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WO2015094767A1 - Méthodes pour maintenir ou augmenter le poids corporel à l'aide d'extrait de thé vert décaféiné - Google Patents

Méthodes pour maintenir ou augmenter le poids corporel à l'aide d'extrait de thé vert décaféiné Download PDF

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Publication number
WO2015094767A1
WO2015094767A1 PCT/US2014/069092 US2014069092W WO2015094767A1 WO 2015094767 A1 WO2015094767 A1 WO 2015094767A1 US 2014069092 W US2014069092 W US 2014069092W WO 2015094767 A1 WO2015094767 A1 WO 2015094767A1
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WO
WIPO (PCT)
Prior art keywords
composition
subject
nutritional
green tea
protein
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Ceased
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PCT/US2014/069092
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English (en)
Inventor
Suzette Pereira
Benjamin Meador
Neile Edens
Gaurav PATEL
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Abbott Laboratories
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Abbott Laboratories
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Publication of WO2015094767A1 publication Critical patent/WO2015094767A1/fr
Anticipated expiration legal-status Critical
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/018—Hydrolysed proteins; Derivatives thereof from animals from milk
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism

Definitions

  • the present disclosure relates to methods for maintaining or increasing bodyweight in a subject susceptible to unintentional weight loss. Particularly, the present disclosure relates to the use of compositions comprising decaffeinated green tea extract to maintain or increase bodyweight in such subject.
  • Unintentional weight loss in a subject due to malnourishment, age, atrophy, or disorders related to age, disease, or atrophy may have a negative impact on the overall health and well being of a subject.
  • unintentional weight loss may lead to weakness, frailty, muscle loss, susceptibility to injury, e.g., increased risk of bone fracture, a decrease in the ability or desire to exercise, and so forth in the subject.
  • a preferred path of maintaining or increasing bodyweight in a subject is maintaining or gaining skeletal muscle mass (lean body mass), which is typically achieved through proper nutrition and exercise. Not all subjects, however, are capable, or even sometimes willing, to exercise in an effort to maintain or increase their bodyweight.
  • the bodyweight of a subject is maintained or increased by administering decaffeinated green tea extract to such subject.
  • a method for maintaining or increasing bodyweight in a subject susceptible to unintentional weight loss includes a step of administering at least one serving per day of a composition including 20 to 2000 mg of a decaffeinated green tea extract per serving to the subject.
  • the administration of the composition to the subject is effective to maintain or increase the bodyweight of the subject.
  • This embodiment is also directed to a composition for use in maintaining or increasing bodyweight in a subject susceptible to unintentional weight loss, the composition comprising: 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • This embodiment is also directed to use of a composition in the manufacture of a medicament for use in maintaining or increasing bodyweight in a subject susceptible to unintentional weight loss, the composition comprising 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • a method of maintaining or increasing bodyweight in a subject susceptible to age-related unintentional weight loss includes a step of administering at least one serving per day of a composition including 20 to 2000 mg of a decaffeinated green tea extract per serving to the subject.
  • the administration of the composition to the subject is effective to maintain or increase the bodyweight of the subject.
  • This embodiment is also directed to a composition for use in maintaining or increasing bodyweight in a subject susceptible to age-related unintentional weight loss, the composition comprising: 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • This embodiment is also directed to use of a composition in the manufacture of a medicament for use in maintaining or increasing bodyweight in a subject susceptible to age- related unintentional weight loss, the composition comprising 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • a method of maintaining or increasing bodyweight in a subject susceptible to disease-related unintentional weight loss includes a step of administering at least one serving per day of a composition including 20 to 2000 mg of a decaffeinated green tea extract per serving to the subject.
  • the administration of the composition to the subject is effective to maintain or increase the bodyweight of the subject.
  • This embodiment is also directed to a composition for use in maintaining or increasing bodyweight in a subject susceptible to disease-related unintentional weight loss, the composition comprising: 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • This embodiment is also directed to use of a composition in the manufacture of a medicament for use in maintaining or increasing bodyweight in a subject susceptible to disease- related unintentional weight loss, the composition comprising 20 to 2000 mg of a decaffeinated green tea extract per serving and wherein the dosage is as least one serving per day.
  • a method of maintaining or increasing bodyweight in a subject susceptible to atrophy-related unintentional weight loss includes a step of administering at least one serving per day of a composition including 20 to 2000 mg of a decaffeinated green tea extract per serving to the subject.
