WO2020247438A1 - Recover dietary supplement - Google Patents

Recover dietary supplement Download PDF

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Publication number
WO2020247438A1
WO2020247438A1 PCT/US2020/035838 US2020035838W WO2020247438A1 WO 2020247438 A1 WO2020247438 A1 WO 2020247438A1 US 2020035838 W US2020035838 W US 2020035838W WO 2020247438 A1 WO2020247438 A1 WO 2020247438A1
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WO
WIPO (PCT)
Prior art keywords
composition
serving
amount
dietary supplement
grams
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Application number
PCT/US2020/035838
Other languages
French (fr)
Inventor
Kurt Seidensticker
Matt Aporta
Corey Friese
Angela Skubal
Original Assignee
Vital Proteins LLC
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Publication date
Application filed by Vital Proteins LLC filed Critical Vital Proteins LLC
Priority to JP2021566068A priority Critical patent/JP2022534861A/en
Priority to BR112021021870A priority patent/BR112021021870A2/en
Priority to EP20818906.8A priority patent/EP3976088A4/en
Priority to US17/595,874 priority patent/US20220233651A1/en
Priority to CA3142007A priority patent/CA3142007A1/en
Priority to CN202080033408.2A priority patent/CN113853212A/en
Priority to AU2020286380A priority patent/AU2020286380A1/en
Publication of WO2020247438A1 publication Critical patent/WO2020247438A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/385—Concentrates of non-alcoholic beverages
    • A23L2/39—Dry compositions
    • 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
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    • A23L33/155—Vitamins A or D
    • 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
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    • A23L33/17—Amino acids, peptides or proteins
    • 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
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    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
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    • 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
    • A23L33/18—Peptides; Protein 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
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
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    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
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    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
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    • 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
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • Connective tissue is a major part of muscles, tendons, ligaments, cartilage, and bones. It is the second biggest mass and organ of the body and is important for physical performance. Connective tissue contains mainly collagen structures, which provides bones, tendons, and ligaments structure. Connective tissue contains a matrix of very flexible collagen strings, which is highly stabilized by cross-linking the gelatin-like strings of collagen with pyridinoline (PD) and deoxypyrolidine (DPD). PD and DPD are present only in mature collagen and not in freshly built collagen. In the process of making collagen, collagen strings are first built and then cross- linked with PD and DPD.
  • PD pyridinoline
  • DPD deoxypyrolidine
  • compositions comprising collagen with branched amino acids have previously been tested to try to replace the collagen lost during strenuous physical activity.
  • researchers have identified that when supplemented with collagen peptides in combination with arginine and branched-chain amino acids, amino acid levels increase to optimal levels in athletes leading to a 54% reduction in injury in weekend warriors and 67% reduction in injury of muscles, tendons, and ligaments in professional athletes.
  • the present invention is directed to a dietary supplement composition
  • a dietary supplement composition comprising collagen peptides, glutamine, and taurine.
  • the composition may further include nine essential amino acids: leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine.
  • the composition of the present invention may be in the form of a solution, suspension, powder, gel, or a liquid.
  • Liquid compositions in turn may be in the form of a concentrated liquid composition, to which a diluent is added, or to fully-diluted liquid compositions, such as ready-to-drink (“RTD”) compositions.
  • RTD ready-to-drink
  • the collagen is present in an amount of about 30 to 60 weight percent of the composition
  • glutamine is present in an amount of about 2 to about 3.5 weight percent of the composition
  • taurine is present in an amount of about 0.2 to about 0.5 weight percent of the composition.
  • the dietary supplement composition may contain collagen in an amount of about 40-55 weight percent of the composition, glutamine in an amount of about 2.75-3.0 weight percent of the composition, and taurine in an amount of about 0.3-0.45 weight percent of the composition.
  • collagen is present in an amount of about 50-55 weight percent of the composition, glutamine is present in an amount of about 2.75-3.0 weight percent of the composition, and taurine is present in an amount of about 0.4-0.42 weight percent of the composition.
  • the present invention also may be described by the amount of collagen, glutamine, and taurine in a standard serving, where the standard serving size is 36-38 grams or, for diluted compositions, 24 fluid ounces.
  • the amount of collagen in the composition is about 10-30 grams/serving
  • the amount of glutamine in the composition is about 0.5- 1.5 grams/serving
  • the amount of taurine in the composition is about 0.1 -0.2 grams/serving.
