WO2022251624A1 - Amino acid hydration formulation and method of use - Google Patents

Amino acid hydration formulation and method of use Download PDF

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Publication number
WO2022251624A1
WO2022251624A1 PCT/US2022/031330 US2022031330W WO2022251624A1 WO 2022251624 A1 WO2022251624 A1 WO 2022251624A1 US 2022031330 W US2022031330 W US 2022031330W WO 2022251624 A1 WO2022251624 A1 WO 2022251624A1
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WIPO (PCT)
Prior art keywords
amino acid
oral composition
acid
dipeptide
beverage
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Ceased
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PCT/US2022/031330
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English (en)
French (fr)
Inventor
Nilesh Bansilal KARAVA
Dattatreya GAJULA
Haiyu Ren
Yu Shi
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Coca Cola Co
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Coca Cola Co
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Publication date
Application filed by Coca Cola Co filed Critical Coca Cola Co
Priority to AU2022280087A priority Critical patent/AU2022280087A1/en
Priority to JP2023573331A priority patent/JP2024520526A/ja
Priority to KR1020237044381A priority patent/KR20240013777A/ko
Priority to CN202280050926.4A priority patent/CN118369093A/zh
Priority to CA3221410A priority patent/CA3221410A1/en
Priority to MX2023014015A priority patent/MX2023014015A/es
Priority to US18/565,042 priority patent/US20240252580A1/en
Priority to EP22812251.1A priority patent/EP4346793A4/en
Publication of WO2022251624A1 publication Critical patent/WO2022251624A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05Dipeptides
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/38Other non-alcoholic beverages
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/385Concentrates of non-alcoholic beverages
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/385Concentrates of non-alcoholic beverages
    • A23L2/39Dry compositions
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/52Adding ingredients
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/52Adding ingredients
    • A23L2/66Proteins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • A23L33/175Amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004Monosaccharides having only carbon, hydrogen and oxygen atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00Function of food ingredients
    • A23V2200/30Foods, ingredients or supplements having a functional effect on health
    • A23V2200/33High-energy foods and drinks, sports drinks
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2250/00Food ingredients
    • A23V2250/02Acid
    • A23V2250/06Amino acid

Definitions

  • the present disclosure generally relates to compositions and methods for hydration or rehydration.
  • beverages and sport drinks which provide the energy source, electrolytes, and water for rehydration.
  • These beverages may contain mixtures of proteins, sugars such as glucose, fructose, maltose, salts, and other additives such as citric acid, glycerol, triacylgylcerol, sodium acid sulfate, which are alleged to be beneficial for rehydration.
  • These beverages and compositions are generally disclosed, for examples, in U.S. Pat. Nos. 4,853,237, 5,447,730, 6,221,910, 6,485,764, 7,001,612, 7,160,565, 8,993,032, and U.S. Pat. App. Nos. 2005/0100637, 2005/0048136, 2009/0117224, 2012/0128815.
  • compositions could be more effective.
  • many compositions do not provide rapid restoration of body fluid and plasma volume, and the duration for rehydration effect is often relatively short.
  • the retention of body fluid after ingesting these compositions may not last long, and the total body fluid decreases quickly to the level prior to rehydration.
  • the effective component of the rehydrating composition and/or the direct evidence of rehydration effect are not clearly indicated in prior disclosures.
  • many existing compositions are high in carbohydrates, and/or other high calorie ingredients that may be less preferred by consumers.
  • the present disclosure presents hydrating and rehydrating compositions and methods that meet the above stated needs.
  • the present disclosure relates to a composition for oral consumption comprising an amino acid formulation.
  • the amino acid formulation may include an amino acid, a dipeptide, an oligopeptide, a carbohydrate-amino acid complex, or any combinations thereof.
  • the amino acid formulation consists essentially of glycine, or a glycine-containing dipeptide, or a carbohydrate-glycine complex, or any combinations thereof.
  • the amino acid formulation or the oral composition is free or substantially free from a branched-chain amino acid (BCAA).
  • the oral composition is a ready-to-drink hydrating beverage.
  • One particular example is a sport beverage or sport drink.
  • the beverage has a concentration of the amino acid formulation from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L based on the total volume of the beverage.
  • the oral composition is in a dry or semi-dry form.
  • a dry powder that is readily soluble in water.
  • a drinkable solution of the dry powder can be readily prepared by dissolving the dry powder in a drinkable medium, wherein the solution has a concentration of the amino acid formulation from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L based on the total volume of the drinkable solution.
  • the present composition further comprises at least one electrolyte.
  • electrolyte examples include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof.
  • the present composition further comprises at least one sweetener.
  • the sweetener can be a carbohydrate, a peptide-based sweetener, a non nutritive sweetener, an artificial sweetener, a commercial sweetener or sweetening composition, or a “natural high potency sweetener” (NHPS).
  • the present composition comprises a low- or non-calorie sweetener.
  • the present composition is free of substantially free from a carbohydrate sweetener.
  • the present composition further include at least one additive, at least one functional ingredient, or both.
  • the present composition has an osmolality from about 250 to about 350 mOsm/kg, or from about 260 to about 340 mOsm/kg, or from about
  • the present disclosure relates to a method for hydration or rehydration.
  • the present method utilizes the compositions described herein for at least one of the following purposes: providing a rapid impact on plasma volume (i.e. D2O or water) restoration during rehydration, attenuating or reversing the effects of dehydration or hypohydration, ameliorating other adverse effects of exercise, heat or other activity which causes bodily fluid loss, providing a positive impact on subsequent physical performance, enhancing the duration of body fluid retention, rapidly increasing plasma volume, maintaining the increased plasma volume for long duration, restoring and maintaining electrolyte balance, providing energy source, balancing or controlling calorie uptake, and stimulating thirst and drinking.
  • plasma volume i.e. D2O or water
  • the present disclosure provides a method of hydrating or rehydrating a human, the method comprising administering an effective amount of the oral composition described herein, wherein the oral composition comprises an amino acid formulation described herein.
  • the oral composition is a ready-to- drink hydrating beverage, or a sports drink, or an enhanced water drink.
  • the concentration of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the oral composition.
  • the oral composition is in a dry or semi dry form.
  • the form of the oral composition may be beverage concentrate, gel, dry powder, tablet, or capsule.
  • the oral composition is in dry powder that is readily soluble in a drinkable medium.
  • the method include preparing a drinkable solution containing the dry powder by dissolving the dry powder in a drinkable medium comprising water, and administering the drinkable solution orally.
  • the concentration of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the drinkable solution.
  • the method include ingesting/consuming the oral composition and a drinkable medium comprising water. Ingestion of the oral composition and a drinkable medium can be concurrently, simultaneously, separately, or successively.
  • the ratio of the oral composition to the drinkable medium is such that the content of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, relative to the total volume of the drinkable medium.
  • the amino acid formulation consists essentially of glycine, or a glycine-containing dipeptide, or a carbohydrate- glycine complex, or any combinations thereof.
  • the plasma volume of the human is increased by at least about 2.5%, or at least about 3%, or at least about 4% on or before 10 minutes after administration of the oral composition. In some embodiments, the plasma volume of the human is increased by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6% on or before 15 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% on or before 30 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% on or before 45 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% on or before 60 minutes after administration of the oral composition.
  • the plasma volume of the human measured at 30 minutes after administration of the oral composition remains substantially unchanged thereafter for at least about 15 minutes, or at least about 30 minutes, or at least about 1 hour.
  • the plasma volume of the human measured at 30 minutes after administration of the oral composition is decreased by less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10% for at least about 30 minutes.
  • the plasma osmolality of the human is maintained in a range from about 270 to about 330 mOsm/kg, or from about 280 to about 320 mOsm/kg, or from about 290 to about 310 mOsm/kg, or from about 290 to about 300 mOsm/kg, in at least 60 minutes after administration of the oral composition.
  • the change of the plasma osmolality of the human is no greater than 3 mOsm/kg in at least 60 minutes after administration of the oral composition.
  • weight percent As used herein, “weight percent,” “wt%, “percent by weight,” “% by weight,” and variations thereof refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used here, “percent,” “%,” and the like are intended to be synonymous with “weight percent,” “wt%,” etc.
  • g represents gram; “kg” represents kilogram or 1000 grams; “L” represents liter; “mg” represents “milligram (10 3 gram);” “mL” or “cc” represents milliliter (10 3 liter).
  • the units “g/lOOg,” “g/lOOmL,” or “g/L” are units of concentration or content of a component in a composition. One “mg/L” equals to one ppm (part per million).
  • Da refers to Dalton, which is the unit for molecular weight; One Da equals to one g/mol.
  • the unit of temperature used herein is degree Celsius (°C).
  • any ranges of values set forth in this specification contemplate all values within the range and are to be construed as support for claims reciting any sub-ranges having endpoints which are real number values within the specified range in question.
  • a disclosure in this specification of a range of from 1 to 5 shall be considered to support claims to any of the following ranges: 1-5; 1-4; 1-3; 1-2; 2-5; 2-4; 2-3; 3-5; 3-4; and 4- 5.
  • substantially free may refer to any component that the composition of the disclosure lacks or mostly lacks. When referring to “substantially free” it is intended that the component is not intentionally added to compositions of the disclosure. Use of the term “substantially free” of a component allows for trace amounts of that component to be included in compositions of the disclosure because they are present in another component. However, it is recognized that only trace or de minimus amounts of a component will be allowed when the composition is said to be “substantially free” of that component. Moreover, if a composition is said to be “substantially free” of a component, if the component is present in trace or de minimus amounts it is understood that it will not affect the effectiveness of the composition.
  • composition may be substantially free of that ingredient.
  • express inclusion of an ingredient allows for its express exclusion thereby allowing a composition to be substantially free of that expressly stated ingredient.
  • the transitional phrase “consisting essentially of’ means that the scope of a claim is to be interpreted to encompass the specified materials or steps recited in the claim and those that do not materially affect the basic and novel characteristic(s) of the claimed disclosure. Thus, the term “consisting essentially of’ when used in a claim of this disclosure is not intended to be interpreted to be equivalent to “comprising.”
  • the terms “increase,” “increasing,” “increased,” “enhance,” “enhanced,” “enhancing,” and “enhancement” (and grammatical variations thereof) describe an elevation of at least about 1%, 5%, 10%, 15%, 25%, 50%, 75%, 100%, 150%, 200%, 300%, 400%, 500% or more as compared to a control.
  • the terms “reduce,” “reduced,” “reducing,” “reduction,” “diminish,” and “decrease” describe, for example, a decrease of at least about 1%, 5%, 10%, 15%, 20%, 25%, 35%, 50%, 75%, 80%,
  • the reduction can result in no or essentially no (i.e., an insignificant amount, e.g., less than about 10% or even 5% or even 1%) detectable activity or amount.
  • Osmolality is defined as the number of dissolved particles in a unit volume of water solution. Osmolarity is defined as the number of dissolved particles in a unit weight of water solution. As a practical matter, osmolality and osmolarity have numerical values which are very close in the ranges involved in the present disclosure and therefore are used interchangeably.
