WO2013056048A2 - Produits nutritionnels comprenant de la bêta-alanine - Google Patents

Produits nutritionnels comprenant de la bêta-alanine Download PDF

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Publication number
WO2013056048A2
WO2013056048A2 PCT/US2012/059954 US2012059954W WO2013056048A2 WO 2013056048 A2 WO2013056048 A2 WO 2013056048A2 US 2012059954 W US2012059954 W US 2012059954W WO 2013056048 A2 WO2013056048 A2 WO 2013056048A2
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Prior art keywords
beta
alanine
nutritional
nutritional liquid
weight
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PCT/US2012/059954
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English (en)
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WO2013056048A3 (fr
Inventor
Timothy M. CHAPMAN
Normanella T. Dewille
Douglas J. WEARLY
Jeffrey H. Baxter
Kelley J. LOWE
Terrance B. MAZER
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Abbott Laboratories
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Publication of WO2013056048A2 publication Critical patent/WO2013056048A2/fr
Publication of WO2013056048A3 publication Critical patent/WO2013056048A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/66—Proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Definitions

  • the present disclosure relates to nutritional products comprising beta-alanine that can be administered without the adverse side-effect of paresthesia. Additionally, the present disclosure relates to methods of reducing the incidence of paresthesia by administering the nutritional products.
  • Manufactured nutritional liquids comprising a targeted selection of nutrition ingredients are well known and widely available, some of which may provide a sole source of nutrition while others may provide a supplemental source.
  • These nutritional liquids include powders that can be reconstituted with water or other aqueous liquid, as well as ready to drink nutritional liquids such as milk or protein based emulsions or non-emulsified or substantially clear liquids. These nutritional liquids are especially useful when formulated with selected nutritional ingredients.
  • HMB beta-hydroxy-beta-methylbutyrate
  • HMB is a naturally occurring amino acid metabolite that is known for use in a variety of nutritional products and supplements. HMB is known for use in such products to help build or maintain healthy muscle mass and strength in selected individuals.
  • Calcium HMB is the most commonly used form of HMB when formulated into oral nutritional products, which products include tablets, capsules, reconstitutable powders, clear nutritional liquids and emulsions.
  • Beta-alanine is an additional selected ingredient that may be useful in nutritional liquids or other nutritional products. Beta-alanine is considered a complement to HMB as it is used for maintaining muscle functionality during exercise or other physical activity. Beta-alanine is a non-essential amino acid and is the only naturally occurring beta-amino acid. Beta-alanine may be useful to increase muscle mass, delay muscular fatigue and increase aerobic and anaerobic endurance.
  • the present disclosure is therefore directed to nutritional products, in the form of nutritional liquids, comprising relatively high concentrations of beta- alanine, alone or in combination with calcium HMB, wherein the resulting nutritional product can be administered without the adverse side-effect of paresthesia caused by ingestion of the beta-alanine.
  • One embodiment of the present disclosure is directed to a nutritional liquid comprising beta-alanine and protein, wherein at least a portion of the beta- alanine resides in a whey protein phospholipids concentrate and oil combination.
  • Another embodiment of the present disclosure is directed to a nutritional liquid comprising beta-alanine, protein, and glycine.
  • Another embodiment of the present disclosure is directed to a nutritional liquid comprising from about 0.26% to about 0.47% by weight beta- alanine, from about 3% to about 8% by weight protein, and from about 0.26% to about 0.38%) by weight glycine.
  • Another embodiment is directed to a method of reducing the incidence of paresthesia caused by ingestion of beta-alanine. The method comprises: administering to an individual a nutritional liquid comprising beta-alanine and protein, wherein at least a portion of the beta-alanine resides in a whey protein phospholipids concentrate and oil combination.
  • Another embodiment of the present disclosure is directed to a method of reducing the incidence of paresthesia caused by ingestion of beta-alanine.
  • the method comprises: administering to an individual a nutritional liquid comprising beta- alanine, protein, and glycine.
  • the nutritional products as described herein comprise specific combinations of beta-alanine, alone, or in combination with calcium HMB and other nutrients to not only provide benefits for individuals concerned with muscle health and functionality, but to reduce the rate at which beta-alanine enters the blood, thereby reducing the incidence of paresthesia associated with ingestion of beta-alanine.
