to different concentrations of CBD.
[018] La figura 4 muestra el resultado de un ensayo de actividad antiviral medida por MTT para células cuando se empleó el virus SARS-CoV-2. [018] Figure 4 shows the result of an antiviral activity assay measured by MTT for cells when the SARS-CoV-2 virus was used.
[019] La figura 5 muestra un ensayo de plaqueo en donde se muestran las placas formadas por el SARS-CoV-2 obtenido del sobrenadante del control del virus sin tratamiento y del tratamiento con CBD (6 uM) del ensayo antiviral. [019] Figure 5 shows a plating assay showing the plaques formed by SARS-CoV-2 obtained from the supernatant of the control of the virus without treatment and of the treatment with CBD (6 uM) of the antiviral assay.
BREVE DESCRIPCIÓN DE LA INVENCIÓN BRIEF DESCRIPTION OF THE INVENTION
[020] De acuerdo con la presente invención, se proporciona un producto alimenticio el cual es una composición o formulación alimenticia o producto nutracéutico con efecto inmunomodulador donde la selección de sus componentes está basada en fundamentos científicos y en modelación informática, en donde el producto o productos alimenticios de la invención tienen efectos de suplementación dirigida a nutrientes dietéticos específicos para alterar y mejorar aspectos de la función inmune ofreciendo una actividad inmunorreguladora debido a la participación de nutrientes o de sus productos en la comunicación dentro y entre leucocitos. [020] According to the present invention, a food product is provided which is a food composition or formulation or nutraceutical product with an immunomodulatory effect where the selection of its components is based on scientific foundations and computer modeling, where the product or Food products of the invention have supplementation effects directed at specific dietary nutrients to alter and improve aspects of immune function offering an immunoregulatory activity due to the participation of nutrients or their products in communication within and between leukocytes.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN DETAILED DESCRIPTION OF THE INVENTION
[021] Los productos alimenticios, composiciones o formulaciones de acuerdo con la presente invención, tienen efectos sobre el sistema inmune, es decir, tienen propiedades inmunomoduladoras ante las infecciones virales, entre las cuales se incluyen pero no se limitan a la COVID-19, en donde el producto o formulación puede ser un suplemento nutricional que está compuesto por una mezcla balanceada de proteínas, aceites vegetales, vitaminas, minerales y como bioingredientes: lactoferrina, probióticos, omega 3, omega 6 y omega 9 y opcionalmente, aceites por ejemplo, cannabidiol (CBD), todos ellos que están directamente relacionados con el fortalecimiento del sistema inmunológico. [021] Food products, compositions or formulations according to the present invention, have effects on the immune system, that is, they have immunomodulatory properties against viral infections, among which are include but are not limited to COVID-19, where the product or formulation can be a nutritional supplement that is composed of a balanced mixture of proteins, vegetable oils, vitamins, minerals and as bio-ingredients: lactoferrin, probiotics, omega 3, omega 6 and omega 9 and optionally, oils for example, cannabidiol (CBD), all of which are directly related to strengthening the immune system.
[022] De acuerdo con el contexto de la presente invención, se definen a continuación las siguientes expresiones a fin de entender que las formulaciones o composiciones alimenticias de la invención tienen aplicaciones en diferentes clases de productos. En efecto, de acuerdo con la invención, se contempla la posibilidad que la composición o formulación alimenticia haga parte de un producto alimentario que se define como todo alimento que mediante procesos industriales químicos y/o físicos de tratamiento, manipulación, conservación y envasado resulte en un producto óptimo para el consumo humano. También, la composición o formulación alimenticia puede hacer parte de un suplemento alimentario, el cual se define como una formulación que se toma por la boca y que puede contener uno o varios ingredientes alimentarios adicionales (como vitaminas, minerales, hierbas, aminoácidos y enzimas entre otros). [022] In accordance with the context of the present invention, the following expressions are defined below in order to understand that the formulations or food compositions of the invention have applications in different classes of products. Indeed, according to the invention, the possibility is contemplated that the food composition or formulation is part of a food product that is defined as any food that, through chemical and / or physical industrial processes of treatment, handling, conservation and packaging, results in an optimal product for human consumption. Also, the composition or food formulation can be part of a food supplement, which is defined as a formulation that is taken by mouth and that can contain one or more additional food ingredients (such as vitamins, minerals, herbs, amino acids and enzymes among others).
[023] También, la composición o formulación alimenticia puede hacer parte de un suplemento dietario el cual se puede definir como cualquier sustancia que se puede ingerir para mejorar la salud o el bienestar y que incluyen vitaminas, minerales y extractos de hierbas y con formas comunes de píldoras o cápsulas. También, la composición o formulación alimenticia puede hacer parte de un producto nutracéutico que se define como cualquier alimento o ingrediente de alimentos que ejerce acción benéfica en la salud y la prevención de enfermedades y también la formulación de la presente invención puede hacer parte de alimentos funcionales que se pueden definir como aquellos que además de sus efectos nutricionales habituales y tienen compuestos biológicos (nutrientes o no nutrientes) con efecto selectivo positivo sobre una o varias funciones del organismo y que presentan efectos beneficiosos para la salud, mejorándola o reduciendo el riesgo de sufrir enfermedades. [023] Also, the food composition or formulation can be part of a dietary supplement which can be defined as any substance that can be ingested to improve health or well-being and that include vitamins, minerals and herbal extracts and with common forms of pills or capsules. Also, the food composition or formulation can be part of a nutraceutical product that is defined as any food or food ingredient that exerts beneficial action in health and disease prevention and also the formulation of the present invention can be part of functional foods that can be defined as those that in addition to their usual nutritional effects and have biological compounds (nutrients or non-nutrients) with a positive selective effect on one or more functions of the body and that present beneficial effects on health, improving it or reducing the risk of suffering from diseases.
[024] La presente invención también considera cualquier otra presentación de la composición o formulación como producto alimenticio, tal como gomas comestibles, barras comestibles energéticas, meriendas o botanas saludables (snacks), galletas y productos de panadería, entre otros. [024] The present invention also considers any other presentation of the composition or formulation as a food product, such as edible gums, edible energy bars, healthy snacks, cookies and bakery products, among others.