  • a solution that has 1/1000 of an osmol dissolved per kilogram has a concentration of 1 milliosmols (“mOs”) per kilogram.
  • An osmol is the number of particles in 1 gram molecular weight of undissociated solute.
  • Tonicity is a measure of the osmotic pressure of a solution relative to the osmotic pressure of the blood fluids.
  • a hypotonic solution is a solution of lower osmotic pressure or tonicity than that of blood.
  • the osmolality of a hypotonic solution is usually in the range of about 80-250 mOs/kg.
  • An isotonic solution has the same tonicity as blood.
  • the osmolality usually ranges from about 280 to about 310 mOs/kg.
  • a hypertonic solution is a solution of greater tonicity than blood. It normally has an osmolality range of about 310-440 mOs/kg. Water has the osmolality of about 10-20 mOs/kg.
  • beverage means any drinkable liquid or semi-liquid, including for example water, flavored water, soft drinks, fruit drinks, tea-based drinks, juice-based drinks, gel drinks, carbonated or non-carbonated drinks, and alcoholic or non-alcoholic drinks.
  • a beverage powder may first be mixed with any drinkable liquid or semi-liquid to obtain a beverage.
  • dehydration is defined as a condition that occurs when the body loses too much water and other fluids that it needs to work normally. Dehydration is usually caused by severe diarrhea and vomiting, but it may also be caused by not drinking enough water or other fluids, sweating too much, fever, urinating too much, taking certain medicines, or physical exertion. Rehydration is the replenishment of water and electrolytes lost through dehydration. Rapid rehydration (or rapid hydration) is the replenishment of water and electrolytes within 30 minutes.
  • amino acid refers to an organic compound or unit that contains amino (-NH2) and carboxyl (-COOH) functional groups.
  • amino acid of the present disclosure broadly encompasses any compound having at least one amino acid unit.
  • amino acid formulation used herein refers to a molecule, a compound, a complex, an oligomer, a polymer, a mixture, or a composition having at least one amino acid unit physically (through non-covenant bonding) or chemically (though covalent, hydrogen, or coordinate bonding) incorporated in the amino acid formulation.
  • Non-limiting examples of amino acid, amino acid compound, and amino acid formulation used herein include aspartic acid, alanine, glycine, glutamic acid, praline, threonine, theanine, cysteine, cystine, alanine, valine, tyrosine, leucine, arabinose, trans-4-hydroxyproline, isoleucine, asparagine, serine, lysine, histidine, ornithine, methionine, carnitine, aminobutyric acid (a-, b-, and/or g-isomers), glutamine, hydroxyproline, taurine, norvaline, sarcosine, and their salt forms such as sodium or potassium salts or acid salts.
  • the amino acid also may be in the D- or L-configuration and in the mono-, di-, or tri-form of the same or different amino acids. Additionally, the amino acids may be a-, b-, and/or g-isomers if appropriate. Combinations of the foregoing amino acids and their corresponding salts (e.g., sodium, potassium, calcium, magnesium salts or other alkali or alkaline earth metal salts thereof, or acid salts) also are suitable additives in some embodiments.
  • the amino acids may be natural or synthetic.
  • the amino acids also may be modified.
  • Modified amino acids refers to any amino acid wherein at least one atom has been added, removed, substituted, or combinations thereof (e.g., N-alkyl amino acid, N-acyl amino acid, or N-methyl amino acid).
  • modified amino acids include amino acid derivatives such as trimethyl glycine, N-methyl-glycine, and N-methyl-alanine.
  • modified amino acids encompass both modified and unmodified amino acids.
  • amino acids also encompass both peptides, oligopeptides, and polypeptides (e.g., dipeptides, tripeptides, tetrapeptides, and pentapeptides) such as glutathione and L-alanyl-L-glutamine.
  • Suitable polyamino acid include poly-L-aspartic acid, poly-L- lysine (e.g., poly-L-a-lysine or poly-L-e-lysine), poly-L-ornithine (e.g., poly-L-a- ornithine or poly-L- e -ornithine), poly-L-alanine, other polymeric forms of amino acids, and salt forms thereof (e.g., calcium, potassium, sodium, or magnesium salts such as L-glutamic acid mono sodium salt).
  • the poly-amino acid additives also may be in the D- or L-configuration.
  • poly-amino acids may be a-, b-, g-, d-, and e- isomers if appropriate. Combinations of the foregoing poly-amino acids and their corresponding salts (e.g., sodium, potassium, calcium, magnesium salts or other alkali or alkaline earth metal salts thereof or acid salts) also are suitable additives in some embodiments.
  • the poly-amino acids described herein also may comprise co-polymers of different amino acids.
  • the poly-amino acids described herein also may comprise co polymers of different amino acids.
  • the poly-amino acids may be natural or synthetic.
  • poly-amino acids also may be modified, such that at least one atom has been added, removed, substituted, or combinations thereof (e.g., N-alkyl polyamino acid or N-acyl poly-amino acid).
  • poly-amino acids encompass both modified and unmodified poly-amino acids.
  • modified poly-amino acids include, but are not limited to, poly-amino acids of various molecular weights (MW), such as poly-L-a-glycine with a MW of about 100, about 200, about 300, about 500, about 1,000, about 1,500, about 6,000, about 25,200, about 63,000, about 83,000, or about 300,000 in Dalton (Da).
  • the amino acid formulation provided herein also include an amino acid derivative, a peptide derivate, a peptide hydrolysate or a peptide residue thereof.
  • FIG. 1 shows the plasma volume changes over time after for various compositions according to Example 1.
  • FIG. 2 shows the plasma osmolality changes over time for various compositions according to Example 1.
  • the present disclosure relates to a composition for oral consumption comprising an amino acid formulation.
  • Amino acids or formulations containing amino acids have been found to increase water absorption in the human intestine in intestinal perfusion tests, which are designed to understand the intestinal water absorption speed.
  • amino acid solutions are directly perfused into the intestine and fluid absorption is measured in a specific segment of the intestine. This method provides valuable insights but does not account for gastric emptying rate and does not provide a direct measurement of the rate of fluid appearance in blood.
  • Six amino acids as shown in Table 1 were previously reported to have effect on electrolyte and water absorption. For example, Hellier et al.
  • ENTERADE® is a commercial food product containing five selected amino acids: threonine, aspartic acid, tyrosine, serine, and valine. However, no direct and clear rehydration effect was provided with respect to the contributing factor of each amino acid, and the beverages compared in the experiments significantly differed from each other with respect to the composition. Table 2. Rehydration compositions of prior disclosures.
  • the present disclosure is based, at least in part, on the findings that amino acid formulation added in a beverage could body fluid volume improvement after exercise and rehydration. A better sustained and replenished body fluid - after rehydration - will provide possible thermoregulatory and performance advantages during subsequent exercise-heat stress.
  • the present disclosure advantageously provides compositions that are effective in improving the rehydration and retention of hydration.
  • the amino acid formulation according to the present disclosure may be an amino acid, or an amino acid compound, or an amino acid-containing composition, or mixtures thereof.
  • test beverage compositions were 1. Aquarius (Aqua) (4% carbohydrate + 18 mmol/L sodium), 2. Low carbohydrate (Low CHO) (3% carbohydrate + 18 mmol/L sodium + Amino Acid), 3. PowerAde Zero (Zero CHO) (0% carbohydrate + 18 mmol/L sodium + Amino Acid)].
  • the study also included water and PowerAde (PWDE) as controls.
  • D2O deuterium oxide
  • D2O deuterium oxide
  • ORS appeared in the blood stream significantly faster than Water and PWDE at 15, 20, 25, 30, 45, and 60 min time point (p ⁇ 05) representing 5 faster hydration.
  • both ORS and PRO showed greater NFB than Water at 120 and 180 min time point (p ⁇ 05).
  • the amino acid formulation comprises an amino acid.
  • amino acid include leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, and tryptophan , or any combination thereof. These amino acids can be categorized as essential amino acids.
  • Other non limiting examples of amino acid include alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine, or any 5 combination thereof. These amino acids can be categorized as non-essential amino acids.
  • the amino acid formulation will comprise at least one essential amino acid and at least one non-essential amino acid.
  • the amino acid formulation consists essentially of glycine and is free or0 substantially free from other amino acid.
  • the amino acid formulation consists essentially of alanine and is free or substantially free from other amino acid.
  • the amino acid formulation consists essentially of glycine and alanine in a ratio from about 100: 1 (w/w) to about 1 : 100 (w/w), and is free or substantially free from other amino acid. It was surprisingly found that the present compositions comprising glycine had excellent performance in rapid hydration, prolonged retention of plasma volume, and prolonged retention of plasma osmolality.
  • the amino acid formulation comprises a dipeptide.
  • dipeptide includes glycine-containing dipeptide, lysine-containing dipeptide, alanine-containing dipeptide, alanine-containing dipeptide, glutamine- containing dipeptide.
  • dipeptide examples include L-alanyl-L-glutamine (L- Ala-L-Gln), glycyl-glycine (Gly-Gly), L-glutamyl-L-alanine (Glu-Ala), Gly-Ala, Ala- Gly, Glu-Gly, Gly-Glu, Glu-Ala, Ala-Glu, commercial dipeptides such as aspartame, carnosine, acetylcarnosine, Val-Tyr, or any stereoisomers thereof, or any salt or derivatives thereof, or any combination thereof.
  • the amino acid formulation consists essentially of a compound selected from the group consisting of Gly-Gly, Ala-Ala, Gly-Ala, Ala-Gly, or salts and derivatives thereof, or any combinations thereof. In one embodiment, the amino acid formulation consists essentially of Gly-Gly.
  • the amino acid formulation comprises a carbohydrate- amino acid complex.
  • the carbohydrate-amino acid complex used herein refers to a compound having both a carbohydrate unit and an amino acid unite that are integrated in the compound through covalent bonding.
  • the carbohydrate unit can be a single sugar molecule or oligosaccharides or polysaccharides.
  • Non-limiting examples of carbohydrate include sucrose, glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheltulose, octolose, fucose, rhamnose, arabinose, turanose, sialose.
  • Non-limiting examples of carbohydrate-amino acid complex include glutamine-glucose, alanine-glucose, glycine-glucose, alanine-glucose, lysine-glucose, or combinations thereof.
  • the amino acid formulation consists essentially of a compound selected from the group consisting of glutamine-glucose, alanine-glucose, glycine-glucose, alanine-glucose, or salts and derivatives thereof, or any combinations thereof.
  • the amino acid formulation comprises a compound selected from the group consisting of an amino acid, a dipeptide, a carbohydrate-amino acid complex, or any combination thereof.
  • the amino acid formulation consists essentially of an amino acid and a dipeptide, wherein the amino acid is glycine or alanine or both, and wherein the dipeptide is Gly-Gly, Ala-Ala, Gly-Ala, Ala-Gly, or any combinations thereof.
  • the concentration of the amino acid formulation in the composition can be from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the composition.
  • the present composition comprises glycine as the only amino acid ingredient, wherein the glycine concentration is from about 4 g/L to about 20 g/L, based on the total volume of the composition.
  • the present composition comprises a branched-chain amino acid (BCAA).