  • Additional components of the composition may include coconut water, electrolytes, such as sodium, potassium, magnesium, and zinc, selenium, and vitamins.
  • the vitamins may include Vitamin B 1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B5, folate, Vitamin C, and Vitamin D.
  • compositions of the present invention are intended to replace collagen broken down during physical activity.
  • Administration of the composition to a patient in need thereof may bring post-collagen levels of the athlete to within 0-5%, 0- 10%, or 0- 15% of the collagen levels pre-workout or PD and DPD levels within 1%, 2%, 5%, or 10% of the pre -workout levels.
  • the present invention relates to a dietary supplement composition that may be consumed as a meal or as a meal supplement to maintain collagen levels in the body, which help to support muscles, joints, tendons, and ligaments.
  • the compositions of the present invention comprise collagen, preferably in the form of collagen peptides, in combination with glutamine and taurine, and preferably with the essential amino acids and branched-chain amino acids.
  • the composition may be used in the form of a liquid, solution, suspension, powder, or gel. If in powder form, the powder preferably is mixed in a soluble liquid prior to administration as directed.
  • Compositions in the form of liquids include concentrated liquid compositions, to which a diluent is added, as well as fully-diluted liquid compositions, such as ready-to-drink (“RTD”) compositions.
  • RTD ready-to-drink
  • Collagen is present in the composition in an amount of about 30 to 60 weight percent of the composition, about 40 to 55 weight percent of the composition, or about 50 to 55 weight percent of the composition.
  • collagen may be present in the composition in an amount of about 10-30 grams/serving, about 15-25 grams/serving, about 17-23 grams/serving, or about 20 grams/serving.
  • collagen may be present in the composition in an amount of about 20 grams/serving.
  • Collagen is a protein and may be present in any available form in the composition. However, the present invention preferably uses collagen peptides. Collagen peptides may be sourced from any known source, including but not limited to, beef, chicken, fish, eggshell membrane, and chicken egg whites.
  • Glutamine is present in the composition in an amount of about 0.5- 1.5 grams/serving, about 0.75-1.25 grams/serving, or about 0.9-1.1 grams/serving, or about 1.0 gram/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
  • glutamine may be present in the composition in an amount of about 2 to about 3.5 weight percent, about 2.5-3.25 weight percent, about 2.75-3.0 weight percent, or about 3 weight percent of the composition.
  • Taurine is also present in the composition in an amount of about 0.1 -0.2 grams/serving, about 0.125-0.175 grams/serving, or about 0.15-0.16 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, taurine may be present in an amount of about 0.2-0.5 weight percent, about 0.3-0.45 weight percent, or about 0.4-0.42 weight percent of the composition. The combination of collagen with glutamine and taurine is believed to provide the enhanced uptake of collagen by the recipient. [0017] In the present invention, the composition may contain one or more of the nine essential amino acids, branched-chain amino acids, and naturally occurring amino acids.
  • the composition of the present invention include the presence of the nine essential amino acids.
  • the nine essential amino acids are leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine.
  • the total amount of these essential amino acids (EAA) in the composition may vary, but, in a 36-38 grams (or 24 fluid ounce) serving size, the EAAs may be present in an amount of about 4-10 grams/serving, about 6.5-9.0 grams/serving, about 7-8 grams/serving, about 5 grams/serving, about 6 grams/serving, about 7 grams/serving, about 8 grams/serving, or about 9 grams/serving.
  • the total amount of the EAAs may be present in an amount of about 15-24, 16- 20, about 17-20, about 17, about 18, about 19, about 20, or about 21 weight percent of the total composition.
  • each essential amino acid may be present in varying amounts, such as about 0.01-3 grams/ serving in a 36-38 grams serving size.
  • each essential amino acid may be present in an amount of about 0.06-8.5 weight percent of the total composition.
  • the amino acid profile of the composition may include naturally occurring amino acids and branched-chain amino acids.
  • branched-chain amino acids may include, but are not limited to, the essential amino acids of isoleucine, leucine, and valine.
  • BCAAs make up about 3-6 grams/serving or about 5 grams/serving of the composition, where the serving size is 36-38 grams/service (or 24 fluid ounces/serving).
  • Naturally occurring amino acids that may be included in the composition include, but are not limited to, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, hydroxylysine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, trypophan, tyrosine, and valine.