[025] El producto alimenticio o composición o formulación con efecto inmunomodulador de acuerdo con la presente intención comprende moléculas bioactivas presentes en extractos de plantas como el cannabis, en especial con el cannabidiol; las proteínas lácteas como la lactoferrina y caseinato de calcio; vitaminas A, B6, B9, B12, C, D3 y E; minerales de magnesio, cobre, zinc, selenio y probióticos, en donde todos estos componentes tienen evidencia de ser promotores nutricionales con beneficios inmunológicos o ser compuestos con capacidad de combatir infecciones virales. [025] The food product or composition or formulation with immunomodulatory effect according to the present intention comprises bioactive molecules present in extracts of plants such as cannabis, especially with cannabidiol; dairy proteins such as lactoferrin and calcium caseinate; vitamins A, B6, B9, B12, C, D3 and E; minerals of magnesium, copper, zinc, selenium and probiotics, where all these components have evidence of being nutritional promoters with immunological benefits or being compounds with the ability to fight viral infections.
[026] Es así, por ejemplo, que se sabe que existe un potencial terapéutico del cannabis medicinal, en especial del compuesto cannabinoide llamado cannabidol (CBD) y ha sido evaluado y validado para ser usado como tratamiento de diversas enfermedades crónicas o virales como La Hepatitis y el VIH. También, se sabe que la lactoferrina, es una glicoproteína multifuncional considerada como una sustancia de la inmunidad innata, ya que estimula o inhibe diversos componentes humorales y celulares implicados en la prevención y resolución de infecciones microbianas y virales. A partir del mecanismo de unión entre esta sustancia y los proteoglicanos de Heparán sulfato (HSPG), receptores de la membrana celular, evita el ingreso del virus en la célula y los probióticos pueden modular la inflamación que tiene lugar en el pulmón como consecuencia de una infección pulmonar. [027] La invención también comprende el proceso para la producción de la composición o formulación o producto alimenticio en forma de nanopartículas, en donde el proceso tiene las siguientes etapas: [026] Thus, for example, it is known that there is a therapeutic potential of medicinal cannabis, especially the cannabinoid compound called cannabidol (CBD) and it has been evaluated and validated to be used as a treatment for various chronic or viral diseases such as La Hepatitis and HIV. Also, it is known that lactoferrin is a multifunctional glycoprotein considered as a substance of innate immunity, since it stimulates or inhibits various humoral and cellular components involved in the prevention and resolution of microbial and viral infections. From the binding mechanism between this substance and Heparan sulfate proteoglycans (HSPG), receptors of the cell membrane, it prevents the entry of the virus into the cell and probiotics can modulate the inflammation that takes place in the lung as a consequence of a lung infection. [027] The invention also comprises the process for the production of the composition or formulation or food product in the form of nanoparticles, wherein the process has the following stages:
[028] Microencapsulación, nanotecnología y secado por aspersión de los aceites vegetales y aceites de origen animal que son fuentes de omega 3, 6 y 9 a un estado sólido mediante secado por aspersión (polvo) en donde la fuente de los aceites se selecciona de aceite de pescado, cañóla, girasol, maíz y linaza. Este proceso de microencapsulación se describe en la patente de invención colombiana C014279296 de Alimentos Secos ALSEC S.A.S, la cual se incorpora en la presente descripción en su totalidad como referencia. [028] Microencapsulation, nanotechnology and spray drying of vegetable oils and oils of animal origin that are sources of omega 3, 6 and 9 to a solid state by spray drying (powder) where the source of the oils is selected from fish oil, rapeseed, sunflower, corn and linseed. This microencapsulation process is described in Colombian invention patent C014279296 by Alimentos Secos ALSEC S.A.S, which is incorporated in the present description in its entirety by reference.
[029] Dosificación: comprende las etapas de pesaje en donde para los micronutrientes, tales como vitaminas y minerales, se debe tener más cuidado en su pesaje ya que se requiere de equipos de mayor precisión. Para los macronutrientes tales como proteínas, carbohidratos y aceites, éstos pueden ser pesados en sistemas convencionales de pesado teniendo siempre presente la exactitud en las cantidades, la cuales dependen de la regulación que exista en el país donde se desee comercializar el producto y la funcionalidad de los componentes de acuerdo con lo reportado para obtener un beneficio nutricional. [029] Dosage: includes the weighing stages where for micronutrients, such as vitamins and minerals, more care must be taken in weighing them since more precision equipment is required. For macronutrients such as proteins, carbohydrates and oils, these can be weighed in conventional weighing systems, always keeping in mind the accuracy of the quantities, which depend on the regulations that exist in the country where the product is to be marketed and the functionality of the the components as reported to obtain a nutritional benefit.
[030] Mezcla: Luego de tener un balance nutricional entre los ingredientes (micronutrientes y macronutrientes) se realiza una mezcla entre ellos, por ejemplo: agentes encapsulantes, aceites vegetales y animales, proteínas lácteas, emulsificantes (mono y diglicéridos), reguladores de pH y acidez, antioxidantes, endulzantes naturales, vitaminas y minerales, probióticos, saborizantes naturales, en este orden o en un orden definido cuando se realiza la estandarización y validación del proceso de mezclado. [030] Mixing: After having a nutritional balance between the ingredients (micronutrients and macronutrients), a mixture is made between them, for example: encapsulating agents, vegetable and animal oils, milk proteins, emulsifiers (mono and diglycerides), pH regulators and acidity, antioxidants, natural sweeteners, vitamins and minerals, probiotics, natural flavorings, in this order or in a defined order when standardizing and validating the mixing process.
[031] Empaque final que hace referencia al producto terminado luego de la mezcla, empacado para su comercialización. [032] La presente invención proporciona una composición, formulación o producto para aplicación en la prevención y/o alivio de síntomas de infecciones del tracto respiratorio en personas comprometidas inmunológicamente. [031] Final packaging that refers to the finished product after mixing, packed for commercialization. [032] The present invention provides a composition, formulation or product for application in the prevention and / or relief of symptoms of respiratory tract infections in immunologically compromised persons.