  • BCAA branched-chain amino acid
  • a branched-chain amino acid is an amino acid having an aliphatic side-chain with a branch (a central carbon atom bound to three or more carbon atoms).
  • BCAA branched-chain amino acid
  • Non- proteinogenic BCAAs include 2-aminoisobutyric acid.
  • a beverage comprises leucine, isoleucine and valine.
  • the BCAA can be in the D- or L-configuration.
  • the present composition may optionally contain a total BCAA in a concentration from about 50 mg/L (ppm) to about 5,000 mg/L, such as, for example, from about 1,000 mg/L to about 5,000 mg/L, from about 2,000 mg/L to about 5,000 mg/L, from about 3,000 mg/L to about 5,000 mg/L, from about 4,000 mg/L to about 5,000 mg/L, from about 1,000 mg/L to about 4,000 mg/L, from about 2,000 mg/L to about 4,000 mg/L, from about 3,000 mg/L to about 4,000 mg/L, from about 1,000 mg/L to about 3,000 mg/L, from about 2,000 mg/L to about 3,000 mg/L or from about 1,000 mg/L to about 2,000 mg/L.
  • a beverage of the present disclosure contains about 2,000 mg/L to about 3,000 mg/L BCAA.
  • the present composition is free or substantially free from a branched-chain amino acid (BCAA).
  • BCAA branched-chain amino acid
  • the present oral composition can contain additional typical beverage ingredients, e.g. at least one electrolyte and/or at least one sweetener and/or at least one functional ingredient and/or at least one additive.
  • electrolyte e.g. at least one electrolyte and/or at least one sweetener and/or at least one functional ingredient and/or at least one additive.
  • the present composition may contain at least one electrolyte.
  • electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof.
  • the electrolytes and ionic components for the present disclosure are usually, but not necessarily, obtainable from their corresponding water-soluble and non-toxic salts. Unless otherwise defined, the amount of electrolytes or ionic components in the composition is based on those present in the final ingestible form. The electrolyte concentration is of the ion only and not the salt.
  • the present composition preferably contains a total electrolyte concentration of at least about 200 mg/L, at least about 300 mg/L, at least about 400 mg/L, at least about 500 mg/L, at least about 600 mg/L, at least about 700 mg/L or at least about 800 mg/L.
  • the present composition contains an electrolyte concentration from about 400 mg/L to about 1,000 mg/L, from about 400 mg/L to about 900 mg/L, from about 400 mg/L to about 800 mg/L, from about 400 mg/L to about 700 mg/L, from about 400 mg/L to about 600 mg/L, from about 400 mg/L to about 500 mg/L, from about 500 mg/L to about 1,000 mg/L.
  • the potassium ion component can be provided by any salt including the chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof.
  • the potassium ions are preferably present in the composition of the present disclosure in an amount of at least 0.0025% to about 0.08% by weight, from about 0.0075% to about 0.06% or from about 0.0075% to about 0.015% by weight.
  • the present composition can contain from about 5 mg/L to about 1,000 mg/L potassium, more preferably from about 50 mg/L to about 300 mg/L, such as, for example, from about 100 mg/L to about 300 mg/L, from about 200 mg/L to about 300 mg/L, from about 50 mg/L to about 200 mg/L, from about 100 mg/L to about 200 mg/L or from about 100 mg/L to about 200 mg/L.
  • the sodium ion component can be provided by any salt such as the chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, lactate or a combination thereof.
  • the sodium ions are preferably present in the present composition in an amount of at least about 0.005% to about 0.1% by weight, from about 0.0075% to about 0.075% or about 0.015% to about 0.05% by weight.
  • the present composition can contain from about 5 mg/L to about 1,000 mg/L sodium, more preferably from about 300 mg/L to about 800 mg/L sodium, such as, for example, from about 300 mg/L to about 700 mg/L, from about 300 mg/L to about 600 mg/L, from about 300 mg/L to about 500 mg/L, from about 300 mg/L to about 400 mg/L, from about 400 mg/L to about 800 mg/L, from about 400 mg/L to about 700 mg/L, from about 400 mg/L to about 600 mg/L from about 400 mg/L to about 500 mg/L, from about 500 mg/L to about 800 mg/L, from about 500 mg/L to about 700 mg/L, from about 500 mg/L to about 600 mg/L, from about 600 mg/L to about 800 mg/L, from about 600 mg/L to about 700 mg/L and from about 700 mg/L to about 800 mg/L.
  • the present composition contains from about 600 mg/L to about 700 mg/L sodium.
  • the calcium ion component can be provided by any salt such as the chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof.
  • the calcium ions are preferably present in the present composition in an amount of at least about 0.0005% to about 0.010% by weight.
  • the present composition can contain from about 5 mg/L to about 1,000 mg/L calcium, more preferably from about 1 mg/L to about 50 mg/L, such as, for example, from about 5 mg/L to about 10 mg/L.
  • the magnesium ion component can be provided by any salt such as the chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof.
  • the magnesium ions are preferably present in the present composition in an amount of at least about 0.0005% to about 0.010% by weight.
  • the present composition can contain from about 5 mg/L to about 1,000 mg/L magnesium, more preferably from about 1 mg/L to about 50 mg/L, such as, for example, from about 5 mg/L to about 20 mg/L.
  • the present composition can contain chloride ion from about 0.005% to about 0.20% by weight, from about 0.01% to about 0.15% or from about 0.02% to about 0.075%.
  • the chloride ion component can be provided by a salt such as sodium chloride, potassium chloride or a combination thereof.
  • a beverage of the present disclosure contains at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium and combinations thereof. In another particular embodiment, a beverage of the present disclosure contains at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium and combinations thereof, wherein the amount of each electrolyte is as provided above.
  • the present composition may optionally include a sweetener.
  • the sweetener can be an artificial or synthetic sweetener, a natural sweetener, a natural high potency sweetener.
  • NHPS natural high potency sweetener
  • the natural high potency sweetener can be provided as a pure compound or, alternatively, as part of an extract.
  • synthetic sweetener refers to any composition which is not found naturally in nature and characteristically has a sweetness potency greater than sucrose, fructose, or glucose, yet has less calories.
  • Non-limiting examples of NHPSs includes stevia and steviol glycosides, such as rebaudioside M, rebaudioside D, rebaudioside A, rebaudioside N, rebaudioside O, rebaudioside E, steviolmonoside, steviolbioside, rubusoside, dulcoside B, dulcoside A, rebaudioside B, rebaudioside G, stevioside, rebaudioside C, rebaudioside F, rebaudioside I, rebaudioside H, rebaudioside L, rebaudioside K, rebaudioside J, rebaudioside M2, rebaudioside D2, rebaudioside S, rebaudioside T, rebaudioside U, rebaudioside V, rebaudioside W, rebaudioside Zl, rebaudioside Z2, rebaudioside IX, enzymatically glucosylated steviol glycosides and combinations
  • a steviol glycoside blend comprises at least about 5% steviol glycoside by weight, such as, for example, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95% or at least about 97%.
  • the steviol glycoside blend comprises at least about 50% steviol glycoside by weight, such as, for example, from about 50% to about 90%, from about 50% to about 80%, from about 50% to about 70%, from about 50% to about 60%, from about 60% to about 90%, from about 60% to about 80%, from about 60% to about 70%, from about 70% to about 90%, from about 70% to about 80% and from about 80% to about 90%.
  • Another exemplary NHPS is Luo Han Guo and the related mogroside compounds, such as grosmogroside I, mogroside IA, mogroside IE, 11-oxomogroside IA, mogroside II, mogroside II A, mogroside II B, mogroside II E, 7-oxomogroside II E, mogroside III, Mogroside HIE, 11- oxomogroside HIE, 11- deoxymogroside III, mogroside IV, Mogroside IVA 11-oxomogroside IV, 11-oxomogroside IV A, mogroside V, isomogroside V, 11 -deoxymogroside V, 7-oxomogroside V, 11- oxomogroside V, isomogroside V, mogroside VI, mogrol, 11-oxomogrol, siamenoside I, isomers of siamenoside I (e.g., grosmogroside I, mogroside IA, mogroside
  • a mogroside blend comprises at least about 5% of the mogroside by weight, such as, for example, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95% or at least about 97%.
  • exemplary NHPSs include monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hemandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I.
  • monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hemandulcin, phyllodulci
  • the sweetener is a carbohydrate sweetener.
  • suitable carbohydrate sweeteners include, but not limited to, the group consisting of sucrose, glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheltulose, octolose, fucose, rhamnose, arabinose, turanose, sialose and combinations thereof.
  • the present composition is free or substantially free from a carbohydrate sweetener.
  • sweeteners include siamenoside, monatin and its salts (monatin SS, RR, RS, SR), curculin, mogrosides, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, steviolbioside and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and salts thereof, aspartame, alitame, saccharin and salts thereof, neo
  • the sweetener is a caloric sweetener or mixture of caloric sweeteners.
  • the caloric sweetener is selected from sucrose, fructose, glucose, high fructose com/starch syrup, a beet sugar, a cane sugar, and combinations thereof.
  • the present composition is free or substantially free from a caloric sweetener.
  • the sweetener is a rare sugar selected from allulose, gulose, kojibiose, sorbose, lyxose, ribulose, xylose, xylulose, D-allose, L-ribose, D- tagatose, L-glucose, L-fucose, L-arabinose, turanose and combinations thereof.
  • the amount of sweetener in the present composition depends on the identity of the sweetener and the desired level of sweetness.
  • the sweetener is present in a sweetening amount, i.e. a concentration that is detectably sweet.
  • sucrose equivalence As would be understood by a person of skill in the art, high potency sweeteners are more potent and therefore lower concentrations are required to achieve a particular sucrose equivalence (SE).
  • the sweetness of a non-sucrose sweetener can be measured against a sucrose reference by determining the non-sucrose sweetener’s sucrose equivalence (SE).
  • SE sucrose equivalence
  • taste panelists are trained to detect sweetness of reference sucrose solutions containing between 1- 15% sucrose (w/v).
  • Other non-sucrose sweeteners are then tasted at a series of dilutions to determine the concentration of the non-sucrose sweetener that is as sweet as a given percent sucrose reference. For example, if a 1% solution of a non-sucrose sweetener is as sweet as a 10% sucrose solution, then the sweetener is said to be 10 times as potent as sucrose, and has 10% sucrose equi
  • the sweetener or sweeteners provides the present composition with a sucrose equivalence of about 1% (w/v), such as, for example, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14% or any range between these values.
  • the present composition has a SE from about 2% to about 14%, such as, for example, from about 2% to about 10%, from about 2% to about 5%, from about 5% to about 15%, from about 5% to about 10% or from about 10% to about 15%.
  • the amount of sucrose, and thus another measure of sweetness, in a reference solution may be described in degrees Brix (°Bx).
  • degrees Brix is 1 gram of sucrose in 100 grams of solution and represents the strength of the solution as percentage by weight (% w/w) (strictly speaking, by mass).