  • the naturally occurring amino acids may or may not be used in the present invention.
  • a blend of one or more of the nine essential amino acids, branched-chain amino acids, and naturally occurring amino acids is present in the composition in an amount of 4-12 grams/serving, at least 5-5.5 grams/serving, about 7-10 grams/serving, about 4 grams/serving, about 4.5 grams/serving, about 5 grams/serving, or about 6 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
  • Additional nutrients may be used in the composition including electrolytes, vitamins, minerals, and other dietary supplements.
  • Suitable electrolytes include, but are not limited to, sodium, potassium, magnesium, calcium, bicarbonate, chloride, and phosphate.
  • the total amount of electrolytes may be added to the composition in an amount of about 0.25-4.0 weight percent of the composition, about 1.0-3.8, or about 1.5.2-3.5 weight percent of the composition.
  • the total electrolytes may be present in a range of about 0.1 to 1.5 grams/serving, about 0.5 to 1.25 grams/serving, about 0.75 to 1.1 grams/serving, or about 0.8 to 1.1 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
  • Sodium may be present in any form, such as sea salt, iodized salt, Himalayan pink sea salt, in an amount of about 0.20-0.325 grams/serving or 0.25-0.30 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, sodium may be present in a range of about 0.5- 1.0 weight percent or about 0.6-0.9 weight percent of the total composition. Potassium may be present in any suitable form, such as a potassium citrate, potassium chloride, potassium sorbate, or the like. Potassium may be present in an amount of about 0.05-0.25 grams/serving or about 0.1-0.2 grams/serving, where the serving size is 36-38 grams/serving.
  • potassium may be present in a range of about 0.4-0.8 or about 0.5-0.7 weight percent of the total composition.
  • Magnesium may be present in any suitable form, such as a potassium citrate. Magnesium may be present may in an amount of about 0.05- 0.2 grams/serving or about 0.075-0.125 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, magnesium may be present in a range of about 0.1-0.6 or about 0.2-0.4 weight percent of the total composition.
  • Zinc may be present in any suitable form, such as a zinc sulfate.
  • Zinc may be present in an amount of about 0.001-0.02 grams/serving or about 0.002-0.004 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, zinc may be present in a range of or about 0.002-0.06 or about 0.005-0.01 weight percent of the total composition.
  • certain minerals and elements may be added to the composition as a dietary supplement.
  • selenium and thiamine are appropriate for use in the composition.
  • Selenium may be present in any suitable form, such as a sodium selenium.
  • Selenium may be present in the composition in an amount of about 0.00001-0.0001 grams/serving, about 0.000015-0.000075 grams/serving, or about 0.00002-0.00004 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
  • selenium may be present in a range of about 0.00002-0.0003, about 0.00004-0.0002, or about 0.00005-0.0001 weight percent of the total composition.
  • Thiamine is a mineral that may be present in any suitable form, such as thiamine HC1.
  • Thiamine may be present in the composition in an amount of about 0.0004-0.002 grams/serving, about 0.0009-0.001 grams/serving, or about 0.0009- 0.004 grams/serving, where the serving size is 36—38 grams/serving (or 24 fluid ounces/serving).
  • thiamine may be present in a range of about 0.001-0.003, or about 0.0025-0.003 weight percent of the total composition.
  • Vitamins may further be added to the composition. Any vitamins suitable for ingestion in a dietary supplement is suitable for use. Suitable vitamins include but are not limited to Vitamin B, including Vitamin B 1 (e.g., as thiamine chloride), Vitamin B2 (e.g., as riboflavin), Vitamin B3 (e.g., niacinamide), Vitamin B6 (e.g., as pyridoxine HC1), Vitamin B5 (e.g., as pantothenic acid or D-caclium pantothenate), and folate (e.g., as folic acid PWD), Vitamin C (e.g., as sodium ascorbate), Vitamin D, Vitamin E, etc.
  • Vitamin B 1 e.g., as thiamine chloride
  • Vitamin B2 e.g., as riboflavin
  • Vitamin B3 e.g., niacinamide
  • Vitamin B6 e.g., as pyridoxine HC1
  • Vitamin B5 e.g
  • each of the vitamins may be independently present in the composition in an amount of about 0-0.2 grams/serving, about 0-1 grams/serving, about 0.2-0.8 grams/serving, or about 0.4-0.6 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
  • each vitamin may be present in a range of about 0-0.25, about 0-0.2, about 0.001- 0.2, or about 0.002-0.175 weight percent of the total composition.