[033] La presente invención además proporciona un método para prevenir la infección del tracto respiratorio y/o síntomas de dicha enfermedad, en donde el método comprende la administración de una cantidad efectiva de la composición, formulación o producto de la presente invención. [033] The present invention further provides a method for preventing respiratory tract infection and / or symptoms of said disease, wherein the method comprises administering an effective amount of the composition, formulation or product of the present invention.
[034] La presente invención se basa en el hecho que sorprendentemente, la composición o formulación tiene un efecto inmunomodulador gracias a la selección de los componentes de dicha composición. A fin de obtener los beneficios de prevención y mitigación de síntomas de enfermedades del tracto respiratorio de personas infectadas, la composición puede estar en cualquier forma adecuada, tal como, por ejemplo, una composición nutricional, un suplemento dietarios, una bebida, un alimento o una composición farmacéutica en donde dicha composición farmacéutica puede ser una forma galénica tal como una tableta, cápsula, pastilla o un polvo en un sachet o un líquido, en donde la composición puede estar con excipientes o portadores farmacéuticamente aceptables. [034] The present invention is based on the fact that surprisingly, the composition or formulation has an immunomodulatory effect thanks to the selection of the components of said composition. In order to obtain the benefits of preventing and alleviating symptoms of diseases of the respiratory tract of infected persons, the composition may be in any suitable form, such as, for example, a nutritional composition, a dietary supplement, a beverage, a food or a pharmaceutical composition wherein said pharmaceutical composition may be a galenic form such as a tablet, capsule, lozenge or a powder in a sachet or liquid, wherein the composition may be with pharmaceutically acceptable excipients or carriers.
[035] El producto alimenticio con efecto inmunomodulador de acuerdo con la presente invención, puede estar en la forma de una composición nutricional en polvo por porción o en polvo en determinadas cantidades de porciones, un suplemento dietario en polvo por porción o en polvo en determinadas cantidades de porciones, o las anteriores en presentación líquida, un alimento o una composición farmacéutica. [035] The food product with immunomodulatory effect according to the present invention may be in the form of a nutritional composition in powder per serving or in powder in certain amounts of servings, a dietary supplement in powder per serving or in powder in certain amounts of servings, or the above in liquid presentation, a food or a pharmaceutical composition.
[036] El producto alimenticio con efecto inmunomodulador de acuerdo con la presente invención cuando es una formulación farmacéutica tiene la forma que se selecciona de una tableta, cápsula, pastilla, un polvo en una porción o en varias porciones y una porción en presentación líquida; en donde la formulación comprende excipientes o portadores farmacéuticamente aceptables. [036] The food product with immunomodulatory effect according to the present invention when it is a pharmaceutical formulation has the form that is selected from a tablet, capsule, lozenge, a powder in one portion or in several portions and a portion in liquid presentation; wherein the formulation comprises pharmaceutically acceptable excipients or carriers.
[037] Ahora, haciendo mención a las proporciones de los componentes de la composición o formulación o producto de acuerdo con la presente invención, la composición comprende lactoferrina entre 3.00% y 4.00% en peso de la composición total, cannabidiol (CBD) en una proporción de 0.05% a 1.00% en peso de la composición total, aceite de girasol alto oleico en un porcentaje de 12.00% en peso de la composición total, aceite de maíz entre un 8.00% y 9.00% en peso de la composición total, aceite de girasol entre un 5.00% y 6.11% en peso de la composición total, aceite de linaza entre un 3.00% y 4.00% en peso de la composición total, aceite de pescado entre un 0.20% y 0.30%, fructooligosacáridos -FOS entre un 16.00% y 17.00% en peso de la composición total, caseinato de calcio entre un 15.00% y 16.00% en peso de la composición total, caseinato de sodio entre un 1 .97% y 2.50% en peso de la composición total, maltodextrina entre un 15.00% y 16.00% en peso de la composición total, almidón modificado entre un 12.00% y 13.00% en peso de la composición total, lecitina de soya entre un 0.40 y 0.60% en peso de la composición total, dextrosa entre un 0.50% y 1.00% en peso de la composición total, polidextrosa entre un 1.00% y 1.50% en peso de la composición total, monoglicéridos destilados entre 0.50% y 1.00% en peso de la composición total, fosfato dipotásico entre 0.50% y 0.70% en peso de la composición total, dióxido de silicio entre 0.30% y 0.40% en peso de la composición total, dióxido de titanio entre 0.020% y 0.022% en peso de la composición total, tocoferoles (gamma, delta, alfa y beta) entre 0.090% y 0.150% en peso de la composición total, ácido ascórbico entre 0.090% y 0.150% en peso de la composición total, carragenano entre un 0.050% y 0.070% en peso de la composición total, éster de ácido de monodiglicérido diacetil tartárico entre 0.040% y 0.060% en peso de la composición total y probióticos (Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans) entre un 0.050 y 0.090% en peso de la composición total. [038] La composición o formulación o suplemento dietario de acuerdo con la presente invención, también puede comprender endulzantes como, por ejemplo, Stevia entre un 0.050% y 0.100% en peso de la composición total. [037] Now, making mention of the proportions of the components of the composition or formulation or product according to the present invention, the composition comprises lactoferrin between 3.00% and 4.00% by weight of the total composition, cannabidiol (CBD) in a proportion from 0.05% to 1.00% by weight of the total composition, high oleic sunflower oil in a percentage of 12.00% by weight of the total composition, corn oil between 8.00% and 9.00% by weight of the total composition, oil sunflower between 5.00% and 6.11% by weight of the total composition, linseed oil between 3.00% and 4.00% by weight of the total composition, fish oil between 0.20% and 0.30%, fructooligosaccharides -FOS between 16.00 % and 17.00% by weight of the total composition, calcium caseinate between 15.00% and 16.00% by weight of the total composition, sodium caseinate between 1.97% and 2.50% by weight of the total composition, maltodextrin between a 15.00% and 16.00% by weight of the total composition, modified starch between 12.00% and 13.00% by weight of the total composition, soy lecithin between 0.40 and 0.60% by weight of the total composition, dextrose between 0.50% and 1.00% by weight of the total composition, polydextrose between 1.00 % and 1.50% by weight of the total composition, distilled monoglycerides between 0.50% and 1.00% by weight of the total composition, dipotassium phosphate between 0.50% and 0.70% by weight of the total composition, silicon dioxide between 0.30% and 0.40% by weight of the total composition, titanium dioxide between 0.020% and 0.022% by weight of the total composition, tocopherols (gamma, delta, alpha and beta) between 0.090% and 0.150% by weight of the total composition, ascorbic acid between 0.090 % and 0.150% by weight of the total composition, carrageenan between 0.050% and 0.070% by weight of the total composition, diacetyl tartaric monodiglyceride acid ester between 0.040% and 0.060% by weight of the total composition and probiotics (Lactobacillus acidophilus , Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans) between 0.050 and 0.090% by weight of the total composition. [038] The composition or formulation or dietary supplement according to the present invention may also comprise sweeteners such as, for example, Stevia between 0.050% and 0.100% by weight of the total composition.