  • incidences of paresthesia can be reduced by including thickening agents in combination with beta-alanine to increase the viscosity of the nutritional products.
  • Increasing the viscosity of the nutritional products will prolong gastric transit time, which as noted above, slows the absorption of beta-alanine.
  • beta-alanine can reside within globules within the nutritional products to slow the release of beta-alanine, attenuating the rise of the blood-plasma beta-alanine concentration. In some embodiments, at least a portion, and suitably, all of the beta-alanine resides in whey protein
  • phospholipids concentrate and oil combinations to slow the release of beta-alanine.
  • the nutritional products comprise beta-alanine and calcium HMB.
  • the nutritional products additionally include high concentrations of protein.
  • substantially clear nutritional liquid and "non-emulsion” as used herein, unless otherwise specified, are used interchangeably to refer to a non- emulsified or similar other liquid having a visibly clear or translucent appearance, which liquid may and typically will have a thin or watery texture with a consistency similar to that of a clear juice and most typically having a viscosity of less than about 25 centipoise as determined by a Brookfield viscometer at 22°C using a #1 spindle at 60 rpm.
  • calcium HMB refers to the calcium salt of beta-hydroxy-beta-methylbutyrate (also referred to as 3 - hydroxy-3 -methyl butyrate, beta-hydroxy isovalerate, or HMB), which is most typically in a monohydrate form. All weights, percentages, and concentrations as used herein to characterize calcium HMB are based on the weight of calcium HMB monohydrate, unless otherwise specified.
  • fat and oil as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or processed from plants or animals. These terms also include synthetic lipid materials so long as such synthetic materials are suitable for oral administration to humans.
  • shelf stable refers to a nutritional liquid that remains commercially stable after being packaged and then stored at 18-24°C for at least 3 months, including from about 6 months to about 24 months, and also including from about 12 months to about 18 months.
  • the various embodiments of the nutritional products of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining nutritional product still contains all of the required ingredients or features as described herein.
  • the term "substantially free” means that the selected nutritional product contains less than a functional amount of the optional ingredient, typically less than about 1%, including less than about 0.5%, including less than about 0.1%, and also including zero percent, by weight of such optional or selected essential ingredient.
  • the nutritional products may comprise, consist of, or consist essentially of the essential elements of the products as described herein, as well as any additional or optional element described herein or otherwise useful in nutritional product applications.
  • the nutritional products of the present disclosure may be in the form of nutritional liquids, which include shelf-stable, ready-to-feed liquids in emulsion or non-emulsion forms, and as a non-emulsion form may be formulated as clear or substantially clear nutritional liquids as described herein.
  • the nutritional products may be formulated with sufficient kinds and amounts of nutrients to provide a sole, primary, or supplemental source of nutrition, or to provide a specialized nutritional product for use in individuals afflicted with specific diseases or conditions or with a targeted nutritional benefit.
  • the nutritional liquids comprise beta-alanine, alone, or in
  • aqueous emulsions comprising fat, typically emulsified fat, as well as non-emulsions that are typically fat free.
  • fat free as used herein, unless otherwise specified, means that the nutritional liquid typically contains less than 1.0%, more typically less than 0.5%, and more typically less than 0.1%, including zero percent, fat by weight of the nutritional liquid.
  • the fat free formulations are typically devoid of added fat except for the fat that is inherent to other raw materials or added fat at low concentrations to aid in the manufacture the liquid.
  • the non-emulsion or fat free embodiments are most typically clear or translucent liquids having a thin or watery texture at room temperature or at the temperature at which the product is consumed.
  • the emulsion embodiments may comprise fat at concentrations ranging from about 1% to about 30%, including from about 2% to about 15%, and also including from about 4% to about 10%>, by weight of the nutritional emulsion.
  • the nutritional liquid embodiments typically contain up to about 98%o by weight of water, including from about 50%> to about 95%, also including from about 60%) to about 90%>, and also including from about 70%> to about 85%, of water by weight of the nutritional liquids.
  • the nutritional liquids may also have a caloric density tailored to the nutritional needs of the ultimate user, although in most instances the liquids comprise from about 100 to about 500 kcal/240 ml, including from about 150 to about 350 kcal/240 ml, and also including from about 200 to about 320 kcal/240 ml.