  • composition may be flavored using any known natural flavors to enhance the flavor of the composition.
  • other additives suitable for dietary supplements including but not limited to, coconut water powder, malic acid, monk fruit extract, and fruit and vegetable juice powder (for color).
  • compositions include, but are not limited, to those described in Tables 1 and 2:
  • Powder 2 Powder 3, Powder 4, and Powder 5 of the present invention:
  • Powder 1, Powder, 2, Powder 3, Powder 4, and Powder 5 are present:
  • amino acid profile is present:
  • BCAAs -Branchcd-Chain Amino Acids
  • the caloric intake of the supplement is less than about 200 calories, less than about 150 calories, about 125 calories, or about 100 calories per serving.
  • the amount of carbohydrates and total sugars in the composition is desirably low.
  • the carbohydrates may be present in an amount of less than 10 grams/serving, less than 8 grams/serving, less than 7 grams/serving, about 6 grams/serving, or about 5 grams/serving.
  • the total sugars is desirably kept low, e.g., less than 6 grams/serving, less than 5 grams/serving, about 5 grams/serving, or about 4 grams/serving.
  • the content of the protein, in the form of collagen or collagen peptides is high, preferably above 10 grams/serving, above 15 gram/serving, above 16 grams/serving, above 17 grams/serving, about 18 grams/serving, about 19 grams/serving, or about 20 grams/serving.
  • no artificial sweeteners or sugars are added to the composition.
  • the present invention is expected to increase the collagen levels of the athlete to within 0-5%, 0-10%, or 0-15% of the collagen levels pre-workout. Furthermore, the levels of PD and DPD in the urine of athletes after supplementation with the composition of the present invention is expected to indicate that the PD and DPD levels are similar to pre-workout levels or within 1%, 2%, 5%, or 10% of the pre-workout levels. Moreover, because the present invention utilizes the nine essential amino acids, vitamins, mineral, and electrolyte, the nutrient levels for these nutrients in the body are greatly enhanced relative to pre-workout levels along with the collagen levels.
  • compositions of the powder formulas Powder 1, Powder 2, Powder 3, Powder 4, and Powder 5 depicted in Table 1 were prepared.
  • compositions of the ready -to drink formulas RTD 1 , RTD 2, and RTD 3 depicted in Table 2 were prepared.

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Abstract

The present invention is directed to a method of replacing collagen broken down during physical activity using a novel dietary supplement. The supplement composition of the present invention comprises collagen, glutamine, taurine, and, optionally, the nine essential amino acids. The uptake of collagen is enhanced using this combination of components to levels substantially near the pre-workout levels.

Description

RECOVERY DIETARY SUPPLEMENT
RELATED APPLICATIONS
[0001] This application claims priority from U.S. Application No. 16/891, 178 filed on June 3, 2020 and U.S. Provisional Application No. 62/856,588 filed on June 3, 2019, both of which are incorporated herin by reference in their entirety.
BACKGROUND
[0002] Connective tissue is a major part of muscles, tendons, ligaments, cartilage, and bones. It is the second biggest mass and organ of the body and is important for physical performance. Connective tissue contains mainly collagen structures, which provides bones, tendons, and ligaments structure. Connective tissue contains a matrix of very flexible collagen strings, which is highly stabilized by cross-linking the gelatin-like strings of collagen with pyridinoline (PD) and deoxypyrolidine (DPD). PD and DPD are present only in mature collagen and not in freshly built collagen. In the process of making collagen, collagen strings are first built and then cross- linked with PD and DPD.
[0003] During training, athletes break down the collagen in their muscles and joints. Urinary analysis of athletes highlight that PD and DPD are excreted in the urine during and after training, which is indicative of collagen breakdown.
[0004] Compositions comprising collagen with branched amino acids have previously been tested to try to replace the collagen lost during strenuous physical activity. Researchers have identified that when supplemented with collagen peptides in combination with arginine and branched-chain amino acids, amino acid levels increase to optimal levels in athletes leading to a 54% reduction in injury in weekend warriors and 67% reduction in injury of muscles, tendons, and ligaments in professional athletes.