[039] La composición o formulación o suplemento dietario de acuerdo con la presente invención, también comprende reguladores de pH, tal como, por ejemplo, citrato de potasio entre un 0.040% y 0.050% en peso de la composición total. [039] The composition or formulation or dietary supplement according to the present invention also comprises pH regulators, such as, for example, potassium citrate between 0.040% and 0.050% by weight of the total composition.
[040] La composición o formulación o compuesto dietario de acuerdo con la presente invención, también comprende saborizantes y aromatizantes naturales o artificiales, tal como, por ejemplo, vainilla, en un porcentaje de 1.70% en peso. [040] The composition or formulation or dietary compound according to the present invention also comprises natural or artificial flavors and flavorings, such as, for example, vanilla, in a percentage of 1.70% by weight.
[041] En una modalidad de la invención, la composición o formulación o suplemento dietario puede comprender además omega 3, omega 6 y omega 9 solos o en combinación en una proporción de 0.05% a 1.00% en peso de la composición, en donde la fuente de omega 3 puede ser aceite vegetal y/o aceite de pescado (DHA- ácido docosahexaenoico; y EPA- ácido eicosapentaenoico), y contiene además fuente de omega 6 y omega 9 a partir de aceite vegetal. Estas cantidades de omegas resultan de un balance nutricional que se hace a partir de la suma de contenido de omega que tiene el aceite de pescado y aceites vegetales (aceite de girasol, aceite de maíz, aceite de linaza, aceite de girasol alto oleico). [041] In one embodiment of the invention, the composition or formulation or dietary supplement may further comprise omega 3, omega 6 and omega 9 alone or in combination in a proportion of 0.05% to 1.00% by weight of the composition, wherein the A source of omega 3 can be vegetable oil and / or fish oil (DHA- docosahexaenoic acid; and EPA- eicosapentaenoic acid), and it also contains a source of omega 6 and omega 9 from vegetable oil. These amounts of omegas result from a nutritional balance that is made from the sum of omega content in fish oil and vegetable oils (sunflower oil, corn oil, linseed oil, high oleic sunflower oil).
[042] La composición o formulación o suplemento dietario de acuerdo con la presente invención, también comprende una mezcla de vitaminas y minerales que está entre un 2.50% y 3.50% en peso; en donde dicha mezcla puede comprender vitamina A entre 446 y 604 mcg, vitamina D3 entre 170 y 230 Ul, vitamina E entre 5.1 y 6.9 mg, vitamina B6 entre 0.77 y 1.04 mg, ácido fólico entre 119 y 161 mcg, vitamina B12 entre 1.53 y 2.1 mcg, vitamina C entre 28.1 y 38.0 mg, cobre entre 510 y 690 mcg, magnesio entre 170 y 230 mg, selenio entre 26.8 y 36.2 mcg y zinc entre 4.51 y 6.10 mg. Para el caso de los minerales, estos provienen de sales y óxidos tales como sulfatos, carbonatos y gluconatos entre otros. [043] En una modalidad de la invención, la lactoferrina que hace parte de la composición puede ser lactoferrina proveniente de cualquier fuente conocida disponible de manera comercial y de grado alimenticio. [042] The composition or formulation or dietary supplement according to the present invention also comprises a mixture of vitamins and minerals that is between 2.50% and 3.50% by weight; where said mixture can comprise vitamin A between 446 and 604 mcg, vitamin D3 between 170 and 230 IU, vitamin E between 5.1 and 6.9 mg, vitamin B6 between 0.77 and 1.04 mg, folic acid between 119 and 161 mcg, vitamin B12 between 1.53 and 2.1 mcg, vitamin C between 28.1 and 38.0 mg, copper between 510 and 690 mcg, magnesium between 170 and 230 mg, selenium between 26.8 and 36.2 mcg and zinc between 4.51 and 6.10 mg. In the case of minerals, these come from salts and oxides such as sulfates, carbonates and gluconates, among others. [043] In one embodiment of the invention, the lactoferrin that is part of the composition can be lactoferrin from any known commercially available food grade source.
[044] En una modalidad de la invención, los probióticos pueden ser Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans o mezclas de los mismos. [044] In one embodiment of the invention, the probiotics can be Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans, or mixtures thereof.
[045] Los aceites de girasol alto oleico, aceite de maíz, aceite de girasol y aceite de linaza pueden ser disponibles de manera comercial y de grado alimenticio. [045] High oleic sunflower oils, corn oil, sunflower oil and linseed oil can be commercially available and food grade.