  • the administration of the composition to the subject is effective to maintain or increase the bodyweight of the subject.
  • This embodiment is also directed to a composition for use in maintaining or increasing bodyweight in a subject susceptible to atrophy-related unintentional weight loss, the composition comprising: 20 to 2000 mg of a decaffeinated green tea extract per serving, and wherein the dosage is at least one serving per day.
  • This embodiment is also directed to use of a composition in the manufacture of a medicament for use in maintaining or increasing bodyweight in a subject susceptible to atrophy- related unintentional weight loss, the composition comprising 20 to 2000 mg of a decaffeinated green tea extract per serving and wherein the dosage is at least one serving per day.
  • a further embodiment is directed to a composition as defined above for use in treatment of the human or animal body by therapy.
  • Figure 1 shows the change in bodyweight of Sprague Dawley rats at the conclusion of an eight week study in which the rats were fed a control diet and a diet containing decaffeinated green tea extract.
  • Figure 2 shows the weekly food intake of Sprague Dawley rats over an eight week study period in which the rats were fed a control diet and a diet containing decaffeinated green tea extract.
  • administering should be understood to include providing the nutritional product to a subject, the act of consuming the nutritional product, and combinations thereof.
  • a nutritional composition in powder form may be reconstituted upon addition of water or another liquid to form a liquid nutritional composition prior to administration to (e.g., providing to or consumption by) a subject.
  • the nutritional compositions comprise at least one of a source of protein, a source of carbohydrate, and a source of fat.
  • the nutritional compositions disclosed herein are generally suitable for oral consumption by a human.
  • liquid nutritional composition refers to nutritional compositions in ready-to-drink liquid form, concentrated liquid form, and nutritional liquids made by reconstituting nutritional powders described herein prior to use.
  • the liquid nutritional composition may also be formulated as a suspension, an emulsion, a solution, and the like.
  • nutritional powder or “reconstitutable powder” as used herein, unless otherwise specified, refers to nutritional compositions in a solid flowable or scoopable form that can be reconstituted with water or another liquid prior to consumption and includes spray-dried powders, dry-mixed, or dry-blended powders, and the like.
  • Some semi-solid examples include puddings, yogurts, gels, gelatins, doughs, and the like.
  • the bodyweight of a subject is maintained or increased by administering decaffeinated green tea extract to such subject.
  • the methods include a step of administering at least one serving per day of a composition including 20 to 2000 mg of a decaffeinated green tea extract per serving to the subject.
  • the administration of the composition to the subject is effective to maintain or increase the bodyweight of the subject.
  • a composition comprising 20 to 2000 mg of a decaffeinated green tea extract per serving is used to maintain or increase (i.e., for use in maintaining or increasing) bodyweight in a subject susceptible to unintentional weight loss by administering at least one serving per day of the composition to the subject.
  • Subjects susceptible to weight loss include those who experience unintentional weight loss, those who are at risk of unintentional weight loss, and combinations of both those who experience and are at risk of unintentional weight loss.
  • Such unintentional weight loss can be due to at least one of age, malnourishment, disease, injury, hospitalization, lack of appetite, lack of mobility, and combinations thereof.
  • the unintentional weight loss can be characterized as age-related weight loss, such as the weight loss due to at least one of sarcopenia, hospitalization, surgery, post-hospitalization rehabilitation, appetite loss, inflammation, dysphagia, cognitive impairment, impaired nutrient absorption, taste aversion, frailty syndrome, and combinations thereof.
  • the unintentional weight loss can be characterized as disease-related weight loss, such as weight loss due to at least one of cancer cachexia, chronic obstructive pulmonary disease (COPD), end stage renal disease (ESRD), congestive heart failure (CHF), acquired immunodeficiency syndrome (AIDS), chemotherapy, medications, acute illness, and combinations thereof.
  • the unintentional weight loss can be characterized as atrophy-related weight loss, such as weight loss due to at least one of lack of mobility, lack of use of extremities, disability, muscular dystrophy, joint disease, and combinations thereof.
  • atrophy-related weight loss such as weight loss due to at least one of lack of mobility, lack of use of extremities, disability, muscular dystrophy, joint disease, and combinations thereof.
  • composition administered to the subject includes 20 to
  • the composition includes 40 to 2000 mg of decaffeinated green tea extract per serving, including from 100 to 2000 mg, from 250 to 2000 mg, from 500 to 2000 mg, from 20 to 1500 mg, from 40 to 1500 mg, from 100 to 1500 mg, and from 250 to 1500 mg of decaffeinated green tea extract per serving.