  • the beverage can be about 1 degree Brix, about 2 degrees Brix, about 3 degrees Brix, about 4 degrees Brix, about 5 degrees Brix, about 6 degrees Brix, about 7 degrees Brix, about 8 degrees Brix, about 9 degrees Brix, about 10 degrees Brix, about 11 degrees Brix, about 12 degrees Brix, about 13 degrees Brix, about 14 degrees Brix or any range between these values.
  • the present composition may optionally include a functional ingredient.
  • exemplary functional ingredients include, but are not limited to, saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof.
  • the functional ingredient is at least one saponin.
  • the at least one saponin may comprise a single saponin or a plurality of saponins as a functional ingredient for the composition provided herein.
  • Saponins are glycosidic natural plant products comprising an aglycone ring structure and one or more sugar moieties.
  • Non-limiting examples of specific saponins for use in particular embodiments of the disclosure include group A acetyl saponin, group B acetyl saponin, and group E acetyl saponin.
  • saponins include soybeans, which have approximately 5% saponin content by dry weight, soapwort plants Saponaria), the root of which was used historically as soap, as well as alfalfa, aloe, asparagus, grapes, chickpeas, yucca, and various other beans and weeds. Saponins may be obtained from these sources by using extraction techniques well known to those of ordinary skill in the art. A description of conventional extraction techniques can be found in U.S. Pat. Appl. No. 2005/0123662.
  • the functional ingredient is at least one antioxidant.
  • antioxidant refers to any substance which inhibits, suppresses, or reduces oxidative damage to cells and biomolecules.
  • antioxidants examples include, but are not limited to, vitamins, vitamin cofactors, minerals, hormones, carotenoids, carotenoid terpenoids, non-carotenoid terpenoids, flavonoids, flavonoid polyphenolics (e.g., bioflavonoids), flavonols, flavones, phenols, polyphenols, esters of phenols, esters of polyphenols, nonflavonoid phenolics, isothiocyanates, and combinations thereof.
  • bioflavonoids bioflavonoids
  • flavonols flavones
  • phenols polyphenols
  • esters of phenols esters of polyphenols
  • nonflavonoid phenolics isothiocyanates
  • the antioxidant is vitamin A, vitamin C, vitamin E, ubiquinone, mineral selenium, manganese, melatonin, oc-carotene, b- carotene, lycopene, lutein, zeanthin, crypoxanthin, reservatol, eugenol, quercetin, catechin, gossypol, hesperetin, curcumin, ferulic acid, thymol, hydroxytyrosol, tumeric, thyme, olive oil, lipoic acid, glutathinone, gutamine, oxalic acid, tocopherol -derived compounds, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), tert-butylhydroquinone, acetic acid, pectin, tocotrienol, tocopherol, coen
  • the antioxidant is a synthetic antioxidant such as butylated hydroxytolune or butylated hydroxyanisole, for example.
  • suitable antioxidants for embodiments of this disclosure include, but are not limited to, fruits, vegetables, tea, cocoa, chocolate, spices, herbs, rice, organ meats from livestock, yeast, whole grains, or cereal grains.
  • polyphenols also known as “polyphenolics”
  • Suitable polyphenols for embodiments of this disclosure include catechins, proanthocyanidins, procyanidins, anthocyanins, quercerin, rutin, reservatrol, isoflavones, curcumin, punicalagin, ellagitannin, hesperidin, naringin, citrus flavonoids, chlorogenic acid, other similar materials, and combinations thereof.
  • the antioxidant is a catechin such as, for example, epigallocatechin gallate (EGCG).
  • the antioxidant is chosen from proanthocyanidins, procyanidins or combinations thereof.
  • the antioxidant is an anthocyanin.
  • the antioxidant is chosen from quercetin, rutin or combinations thereof.
  • the antioxidant is reservatrol.
  • the antioxidant is an isoflavone.
  • the antioxidant is curcumin.
  • the antioxidant is chosen from punicalagin, ellagitannin or combinations thereof.
  • the antioxidant is chlorogenic acid.
  • the functional ingredient is at least one dietary fiber.
  • Numerous polymeric carbohydrates having significantly different structures in both composition and linkages fall within the definition of dietary fiber. Such compounds are well known to those skilled in the art, non-limiting examples of which include non starch polysaccharides, lignin, cellulose, methylcellulose, the hemicelluloses, b- glucans, pectins, gums, mucilage, waxes, inulins, oligosaccharides, fructooligosaccharides, cyclodextrins, chitins, and combinations thereof.
  • dietary fiber generally is derived from plant sources, indigestible animal products such as chitins are also classified as dietary fiber.
  • Chitin is a polysaccharide composed of units of acetylglucosamine joined by b(l-4) linkages, similar to the linkages of cellulose.
  • the functional ingredient is at least one fatty acid.
  • fatty acid refers to any straight chain monocarboxylic acid and includes saturated fatty acids, unsaturated fatty acids, long chain fatty acids, medium chain fatty acids, short chain fatty acids, fatty acid precursors (including omega-9 fatty acid precursors), and esterified fatty acids.
  • long chain polyunsaturated fatty acid refers to any polyunsaturated carboxylic acid or organic acid with a long aliphatic tail.
  • omega-3 fatty acid refers to any polyunsaturated fatty acid having a first double bond as the third carbon-carbon bond from the terminal methyl end of its carbon chain.
  • the omega-3 fatty acid may comprise a long chain omega-3 fatty acid.
  • omega-6 fatty acid any polyunsaturated fatty acid having a first double bond as the sixth carbon-carbon bond from the terminal methyl end of its carbon chain.
  • Suitable omega-3 fatty acids for use in embodiments of the present disclosure can be derived from algae, fish, animals, plants, or combinations thereof, for example.
  • suitable omega-3 fatty acids include, but are not limited to, linolenic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid, eicosatetraenoic acid and combinations thereof.
  • suitable omega- 3 fatty acids can be provided in fish oils, (e.g., menhaden oil, tuna oil, salmon oil, bonito oil, and cod oil), microalgae omega-3 oils or combinations thereof.
  • suitable omega-3 fatty acids may be derived from commercially available omega-3 fatty acid oils such as Microalgae DHA oil (from Martek, Columbia, MD), OmegaPure (from Omega Protein, Houston, TX), Marinol C-38 (from Lipid Nutrition, Channahon, IL), Bonito oil and MEG-3 (from Ocean Nutrition, Dartmouth, NS), Evogel (from Symrise, Holzminden, Germany), Marine Oil, from tuna or salmon (from Arista Wilton, CT), OmegaSource 2000, Marine Oil, from menhaden and Marine Oil, from cod (from OmegaSource, RTP, NC).
  • omega-3 fatty acid oils such as Microalgae DHA oil (from Martek, Columbia, MD), OmegaPure (from Omega Protein, Houston, TX), Marinol C-38 (from Lipid Nutrition, Channahon, IL), Bonito oil and MEG-3 (from Ocean Nutrition, Dartmouth, NS), Evogel (from Symrise, Holzminden, Germany), Marine Oil, from tuna or salmon (
  • Suitable omega-6 fatty acids include, but are not limited to, linoleic acid, gamma- linolenic acid, dihommo-gamma-linolenic acid, arachidonic acid, eicosadienoic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid and combinations thereof.
  • Suitable esterified fatty acids for embodiments of the present disclosure include, but are not limited to, monoacylgycerols containing omega-3 and/or omega-6 fatty acids, diacylgycerols containing omega-3 and/or omega-6 fatty acids, or triacylgycerols containing omega-3 and/or omega-6 fatty acids and combinations thereof.
  • the functional ingredient is at least one vitamin.
  • Suitable vitamins include, vitamin A, vitamin D, vitamin E, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B 12, and vitamin C.
  • vitamin includes pseudo-vitamins.
  • the vitamin is a fat- soluble vitamin chosen from vitamin A, D, E,
  • the vitamin is a water-soluble vitamin chosen from vitamin Bl, vitamin B2, vitamin B3, vitamin B6, vitamin B 12, folic acid, biotin, pantothenic acid, vitamin C and combinations thereof.
  • the functional ingredient is glucosamine, optionally further comprising chondroitin sulfate.
  • the functional ingredient is at least one mineral.
  • Minerals in accordance with the teachings of this disclosure, comprise inorganic chemical elements required by living organisms. Minerals are comprised of a broad range of compositions (e.g., elements, simple salts, and complex silicates) and also vary broadly in crystalline structure. They may naturally occur in foods and beverages, may be added as a supplement, or may be consumed or administered separately from foods or beverages.
  • Minerals may be categorized as either bulk minerals, which are required in relatively large amounts, or trace minerals, which are required in relatively small amounts.
  • Bulk minerals generally are required in amounts greater than or equal to about 100 mg per day and trace minerals are those that are required in amounts less than about 100 mg per day.
  • the mineral is chosen from bulk minerals, trace minerals or combinations thereof.
  • Non-limiting examples of bulk minerals include calcium, chlorine, magnesium, phosphorous, potassium, sodium, and sulfur.
  • Non limiting examples of trace minerals include chromium, cobalt, copper, fluorine, iron, manganese, molybdenum, selenium, zinc, and iodine. Although iodine generally is classified as a trace mineral, it is required in larger quantities than other trace minerals and often is categorized as a bulk mineral.
  • the mineral is a trace mineral, believed to be necessary for human nutrition, non-limiting examples of which include bismuth, boron, lithium, nickel, rubidium, silicon, strontium, tellurium, tin, titanium, tungsten, and vanadium.
  • the minerals embodied herein may be in any form known to those of ordinary skill in the art.
  • the minerals may be in their ionic form, having either a positive or negative charge.
  • the minerals may be in their molecular form.
  • sulfur and phosphorous often are found naturally as sulfates, sulfides, and phosphates.
  • the functional ingredient is at least one preservative.
  • the preservative is chosen from antimicrobials, antioxidants, antienzymatics or combinations thereof.
  • antimicrobials include sulfites, propionates, benzoates, sorbates, nitrates, nitrites, bacteriocins, salts, sugars, acetic acid, dimethyl dicarbonate (DMDC), ethanol, and ozone.
  • the preservative is a sulfite. Sulfites include, but are not limited to, sulfur dioxide, sodium bisulfite, and potassium hydrogen sulfite.
  • the preservative is a propionate.
  • Propionates include, but are not limited to, propionic acid, calcium propionate, and sodium propionate.
  • the preservative is a benzoate. Benzoates include, but are not limited to, sodium benzoate and benzoic acid.
  • the preservative is a sorbate. Sorbates include, but are not limited to, potassium sorbate, sodium sorbate, calcium sorbate, and sorbic acid.
  • the preservative is a nitrate and/or a nitrite. Nitrates and nitrites include, but are not limited to, sodium nitrate and sodium nitrite.
  • the at least one preservative is a bacteriocin, such as, for example, nisin.
  • the preservative is ethanol.
  • the preservative is ozone.
  • anti-enzymatis suitable for use as preservatives in particular embodiments of the disclosure include ascorbic acid, citric acid, and metal chelating agents such as ethylenediaminetetraacetic acid (EDTA).
  • the functional ingredient is an additional hydration agent to the amino acid formulation.
  • the additional hydration agent can be a synergist when combined with the amino acid formulation further enhances the hydration or rehydration effect of the composition.