[0005] However, there remains a need to increase the uptake of collagen along with address other nutrient deficiencies, including the replacement of other amino acids, vitamins, minerals, and electrolytes lost during strenuous physical activity. The present invention resolves this deficiency and enhances the uptake of collagen peptides based on the components of the composition.
SUMMARY
[0006] The present invention is directed to a dietary supplement composition comprising collagen peptides, glutamine, and taurine. The composition may further include nine essential amino acids: leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine. The composition of the present invention may be in the form of a solution, suspension, powder, gel, or a liquid. Liquid compositions in turn may be in the form of a concentrated liquid composition, to which a diluent is added, or to fully-diluted liquid compositions, such as ready-to-drink (“RTD”) compositions.
[0007] In one embodiment, the collagen is present in an amount of about 30 to 60 weight percent of the composition, glutamine is present in an amount of about 2 to about 3.5 weight percent of the composition, and taurine is present in an amount of about 0.2 to about 0.5 weight percent of the composition.
[0008] Alternatively, the dietary supplement composition may contain collagen in an amount of about 40-55 weight percent of the composition, glutamine in an amount of about 2.75-3.0 weight percent of the composition, and taurine in an amount of about 0.3-0.45 weight percent of the composition. In another embodiment, collagen is present in an amount of about 50-55 weight percent of the composition, glutamine is present in an amount of about 2.75-3.0 weight percent of the composition, and taurine is present in an amount of about 0.4-0.42 weight percent of the composition.
[0009] The present invention also may be described by the amount of collagen, glutamine, and taurine in a standard serving, where the standard serving size is 36-38 grams or, for diluted compositions, 24 fluid ounces. In one embodiment of the present invention, the amount of collagen in the composition is about 10-30 grams/serving, the amount of glutamine in the composition is about 0.5- 1.5 grams/serving, and the amount of taurine in the composition is about 0.1 -0.2 grams/serving.
[0010] Additional components of the composition may include coconut water, electrolytes, such as sodium, potassium, magnesium, and zinc, selenium, and vitamins. The vitamins may include Vitamin B 1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B5, folate, Vitamin C, and Vitamin D.
[0011] The compositions of the present invention are intended to replace collagen broken down during physical activity. Administration of the composition to a patient in need thereof may bring post-collagen levels of the athlete to within 0-5%, 0- 10%, or 0- 15% of the collagen levels pre-workout or PD and DPD levels within 1%, 2%, 5%, or 10% of the pre -workout levels.
DETAILED DESCRIPTION OF THE INVENTION
[0012] The present invention relates to a dietary supplement composition that may be consumed as a meal or as a meal supplement to maintain collagen levels in the body, which help to support muscles, joints, tendons, and ligaments. The compositions of the present invention comprise collagen, preferably in the form of collagen peptides, in combination with glutamine and taurine, and preferably with the essential amino acids and branched-chain amino acids. The composition may be used in the form of a liquid, solution, suspension, powder, or gel. If in powder form, the powder preferably is mixed in a soluble liquid prior to administration as directed. Compositions in the form of liquids include concentrated liquid compositions, to which a diluent is added, as well as fully-diluted liquid compositions, such as ready-to-drink (“RTD”) compositions.
[0013] Collagen is present in the composition in an amount of about 30 to 60 weight percent of the composition, about 40 to 55 weight percent of the composition, or about 50 to 55 weight percent of the composition. Alternatively, in a standard serving size of 36-38 gram or 24 fluid ounces, collagen may be present in the composition in an amount of about 10-30 grams/serving, about 15-25 grams/serving, about 17-23 grams/serving, or about 20 grams/serving. In a preferred embodiment, collagen may be present in the composition in an amount of about 20 grams/serving.
[0014] Collagen is a protein and may be present in any available form in the composition. However, the present invention preferably uses collagen peptides. Collagen peptides may be sourced from any known source, including but not limited to, beef, chicken, fish, eggshell membrane, and chicken egg whites.
[0015] Glutamine is present in the composition in an amount of about 0.5- 1.5 grams/serving, about 0.75-1.25 grams/serving, or about 0.9-1.1 grams/serving, or about 1.0 gram/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, glutamine may be present in the composition in an amount of about 2 to about 3.5 weight percent, about 2.5-3.25 weight percent, about 2.75-3.0 weight percent, or about 3 weight percent of the composition.