  • the decaffeinated green tea extracts disclosed herein are derived from green tea leaves, in which the polyphenol epigallocatechin gallate ("EGCg") alone, or in combination with other polyphenol compounds, are isolated from green tea as an extract.
  • suitable green tea extracts are in the form of a liquid, a solid ⁇ e.g., a powder), and mixtures thereof.
  • the extract is decaffeinated such that it contains less than 1% by weight solids of caffeine, including less than 0.5%, less than 0.1%), and less than 0.01% by weight solids of caffeine.
  • the decaffeinated green tea extract contains no caffeine, i.e., zero caffeine.
  • suitable decaffeinated green tea extracts used with the nutritional compositions disclosed herein may contain other polyphenols including but not limited to, other catechins such as catechin (i.e., (+)-catechin, also known as "C”), epicatechin (“EC”), gallocatechin (“GC”), epigallocatechin (“EGC”), and epicatechin gallate (“ECg”); flavones such as apigenin, isoviloxin, sapotarin, and vicenin-2; flavonols such as kaempherol, quercetin, myricetin; condensed flavanoids, and tannin glycosides.
  • catechins i.e., (+)-catechin, also known as "C”
  • C epicatechin
  • GC gallocatechin
  • ECG epigallocatechin
  • ECg epicatechin gallate
  • flavones such as apigenin, isoviloxin, sapotarin, and vicenin-2
  • flavonols such as
  • the decaffeinated green tea extract contains at least 30%> by weight solids of EGCg , including at least 45%, at least 50%>, at least 70%, at least 80%, at least 90%, and at least 100% by weight solids of EGCg.
  • the decaffeinated green tea extract contains 30% to 100% by weight solids of EGCg, including from 45% to 100%, 50% to 100%, 70% to 100%, 80% to 100%, and 90% to 100% by weight solids of EGCg.
  • the decaffeinated green tea extract contains at least 3% to 20% by weight solids of EC, including from 4% to 15%, and from 5% to 10%> by weight solids of EC.
  • the EC content of the compositions disclosed herein may be fortified or supplemented by including sources of EC other than green tea extract, such as cocoa.
  • the decaffeinated green tea extract is formulated into a suitable composition and then, in accordance with the methods disclosed herein, administered to a subject in a form adapted to the chosen route of administration.
  • the compositions disclosed herein are decaffeinated, i.e., the composition contains less than 1% by weight solids of caffeine based on the total weight of the composition, including less than 0.5%, less than 0.1%, and less than 0.01% by weight solids of caffeine based on the total weight of the composition.
  • the compositions disclosed herein may also contain no caffeine, i.e. , zero caffeine.
  • the compositions include, but are not limited to, those suitable for oral administration.
  • Oral administration includes any form of administration in which the composition including the decaffeinated green tea extract passes through the esophagus of the subject.
  • oral administration typically refers to oral consumption, but may also include nasogastric intubation, in which a tube is run from the nose to the stomach of the subject to administer the composition.
  • suitable forms of the composition for oral administration to the subject include caplets, tablets, pills, capsules, chewable tablets, quick dissolve tablets, effervescent tablets, solutions, suspensions, emulsions, multi-layer tablets, bi-layer tablets, soft gelatin capsules, hard gelatin capsules, lozenges, chewable lozenges, beads, granules, particles, microparticles, dispersible granules, sachets, and combinations thereof.
  • the compositions may be formulated consisting of or consisting essentially of decaffeinated green tea extract.
  • the compositions containing the decaffeinated green tea extract are formulated as a nutritional composition.
  • Such nutritional compositions disclosed herein are useful to provide supplemental, primary, or sole sources of nutrition, including providing the subjects one or more benefits as described herein.
  • the nutritional composition provides up to 500 kcal of energy per serving or dose, including from 20 kcal to 500 kcal, from 75 kcal to 500 kcal, from 150 kcal to 500 kcal, from 150 kcal to 500 kcal, from 300 kcal to 500 kcal, or from 400 kcal to 500 kcal per serving.
  • the nutritional compositions disclosed herein are decaffeinated, i.e., nutritional composition contains less than 1% by weight solids of caffeine based on the total weight of the nutritional composition, including less than 0.5%, less than 0.1%), and less than 0.01% by weight solids of caffeine based on the total weight of the nutritional composition.