  • the additional hydration agent is a carbohydrate to supplement energy stores burned by muscles.
  • suitable carbohydrates for use in particular embodiments of this disclosure are described in U.S. Patent Numbers 4,312,856, 4,853,237, 5,681,569, and 6,989,171.
  • suitable carbohydrates include monosaccharides, di saccharides, oligosaccharides, complex polysaccharides or combinations thereof.
  • suitable types of monosaccharides for use in particular embodiments include trioses, tetroses, pentoses, hexoses, heptoses, octoses, and nonoses.
  • Non-limiting examples of specific types of suitable monosaccharides include glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheltulose, octolose, and sialose.
  • suitable disaccharides include sucrose, lactose, and maltose.
  • Non-limiting examples of suitable oligosaccharides include saccharose, maltotriose, and maltodextrin.
  • the carbohydrates are provided by a corn syrup, a beet sugar, a cane sugar, a juice, or a tea.
  • the additional hydration agent is a flavanol that provides cellular rehydration.
  • Flavanols are a class of natural substances present in plants, and generally comprise a 2-phenylbenzopyrone molecular skeleton attached to one or more chemical moieties.
  • suitable flavanols for use in particular embodiments of this disclosure include catechin, epicatechin, gallocatechin, epigallocatechin, epicatechin gallate, epigallocatechin 3 -gallate, theaflavin, theaflavin 3-gallate, theaflavin 3’-gallate, theaflavin 3,3’ gallate, thearubigin or combinations thereof.
  • Several common sources of flavanols include tea plants, fruits, vegetables, and flowers. In preferred embodiments, the flavanol is extracted from green tea.
  • the additional hydration agent is a glycerol solution to enhance exercise endurance.
  • the ingestion of a glycerol containing solution has been shown to provide beneficial physiological effects, such as expanded blood volume, lower heart rate, and lower rectal temperature.
  • the functional ingredient is chosen from at least one probiotic, prebiotic and combination thereof.
  • the probiotic is a beneficial microorganism that affects the human body’s naturally-occurring gastrointestinal microflora.
  • probiotics include, but are not limited to, bacteria of the genus Lactobacilli , Bifidobacteria , Streptococci , or combinations thereof, that confer beneficial effects to humans.
  • the at least one probiotic is chosen from the genus Lactobacilli.
  • the probiotic is chosen from the genus Bifidobacteria.
  • the probiotic is chosen from the genus Streptococcus.
  • Probiotics that may be used in accordance with this disclosure are well-known to those of skill in the art.
  • Non-limiting examples of foodstuffs comprising probiotics include yogurt, sauerkraut, kefir, kimchi, fermented vegetables, and other foodstuffs containing a microbial element that beneficially affects the host animal by improving the intestinal microbalance.
  • Prebiotics include, without limitation, mucopolysaccharides, oligosaccharides, polysaccharides, amino acids, vitamins, nutrient precursors, proteins and combinations thereof.
  • the prebiotic is chosen from dietary fibers, including, without limitation, polysaccharides and oligosaccharides.
  • Non-limiting examples of oligosaccharides that are categorized as prebiotics in accordance with particular embodiments of this disclosure include fructooligosaccharides, inulins, isomalto-oligosaccharides, lactilol, lactosucrose, lactulose, pyrodextrins, soy oligosaccharides, transgalacto-oligosaccharides, and xylo-oligosaccharides.
  • the prebiotic is an amino acid. Although a number of known prebiotics break down to provide carbohydrates for probiotics, some probiotics also require amino acids for nourishment.
  • Prebiotics are found naturally in a variety of foods including, without limitation, bananas, berries, asparagus, garlic, wheat, oats, barley (and other whole grains), flaxseed, tomatoes, Jerusalem artichoke, onions and chicory, greens (e.g., dandelion greens, spinach, collard greens, chard, kale, mustard greens, turnip greens), and legumes (e.g., lentils, kidney beans, chickpeas, navy beans, white beans, black beans).
  • the functional ingredient is at least one weight management agent.
  • a weight management agent includes an appetite suppressant and/or a thermogenesis agent.
  • appetite suppressant includes an appetite suppressant and/or a thermogenesis agent.
  • the phrases “appetite suppressant”, “appetite satiation compositions”, “satiety agents”, and “satiety ingredients” are synonymous.
  • the phrase “appetite suppressant” describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, pharmaceutical drugs, and combinations thereof, that when delivered in an effective amount, suppress, inhibit, reduce, or otherwise curtail a person’s appetite.
  • thermogenesis agent describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, pharmaceutical drugs, and combinations thereof, that when delivered in an effective amount, activate or otherwise enhance a person’s thermogenesis or metabolism.
  • Suitable weight management agents include macronutrients selected from the group consisting of proteins, carbohydrates, dietary fats, and combinations thereof. Consumption of proteins, carbohydrates, and dietary fats stimulates the release of peptides with appetite suppressing effects. For example, consumption of proteins and dietary fats stimulates the release of the gut hormone cholecytokinin (CCK), while consumption of carbohydrates and dietary fats stimulates release of Glucagon-like peptide 1 (GLP-1).
  • CCK gut hormone cholecytokinin
  • GLP-1 Glucagon-like peptide 1
  • Suitable macronutrient weight management agents also include carbohydrates.
  • Carbohydrates generally comprise sugars, starches, cellulose and gums that the body converts into glucose for energy. Carbohydrates often are classified into two categories, digestible carbohydrates (e.g., monosaccharides, disaccharides, and starch) and non- digestible carbohydrates (e.g., dietary fiber). Studies have shown that non-digestible carbohydrates and complex polymeric carbohydrates having reduced absorption and digestibility in the small intestine stimulate physiologic responses that inhibit food intake. Accordingly, the carbohydrates embodied herein desirably comprise non- digestible carbohydrates or carbohydrates with reduced digestibility.
  • Non-limiting examples of such carbohydrates include polydextrose; inulin; monosaccharide-derived polyols such as erythritol, mannitol, xylitol, and sorbitol; disaccharide- derived alcohols such as isomalt, lactitol, and maltitol; and hydrogenated starch hydrolysates.
  • monosaccharide-derived polyols such as erythritol, mannitol, xylitol, and sorbitol
  • disaccharide- derived alcohols such as isomalt, lactitol, and maltitol
  • hydrogenated starch hydrolysates include polydextrose; inulin; monosaccharide-derived polyols such as erythritol, mannitol, xylitol, and sorbitol; disaccharide- derived alcohols such as isomalt, lactitol, and mal
  • the weight management agent is a dietary fat.
  • Dietary fats are lipids comprising combinations of saturated and unsaturated fatty acids. Polyunsaturated fatty acids have been shown to have a greater satiating power than mono-unsaturated fatty acids. Accordingly, the dietary fats embodied herein desirably comprise poly-unsaturated fatty acids, non-limiting examples of which include triacylglycerols.
  • the weight management agent is an herbal extract. Extracts from numerous types of plants have been identified as possessing appetite suppressant properties.
  • Non-limiting examples of plants whose extracts have appetite suppressant properties include plants of the genus Hoodia , Trichocaulon , Caralluma , Stapelia , Orbea, Asclepias, and Camelia.
  • Other embodiments include extracts derived from Gymnema Sylvestre, Kola Nut, Citrus Auran tium, Yerba Mate, Griff onia Simplicifolia, Guarana, myrrh, guggul Lipid, and black current seed oil.
  • the herbal extracts may be prepared from any type of plant material or plant biomass.
  • plant material and biomass include the stems, roots, leaves, dried powder obtained from the plant material, and sap or dried sap.
  • the herbal extracts generally are prepared by extracting sap from the plant and then spray-drying the sap. Alternatively, solvent extraction procedures may be employed. Following the initial extraction, it may be desirable to further fractionate the initial extract (e.g., by column chromatography) in order to obtain an herbal extract with enhanced activity. Such techniques are well known to those of ordinary skill in the art.
  • the herbal extract is derived from a plant of the genus Hoodia.
  • a sterol glycoside of Hoodia known as P57, is believed to be responsible for the appetite- suppressant effect of the Hoodia species.
  • the herbal extract is derived from a plant of the genus Caralluma , non-limiting examples of which include caratuberside A, caratuberside B, bouceroside I, bouceroside II, bouceroside III, bouceroside IV, bouceroside V, bouceroside VI, bouceroside VII, bouceroside VIII, bouceroside IX, and bouceroside X.
  • the at least one herbal extract is derived from a plant of the genus Trichocaulon.
  • Trichocaulon plants are succulents that generally are native to southern Africa, similar to Hoodia, and include the species T piliferum and T officinale.
  • the herbal extract is derived from a plant of the genus Stapelia or Orbea.
  • saponins such as pregnane glycosides, which include stavarosides A, B, C, D, E, F, G, H, I, J, and K.
  • the herbal extract is derived from a plant of the genus Asclepias.
  • the extracts comprise steroidal compounds, such as pregnane glycosides and pregnane aglycone, having appetite suppressant effects.
  • the weight management agent is an exogenous hormone having a weight management effect.
  • hormones include CCK, peptide YY, ghrelin, bombesin and gastrin-releasing peptide (GRP), enterostatin, apolipoprotein A-IV, GLP- 1, amylin, somastatin, and leptin.
  • the weight management agent is a pharmaceutical drug.
  • Non limiting examples include phentenime, diethylpropion, phendimetrazine, sibutramine, rimonabant, oxyntomodulin, floxetine hydrochloride, ephedrine, phenethylamine, or other stimulants.
  • the functional ingredient is at least one osteoporosis management agent.
  • the osteoporosis management agent is at least one calcium source.
  • the calcium source is any compound containing calcium, including salt complexes, solubilized species, and other forms of calcium.
  • Non-limiting examples of calcium sources include amino acid chelated calcium, calcium carbonate, calcium oxide, calcium hydroxide, calcium sulfate, calcium chloride, calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium citrate, calcium malate, calcium citrate malate, calcium gluconate, calcium tartrate, calcium lactate, solubilized species thereof, and combinations thereof.
  • the osteoporosis management agent is a magnesium source.
  • the magnesium source is any compound containing magnesium, including salt complexes, solubilized species, and other forms of magnesium.
  • Non limiting examples of magnesium sources include magnesium chloride, magnesium citrate, magnesium gluceptate, magnesium gluconate, magnesium lactate, magnesium hydroxide, magnesium picolate, magnesium sulfate, solubilized species thereof, and mixtures thereof.
  • the magnesium source comprises an amino acid chelated or amino acid formulation chelated magnesium.
  • the osteoporosis agent is chosen from vitamins D, C, K, their precursors and/or beta-carotene and combinations thereof.
  • Non-limiting examples of suitable plants and plant extracts as osteoporosis management agents include species of the genus Taraxacum and Amelanchier, as disclosed in U.S. Patent Publication No. 2005/0106215, and species of the genus Lindera, Artemisia, Acorns, Carthamus,
  • the functional ingredient is at least one phytoestrogen.
  • Phytoestrogens are compounds found in plants which can typically be delivered into human bodies by ingestion of the plants or the plant parts having the phytoestrogens.