  • the nutritional liquids may also have a pH ranging from about 2.8 to about 8.0, but most typically have a pH of from about 2.8 to about 7.3, including from about 6.8 to about 8.0 and also including from about 2.8 to about 4.6, including from about 2.9 to about 4.2, and also including from about 3.1 to about 3.9.
  • the product pH is maintained at between about 2.8 and about 4.6, the calcium HMB in the formulation does not interact with the soluble proteins in the liquid. This avoids the formation of sediment, gelation, and coagulation. Within this low pH range, the undesirable sediment, gelation and coagulation is prevented even at temperatures greater than 180°F, which is the minimum temperature required for a suitable process for acidified products.
  • the serving size for the nutritional products can vary depending upon a number of variables, a typical serving size ranges from about 100 to about 300 ml (approximately 3 ounces to 10 ounces), including from about 150 to about 250 ml (approximately 5 ounces to 8.4 ounces), including from about 190 ml to about 240 ml approximately 6.4 ounces to 8.4 ounces), and including about 237 ml (approximately 8 ounces).
  • the nutritional products comprise beta-alanine.
  • Beta-alanine can be included in the nutritional liquids in amounts ranging from about 0.8 grams to about 1.2 grams per 8-ounce serving, including from about 0.9 grams to about 1.1 grams per 8-ounce serving, and including about 1.0 gram per 8-ounce serving.
  • the nutritional liquids include beta- alanine in concentrations ranging from about 0.25% to about 0.50% by weight, including from about 0.26% to about 0.47% by weight.
  • the nutritional product is a substantially clear nutritional liquid, the liquid includes from about 0.26% to about 0.40% by weight of beta-alanine.
  • the nutritional liquid is an emulsion, the emulsion includes beta-alanine in concentrations of from about 0.31% to about 0.47% by weight.
  • the nutritional products may be formulated with the addition of beta- alanine, or may otherwise be prepared so as to contain beta-alanine in the finished product.
  • Any source of beta-alanine is suitable for use in the products described herein provided that the finished product contains beta-alanine at the desired level.
  • Such sources may and typically do include free beta-alanine as well as other sources that provide free beta-alanine in the nutritional product during or after formulation.
  • At least a portion of the beta-alanine resides in a whey protein phospholipids concentrate and oil combination.
  • Milk fat is secreted from mammary epithelial cells as fat globules which are primarily composed of a globule of triglyceride surrounded by a lipid bilayer membrane similar to the apical membrane of the epithelial cells.
  • This whey protein phospholipids concentrate helps to stabilize the fat globules in an emulsion within the aqueous environment of milk.
  • the whey protein phospholipids concentrate and oil combination includes the soy lecithin and oils and oil-soluble vitamins described herein in combination with whey protein phospholipids concentrate.
  • the whey protein phospholipids concentrate in combination with the oil encapsulates the beta-alanine. Through encapsulation, it is possible to provide a sustained, slower release of beta- alanine into the blood, thereby reducing the adverse side-effect of paresthesia typically caused by the ingestion of beta-alanine.
  • the amount of whey protein phospholipids concentrate for use in the nutritional liquids of these embodiments range from about 0.5 grams to about 5.0 grams per 8-ounce serving, including from about 0.6 grams to about 3.0 grams per 8-ounce serving, including from about 0.7 grams to about 1.0 gram per 8-ounce serving, and including about 0.8 grams per 8- ounce serving.
  • At least about 10% of the beta-alanine resides in the whey protein phospholipids concentrate and oil combination, including at least about 25%, including at least about 50%>, including at least about 60%>, including at least about 70%), including at least about 80%>, including at least bout 90%>, and including 100% of the total beta-alanine in the nutritional liquid may reside in the whey protein phospholipids concentrate and oil combination.
  • the present formulations may further comprise proteins or hydrolyzed proteins that contain peptides having beta-alanine moieties, the beta- alanine from such peptide-bound moieties are not considered part of the beta-alanine feature when defining the present disclosure.
  • One suitable source of beta-alanine is commercially available from Compounds Solutions (Escondido, California).
  • the nutritional products may additionally comprise calcium HMB in combination with the beta-alanine.
  • the products are either formulated with the addition of calcium HMB, most typically as a monohydrate, or are otherwise prepared so as to contain calcium and HMB in the finished product.