[046] La composición o formulación o suplemento dietario se realiza por mezclado, este proceso es una operación unitaria altamente utilizada en el procesamiento de alimentos, en la cual se obtiene una distribución homogénea de las materias primas por medios mecánicos. Se usan diferentes diseños de equipos como son: mezcladores de volteo que pueden ser un cilindro horizontal, doble cono, cono oblicuo, cono en V o cono en Y; mezclador de cintas donde dichas cintas metálicas son giratorias en forma helicoidal; mezcladores verticales de tornillos que consiste en que el tornillo gira sobre su eje de forma longitudinal y el turbo mezclador, en el cual el producto sea removido por el aspa inferior permitiendo lanzar el producto hacia el picador, triturando y eliminando así los grumos en la mezcla de polvos. [046] The composition or formulation or dietary supplement is made by mixing, this process is a unit operation highly used in food processing, in which a homogeneous distribution of raw materials is obtained by mechanical means. Different equipment designs are used such as: turning mixers that can be a horizontal cylinder, double cone, oblique cone, V cone or Y cone; ribbon mixer where said metallic ribbons are rotatable in a helical way; vertical screw mixers that consists of the screw turning longitudinally on its axis and the turbo mixer, in which the product is removed by the lower blade allowing the product to be thrown towards the chopper, crushing and thus eliminating the lumps in the mixture of powders.
[047] En el proceso de mezclado es importante caracterizar cada una de las materias primas que componen la composición, formulación o suplemento, se debe identificar el tamaño de partícula, densidad, higroscopicidad, adhesividad y susceptibilidad a cargas electrostáticas. El tamaño de partícula es el factor de mayor influencia para obtener una mezcla uniforme de los productos en polvo y evitar que ocurra segregación, a medida que aumenta el tamaño de partícula de cada materia prima se requiere más tiempo para obtener un mezclado completamente uniforme, de tal modo que el coeficiente de variación entre las muestras de cada lote sea menor. [048] Primero se identifica la proporción de cada materia prima para seleccionar en que parte del proceso son adicionados, el componente que se encuentra en menor proporción dificulta la incorporación en la homogeneidad de la mezcla y el de mayor proporción genera facilidad, el cual permite pre-dispersar los componentes minoritarios, por lo cual, en un aspecto de la invención, se prefiere hacer una pre mezcla de los componentes que están en menor proporción y luego mezclarlos con los componentes que están en mayor proporción dentro de la composición porcentual o producto final. [047] In the mixing process it is important to characterize each of the raw materials that make up the composition, formulation or supplement, the particle size, density, hygroscopicity, adhesiveness and susceptibility to electrostatic charges must be identified. The particle size is the factor of greatest influence to obtain a uniform mixture of the powdered products and prevent segregation from occurring, as the particle size of each raw material increases, more time is required to obtain a completely uniform mixing, of such that the coefficient of variation between the samples of each lot is lower. [048] First, the proportion of each raw material is identified to select in which part of the process they are added, the component that is in the smallest proportion makes it difficult to incorporate into the homogeneity of the mixture and the one with the highest proportion generates ease, which allows pre-dispersing the minority components, therefore, in one aspect of the invention, it is preferred to pre-mix the components that are in a lower proportion and then mix them with the components that are in a higher proportion within the percentage composition or product. final.
[049] El tiempo de mezclado y los componentes que se van a incorporar se controlan con exactitud, si se excede, la uniformidad de la mezcla se rompe y comienza a presentarse separación o segregación de los ingredientes. Para determinar el tiempo óptimo, se toman muestras de la mezcla en diferentes tiempos y en las etapas del mezclado; cada muestra se analiza para validar la composición o concentración de los componentes, se tiene en cuenta la desviación estándar de cada lote medida para cada tiempo, se evalúa el funcionamiento del mezclador y eficiencia del mezclado para calcular el tiempo óptimo de mezclado, dado que homogeneidad del producto depende de este factor. [049] The mixing time and the components to be incorporated are precisely controlled, if it is exceeded, the uniformity of the mixture is broken and separation or segregation of the ingredients begins to occur. To determine the optimum time, samples of the mixture are taken at different times and in the mixing stages; Each sample is analyzed to validate the composition or concentration of the components, the standard deviation of each batch measured for each time is taken into account, the operation of the mixer and mixing efficiency are evaluated to calculate the optimal mixing time, given that homogeneity of the product depends on this factor.
EJEMPLOS EXAMPLES
[050] Con la creciente pandemia de la COVID-19 causada por el nuevo y desafiante tratamiento del coronavirus SARS-CoV2 zoonótico, existe una necesidad urgente de nuevas terapias y estrategias de prevención que puedan ayudar a reducir la propagación de la enfermedad y reducir la mortalidad. El bloqueo de la entrada viral y del virus y por lo tanto, la propagación constituyen vías terapéuticas plausibles. Al igual que otros patógenos respiratorios, el SARS-CoV2 se transmite a través de gotitas respiratorias, con potencial de aerosol y diseminación por contacto. Utiliza la entrada mediada por el receptor en el huésped humano a través de la enzima convertidora de angiotensina II (ACE2) que se expresa en el tejido pulmonar, así como en la mucosa oral y nasal, los riñones, los testículos y el tracto gastrointestinal. La modulación de los niveles de ACE2 en estos tejidos de entrada puede resultar una estrategia plausible para disminuir la susceptibilidad a la enfermedad. Dada la actual situación epidemiológica grave y en rápida evolución, se deben considerar todas las oportunidades y vías terapéuticas posibles. El presente estudio es crucial para el análisis futuro de los efectos de la composición o formulación o suplemento dietario de acuerdo con la presente invención y la participación de cannabidiol (CBD) medicinal en la composición de la invención como un producto ideal para la prevención y tratamiento de enfermedades asociadas con infecciones respiratorias, especialmente con SARS-Covid 2 (COVID- 19). [050] With the growing COVID-19 pandemic caused by the challenging new treatment of the zoonotic SARS-CoV2 coronavirus, there is an urgent need for new therapies and prevention strategies that can help reduce the spread of the disease and reduce the mortality. Blocking viral and virus entry and thus spread are plausible therapeutic avenues. Like other respiratory pathogens, SARS-CoV2 is transmitted through respiratory droplets, with the potential for aerosolization and spread by contact. Utilizes receptor-mediated entry into the human host via angiotensin II converting enzyme (ACE2) that is expressed in tissue pulmonary, as well as in the oral and nasal mucosa, the kidneys, the testes and the gastrointestinal tract. Modulation of ACE2 levels in these input tissues may be a plausible strategy to decrease susceptibility to disease. Given the current serious and rapidly evolving epidemiological situation, all possible therapeutic opportunities and avenues should be considered. The present study is crucial for the future analysis of the effects of the composition or formulation or dietary supplement according to the present invention and the participation of medicinal cannabidiol (CBD) in the composition of the invention as an ideal product for prevention and treatment of diseases associated with respiratory infections, especially with SARS-Covid 2 (COVID-19).