  • phytoestrogen refers to any substance which, when introduced into a body causes an estrogen like effect of any degree.
  • a phytoestrogen may bind to estrogen receptors within the body and have a small estrogen-like effect.
  • phytoestrogens examples include, but are not limited to, isoflavones, stilbenes, lignans, resorcyclic acid lactones, coumestans, coumestrol, equol, and combinations thereof.
  • Sources of suitable phytoestrogens include, but are not limited to, whole grains, cereals, fibers, fruits, vegetables, black cohosh, agave root, black currant, black haw, chasteberries, cramp bark, dong quai root, devil's club root, false unicorn root, ginseng root, groundsel herb, licorice, liferoot herb, motherwort herb, peony root, raspberry leaves, rose family plants, sage leaves, sarsaparilla root, saw palmetto berried, wild yam root, yarrow blossoms, legumes, soybeans, soy products (e.g., miso, soy flour, soymilk, soy nuts, soy protein isolate, tempen, or tofu) chick peas, nuts, lentils, seeds, clover, red clover, dandelion leaves, dandelion roots, fenugreek seeds, green tea, hops, red wine, flaxseed, garlic, onions, linseed, bo
  • Isoflavones belong to the group of phytonutrients called polyphenols.
  • polyphenols also known as “polyphenolics”
  • polyphenolics are a group of chemical substances found in plants, characterized by the presence of more than one phenol group per molecule.
  • Suitable phytoestrogen isoflavones in accordance with embodiments of this disclosure include genistein, daidzein, glycitein, biochanin A, formononetin, their respective naturally occurring glycosides and glycoside conjugates, matairesinol, secoisolariciresinol, enter olactone, enterodiol, textured vegetable protein, and combinations thereof.
  • Suitable sources of isoflavones for embodiments of this disclosure include, but are not limited to, soy beans, soy products, legumes, alfalfa sprouts, chickpeas, peanuts, and red clover.
  • the functional ingredient is at least one long chain primary aliphatic saturated alcohol.
  • Long-chain primary aliphatic saturated alcohols are a diverse group of organic compounds.
  • the term alcohol refers to the fact these compounds feature a hydroxyl group (-OH) bound to a carbon atom.
  • Non-limiting examples of particular long-chain primary aliphatic saturated alcohols for use in particular embodiments of the disclosure include the 8 carbon atom 1-octanol, the 9 carbon 1-nonanol, the 10 carbon atom 1-decanol, the 12 carbon atom 1-dodecanol, the 14 carbon atom 1-tetradecanol, the 16 carbon atom 1-hexadecanol, the 18 carbon atom 1-octadecanol, the 20 carbon atom 1-eicosanol, the 22 carbon 1-docosanol, the 24 carbon 1-tetracosanol, the 26 carbon 1-hexacosanol, the 27 carbon 1-heptacosanol, the 28 carbon 1-octanosol, the 29 carbon 1-nonacosano
  • the long-chain primary aliphatic saturated alcohol is a policosanol.
  • Policosanol is the term for a mixture of long-chain primary aliphatic saturated alcohols composed primarily of 28 carbon 1-octanosol and 30 carbon 1- triacontanol, as well as other alcohols in lower concentrations such as 22 carbon 1- docosanol, 24 carbon 1-tetracosanol, 26 carbon 1-hexacosanol, 27 carbon 1- heptacosanol, 29 carbon 1-nonacosanol, 32 carbon 1- dotriacontanol, and 34 carbon 1- tetracontanol.
  • the functional ingredient is at least one phytosterol, phytostanol or combination thereof.
  • the phrases “stand”, “plant stand” and “phytostanol” are synonymous. Plant sterols and stands are present naturally in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, vegetable oils, bark of the trees and other plant sources. Sterols are a subgroup of steroids with a hydroxyl group at C-3. Generally, phytosterols have a double bond within the steroid nucleus, like cholesterol; however, phytosterols also may comprise a substituted side chain (R) at C-24, such as an ethyl or methyl group, or an additional double bond. The structures of phytosterols are well known to those of skill in the art.
  • At least 44 naturally-occurring phytosterols have been discovered, and generally are derived from plants, such as com, soy, wheat, and wood oils; however, they also may be produced synthetically to form compositions identical to those in nature or having properties similar to those of naturally-occurring phytosterols.
  • Non-limiting suitable phytosterols include, but are not limited to, 4-desmethyl sterols (e.g., b- sitosterol, campesterol, stigmasterol, brassicasterol, 22-dehydrobrassicasterol, and A5- avenasterol), 4-monomethyl sterols, and 4,4- dimethyl sterols (triterpene alcohols) (e.g., cycloartol, 24-methylenecycloartanol, and cyclobranol).
  • 4-desmethyl sterols e.g., b- sitosterol, campesterol, stigmasterol, brassicasterol, 22-dehydrobrassicasterol, and A5- avenasterol
  • 4-monomethyl sterols e.g., 4-monomethyl sterols
  • 4,4- dimethyl sterols triterpene alcohols
  • phytostanols are saturated sterol alcohols present in only trace amounts in nature and also may be synthetically produced, such as by hydrogenation of phytosterols. Suitable phytostanols include, but are not limited to, b-sitostanol, campestanol, cycloartanol, and saturated forms of other triterpene alcohols.
  • Both phytosterols and phytostanols include the various isomers such as the a and b isomers.
  • the phytosterols and phytostanols of the present disclosure also may be in their ester form. Suitable methods for deriving the esters of phytosterols and phytostanols are well known to those of ordinary skill in the art, and are disclosed in U.S. Patent Numbers 6,589,588, 6,635,774, 6,800,317, and U.S. Pat. App. No. 2003/0045473.
  • suitable phytosterol and phytostanol esters include sitosterol acetate, sitosterol oleate, stigmasterol oleate, and their corresponding phytostanol esters.
  • the phytosterols and phytostanols of the present disclosure also may include their derivatives.
  • Exemplary additives include, but not limited to, carbohydrates, polyols, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, caffeine, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, plant extracts, flavonoids, alcohols, polymers and combinations thereof.
  • the composition further comprises one or more polyols.
  • polyol refers to a molecule that contains more than one hydroxyl group.
  • a polyol may be a diol, triol, or a tetrad which contains 2, 3, and 4 hydroxyl groups respectively.
  • a polyol also may contain more than 4 hydroxyl groups, such as a pentad, hexaol, heptaol, or the like, which contain 5, 6, or 7 hydroxyl groups, respectively.
  • a polyol also may be a sugar alcohol, polyhydric alcohol, or polyalcohol which is a reduced form of carbohydrate, wherein the carbonyl group (aldehyde or ketone, reducing sugar) has been reduced to a primary or secondary hydroxyl group.
  • Non-limiting examples of polyols in some embodiments include maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propylene glycol, glycerol (glycerin), threitol, galactitol, palatinose, reduced isomalto-oligosaccharides, reduced xylo- oligosaccharides, reduced gentio-oligosaccharides, reduced maltose syrup, reduced glucose syrup, and sugar alcohols or any other carbohydrates capable of being reduced which do not adversely affect taste.
  • Suitable sugar acid additives include, but are not limited to, aldonic, uronic, aldaric, alginic, gluconic, glucuronic, glucaric, galactaric, galacturonic, and salts thereof (e.g., sodium, potassium, calcium, magnesium salts or other physiologically acceptable salts), and combinations thereof.
  • Suitable nucleotide additives include, but are not limited to, inosine monophosphate (IMP), guanosine monophosphate (GMP), adenosine monophosphate (AMP), cytosine monophosphate (CMP), uracil monophosphate (UMP), inosine diphosphate, guanosine diphosphate, adenosine diphosphate, cytosine diphosphate, uracil diphosphate, inosine triphosphate, guanosine triphosphate, adenosine triphosphate, cytosine triphosphate, uracil triphosphate, alkali or alkaline earth metal salts thereof, and combinations thereof.
  • IMP inosine monophosphate
  • GMP guanosine monophosphate
  • AMP adenosine monophosphate
  • CMP cytosine monophosphate
  • UMP uracil monophosphate
  • inosine diphosphate guanosine diphosphate
  • nucleotides described herein also may comprise nucleotide-related additives, such as nucleosides or nucleic acid bases (e.g., guanine, cytosine, adenine, thymine, uracil).
  • nucleosides or nucleic acid bases e.g., guanine, cytosine, adenine, thymine, uracil.
  • Suitable organic acid additives include any compound which comprises a - COOH moiety, such as, for example, C2-C30 carboxylic acids, substituted hydroxyl C2-C30 carboxylic acids, butyric acid (ethyl esters), substituted butyric acid (ethyl esters), benzoic acid, substituted benzoic acids (e.g, 2,4-dihydroxybenzoic acid), substituted cinnamic acids, hydroxyacids, substituted hydroxybenzoic acids, anisic acid substituted cyclohexyl carboxylic acids, tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid, glucoheptonic acids, adipic acid, hydroxycitric acid, malic acid, fruitaric acid (a blend of malic, fumaric, and tartaric acids), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, amino acid
  • organic acid additives also may be in either the D- or L-configuration.
  • Suitable organic acid additive salts include, but are not limited to, sodium, calcium, potassium, and magnesium salts of all organic acids, such as salts of citric acid, malic acid, tartaric acid, fumaric acid, lactic acid (e.g, sodium lactate), alginic acid (e.g, sodium alginate), ascorbic acid (e.g, sodium ascorbate), benzoic acid (e.g, sodium benzoate or potassium benzoate), sorbic acid and adipic acid.
  • organic acid additives described optionally may be substituted with at least one group chosen from hydrogen, alkyl, alkenyl, alkynyl, halo, haloalkyl, carboxyl, acyl, acyloxy, amino, amido, carboxyl derivatives, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl, sulfmyl, sulfamyl, carboxalkoxy, carboxamido, phosphonyl, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oximino, hydrazino, carbamyl, phosphor or phosphonato.
  • the organic acid additive is present in the sweetener composition in an amount effective to provide a concentration
  • Suitable inorganic acid additives include, but are not limited to, phosphoric acid, phosphorous acid, polyphosphoric acid, hydrochloric acid, sulfuric acid, carbonic acid, sodium dihydrogen phosphate, and alkali or alkaline earth metal salts thereof (e.g, inositol hexaphosphate Mg/Ca).
  • Suitable bitter compound additives include, but are not limited to, caffeine, quinine, urea, bitter orange oil, naringin, quassia, and salts thereof.
  • Suitable flavorants and flavoring ingredient additives include, but are not limited to, vanillin, vanilla extract, mango extract, cinnamon, citrus, coconut, ginger, viridiflorol, almond, menthol (including menthol without mint), grape skin extract, and grape seed extract.
  • “Flavorant” and “flavoring ingredient” are synonymous and can include natural or synthetic substances or combinations thereof. Flavorants also include any other substance which imparts flavor and may include natural or non-natural (synthetic) substances which are safe for human or animals when used in a generally accepted range.