  • Any source of HMB is suitable for use herein provided that the finished product contains calcium and HMB, although such a source is preferably calcium HMB and is most typically added as such to the nutritional product during formulation.
  • the term "added calcium HMB” as used herein means a calcium salt of HMB, most typically as monohydrate calcium salt of HMB, as the HMB source added to the nutritional product.
  • HMB monohydrate is the preferred source of HMB for use herein
  • suitable sources may include HMB as the free acid, a salt, an anhydrous salt, an ester, a lactone, or other product forms that otherwise provide a bioavailable form of HMB from the nutritional product.
  • suitable salts of HMB for use herein include HMB salts, hydrated or anhydrous, of sodium, potassium, magnesium, chromium, calcium, or other non-toxic salt form.
  • Calcium HMB monohydrate is preferred and is commercially available from
  • Calcium HMB may be included in the nutritional liquids in amounts ranging from about 1.0 grams to about 2.0 grams per 8-ounce serving, including from about 1.1 grams to about 1.8 grams per 8-ounce serving, and including about 1.5 grams per 8-ounce serving.
  • the nutritional liquids may include calcium HMB in concentrations ranging from about 0.40% to about 0.60%> by weight, including from about 0.42% to about 0.45%) by weight, and including about 0.44%> by weight.
  • the nutritional liquid when used in an emulsion, may include calcium HMB in a concentration of about 0.47% by weight.
  • the nutritional liquid when used in a substantially clear liquid, may include calcium HMB in a concentration of about 0.40% by weight.
  • the nutritional products may further comprise any protein or sources thereof that are suitable for use in oral nutritional products and are compatible with the essential elements and features of such products.
  • Total protein concentrations in the nutritional liquids may range from about 0.5% to about 30%, including from about 1%) to about 15%), including from about 2%> to about 10%>, and also including from about 3%) to about 8%>, including from about 3%> to about 7%>, and including from about 3% to about 6.72% by weight of the nutritional liquid.
  • the nutritional product when the nutritional product is an emulsion, the emulsion includes protein in a total concentration of about 6.77% by weight.
  • the clear liquid includes protein in a total concentration of from about 3.00% to about 4.47% by weight.
  • total protein is included in the nutritional liquids in amounts of from about 9 grams to less than 20 grams per 8-ounce serving.
  • the protein is included in amounts of from about 12 grams to less than 20 grams per 8-ounce serving, including about 17 grams per 8-ounce serving.
  • the protein is included in amounts of from about 9 grams to about 14 grams per 8-ounce serving, including from about 10 grams to about 12 grams per 8- ounce serving.
  • Non-limiting examples of suitable protein or sources thereof for use in the nutritional products include hydrolyzed, partially hydrolyzed or non-hydrolyzed (i.e., intact) proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, pea) or combinations thereof.
  • milk e.g., casein, whey
  • animal e.g., meat, fish
  • cereal e.g., rice, corn
  • vegetable e.g., soy, pea
  • suitable protein or sources thereof for use in the nutritional products include hydrolyzed, partially hydrolyzed or non-hydrolyzed (i.e., intact) proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (
  • the protein in the nutritional products may include intact proteins as that term is defined herein to improve product stability and minimize the development of bitter flavors and after taste in the formulation during shelf life.
  • the nutritional products may further comprise any carbohydrates that are suitable for use in an oral nutritional product and are compatible with the essential elements and features of such products.
  • Carbohydrate concentrations in the nutritional liquids may range from about 5% to about 40%, including from about 7% to about 30%>, including from about 10%> to about 25%, by weight of the nutritional liquid.
  • Non-limiting examples of suitable carbohydrates or sources thereof for use in the nutritional products described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), artificial sweeteners (e.g., sucralose, acesulfame potassium, stevia) and combinations thereof.
  • maltodextrin hydrolyzed or modified starch or cornstarch
  • glucose polymers e.g., corn syrup, corn syrup solids
  • rice-derived carbohydrates sucrose, glucose, fructose, lactose, high fructose corn syrup, honey
  • sugar alcohols e.g., maltitol, erythritol, sorbitol
  • artificial sweeteners e.g., su
  • the nutritional products may further comprise fat, most typically as emulsified fat, concentrations of which may range from about 1% to about 30%, including from about 2% to about 15%, and also including from about 4% to about 10%), by weight of the nutritional liquid.