[0016] Taurine is also present in the composition in an amount of about 0.1 -0.2 grams/serving, about 0.125-0.175 grams/serving, or about 0.15-0.16 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, taurine may be present in an amount of about 0.2-0.5 weight percent, about 0.3-0.45 weight percent, or about 0.4-0.42 weight percent of the composition. The combination of collagen with glutamine and taurine is believed to provide the enhanced uptake of collagen by the recipient. [0017] In the present invention, the composition may contain one or more of the nine essential amino acids, branched-chain amino acids, and naturally occurring amino acids.
[0018] Inone embodiment, the composition of the present invention include the presence of the nine essential amino acids. The nine essential amino acids are leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine. The total amount of these essential amino acids (EAA) in the composition may vary, but, in a 36-38 grams (or 24 fluid ounce) serving size, the EAAs may be present in an amount of about 4-10 grams/serving, about 6.5-9.0 grams/serving, about 7-8 grams/serving, about 5 grams/serving, about 6 grams/serving, about 7 grams/serving, about 8 grams/serving, or about 9 grams/serving. Alternatively the total amount of the EAAs may be present in an amount of about 15-24, 16- 20, about 17-20, about 17, about 18, about 19, about 20, or about 21 weight percent of the total composition. Individually, each essential amino acid may be present in varying amounts, such as about 0.01-3 grams/ serving in a 36-38 grams serving size. Alternatively, each essential amino acid may be present in an amount of about 0.06-8.5 weight percent of the total composition.
[0019] The amino acid profile of the composition may include naturally occurring amino acids and branched-chain amino acids. For example, branched-chain amino acids (BCAAs) may include, but are not limited to, the essential amino acids of isoleucine, leucine, and valine. In one embodiment, BCAAs make up about 3-6 grams/serving or about 5 grams/serving of the composition, where the serving size is 36-38 grams/service (or 24 fluid ounces/serving). Naturally occurring amino acids that may be included in the composition include, but are not limited to, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, hydroxylysine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, trypophan, tyrosine, and valine. In some embodiments, the naturally occurring amino acids may or may not be used in the present invention.
[0020] In an embodiment of the present invention, a blend of one or more of the nine essential amino acids, branched-chain amino acids, and naturally occurring amino acids is present in the composition in an amount of 4-12 grams/serving, at least 5-5.5 grams/serving, about 7-10 grams/serving, about 4 grams/serving, about 4.5 grams/serving, about 5 grams/serving, or about 6 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving).
[0021] Additional nutrients may be used in the composition including electrolytes, vitamins, minerals, and other dietary supplements. Suitable electrolytes include, but are not limited to, sodium, potassium, magnesium, calcium, bicarbonate, chloride, and phosphate. The total amount of electrolytes may be added to the composition in an amount of about 0.25-4.0 weight percent of the composition, about 1.0-3.8, or about 1.5.2-3.5 weight percent of the composition. Alternatively, the total electrolytes may be present in a range of about 0.1 to 1.5 grams/serving, about 0.5 to 1.25 grams/serving, about 0.75 to 1.1 grams/serving, or about 0.8 to 1.1 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Sodium may be present in any form, such as sea salt, iodized salt, Himalayan pink sea salt, in an amount of about 0.20-0.325 grams/serving or 0.25-0.30 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, sodium may be present in a range of about 0.5- 1.0 weight percent or about 0.6-0.9 weight percent of the total composition. Potassium may be present in any suitable form, such as a potassium citrate, potassium chloride, potassium sorbate, or the like. Potassium may be present in an amount of about 0.05-0.25 grams/serving or about 0.1-0.2 grams/serving, where the serving size is 36-38 grams/serving. Alternatively, potassium may be present in a range of about 0.4-0.8 or about 0.5-0.7 weight percent of the total composition. Magnesium may be present in any suitable form, such as a potassium citrate. Magnesium may be present may in an amount of about 0.05- 0.2 grams/serving or about 0.075-0.125 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, magnesium may be present in a range of about 0.1-0.6 or about 0.2-0.4 weight percent of the total composition. Zinc may be present in any suitable form, such as a zinc sulfate. Zinc may be present in an amount of about 0.001-0.02 grams/serving or about 0.002-0.004 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, zinc may be present in a range of or about 0.002-0.06 or about 0.005-0.01 weight percent of the total composition.