  • the nutritional compositions disclosed herein may also contain no caffeine, i.e., zero caffeine.
  • the nutritional compositions comprise at least one of a source of protein, a source of carbohydrate, a source of fat, and combinations thereof.
  • the nutritional compositions are provided as needed to supply the desired level of decaffeinated green tea extract, including providing at least one serving per day to achieve the desired effect.
  • the foregoing should be understood to include, but not be limited to, one serving per day, two servings per day, three servings per day, four servings per day, etc.
  • the compositions disclosed herein are administered in at least one serving per day or at least two servings per day.
  • the compositions disclosed herein are continuously administered up to 24 hr/day by infusion through a nasogastric, gastric, or jejeunal feeding tube.
  • compositions including the decaffeinated green tea extract disclosed herein can also be referred to herein as medicaments.
  • decaffeinated green tea extract can be used for the preparation or manufacture of a medicament for treating a subject susceptible to unintentional weight loss to maintain or increase bodyweight.
  • compositions disclosed herein are administered to the subject for at least 3 days.
  • the compositions disclosed herein can be administered to a subject for at least 1 week, for at least 10 days, for at least 2 weeks, for at least 1 month, for at least 6 months, or for at least 1 year.
  • the number of days is intended to reflect the days in which a subject has been instructed to be administered the composition, and in which the composition is actually administered for at least 65%, including at least 90%, of the instructed days during the period of administration.
  • compositions disclosed herein are administered for at least 3 days, including from 3 to 10 days.
  • compositions disclosed herein are administered for greater than 10 days, including from greater than 10 days up to 14 days, from greater than 10 days up to 21 days, from greater than 10 days up to 1 month, from greater than 10 days up to 6 months, and from greater than 10 days up to 1 year, or for greater than 10 days to longer than 1 year.
  • the compositions disclosed herein containing the decaffeinated green tea extract are nutritional compositions.
  • the nutritional compositions are formulated as, and intended for consumption in, any known or otherwise suitable oral product form consistent with the forms described herein.
  • any solid, liquid, semi-solid, semi-liquid, or powder product form, including combinations or variations thereof, are suitable for use herein, provided that such forms allow for safe and effective delivery to the individual via oral administration, of the ingredients as also defined herein.
  • the nutritional composition is a solid nutritional product.
  • solid nutritional products include snack and meal replacement products, including those formulated as bars, sticks, cookies or breads or cakes or other baked goods, frozen liquids, candy, breakfast cereals, powders or granulated solids or other particulates, snack chips or bites, frozen or retorted entrees and so forth.
  • the serving is within a range of 25 grams (g) to 200 g.
  • the nutritional composition is a liquid nutritional composition.
  • liquid nutritional compositions include snack and meal replacement products, hot or cold beverages, carbonated or non-carbonated beverages, juices or other acidified beverages, milk or soy-based beverages, shakes, coffees, teas, and so forth.
  • the liquid nutritional compositions can be formulated as suspensions or emulsions, or the liquid nutritional compositions can also be formulated in any other suitable forms such as clear liquids, solutions, liquid gels, liquid yogurts, and so forth.
  • the serving is within a range of 30 milliliters (mL) to 500 mL ( ⁇ 1 fl oz to ⁇ 17 fl oz), including from 1 10 mL to 500 mL ( ⁇ 3.7 fl oz to ⁇ 17 fl oz), including from 1 10 mL to 417 mL ( ⁇ 3.7 fl oz to ⁇ 14 fl oz), including from 120 mL to 500 mL ( ⁇ 4 fl oz to -17 fl oz), including from 120 mL to 417 mL ( ⁇ 4 fl oz to -14 fl oz), including from 177 mL to 417 mL ( ⁇ 6 fl oz to ⁇ 14 fl oz), including from 207 milliliters to 296 milliliters ( ⁇ 7 fl oz to ⁇ 10 fl oz), including from 230 m
  • the nutritional compositions disclosed herein include at least one of a source of protein, a source of carbohydrate, a source of fat, and combinations thereof.
  • the source of protein is present in the nutritional composition in an amount sufficient to provide 5 g to 50 g of protein per serving, including from 6 g to 45 g, and from 10 g to 30 g of protein per serving.
  • any source of protein may be used so long as it is suitable for nutritional compositions and is otherwise compatible with any other selected ingredients or features in the nutritional composition.