  • Suitable sources of fat for use herein include any fat or fat source that is suitable for use in an oral nutritional product and is compatible with the essential elements and features of such products.
  • Non-limiting examples of suitable fats or sources thereof for use in the nutritional emulsions described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.
  • coconut oil fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.
  • MCT oil medium chain triglycerides
  • sunflower oil high oleic sunflower oil
  • palm and palm kernel oils palm olein
  • canola oil marine oils, cotton
  • the nutritional products may additionally comprise one or more thickeners (i.e., thickening agents).
  • thickeners i.e., thickening agents.
  • the addition of thickeners reduces the incidences of paresthesia by inducing the feeling of satiety, which prolongs gastric transit time as discussed above.
  • Exemplary thickeners include gum arabic, sodium
  • cereal beta-glucans i.e., oat beta-glucan, barley beta- glucan
  • carrageenan psyllium.
  • Gellan gum is a water-soluble polysaccharide produced by
  • Pseudomonas elodea As gellan gum is shear thinning, it can be used in the nutritional liquids without producing a viscous, unappealing textured product.
  • Low acyl gellan gum particularly preferred for use in the nutritional products of the present disclosure includes low acyl gellan gum.
  • Low acyl gellan gum also known as and commonly referred to as deacylated gellan gum
  • the gellan gum has been treated such that it forms firm, non-elastic, brittle gels, that are heat stable, as compared to "high acyl” which forms soft, very elastic, non-brittle gels.
  • Kelcogel F CP Kelco U.S. Inc., Atlanta Georgia.
  • the thickeners, and particularly gellan gum are present in the nutritional liquids in concentrations ranging from about 0.03% to about 0.05%, including from about 0.035%) to about 0.045%), and including about 0.04%> by weight of the nutritional liquid.
  • the nutritional products may optionally include an ingredient that competes with beta-alanine by binding to receptors in the small intestines, including GABA receptors. By reducing the rate of delivery of the beta-alanine to these receptors, it is believed that peak blood levels of beta-alanine will be reduced, thereby diminishing the paresthesia effect.
  • exemplary site competitors for use in the nutritional liquids include glycine and taurine. Suitable commercially available sources of glycine and taurine can be obtained from Ajinomoto, Chicago, Illinois.
  • the nutritional products may include one or more site competitors in the range of from about 0.04 grams to about 1.6 grams per 8-ounce serving, including about 0.1 grams to about 1.0 gram per 8-ounce serving, including about 0.5 grams to about 1.0 gram per 8-ounce serving, and including about 0.8 grams per 8-ounce serving.
  • the nutritional liquids include one or more site competitors in concentrations ranging from about 0.26% to about 0.95% by weight, including from about 0.26%) to about 0.47%> by weight.
  • the nutritional liquid is an emulsion, and the emulsion includes a site competitor in an amount of from about 0.32% to about 0.47% by weight.
  • the nutritional liquid is a substantially clear liquid including a site competitor in concentrations ranging from about 0.26% to about 0.38% by weight.
  • the nutritional products may optionally include one or more flavoring agents to mask the sensations experienced during incidences of paresthesia.
  • menthol provides a cooling sensation that can mask the tingling/prickly sensations induced by paresthesia. Further, menthol binds to a number of taste receptors as well as kappa opioid receptors that may further mask the sensations induced by paresthesia.
  • menthol is included in concentrations ranging from about 0.01% to about 1.0% by weight, including from about 0.02%) to about 0.5%> by weight, including from about 0.03%> to about 0.1 % by weight, and including about 0.05%> by weight of the nutritional liquid.
  • the nutritional products described herein may further comprise other optional ingredients that may modify the physical, chemical, hedonic or processing characteristics of the products or serve as pharmaceutical or additional nutritional components when used in the targeted population.
  • optional ingredients are known or otherwise suitable for use in other nutritional products and may also be used in the nutritional products described herein, provided that such optional ingredients are safe and effective for oral administration and are compatible with the essential and other ingredients in the selected product form.
  • Non-limiting examples of such optional ingredients include preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as described herein, colorants, and stabilizers, and so forth.