[0022] In addition, certain minerals and elements may be added to the composition as a dietary supplement. For example, selenium and thiamine are appropriate for use in the composition. Selenium may be present in any suitable form, such as a sodium selenium. Selenium may be present in the composition in an amount of about 0.00001-0.0001 grams/serving, about 0.000015-0.000075 grams/serving, or about 0.00002-0.00004 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, selenium may be present in a range of about 0.00002-0.0003, about 0.00004-0.0002, or about 0.00005-0.0001 weight percent of the total composition. Thiamine is a mineral that may be present in any suitable form, such as thiamine HC1. Thiamine may be present in the composition in an amount of about 0.0004-0.002 grams/serving, about 0.0009-0.001 grams/serving, or about 0.0009- 0.004 grams/serving, where the serving size is 36—38 grams/serving (or 24 fluid ounces/serving). Alternatively, thiamine may be present in a range of about 0.001-0.003, or about 0.0025-0.003 weight percent of the total composition.
[0023] Vitamins may further be added to the composition. Any vitamins suitable for ingestion in a dietary supplement is suitable for use. Suitable vitamins include but are not limited to Vitamin B, including Vitamin B 1 (e.g., as thiamine chloride), Vitamin B2 (e.g., as riboflavin), Vitamin B3 (e.g., niacinamide), Vitamin B6 (e.g., as pyridoxine HC1), Vitamin B5 (e.g., as pantothenic acid or D-caclium pantothenate), and folate (e.g., as folic acid PWD), Vitamin C (e.g., as sodium ascorbate), Vitamin D, Vitamin E, etc. In the context of the present invention, each of the vitamins may be independently present in the composition in an amount of about 0-0.2 grams/serving, about 0-1 grams/serving, about 0.2-0.8 grams/serving, or about 0.4-0.6 grams/serving, where the serving size is 36-38 grams/serving (or 24 fluid ounces/serving). Alternatively, each vitamin may be present in a range of about 0-0.25, about 0-0.2, about 0.001- 0.2, or about 0.002-0.175 weight percent of the total composition.
[0024] Moreover, the composition may be flavored using any known natural flavors to enhance the flavor of the composition. Additionally, other additives suitable for dietary supplements, including but not limited to, coconut water powder, malic acid, monk fruit extract, and fruit and vegetable juice powder (for color).
[0025] In accordance with the present invention, suitable compositions include, but are not limited, to those described in Tables 1 and 2:
TABLE 1: Nutritional information on five powder compositions (Powder 1,
Powder 2, Powder 3, Powder 4, and Powder 5 of the present invention:
Figure imgf000007_0001
Figure imgf000008_0001
[0026] For each of the powder compositions, Powder 1, Powder, 2, Powder 3, Powder 4, and Powder 5, the following ingredients are present:
Figure imgf000008_0002
Figure imgf000009_0001
TABLE 2: Nutritional information on ready-to-drink compositions (RTD 1, RTD 2, and RTD 3) of the present invention.
Figure imgf000009_0002
[0027] For each of the ready-to-drink compositions, RTD 1, RTD 2, and RTD 3, the following ingredients are present:
Figure imgf000010_0001
[0028] In an embodiment of the present invention, the following amino acid profile is present:
Figure imgf000010_0002
Figure imgf000011_0001
** Essential amino acids
-Branchcd-Chain Amino Acids (BCAAs)
[0029] In an embodiment of the present invention, the caloric intake of the supplement is less than about 200 calories, less than about 150 calories, about 125 calories, or about 100 calories per serving. Additionally, the amount of carbohydrates and total sugars in the composition is desirably low. For example, the carbohydrates may be present in an amount of less than 10 grams/serving, less than 8 grams/serving, less than 7 grams/serving, about 6 grams/serving, or about 5 grams/serving. Similarly, the total sugars is desirably kept low, e.g., less than 6 grams/serving, less than 5 grams/serving, about 5 grams/serving, or about 4 grams/serving. As noted above, the content of the protein, in the form of collagen or collagen peptides, is high, preferably above 10 grams/serving, above 15 gram/serving, above 16 grams/serving, above 17 grams/serving, about 18 grams/serving, about 19 grams/serving, or about 20 grams/serving. In another embodiment of the invention, no artificial sweeteners or sugars are added to the composition.