Ejemplo 1 Example 1
[051] El presente ejemplo ilustra una modalidad del producto o composición de acuerdo con la presente invención en donde se realiza un bache de los componentes de acuerdo con las siguientes características. Se toma un lote 180 kg de producto para lo cual se utilizaron las siguientes cantidades en peso de acuerdo con los rangos de porcentaje indicados en la presente invención para la composición o producto final:
Figure imgf000018_0001
Figure imgf000019_0001
[051] The present example illustrates an embodiment of the product or composition according to the present invention where a batch of the components is made according to the following characteristics. A 180 kg batch of product is taken for which the following amounts by weight were used according to the percentage ranges indicated in the present invention for the composition or final product:
Figure imgf000018_0001
Figure imgf000019_0001
Ejemplo 2
Figure imgf000019_0002
Figure imgf000020_0001
Example 2
Figure imgf000019_0002
Figure imgf000020_0001
[052] Se realizó la cuantificación de la actividad antiviral in vitro de compuestos naturales sobre el SARS-COV-2, el cual se llevó a cabo mediante un ensayo de viabilidad celular realizado con la composición o producto final (denominado Inmunut) y de acuerdo con la figura 1 , mostró que las concentraciones de 500ug/ml_ o inferiores alcanzaron niveles de viabilidad celular superiores al 80%, en algunos casos alcanzaron el 100% de viabilidad celular, lo que significa que dichas concentraciones poseen muy baja o nula citotoxicidad. Por lo tanto, las concentraciones no citotóxicas que se pueden evaluar para determinar la AAV (Actividad antiviral) del producto Inmunut (composición de acuerdo con la presente invención), son las concentraciones iguales o inferiores a 500ug/MI. [052] The in vitro antiviral activity of natural compounds was quantified on SARS-COV-2, which was carried out by means of a cell viability test carried out with the composition or final product (called Immunut) and according to With figure 1, it showed that concentrations of 500ug / ml_ or lower reached levels of cell viability higher than 80%, in some cases they reached 100% cell viability, which means that these concentrations have very low or no cytotoxicity. Therefore, the non-cytotoxic concentrations that can be evaluated to determine the AAV (Antiviral Activity) of the Immunut product (composition according to the present invention), are the concentrations equal to or less than 500ug / MI.
[053] En este sentido, se realizó el ensayo de actividad antiviral medido por MTT (basado en el cambio de color que ocurre al reducirse la sustancia bromuro de 3- 4,5-dimetiltiazol-2-il-2.5 difeniltetrazolio por la acción de enzimas mitocondriales) del producto Inmunut (producto de acuerdo con la presente invención) y de acuerdo con la figura 2, mostró que la concentración de 500ug/ml_ alcanzó el mayor porcentaje de actividad antiviral, con una media del 46%-85%, seguido por la concentración de 250ug/ml_ y 125ug/ml_, con una actividad antiviral media de 33% y 35%, respectivamente. No se observó diferencia estadísticamente significativa entre estas concentraciones y el control positivo de inhibición Cloroquina, la cual mostró una inhibición media del 73%. [053] In this sense, the antiviral activity assay measured by MTT was carried out (based on the color change that occurs when the substance 3- 4,5-dimethylthiazol-2-yl-2.5-diphenyltetrazolium bromide is reduced by the action of mitochondrial enzymes) of the Immunut product (product according to the present invention) and according to figure 2, it showed that the concentration of 500ug / ml_ reached the highest percentage of antiviral activity, with an average of 46% -85%, followed by the concentration of 250ug / ml_ and 125ug / ml_, with a mean antiviral activity of 33% and 35%, respectively. No statistically significant difference was observed between these concentrations and the Chloroquine inhibition positive control, which showed a mean inhibition of 73%.
[054] Respecto al ensayo de viabilidad celular con el compuesto CBD, en la figura 3 se puede observar que las concentraciones iguales o superiores 12uM mostraron una viabilidad celular inferior al 18%; en contraste, las concentraciones iguales o inferiores a 6uM, mostraron una viabilidad celular superior al 80%; por lo tanto, esta concentración y concentraciones inferiores, fueron seleccionadas para realizar los ensayos antivirales del CBD. El Ensayo de viabilidad celular medida por MTT (figura 3), muestra el porcentaje de células vivas, después del tratamiento con las diferentes concentraciones del compuesto CBD preparado en DMSO (0.4%, concentración final) y posterior a 48h de cultivo celular. La gráfica muestra la media de cada medición y la desviación estándar. Se realizaron 2 experimentos con 4 réplicas cada uno. [054] Regarding the cell viability test with the CBD compound, in figure 3 it can be seen that concentrations equal to or greater than 12uM showed a cell viability less than 18%; in contrast, concentrations equal to or less than 6uM showed a cell viability greater than 80%; therefore, this concentration and lower concentrations were selected to perform the antiviral trials of CBD. The cell viability assay measured by MTT (figure 3) shows the percentage of living cells, after treatment with the different concentrations of the CBD compound prepared in DMSO (0.4%, final concentration) and after 48h of cell culture. The graph shows the mean of each measurement and the standard deviation. 2 experiments were performed with 4 replicates each.