  • Non-limiting examples of proprietary flavorants include DOHLERTM Natural Flavoring Sweetness Enhancer K14323 (DOHLERTM, Darmstadt, Germany), SymriseTM Natural Flavor Mask for Sweeteners 161453 and 164126 (SYMRISETM, Holzminden, Germany), Natural AdvantageTM Bitterness Blockers 1, 2, 9 and 10 (Natural AdvantageTM, Freehold, New Jersey, U.S.A.), and SUCRAMASKTM (Creative Research Management, Stockton, California, U.S.A.).
  • Suitable polymer additives include, but are not limited to, chitosan, pectin, pectic, pectinic, polyuronic, polygalacturonic acid, starch, food hydrocolloid or crude extracts thereof (e.g., gum acacia Senegal (FIBERGUMTM), gum acacia seyal, carageenan), poly-L-lysine (e.g., poly-L-a-lysine or poly-L-e-lysine), poly-L-ornithine (e.g., poly-L-a-omithine or poly- L-e-ornithine), polypropylene glycol, polyethylene glycol, poly(ethylene glycol methyl ether), polyarginine, polyaspartic acid, polyglutamic acid, polyethylene imine, alginic acid, sodium alginate, propylene glycol alginate, and sodium polyethyleneglycolalginate, sodium hexametaphosphate and its salts,
  • Suitable protein or protein hydrolysate additives include, but are not limited to, bovine serum albumin (BSA), whey protein (including fractions or concentrates thereof such as 90% instant whey protein isolate, 34% whey protein, 50% hydrolyzed whey protein, and 80% whey protein concentrate), soluble rice protein, soy protein, protein isolates, protein hydrolysates, reaction products of protein hydrolysates, glycoproteins, and/or proteoglycans containing amino acids (e.g., glycine, alanine, serine, threonine, asparagine, glutamine, arginine, valine, isoleucine, leucine, norvaline, methionine, proline, tyrosine, hydroxyproline, and the like), collagen (e.g., gelatin), partially hydrolyzed collagen (e.g., hydrolyzed fish collagen), and collagen hydrolysates (e.g., porcine collagen hydrolysate).
  • BSA bovine
  • the oral composition for hydration or rehydration may comprise protein hydrolysate additive.
  • the composition may include protein hydrolysate additive as a replacement to the amino acid, such that the protein hydrolysate would be the sole source, if any, of amino acids in the composition.
  • at least one protein hydrolysate, such as whey protein, would include BCAA without the addition of other amino acids in the oral composition for hydration or rehydration formulation.
  • the oral composition for hydration or rehydration comprises at least one protein hydrolysate, such as whey protein, that would include BCAA, but would also include the addition of other amino acids in the oral composition for hydration or rehydration formulation which would be of additive effect to the total percent of amino acid in the oral composition for hydration or rehydration formulation.
  • protein hydrolysate such as whey protein
  • Suitable surfactant additives include, but are not limited to, polysorbates (e.g., polyoxyethylene sorbitan monooleate (polysorbate 80), polysorbate 20, polysorbate 60), sodium dodecylbenzenesulfonate, dioctyl sulfosuccinate or dioctyl sulfosuccinate sodium, sodium dodecyl sulfate, cetylpyridinium chloride (hexadecylpyridinium chloride), hexadecyltrimethylammonium bromide, sodium cholate, carbamoyl, choline chloride, sodium glycocholate, sodium taurodeoxycholate, lauric arginate, sodium stearoyl lactylate, sodium taurocholate, lecithins, sucrose oleate esters, sucrose stearate esters, sucrose palmitate esters, sucrose laurate esters, and other emulsifiers, and the
  • Suitable flavonoid additives are classified as flavonols, flavones, flavanones, flavan-3- ols, isoflavones, or anthocyanidins.
  • flavonoid additives include, but are not limited to, catechins (e.g., green tea extracts such as PolyphenonTM 60, PolyphenonTM 30, and PolyphenonTM 25 (Mitsui Norin Co., Ltd., Japan), polyphenols, rutins (e.g., enzyme modified rutin SanmelinTM AO (San-fi Gen F.F.I., Inc., Osaka, Japan)), neohesperidin, naringin, neohesperidin dihydrochalcone, and the like.
  • Suitable alcohol additives include, but are not limited to, ethanol.
  • Suitable astringent compound additives include, but are not limited to, tannic acid, europium chloride (EuCb), gadolinium chloride (GdCb), terbium chloride (TbCb), alum, tannic acid, and polyphenols (e.g., tea polyphenols).
  • the present composition may generally be in any edible form, such as liquid, semi-liquid, solid, or semi-solid.
  • the present composition is a beverage or beverage product.
  • One example of the beverage is a ready-to-drink beverage.
  • Ready-to-drink beverages include carbonated and non-carbonated beverages.
  • Carbonated beverages include, but are not limited to, frozen carbonated beverages, enhanced sparkling beverages, cola, fruit-flavored sparkling beverages (e.g. lemon- lime, orange, grape, strawberry and pineapple), ginger-ale, soft drinks and root beer.
  • Non-carbonated beverages include, but are not limited to, fruit juice, fruit-flavored juice, juice drinks, nectars, vegetable juice, vegetable-flavored juice, sports drinks, energy drinks, enhanced water drinks, enhanced water with vitamins, near water drinks (e.g., water with natural or synthetic flavorants), coconut water, tea type drinks (e.g. black tea, green tea, red tea, oolong tea), coffee, cocoa drink, beverage containing milk components (e.g. milk beverages, coffee containing milk components, cafe au lait, milk tea, fruit milk beverages), beverages containing cereal extracts and smoothies.
  • fruit juice fruit-flavored juice, juice drinks, nectars, vegetable juice, vegetable-flavored juice, sports drinks, energy drinks, enhanced water drinks, enhanced water with vitamins, near water drinks (e.g., water with natural or synthetic flavorants), coconut water, tea type drinks (e.g. black tea, green tea, red tea, oolong tea), coffee, cocoa drink, beverage containing milk components (e.g. milk beverages, coffee containing milk components, cafe au lait, milk
  • the present disclosure relates to a sports drink or an enhanced water drink.
  • the beverage can be a full-calorie beverage that has up to about 120 calories per 8 oz Serving.
  • the beverage can be a mid-calorie beverage that has up to about 60 calories per 8 oz. serving.
  • the beverage can be a low-calorie beverage that has up to about 40 calories per 8 oz. serving.
  • the beverage can be a zero-calorie that has less than about 5 calories per 8 oz. serving.
  • the beverage does not contain milk and/or dairy components.
  • the amino acid formulation concentration of the beverage after three months of storage at 5 °C is at least 90% of the initial amino acid formulation concentration, at least 95% of the initial amino acid formulation concentration, at least 97% of the initial amino acid formulation concentration, at least 98% of the initial amino acid formulation concentration, or at least 99% of the initial amino acid formulation concentration.
  • “Initial concentration” refers to the concentration of amino acid formulation measured upon formulation, e.g. within 24 hours of preparing the beverage.
  • the amino acid formulation concentration of the beverage is at least 90% of the initial amino acid formulation concentration when stored at 5 °C for four months, five months, six months, seven months, eight months, nine months, ten months, eleven months or twelve months.
  • the present beverage has a plasma osmolality in a range from about 250 to about 350 mOsm/kg, or from about 270 to about 330 mOsm/kg, or from about 290 to about 310 mOsm/kg, or from about 290 to about 300 mOsm/kg.
  • the present disclosure also provides a method of preparing a ready-to-drink beverage comprising (i) providing a beverage matrix and (ii) adding the beverage ingredients described herein above to the beverage matrix, thereby providing a ready- to-drink beverage.
  • the method optionally includes a further mixing step whereby the beverage ingredients and matrix are mixed to promote dissolution.
  • the method can also optionally include a heating step, whereby the beverage ingredients and matrix are heated to promote dissolution.
  • beverage matrices include water of beverage quality, for example tap water, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, demineralized water and combinations thereof.
  • Additional suitable matrices include, but are not limited to phosphoric acid, phosphate buffer, citric acid, citrate buffer and carbon-treated water.
  • the method can be performed at any temperature required to formulate the ready -to-drink beverage. For example, for ingredients that are temperature sensitive, the method is carried out below 70 °C. Similarly, the beverage ingredients can be added to the beverage matrix in any order.
  • the present composition is in a dry or semi-dry form such as a dry powder, a beverage concentrate, a tablet, a capsule, a gel, a gum.
  • the dry composition can be readily consumable or be readily and rapidly soluble in a drinkable medium such as water.
  • the present compositions may be prepared in concentrate or powder form to be reconstituted for use by the subject by the addition of water or any other appropriate liquid. Such reconstitution is made with the requisite amounts of water/liquid to ensure that the beverage to be consumed contains the active components in the proportions previously noted.
  • the composition may be solubilized in water/liquid and then brought to a frozen state, so as to provide, for example, flavored ices on sticks, like the ones known under the commercial name or trade mark “Popsicle.”
  • a method for preparing a ready -to-drink solution comprising amino acid formulation comprises mixing an oral composition described herein with a drinkable medium in a weight ratio such that the concentration of amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L based on the total volume of the ready -to-drink solution.
  • Exemplary drinkable media include water of beverage quality, for example tap water, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, demineralized water, and combinations thereof.
  • the drinkable medium may also be an existing beverage such as sparkling water, juice, tea, milk, or coffee.
  • the present composition may be prepared as a dry powder mixture.
  • the dry powder mixture is combined with a support for dispersion in water/liquid, such as maltodextrin, with a non-glucose sweet taste base, such as neohesperidine dihydrochalcone, at a level so as not to exceed 120 kcal/L, when reconstituted, and possibly flavored with fruit extracts or aromas, such as orange, lemon, strawberry, or others.
  • a support for dispersion in water/liquid such as maltodextrin
  • a non-glucose sweet taste base such as neohesperidine dihydrochalcone
  • One dose is intended for dissolution in 591 ml drinking water/liquid (one standard sports bottle).
  • the concentrations are merely indicative, and more concentrated drinks may be prepared on the same formula basis.
  • the above powder mix may be added to a suitable support for tablet compression, with good organoleptic properties, such as sorbitol and magnesium stearate.
  • the mass is possibly edulcorated with a known natural sweetener such as Neohesperidine dihydrochalcone and the total energy content should not exceed 120 kcal in the average daily intake.
  • the product may be flavored with any choice of fruit or other flavors, such as orange, lemon, menthol, eucaplytol, or the like.
  • the compressed tablets (or equivalent solid forms with the same composition) are intended for an average daily intake of between 5 and 10 tablets.
  • the present disclosure relates to methods for hydration or rehydration.
  • the method generally includes administering any oral composition described herein.
  • the present method generally utilizes the compositions described herein for at least one of the following purposes: providing a quick impact on plasma volume restoration during rehydration stage, attenuating or reversing the effects of dehydration or hypohydration, ameliorating other adverse effects of exercise, heat or other activity which causes bodily fluid loss, providing positive impact on following physical performance, enhancing the duration of body fluid retention, rapidly increasing the plasma volume, maintaining the increased plasma volume for long duration, restoring electrolyte balance, providing energy source, improving physical performance, limiting or reducing calorie uptake.
  • the present disclosure provides a method of hydrating or rehydrating a human, the method comprising administering an effective amount of the oral composition described herein, wherein the oral composition comprises an amino acid formulation described herein.