[0030] The present invention is expected to increase the collagen levels of the athlete to within 0-5%, 0-10%, or 0-15% of the collagen levels pre-workout. Furthermore, the levels of PD and DPD in the urine of athletes after supplementation with the composition of the present invention is expected to indicate that the PD and DPD levels are similar to pre-workout levels or within 1%, 2%, 5%, or 10% of the pre-workout levels. Moreover, because the present invention utilizes the nine essential amino acids, vitamins, mineral, and electrolyte, the nutrient levels for these nutrients in the body are greatly enhanced relative to pre-workout levels along with the collagen levels.
[0031] POWDER EXAMPLES
[0032] Compositions of the powder formulas Powder 1, Powder 2, Powder 3, Powder 4, and Powder 5 depicted in Table 1 were prepared.
[0033] RTD EXAMPLES
[0034] Compositions of the ready -to drink formulas RTD 1 , RTD 2, and RTD 3 depicted in Table 2 were prepared.

Claims

Claims
1. A dietary supplement composition comprising collagen in an amount of about 15-25 grams per serving of the composition, glutamine in an amount of about 0.5- 1.5 grams per serving of the composition, and taurine in an amount of about 0.1 -0.2 grams per serving of the composition, wherein a serving of the composition is 36-38 grams or 24 fluid ounces.
2. The dietary supplement composition of claim 1, wherein the composition further comprises at least one branched amino acid selected from the group consisting of leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, methionine, and glutamine.
3. The dietary supplement composition of claim 2, wherein the composition is a powder.
4. The dietary supplement composition of claim 2, wherein the composition is a liquid.
5. The dietary supplement composition of claim 2, wherein collagen is present in an amount of about 17-23 grams per serving of the composition, glutamine in an amount of about 0.75- 1.25 grams per serving ofthe composition, and taurine in an amount of about 0.125-0.175 grams per serving of the composition.
6. The dietary supplement composition of claim 2, wherein collagen is present in an amount of about 20 grams per serving of the composition, glutamine in an amount of about 0.97 grams per serving of the composition, and taurine in an amount of about 0.135 grams per serving of the composition.
7. The dietary supplement composition of claim 2, wherein the composition comprises leucine and isoleucine.
8. The dietary supplement composition of claim 3, wherein the composition further comprises powdered coconut water in an amount of about 10 to 20 weight percent of the composition.
9. The dietary supplement composition of claim 2, wherein the composition further comprises electrolytes selected from the group consisting of sodium, potassium, magnesium, zinc, calcium, bicarbonate, chloride, and phosphate.
10. The dietary supplement composition of claim 2, wherein the composition comprises the nine essential amino acids in a total amount of about 6-10 grams per serving of the composition.
1 1. The dietary supplement composition of claim 6, wherein the composition comprises the nine essential amino acids in a total amount of about 8 grams per serving of the composition.
12. The dietary supplement composition of claim 2, further comprising selenium.
13. The dietary supplement composition of claim 2, further comprising one or more of the following vitamins: Vitamin Bl, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B5, folate, Vitamin C, Vitamin D, and Vitamin E.
14. The dietary supplement composition of claim 1, further comprising at least one amino acid, wherein the amino acid profile of the composition is as follows:
Figure imgf000014_0001
15. The dietary supplement composition of claim 14, wherein collagen is present in an amount of about 20 grams per serving of the composition, glutamine in an amount of about 0.97 grams per serving of the composition, taurine in an amount of about 0.135 grams per serving of the composition, and the composition further comprises the nine essential amino acids in a total amount of about 8 grams per serving of the composition.
16. An amino acid blend having the following amino acid profile per 36-38 gram or 24 fluid ounce serving:
Figure imgf000015_0001
17. A method of replacing collagen broken down during physical activity comprising administering to a patient in need thereof the composition of claim 2 following said physical activity.
18. A method of replacing collagen broken down during physical activity comprising administering to a patient in need thereof the composition of claim 6 following said physical activity.
19. A method of replacing collagen broken down during physical activity comprising administering to a patient in need thereof the composition of claim 10 following said physical activity.
20. A method of replacing collagen following physical activity comprising administering to a patient in need thereof the composition of claim 16.
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JP2022534861A (en) 2022-08-04
EP3976088A1 (en) 2022-04-06
US20220233651A1 (en) 2022-07-28
CA3142007A1 (en) 2020-12-10
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US11666639B2 (en) 2023-06-06
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