  • the products may further comprise vitamins or related nutrients, non- limiting examples of which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
  • vitamins or related nutrients include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
  • the products may further comprise minerals, non- limiting examples of which include phosphorus, magnesium, calcium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
  • minerals non- limiting examples of which include phosphorus, magnesium, calcium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
  • the nutritional products for use herein may be manufactured by any known or otherwise suitable method for making the nutritional product form selected.
  • Nutritional liquids may be prepared, for example, by any of the well known methods of formulating nutritional liquids by way of retort, aseptic packaging, or hot fill processing methods. Such methods are well known in the nutrition formulation and manufacturing arts.
  • a nutritional liquid is prepared using at least a carbohydrate -mineral (CHO-MIN) slurry, and if the composition includes protein and or fat, a protein-in-fat (PIF) slurry and a protein-in-water (PIW) slurry.
  • the CHO-MIN slurry is formed by adding with heated agitation to water: minerals (e.g., potassium citrate, dipotassium phosphate, sodium citrate, etc.), trace and ultra trace minerals (TM/UTM premix), thickening or suspending agents (e.g. Avicel, gellan gum), additional fiber, and calcium HMB, if present.
  • minerals e.g., potassium citrate, dipotassium phosphate, sodium citrate, etc.
  • TM/UTM premix trace and ultra trace minerals
  • thickening or suspending agents e.g. Avicel, gellan gum
  • additional fiber e.g. Avicel, gellan gum
  • the resulting CHO-MIN slurry is held for 10 minutes with continued heat and agitation before adding additional minerals (e.g., potassium chloride, magnesium carbonate, potassium iodide, etc.) and/or carbohydrates (e.g., fructooligosaccharide, sucrose, corn syrup, etc.).
  • additional minerals e.g., potassium chloride, magnesium carbonate, potassium iodide, etc.
  • carbohydrates e.g., fructooligosaccharide, sucrose, corn syrup, etc.
  • the PIF slurry is formed by heating and mixing the selected oils (e.g., canola oil, corn oil, fish oil, etc.) and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein (e.g., whey protein concentrate, etc.) with continued heat and agitation.
  • oils e.g., canola oil, corn oil, fish oil, etc.
  • an emulsifier
  • the PIW slurry is then formed by mixing with heat and agitation the remaining protein (e.g., milk protein concentrate, soy protein isolate, etc.) into water.
  • Beta-alanine is added alone as an additional slurry or can be included in the oil blend of the PIF slurry.
  • the resulting slurries are then blended together with heated agitation and the pH adjusted to the desired range, typically from 6.6-7.0, after which the composition is subjected to high-temperature short-time (HTST) processing during which the composition is heat treated, emulsified and homogenized, and then allowed to cool.
  • HTST high-temperature short-time
  • Water soluble vitamins and ascorbic acid are added, the pH is again adjusted to the desired range if necessary, fiavors are added, and water is added to achieve the desired total solid level.
  • the composition is then aseptically packaged to form an aseptically packaged nutritional liquid, or the composition is added to retort stable containers and then subjected to retort sterilization to form retort sterilized nutritional liquids.
  • beta-alanine resides in a whey protein phospholipids concentrate and oil combination
  • the beta-alanine that resides in the whey protein phospholipids concentrate and oil combination is added into the PIF slurry.
  • all oils are added to form the oil blend described above (e.g., canola oil, corn oil, fish oil, etc.) and then whey protein phospholipids concentrate are added with beta-alanine into the oil blend.
  • the remaining oil soluble ingredients are then added and the PIF slurry is blended with the other slurries as described above.
  • the nutritional products are useful as a nutrition source as well as to help promote healthy muscle development and maintenance and for enhancing performance endurance in individuals. Additionally, the nutritional products may be particularly suitable for use in older and elderly individuals in need of maintaining healthy muscle mass, strength and functionality. The nutritional products may help in reducing the frailty of older adults and improve muscle tone.
  • the nutritional products further can be administered to individuals without the adverse side-effect of paresthesia caused by ingestion of beta-alanine.
  • the products are formulated such to attenuate the rise of beta-alanine concentration in the blood-plasma, which reduces sensations common of paresthesia, including burning, flushing, headaches, heart palpitations, itching, numbness, prickly/tingling, and swollenness.
  • nutritional compositions including various levels of protein and fat were evaluated after ingestion for their effect on reducing the symptoms of paresthesia caused by beta-alanine. Particularly, subjects administered the nutritional compositions were evaluated for paresthesia sensations including: burning, flushed, headache, heart palpitations, itching, numbness, prickly/tingling, and swollenness.