  • Administration of the oral composition can be before, during, or after dehydration or loss of body fluid.
  • the method comprises administering a sports beverage to an human described herein, wherein the sports drink is further configured to enhance sports performance of the human, reduce lactate production, reduce perceived exhaustion, reduce muscle soreness (both actual muscle damage and perceived soreness), improve time to exhaustion, improve time trial performance, improve power output, reduce production of lactic acid, and reduce net fluid loss observed with exercise.
  • enhanced sports performance refers to an improvement in sports performance associated with consuming embodiments of the sports beverages provided herein, as compared to sports performance without consuming the sports beverage or water.
  • the sports beverage may be consumed before, during, or after sports performance.
  • sports performance refers to both endurance exercise and non-endurance exercise. Endurance exercise includes aerobic activities over prolonged periods of time (e.g., greater than about 30 minutes) while non-endurance exercise includes aerobic activities over a shorter period of time (e.g., less than about 30 minutes).
  • the present disclosure relates to a method of enhancing athletic performance comprising administering/consuming a sports beverage before, during, or after endurance exercise, wherein the sports beverage comprises an aqueous solution of an amino acid formulation described herein, wherein the amino acid formulation is in an amount from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the sports beverage.
  • the amino acid formulation consists essentially of glycine.
  • the sports drink comprises glycine as the only amino acid and is free or substantially free from other amino acid.
  • the amino acid formulation consists essentially of glycine, or a glycine-containing dipeptide, or a carbohydrate-glycine complex, or any combinations thereof.
  • the method include preparing a drinkable solution by dissolving a dry powder composition comprising the amino acid formulation in a drinkable medium comprising water, and administering the drinkable solution orally.
  • the concentration of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the drinkable solution.
  • the method include consuming/ingesting the oral composition and a drinkable medium comprising water. Ingestion of the oral composition and a drinkable medium can be concurrently, simultaneously, separately, or successively.
  • the ratio of the oral composition to the drinkable medium is such that the content of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, relative to the total volume of the drinkable medium.
  • the methods according to the present disclosure provide rapid and effective hydration and retention of body fluid of a human.
  • the plasma volume of the human is increased by at least about 2.5%, or at least about 3%, or at least about 4% in about 10 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6% in about 15 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% in about 30 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% in about 45 minutes after administration of the oral composition.
  • the plasma volume of the human is increased by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% on in about 60 minutes after administration of the oral composition.
  • the plasma volume of the human measured at 30 minutes after administration of the oral composition remains substantially unchanged thereafter for at least about 15 minutes, or at least about 30 minutes, or at least about 1 hour.
  • the plasma volume of the human measured at 30 minutes after administration of the oral composition is decreased by less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10% for at least about 30 minutes.
  • the plasma osmolality of the human is maintained in a range from about 270 to about 330 mOsm/kg, or from about 280 to about 320 mOsm/kg, or from about 290 to about 310 mOsm/kg, or from about 290 to about 300 mOsm/kg, in at least 60 minutes after administration of the oral composition.
  • the change of the plasma osmolality of the human is no greater than 3 mOsm/kg in at least 60 minutes after administration of the oral composition.
  • Example 1 Beverages comprising amino acid formulations and rehydration test.
  • Bev 780 comprises glycine in an amount of about 9.14 g/L in water.
  • Bev 236 comprises L-alanine in an amount of about 5.96 g/L in water.
  • Bev 588 is a control beverage with no added amino acid.
  • Exercise-Heat Session During the exercise-heat/dehydration sessions, all proper safety precautions monitoring heart rate, core temperature were employed during the exercise bout in the heat (as required in all of our previous studies). In each experiment, following the point of eliciting dehydration of -1.5% body mass, subjects were instructed to begin the rehydration phase following a cool-down (ice sheet, air- conditioned room and brief shower). The fluid deficit incurred by the dehydration protocols was calculated from the acute change in body mass from pre- (baseline value calculated from mean of days 1, 2 and 3) to post- exercise/heat exposure (corrected for any food, fluid consumption, urine or feces loss) and expressed as a percent from baseline body mass (Cheuvront et.al.
  • Urine output and body mass were assessed every hour over 3 hours (following initial ingestion of compositions) to determine the cumulative urine mass and urine osmolality.
  • Whole blood were analyzed for hemoglobin, hematocrit, and plasma for osmolality.
  • Plasma volume change over time after administration of the beverage was measured and summarized in FIG. 1.
  • consumption of Bev 780 having about 9.14 g/L of glycine could rapidly increase the plasma volume by at least 3% at time zero, by at least 4% after 15 minutes, at least 6% after 30 minutes.
  • the plasma volume measured at 30 minutes after consumption did not show significant change thereafter, and the plasma volume was found to remain at an increased level at least 5% higher compared to the level prior to rehydration.
  • Bev 236 comprising about 5.96 g/L of alanine also showed rapid increase of plasma volume in 30 minutes after consumption.
  • Bev 780 tended to be higher in the total plasma volume increase compared to the control (Bev 588) at 45 minutes.
  • Bev 780 was also found to be higher in the total plasma volume increase compared with Bev 236 at 60 minutes. Compared with the control beverage (Bev 588), the beverages comprising amino acid formulations clearly showed the significant improvement in the retention of plasma volume. These results further support the rehydration effectiveness of amino acids.
  • the higher plasma osmolality (FIG. 2) combined with higher total plasma volume (FIG. 1) further support improved restoration and retention of critical elements such as electrolytes after consuming the present compositions. Further, the higher osmolality caused by the amino acid containing beverages was found to effectively stimulate the thirst and stimulate the drinking need of the tested volunteers.
  • An oral composition for hydration or rehydration comprising an amino acid formulation.
  • the amino acid formulation comprises a compound selected from the group consisting of an amino acid, a dipeptide, a carbohydrate-amino acid complex, or any combination thereof.
  • the amino acid is selected from the group consisting of leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine, or any combination thereof.
  • the concentration of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the oral composition.
  • An oral composition being a ready-to-drink hydrating beverage, wherein the oral composition comprise an amino acid formulation, wherein the amino acid formulation consists essentially of glycine, and wherein the glycine concentration is from about 4 g/L to about 20 g/L, based on the total volume of the oral composition.
  • the sweetener is selected from the group comprising stevia and steviol glycosides, Luo Han Guo and the related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hemandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and salts thereof,
  • a method of hydrating or rehydrating a human comprising administering an oral composition, the oral composition comprising an amino acid formulation.
  • the amino acid formulation comprises a compound selected from the group consisting of an amino acid, a dipeptide, a carbohydrate-amino acid complex, or any combination thereof.
  • any one of clauses 22-29 wherein the concentration of the amino acid formulation is from about 1 g/L to about 50 g/L, or from about 2 g/L to about 30 g/L, or from about 3 g/L to about 30 g/L, or from about 4 g/L to about 20 g/L, or from about 5 g/L to about 10 g/L, or from about 0.05 g/L to about 1 g/L, based on the total volume of the oral composition.
  • the oral composition is a ready -to-drink hydrating beverage
  • the amino acid formulation consists essentially of glycine
  • the glycine concentration is from about 4 g/L to about 20 g/L based on the total volume of the beverage.
  • a method for improving physical or sports performance comprising administering any oral composition according to clauses 1-21 and 53.
  • compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this disclosure have been described in terms of the foregoing illustrative embodiments, it will be apparent to those of skill in the art that variations, changes, modifications, and alterations may be applied to the composition, methods, and in the steps or in the sequence of steps of the methods described herein, without departing from the true concept, spirit, and scope of the disclosure. More specifically, it will be apparent that certain agents, additives, and ingredients that are similar according to their physical, chemical, physiological, and/or gustative properties may be substituted for the agents, additives and ingredients described herein while the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the disclosure as defined by the hereinafter appended claims.

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JP2023573331A JP2024520526A (ja) 2021-05-28 2022-05-27 アミノ酸水分補給剤及び使用方法
KR1020237044381A KR20240013777A (ko) 2021-05-28 2022-05-27 아미노산 수화 제형 및 사용 방법
CN202280050926.4A CN118369093A (zh) 2021-05-28 2022-05-27 氨基酸水合配制品及使用方法
CA3221410A CA3221410A1 (en) 2021-05-28 2022-05-27 Amino acid hydration formulation and method of use
MX2023014015A MX2023014015A (es) 2021-05-28 2022-05-27 Formulación aminoácidica hidratante y método de uso.
US18/565,042 US20240252580A1 (en) 2021-05-28 2022-05-27 Amino acid hydration formulation and method of use
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240099969A1 (en) * 2022-09-20 2024-03-28 Entrinsic, LLC Generation of hydration-targeted formulations and methods of use therein
WO2024215684A1 (en) * 2023-04-11 2024-10-17 Nxclns Holdings, Inc. High efficacy hydration composition, production method, and use.
KR102794409B1 (ko) * 2023-10-31 2025-04-14 (주)링티 피로회복과 지구력 증진 효과를 가지는 신규한 아미노산 조성물 및 이의 용도

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4686419A1 (en) * 2024-07-29 2026-02-04 Salssa Enterprises S.L. Food composition, and uses thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5561111A (en) * 1994-12-23 1996-10-01 The University Of Virginia Patent Foundation Stable glutamine derivatives for oral and intravenous rehydration and nutrition therapy
EP0904071B1 (en) * 1996-05-14 2000-11-15 Norbrook Laboratories Limited Oral rehydration product comprising glutamine
US20140377374A1 (en) * 2012-02-08 2014-12-25 University Of Florida Research Foundation, Inc. Materials and methods for treating diarrhea
US10463067B2 (en) * 2014-11-19 2019-11-05 Kalmarna Limited Oral rehydration composition and methods thereof

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201405551XA (en) * 2012-03-09 2014-10-30 Meiji Co Ltd Foods or beverages providing excellent water absorption
CN112753922A (zh) * 2021-01-25 2021-05-07 北京大学第三医院(北京大学第三临床医学院) 一种促进恢复的固体运动饮料及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5561111A (en) * 1994-12-23 1996-10-01 The University Of Virginia Patent Foundation Stable glutamine derivatives for oral and intravenous rehydration and nutrition therapy
EP0904071B1 (en) * 1996-05-14 2000-11-15 Norbrook Laboratories Limited Oral rehydration product comprising glutamine
US20140377374A1 (en) * 2012-02-08 2014-12-25 University Of Florida Research Foundation, Inc. Materials and methods for treating diarrhea
US10463067B2 (en) * 2014-11-19 2019-11-05 Kalmarna Limited Oral rehydration composition and methods thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4346793A4 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240099969A1 (en) * 2022-09-20 2024-03-28 Entrinsic, LLC Generation of hydration-targeted formulations and methods of use therein
WO2024215684A1 (en) * 2023-04-11 2024-10-17 Nxclns Holdings, Inc. High efficacy hydration composition, production method, and use.
KR102794409B1 (ko) * 2023-10-31 2025-04-14 (주)링티 피로회복과 지구력 증진 효과를 가지는 신규한 아미노산 조성물 및 이의 용도

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