WO2021074706A1 - Produit alimentaire à effet immunomodulateur - Google Patents

Produit alimentaire à effet immunomodulateur 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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weight
total composition
composition
vitamin
omega
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PCT/IB2020/056982
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English (en)
Spanish (es)
Inventor
Alejandro Mauricio Vargas Upegui
Original Assignee
Alsec Alimentos Secos S.A.S
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Priority to PCT/IB2020/056982 priority Critical patent/WO2021074706A1/fr
Publication of WO2021074706A1 publication Critical patent/WO2021074706A1/fr
Priority to CONC2021/0008245A priority patent/CO2021008245A2/es

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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

La présente invention concerne une composition ou un complément alimentaire à effet immunomodulateur, ce produit étant caractérisé en ce qu'il comprend de la lactoferrine, du cannabidiol (CBD), de l'huile de tournesol à haute teneur en acide oléique, de l'huile de maïs, de l'huile de tournesol, de l'huile de lin, de l'huile de poisson, des fructo-oligosaccharides (FOS), du caséinate de calcium, du caséinate de sodium, de la maltodextrine, de l'amidon modifié, de la lécitine de soja, du dextrose, du polydextrose, des monoglycérides, du phosphate dipotassique, du dioxyde de silicium, du dioxyde de titane, des tocophérols, de l'acide ascorbique, du carraghénane, de l'ester d'acide de monoglycéride diacétyle tartrique et des probiotiques. Ledit produit peut également contenir des vitamines et des minéraux, de l'oméga 3, de l'oméga 6, des régulateurs de pH, des édulcorants et des arômes. Il trouve une application dans l'industrie alimentaire et pharmacologique pour la prévention et le traitement d'infections virales causées par des virus tels que le coronavirus SARS-CoV-2. Il peut se présenter sous la forme d'une composition nutritionnelle ou d'une formulation pharmaceutique.
PCT/IB2020/056982 2020-07-24 2020-07-24 Produit alimentaire à effet immunomodulateur WO2021074706A1 (fr)

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CONC2021/0008245A CO2021008245A2 (es) 2020-07-24 2021-06-24 Producto alimenticio con efecto inmunomodulador

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202100015791A1 (it) * 2021-06-16 2022-12-16 Aqma Italia S P A Composizione ad attivita’ immunostimolante ed immunoregolatrice per promuovere la risposta immunitaria dell’organismo umano
WO2023044135A1 (fr) * 2021-09-17 2023-03-23 1242753 Ontario Inc. Compositions dérivées de psilocybine et leurs procédés d'utilisation
WO2024144735A1 (fr) * 2022-12-28 2024-07-04 Chivalric Regulus Biyoteknoloji Anonim Sirketi Complément alimentaire microencapsulé contenant des micro-organismes probiotiques

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090202613A1 (en) * 2008-02-11 2009-08-13 Tabatchnick Fine Foods, Inc. Nutritionally Enhanced Therapeutic Preventative Food Supplement and Method of Making Same
CN102090558A (zh) * 2010-12-09 2011-06-15 上海交大昂立股份有限公司 一种含益生菌、dha和乳铁蛋白的组合物及其应用
US20120171164A1 (en) * 2010-12-29 2012-07-05 Anja Wittke Use of nutritional compositions including lactoferrin in supporting resistance to viral respiratory tract infections
WO2014155186A1 (fr) * 2013-03-27 2014-10-02 Palsgaard Industri De Mexico, S. De R.L. De C.V. Complément alimentaire pour personnes souffrant de trisomie 21, de trouble du spectre autiste et/ou de trouble du déficit de l'attention avec ou sans hyperactivité
US20170188616A1 (en) * 2015-12-17 2017-07-06 Therabis, Llc Cannabinoid-enriched supplement

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090202613A1 (en) * 2008-02-11 2009-08-13 Tabatchnick Fine Foods, Inc. Nutritionally Enhanced Therapeutic Preventative Food Supplement and Method of Making Same
CN102090558A (zh) * 2010-12-09 2011-06-15 上海交大昂立股份有限公司 一种含益生菌、dha和乳铁蛋白的组合物及其应用
US20120171164A1 (en) * 2010-12-29 2012-07-05 Anja Wittke Use of nutritional compositions including lactoferrin in supporting resistance to viral respiratory tract infections
WO2014155186A1 (fr) * 2013-03-27 2014-10-02 Palsgaard Industri De Mexico, S. De R.L. De C.V. Complément alimentaire pour personnes souffrant de trisomie 21, de trouble du spectre autiste et/ou de trouble du déficit de l'attention avec ou sans hyperactivité
US20170188616A1 (en) * 2015-12-17 2017-07-06 Therabis, Llc Cannabinoid-enriched supplement

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202100015791A1 (it) * 2021-06-16 2022-12-16 Aqma Italia S P A Composizione ad attivita’ immunostimolante ed immunoregolatrice per promuovere la risposta immunitaria dell’organismo umano
EP4104852A1 (fr) * 2021-06-16 2022-12-21 Aqma Italia S.p.A. Composition avec activité immunostimulante et immunorégulatrice pour promouvoir la réponse immunitaire de l'organisme humain
WO2023044135A1 (fr) * 2021-09-17 2023-03-23 1242753 Ontario Inc. Compositions dérivées de psilocybine et leurs procédés d'utilisation
GB2625237A (en) * 2021-09-17 2024-06-12 1242753 Ontario Inc Psilocybin derived compositions and methods of using same
WO2024144735A1 (fr) * 2022-12-28 2024-07-04 Chivalric Regulus Biyoteknoloji Anonim Sirketi Complément alimentaire microencapsulé contenant des micro-organismes probiotiques

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