  • nutritional compositions including various gums and fibers were evaluated after ingestion for their effect on reducing the symptoms of paresthesia caused by beta-alanine. Particularly, subjects administered the nutritional compositions were evaluated for paresthesia sensations including: burning, flushed, headache, heart palpitations, itching, numbness, prickly/tingling, and swollenness.
  • All nutritional compositions evaluated included 12 grams per 8- ounce serving of protein (80% by weight milk protein concentrate and 20% by weight soy protein isolate) and 6 grams per 8-ounce serving of fat (blend of soy oil, corn oil, canola oil, and soy lecithin). The following gums and fibers were added to the nutritional compositions for evaluation of reducing the symptoms of paresthesia.
  • nutritional compositions were evaluated after ingestion for their effects on reducing the symptoms of paresthesia caused by beta- alanine. Particularly, subjects administered the nutritional compositions were evaluated for paresthesia sensations including: burning, flushed, headache, heart palpitations, itching, numbness, prickly/tingling, and swollenness.
  • All nutritional compositions evaluated included 12 grams per 8- ounce serving of protein (80% by weight milk protein concentrate and 20% by weight soy protein isolate) and 6 grams per 8-ounce serving of fat (blend of soy oil, corn oil, canola oil, and soy lecithin). The following additional ingredients added to the nutritional compositions are shown below.
  • nutritional compositions including glycine were evaluated after ingestion for their effects on reducing the symptoms of paresthesia caused by beta-alanine. Particularly, subjects administered the nutritional compositions were evaluated for paresthesia sensations including: burning, flushed, headache, heart palpitations, itching, numbness, prickly/tingling, and swollenness.
  • All nutritional compositions evaluated are clear nutritional liquids including 10 grams per 10-ounce serving of protein (100% by weight soy protein isolate). Beta-alanine and glycine concentrations added to the clear nutritional liquids are shown below.
  • Example 5 illustrates an emulsion of the present disclosure including calcium HMB and beta-alanine, the ingredients of which are listed in the table below. All ingredient amounts are listed as pound per approximately 1000 pounds batch of product, unless otherwise specified.
  • Vitamin D3 0.00001308
  • Example 6 illustrates an emulsion of the present disclosure including calcium HMB and beta-alanine, the ingredients of which are listed in the table below. All ingredient amounts are listed as pound per approximately 1000 pounds batch of product, unless otherwise specified.
  • Vitamin D3 0.00001308
  • Example 7 illustrates an emulsion of the present disclosure including calcium HMB and beta-alanine, the ingredients of which are listed in the table below. All ingredient amounts are listed as pound per approximately 1000 pounds batch of product, unless otherwise specified.
  • Vitamin D3 0.00001308
  • Example 8 illustrates a substantially clear nutritional liquid of the present disclosure including calcium HMB and beta-alanine, the ingredients of which are listed in the table below. This liquid has a pH of between 2.9 and 4.0 and remains physically stable over a shelf life of about 18 months. All ingredient amounts are listed as pound per approximately 1000 pounds batch of product, unless otherwise specified.
  • Chromium Chloride hexahydrate 0.000430
  • Example 9 illustrates a substantially clear nutritional liquid of the present disclosure including calcium HMB and beta-alanine, the ingredients of which are listed in the table below. This liquid has a pH of between 2.9 and 4.0 and remains physically stable over a shelf life of about 18 months. All ingredient amounts are listed as pound per approximately 1000 pounds batch of product, unless otherwise specified.
  • Chromium Chloride hexahydrate 0.000430

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Abstract

La présente invention concerne des produits nutritionnels et, en particulier, des liquides nutritionnels comprenant de la bêta-alanine. Les produits nutritionnels apportent non seulement des bénéfices aux individus concernés par la santé et la fonctionnalité des muscles, mais peuvent également être administrés sans l'effet indésirable de la paresthésie provoqué par l'ingestion de bêta-alanine.