[055] Como se puede ver en la figura 4, el ensayo de actividad antiviral medido por MTT y usando el virus SARS-CoV-2 con una MOI de 0.1 M, se puede observar en la figura 4; se observa que el compuesto CBD a la concentración de 6uM alcanzó la mayor actividad antiviral con una media de 27.4%, seguido por la concentración de 3uM con una media de 12%; no se observó diferencia estadísticamente significativa entre estas concentraciones y el control positivo de inhibición de la replicación viral usado en este experimento o Cloroquina, la cual mostró una inhibición media del 73%; las demás concentraciones no tuvieron un efecto antiviral importante. Porcentaje de actividad antiviral calculada a partir del ensayo MTT de viabilidad celular. La gráfica 4 muestra el porcentaje de AAV del compuesto CBD en las diferentes concentraciones cuando se usó el virus SARS-CoV-2 a una MOI de 0.1. La gráfica muestra la media de cada medición y la desviación estándar. Se realizaron 2 experimentos con 4 réplicas cada uno. CLQ: Cloroquina, control positivo de inhibición de la replicación viral. [055] As can be seen in figure 4, the antiviral activity assay measured by MTT and using the SARS-CoV-2 virus with an MOI of 0.1 M, can be seen in figure 4; It is observed that the CBD compound at the concentration of 6uM reached the highest antiviral activity with an average of 27.4%, followed by the concentration of 3uM with an average of 12%; no statistically significant difference was observed between these concentrations and the positive control of inhibition of viral replication used in this experiment or Chloroquine, which showed a mean inhibition of 73%; the other concentrations did not have a significant antiviral effect. Percentage of antiviral activity calculated from the MTT cell viability assay. Graph 4 shows the percentage of AAV of the CBD compound in the different concentrations when the SARS-CoV-2 virus was used at an MOI of 0.1. The graph shows the mean of each measurement and the standard deviation. 2 experiments were performed with 4 replicates each. CLQ: Chloroquine, positive control for inhibition of viral replication.
[056] Como se muestra en la figura 5, a partir de los sobrenadantes obtenidos en el ensayo de actividad antiviral, a la máxima concentración evaluada del compuesto (6uM), se determinó el título del virus por ensayo de plaqueo. Se puede observar que el título viral en presencia del tratamiento fue en promedio de 8,25x103 UFP/mL, mientras que, en el control de virus sin tratamiento, el título viral fue en promedio de 1 ,08x105 UFP/mL, lo que significa una reducción del 92.4% de las partículas virales infecciosas de SARS- CoV-2 por el compuesto CBD. En la figura 5 se observa el ensayo de plaqueo en el cual se muestran las placas formadas por el SARS-CoV-2 obtenido del sobrenadante del control de virus sin tratamiento y del tratamiento con CBD (6uM), del ensayo antiviral. Se observan las condiciones sin diluir y las diluciones desde 101 hasta 104. El resultado se expresa en unidades formadoras de placa (UFP)/ml_. CC: control de células sin infectar. [056] As shown in Figure 5, from the supernatants obtained in the antiviral activity assay, at the maximum evaluated concentration of the compound (6uM), the virus titer was determined by plating assay. It can be seen that the viral titer in the presence of the treatment was on average 8.25x10 3 PFU / mL, while, in the virus control without treatment, the viral titer was on average 1.08x10 5 PFU / mL, which which means a 92.4% reduction in viral particles infectious diseases of SARS-CoV-2 by the compound CBD. Figure 5 shows the plating test in which the plaques formed by SARS-CoV-2 obtained from the supernatant of the untreated virus control and from the treatment with CBD (6uM) of the antiviral assay are shown. Undiluted conditions and dilutions from 10 1 to 10 4 are observed. The result is expressed in plaque forming units (PFU) / ml_. CC: uninfected cell control.
[057] De acuerdo con los resultados obtenidos, se puede indicar que la composición o formulación o producto de la presente invención tiene actividad deseada y promisoria para la prevención o mitigación de los síntomas causados por enfermedades virales respiratorias relacionadas con la Coronarivus causada por el virus SARS-Cov-2 (Covid 19) gracias a los componentes de la misma y en especial con la presencia del Cannabidiol CBD y lactoferrina. [057] According to the results obtained, it can be indicated that the composition or formulation or product of the present invention has desired and promising activity for the prevention or mitigation of symptoms caused by respiratory viral diseases related to Coronarivus caused by the virus SARS-Cov-2 (Covid 19) thanks to its components and especially with the presence of Cannabidiol CBD and lactoferrin.

Claims

REIVINDICACIONES
1. Un producto alimenticio con efecto inmunomodulador caracterizado porque comprende lactoferrina entre 3.00% y 4.00% en peso de la composición total, cannabidiol (CBD) en una proporción de 0.05% a 1.00% en peso de la composición total, aceite de girasol alto oleico en un porcentaje de 12.00% en peso de la composición total, aceite de maíz entre un 8.00% y 9.00% en peso de la composición total, aceite de girasol entre un 5.00% y 6.11 % en peso de la composición total, aceite de linaza entre un 3.00% y 4.00% en peso de la composición total, aceite de pescado entre un 0.20% y 0.30%, fructooligosacáridos-FOS entre un 16.00% y 17.00% en peso de la composición total, caseinato de calcio entre un 15.00% y 16.00% en peso de la composición total, caseinato de sodio entre un 1.97% y 2.50% en peso de la composición total, maltodextrina entre un 15.00% y 16.00% en peso de la composición total, almidón modificado entre un 12.00% y 13.00% en peso de la composición total, lecitina de soya entre un 0.40 y 0.60% en peso de la composición total, dextrosa entre un 0.50% y 1.00% en peso de la composición total, polidextrosa entre un 1.00% y 1.50% en peso de la composición total, monoglicéridos destilados entre 0.50% y 1.00% en peso de la composición total, fosfato dipotásico entre 0.50% y 0.70% en peso de la composición total, dióxido de silicio entre 0.30% y 0.40% en peso de la composición total, dióxido de titanio entre 0.020% y 0.022% en peso de la composición total, tocoferoles (gamma, delta, alfa y beta) entre 0.090% y 0.150% en peso de la composición total, ácido ascórbico entre 0.090% y 0.150% en peso de la composición total, carragenano entre un 0.050% y 0.070% en peso de la composición total, éster de ácido de monodiglicérido diacetil tartárico entre 0.040% y 0.060% en peso de la composición total y probióticos entre un 0.050 y 0.090% en peso de la composición total. 1. A food product with immunomodulatory effect characterized in that it comprises lactoferrin between 3.00% and 4.00% by weight of the total composition, cannabidiol (CBD) in a proportion of 0.05% to 1.00% by weight of the total composition, high oleic sunflower oil in a percentage of 12.00% by weight of the total composition, corn oil between 8.00% and 9.00% by weight of the total composition, sunflower oil between 5.00% and 6.11% by weight of the total composition, linseed oil between 3.00% and 4.00% by weight of the total composition, fish oil between 0.20% and 0.30%, fructooligosaccharides-FOS between 16.00% and 17.00% by weight of the total composition, calcium caseinate between 15.00% and 16.00% by weight of the total composition, sodium caseinate between 1.97% and 2.50% by weight of the total composition, maltodextrin between 15.00% and 16.00% by weight of the total composition, modified starch between 12.00% and 13.00% by weight of the total composition, soy lecithin between 0 .40 and 0.60% by weight of the total composition, dextrose between 0.50% and 1.00% by weight of the total composition, polydextrose between 1.00% and 1.50% by weight of the total composition, distilled monoglycerides between 0.50% and 1.00% by weight of the total composition, dipotassium phosphate between 0.50% and 0.70% by weight of the total composition, silicon dioxide between 0.30% and 0.40% by weight of the total composition, titanium dioxide between 0.020% and 0.022% by weight of the total composition, tocopherols (gamma, delta, alpha and beta) between 0.090% and 0.150% by weight of the total composition, ascorbic acid between 0.090% and 0.150% by weight of the total composition, carrageenan between 0.050% and 0.070% by weight of the total composition, diacetyl tartaric monodiglyceride acid ester between 0.040% and 0.060% by weight of the total composition and probiotics between 0.050 and 0.090% by weight of the total composition.
2. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque los probióticos se seleccionan del grupo que consiste de Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans o mezclas de los mismos. 2. The food product with immunomodulatory effect according to claim 1, characterized in that the probiotics are selected from group consisting of Lactobacillus acidophilus, Lactobacillus rhamnosu, Lactobacillus plantarum, Bifidobacterium lactis, Bacillus Coagulans or mixtures thereof.
3. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque comprende una mezcla de vitaminas y minerales entre un 2.50% y 3.50% en peso; en donde dicha mezcla comprende vitamina A entre 446 y 604 mcg, vitamina D3 entre 170 y 230 Ul, vitamina E entre 5.1 y 6.9 mg, vitamina B6 entre 0.77 y 1.04 mg, ácido fólico entre 119 y 161 mcg, vitamina B12 entre 1.53 y 2.1 mcg, vitamina C entre 28.1 y 38.0 mg, cobre entre 510 y 690 mcg, magnesio entre 170 y 230 mg, selenio entre 26.8 y 36.2 mcg y zinc entre 4.51 y 6.10 mg. 3. The food product with immunomodulatory effect according to claim 1, characterized in that it comprises a mixture of vitamins and minerals between 2.50% and 3.50% by weight; where said mixture comprises vitamin A between 446 and 604 mcg, vitamin D3 between 170 and 230 IU, vitamin E between 5.1 and 6.9 mg, vitamin B6 between 0.77 and 1.04 mg, folic acid between 119 and 161 mcg, vitamin B12 between 1.53 and 2.1 mcg, vitamin C between 28.1 and 38.0 mg, copper between 510 and 690 mcg, magnesium between 170 and 230 mg, selenium between 26.8 and 36.2 mcg and zinc between 4.51 and 6.10 mg.
4. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque comprende además omega 3, omega 6 y omega 9 solos o en combinación en una proporción de 0.05% a 1.00% en peso de la composición, en donde la fuente de omega 3 es aceite vegetal y aceite de pescado (DHA y EPA), y contiene además fuente de omega 6 y omega 9 a partir de aceite vegetal. 4. The food product with immunomodulatory effect according to claim 1, characterized in that it also comprises omega 3, omega 6 and omega 9 alone or in combination in a proportion of 0.05% to 1.00% by weight of the composition, wherein the source omega 3 is vegetable oil and fish oil (DHA and EPA), and also contains a source of omega 6 and omega 9 from vegetable oil.
5. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque también comprende como regulador de pH citrato de potasio entre un 0.040% y 0.050% en peso de la composición total. 5. The food product with immunomodulatory effect according to claim 1, characterized in that it also comprises as a pH regulator potassium citrate between 0.040% and 0.050% by weight of the total composition.
6. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque comprende saborizantes y aromatizantes tal como vainilla, en un porcentaje de 1.7% en peso de la composición total. 6. The food product with immunomodulatory effect according to claim 1, characterized in that it comprises flavors and flavorings such as vanilla, in a percentage of 1.7% by weight of the total composition.
7. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque además comprende endulzantes tal como Stevia entre un 0.050% y 0.100% en peso de la composición total.7. The food product with immunomodulatory effect according to claim 1, characterized in that it also comprises sweeteners such as Stevia between 0.050% and 0.100% by weight of the total composition.
8. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 1 , caracterizado porque está en la forma de una composición nutricional en polvo por porción o en polvo en determinadas cantidades de porciones, un suplemento dietario en polvo por porción o en polvo en determinadas cantidades de porciones, o las anteriores en presentación líquida, un alimento o una composición farmacéutica. 8. The food product with immunomodulatory effect according to claim 1, characterized in that it is in the form of a composition nutritional powder per serving or powder in certain amounts of servings, a dietary supplement in powder per serving or powder in certain amounts of servings, or the above in liquid form, a food or a pharmaceutical composition.
9. El producto alimenticio con efecto inmunomodulador de acuerdo con la reivindicación 8, caracterizado porque cuando es una formulación farmacéutica tiene la forma que se selecciona de una tableta, cápsula, pastilla, un polvo en una porción o en varias porciones y una porción en presentación líquida; en donde la formulación comprende excipientes o portadores farmacéuticamente aceptables. 9. The food product with immunomodulatory effect according to claim 8, characterized in that when it is a pharmaceutical formulation it has the form that is selected from a tablet, capsule, lozenge, a powder in a portion or in several portions and a portion in presentation liquid; wherein the formulation comprises pharmaceutically acceptable excipients or carriers.
PCT/IB2020/056982 2020-07-24 2020-07-24 Food product with immunomodulator effect WO2021074706A1 (en)

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