  • the at least one source of protein may include, but is not limited to, intact, hydrolyzed, and partially hydrolyzed protein, 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), and combinations thereof.
  • the at least one source of protein may also include a mixture amino acids (often described as free amino acids) known for use in nutritional products or a combination of such amino acids with the intact, hydrolyzed, and partially hydrolyzed proteins described herein.
  • the amino acids may be naturally occurring or synthetic amino acids.
  • suitable sources of protein used in the nutritional compositions disclosed herein include, but are not limited to, whey protein concentrates, whey protein isolates, whey protein hydrolysates, acid caseins, sodium casemates, calcium casemates, potassium casemates, casein hydrolysates, milk protein concentrates, milk protein isolates, milk protein hydrolysates, nonfat dry milk, condensed skim milk, soy protein concentrates, soy protein isolates, soy protein hydrolysates, pea protein concentrates, pea protein isolates, pea protein hydrolysates, collagen proteins, potato proteins, rice proteins, insect proteins, earthworm proteins, fungal (e.g., mushroom) proteins, proteins expressed by microorganisms (e.g., bacteria and algae), the like, and combinations thereof.
  • the nutritional compositions can include any individual source of protein or combination of the various sources of protein listed above.
  • the protein when the nutritional composition is a liquid and has a pH ranging from 2 to 5, e.g., clear nutritional liquids (discussed infra), the protein is limited to proteins that are soluble in an aqueous composition at this pH level.
  • proteins soluble in an aqueous composition at a pH of 2 to 5 include, but are not limited to, sources of whey-based proteins such as whey protein concentrates, whey protein isolates including either acidified or non-acidified whey protein isolates, whey protein hydrolysates; certain soy-based proteins such as acidified soy protein isolates and soy protein hydrolysates; certain casein-based proteins such as casein hydrolysates; certain pea-based proteins such as pea hydrolysates; the like; and combinations thereof.
  • sources of whey-based proteins such as whey protein concentrates, whey protein isolates including either acidified or non-acidified whey protein isolates, whey protein hydrolysates; certain soy-based proteins such as acidified soy protein isolates and soy protein hydrolysates; certain casein-based proteins such as casein hydrolysates; certain pea-based proteins such as pea hydrolysates; the like; and combinations thereof.
  • the composition is a nutritional composition and contains a source of carbohydrate
  • the source of carbohydrate is present in an amount sufficient to provide the nutritional composition 15 g to 110 g of carbohydrate per serving, including from 25 g to 90 g, and 40 g to 65 g of carbohydrate per serving.
  • Carbohydrates suitable for use in the nutritional compositions disclosed herein may be simple, complex, variations, or combinations thereof. Any source of carbohydrate may be used so long as it is suitable for use in nutritional compositions and is otherwise compatible with any other selected ingredients or features present in the nutritional composition.
  • Non- limiting examples of a source of carbohydrate suitable for use in the nutritional compositions disclosed herein include maltodextrin, hydrolyzed or modified starch or cornstarch; glucose polymers; corn syrup; corn syrup solids; rice-derived carbohydrates; high fructose corn syrup; honey; sugar alcohols, such as maltitol, erythritol, sorbitol, glycerine, and the like, and the like; sucrose; glucose; fructose; lactose; isomaltulose, sucromalt, pullulan, potato starch, and other slowly-digested carbohydrates; oligosaccharides such as fructo-oligosaccharides; dietary fibers including, but not limited to, oat fiber, soy fiber, gum arabic, sodium carboxymethylcellulose, methylcellulose, guar gum, gellan gum, locust bean gum, konjac flour, hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum aca
  • the nutritional compositions can include any individual source of carbohydrate or combination of the various sources of carbohydrate listed above.
  • the source of fat is present in an amount sufficient to provide the nutritional composition 2 g to 45 g of at least one source of fat per serving, including form 5 g to 35 g, and 10 g to 30 g of fat per serving.
  • the nutritional composition is in the form of a liquid emulsion.
  • any source of fat may be used so long as it is suitable for use in nutritional compositions and is otherwise compatible with any other selected ingredients or features present in the nutritional composition.
  • the nutritional compositions disclosed herein that contain fat are liquid emulsions, particularly aqueous emulsions, having a pH ranging from 5 to 8, including a pH of 6 to 7, and including a pH of 6.6 to 7.
  • the source of fat may be derived from plants, animals, and combinations thereof.