PCT/US2012/059954 2011-10-13 2012-10-12 Produits nutritionnels comprenant de la bêta-alanine WO2013056048A2 (fr)

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WO2013170189A1 (fr) * 2012-05-11 2013-11-14 Abbott Laboratories Combinaison de bêta-hydroxy-bêta-méthylbutyrate et de bêta-alanine destinée à augmenter le débit musculaire
US8778994B2 (en) 2004-03-26 2014-07-15 Abbott Laboratories Method of using beta-hydroxy-beta-methylbutyrate and fatty acids for treating disease-associated wasting
US8778992B2 (en) 2005-12-19 2014-07-15 Abbott Laboratories Method of using beta-hydroxy-beta-methylbutyrate to treat allergies and asthma
EP2948139A4 (fr) * 2013-01-28 2016-07-20 Hector L Lopez Procédés d'amélioration de la tolérance à -alanine, de sa pharmacodynamie et de son efficacité et son utilisation
WO2021236440A1 (fr) * 2020-05-20 2021-11-25 Advanced Food Concepts, Inc. Composition d'amélioration des performances athlétiques utilisant du menthol
CN113812635A (zh) * 2021-09-22 2021-12-21 大连医诺生物股份有限公司 微囊化β-丙氨酸、其制备方法及应用
WO2022090473A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et procédés d'utilisation de telles compositions pour favoriser la croissance musculaire
WO2022090457A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et procédés d'utilisation de telles compositions pour traiter une cachexie ou une précachexie
WO2022090458A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et méthodes d'utilisation de telles compositions pour le traitement de la sarcopénie et de la fragilité
WO2022090456A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et méthodes d'utilisation de telles compositions pour la rééducation

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Publication number Priority date Publication date Assignee Title
US8778994B2 (en) 2004-03-26 2014-07-15 Abbott Laboratories Method of using beta-hydroxy-beta-methylbutyrate and fatty acids for treating disease-associated wasting
US8778993B2 (en) 2004-03-26 2014-07-15 Abbott Laboratories Method of using β-hydroxy-β-methylbutyrate for the treatment of disease conditions
US8785496B2 (en) 2004-03-26 2014-07-22 Abbott Laboratories Method of using beta-hydroxy-beta-methylbutyrate for treating disease-associated wasting
US8785495B2 (en) 2004-03-26 2014-07-22 Abbott Laboratories Compositions including beta-hydroxy-beta-methylbutyrate
US8778992B2 (en) 2005-12-19 2014-07-15 Abbott Laboratories Method of using beta-hydroxy-beta-methylbutyrate to treat allergies and asthma
US8796333B2 (en) 2005-12-19 2014-08-05 Abbott Laboratories Method of using β-hydroxy-β-methylbutyrate to treat a condition
WO2013170189A1 (fr) * 2012-05-11 2013-11-14 Abbott Laboratories Combinaison de bêta-hydroxy-bêta-méthylbutyrate et de bêta-alanine destinée à augmenter le débit musculaire
US10130715B2 (en) 2013-01-28 2018-11-20 Hector L. Lopez Methods of improving tolerability, pharmacodynamics, and efficacy of β-alanine and use therefor
EP2948139A4 (fr) * 2013-01-28 2016-07-20 Hector L Lopez Procédés d'amélioration de la tolérance à -alanine, de sa pharmacodynamie et de son efficacité et son utilisation
WO2021236440A1 (fr) * 2020-05-20 2021-11-25 Advanced Food Concepts, Inc. Composition d'amélioration des performances athlétiques utilisant du menthol
US11850217B2 (en) 2020-05-20 2023-12-26 Advanced Food Concepts, Inc. Athletic performance enhancement composition using menthol
WO2022090473A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et procédés d'utilisation de telles compositions pour favoriser la croissance musculaire
WO2022090457A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et procédés d'utilisation de telles compositions pour traiter une cachexie ou une précachexie
WO2022090458A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et méthodes d'utilisation de telles compositions pour le traitement de la sarcopénie et de la fragilité
WO2022090456A1 (fr) * 2020-10-30 2022-05-05 Société des Produits Nestlé S.A. Compositions contenant du nicotinamide et de la vitamine b6 et méthodes d'utilisation de telles compositions pour la rééducation
CN113812635A (zh) * 2021-09-22 2021-12-21 大连医诺生物股份有限公司 微囊化β-丙氨酸、其制备方法及应用
CN113812635B (zh) * 2021-09-22 2023-12-19 大连医诺生物股份有限公司 微囊化β-丙氨酸、其制备方法及应用

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