  • Non-limiting examples of suitable sources of fat for use in the nutritional compositions described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, medium chain triglyceride oil (MCT oil), high gamma linolenic (GLA) safflower oil, sunflower oil, high oleic sunflower oil, palm oil, palm kernel oil, palm olein, canola oil, marine oils, algal oils, cottonseed oils, interesterified oils, transesterified oils, the like, and combinations thereof.
  • the nutritional compositions can include any individual source of fat or combination of the various sources of fat listed above.
  • the nutritional composition may contain a limited amount of fat.
  • the limited amount of fat may be due at least in part to the desired clarity and desired pH of the liquid nutritional composition.
  • the liquid nutritional compositions desired to be clear, or at least substantially translucent are substantially free of fat.
  • substantially free of fat refers to nutritional compositions containing less than 0.5%, and including less than 0.1% by weight solids of fat based on the total weight of the composition. “Substantially free of fat” also may refer to nutritional compositions disclosed herein that contain no fat, i.e., zero fat.
  • liquid nutritional compositions that have a desired acidic pH in the range of 2 to 5, e.g., juices, fruit juices, fruit- flavored beverages, etc., typically are substantially free of fat.
  • Liquid nutritional compositions that are both clear and have a pH ranging from 2 to 5 are also typically substantially free of fat.
  • the nutritional composition is a clear liquid nutritional product having a pH of 2 to 5 and having no more than 0.5 weight % fat based on the total weight of the nutritional composition.
  • the pH of the nutritional composition may be from 2.5 to 4.6, including a pH of 3 to 3.5.
  • the fat may be present as a result of being inherently present in another ingredient ⁇ e.g., a source of protein), may be present as a result of being added as one of more separate sources of fat, or a combination thereof.
  • the amount or concentration of the at least one of a source of protein, source of carbohydrate, and source of fat present in the nutritional compositions disclosed herein may vary widely depending on the product formulation of the nutritional composition ⁇ e.g. , clear liquid, a fat-based emulsion, etc.).
  • the amount or concentration of the at least one of a source of protein, source of carbohydrate, and source of fat may be characterized based upon a percentage of the total calories per serving in the nutritional composition.
  • the amount or concentration of the at least one of a source of protein, source of carbohydrate, and source of fat present in the nutritional composition can be within the ranges described in Samples A-E, as shown in the Table 1 below.
  • the nutritional compositions disclosed herein may include other compounds or sources of such compounds that are anabolic for muscle, stimulate muscle protein synthesis, decrease muscle protein degradation, or combinations thereof.
  • examples of such compounds include, but are not limited to, leucine, isoleucine, valine, glycine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, carnitine, carnosine, creatine, taurine, arginine, anserine, mushroom extract, cordycepic acid, spinach extract, arugula extract, broccoli extract, eggplant skin extract, plum extract, apple extract, ursolic acid, grape extract, resveratrol, bioidentical stilbenes such as pTeroPureTM, olive extract, alpha-ketoisocaproic acid, alpha-hydroxyisocaproic acid, and metabolites of any of the foregoing.
  • the nutritional compositions disclosed herein include at least one source of a compound selected from the group consisting of leucine, isoleucine, valine, glycine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, carnitine, carnosine, creatine, alpha-ketoisocaproate, metabolites of any of the foregoing, and combinations thereof.
  • a suitable metabolite of leucine is beta-hydroxy-beta-methylbutyrate (HMB).
  • Suitable sources of HMB 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 in 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.
  • the nutritional composition may comprise 0.5 g to 3.5 g of HMB per serving, including 1 g to 3 g of HMB per serving.
  • nutritional compositions disclosed herein may include at least one of a food-grade acid.
  • certain of the nutritional compositions disclosed herein have a pH of 2 to 5, and in certain of the preceding embodiments, a pH of 2.5 to 4.6 or a pH of 3 to 3.5.
  • the food-grade acid may be added to the nutritional composition to adjust the pH of the overall nutritional composition to obtain a pH from 2 to 5, a pH from 2.5 to 4.6, or a pH from 3 to 3.5. Any suitable food-grade acid that is capable of adjusting the pH of the nutritional composition to a pH ranging from 2.5 to 4.6, or a pH ranging from 3 to 3.5 may be used.
  • Non- limiting examples of such suitable food-grade acids include citric acid, acetic acid, lactic acid, maleic acid, ascorbic acid, phosphoric acid, hydrochloric acid, and the like.
  • the amount or concentration of the food-grade acid required to obtain the intended pH depends on various factors, such as the initial pH of the finalized formulation, the relative strength or weakness of the selected food-grade acid, the concentration of the selected food-grade acid, the quantity of the nutritional composition, etc.
  • the type of acid selected may also be based on the type of flavor desired in the nutritional composition, e.g., for a lemon flavored product, citric acid is more suitable, while for the apple flavored product, maleic acid is more suitable.
  • the pH can also be adjusted by addition of clear juices, e.g., cranberry, lemon juice, lime juice, pineapple juice, and the like, including mixtures and combinations thereof, can be added to adjust the pH to desired levels.
  • a suitable food grade base e.g., sodium hydroxide, calcium hydroxide, potassium hydroxide and the like, can be used to bring the pH of the nutritional composition to the desired level.
  • the nutritional compositions disclosed herein may include a high intensity sweetener to counter, mask, or otherwise obscure the potent taste of the green tea extract, particularly the EGCg present in the green tea extract, which may be described as sour, astringent, and bitter, as well as to counter, mask, or otherwise obscure the taste any of the other polyphenols in the green tea extract that may be present in the composition.
  • high intensity sweeteners examples include, but are not limited to, sucralose, acesulfame potassium (also known as “acesulfame K” or “ace K"), aspartame, stevia, neotame, neohesperidine DC, alitame, monellin, thaumatin, mogrosides, monk fruit, and the like. Combinations of the high intensity sweeteners listed above may be used.
  • the amount of the high intensity sweetener in the nutritional composition may vary depending upon the particular high intensity sweetener selected, other ingredients in the formulation, and other formulation or product target variables.
  • acesulfame K is approximately 200 times sweeter than sucrose as compared to sucralose which is approximately 600 times sweeter than sucrose
  • sweeteners that may at least partially counter or at least partially mask the taste of green tea extract in such nutritional compositions.
  • the nutritional compositions disclosed herein may comprise a viscosity agent, e.g., thickening agent.
  • a viscosity agent e.g., thickening agent.
  • the viscosity agent is used in the thicker types of liquid nutritional compositions, e.g., the fat-based emulsions, shakes, etc.
  • Any viscosity agent that is known or otherwise suitable for use in a nutritional composition is also suitable for use herein, some non-limiting examples of which include starches, such as modified corn starch, wheat starch (including pregelatinized wheat starch), potato starch, rice starch, tapioca starch, and the like; blends of cellulose gel and cellulose gum; blends of microcrystalline cellulose and sodium carboxymethyl cellulose; pectin; carrageenan; agar; gellan gum; alginates; gum acacia; gelatin; methyl cellulose; hydroxypropylcellulose; and combinations thereof.
  • starches such as modified corn starch, wheat starch (including pregelatinized wheat starch), potato starch, rice starch, tapioca starch, and the like
  • blends of cellulose gel and cellulose gum blends of microcrystalline cellulose and sodium carboxymethyl cellulose
  • pectin carrageenan
  • agar gellan gum
  • alginates alginates
  • gum acacia gelatin
  • the viscosity agent is present in an amount of 0 to about 5.0%, including from about 0.1 % to about 3%, including from about 0.5%> to about 1.5%, by weight solids based on the total weight of the nutritional composition.
  • the nutritional compositions disclosed herein may also contain other ingredients, non-limiting examples of which include, preservatives, antioxidants in addition to those found in the green tea extract, buffers, pharmaceutical actives, additional nutrients, colorants, flavors, emulsifiers, anti-foam agents, and the like.
  • the nutritional compositions disclosed herein may also contain vitamins or related nutrients including, but not limited to, curcumin, lutein, fish oil, vitamin A, vitamin D (cholecalciferol, 25-hydroxycholecalciferol, 1,25- dihydroxycholecalciferol, 24,25-dihydroxycholecalciferol, ergocalciferol), vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, derivatives thereof, and combinations thereof.
  • vitamins or related nutrients including, but not limited to, curcumin, lutein, fish oil, vitamin A, vitamin D (cholecalciferol, 25-hydroxycholecalciferol, 1,25- dihydroxycholecalciferol, 24,25-dihydroxycholecalciferol, ergocalciferol), vitamin E, vitamin K, thiamine
  • the nutritional compositions disclosed herein may also contain minerals, including, but not limited to, phosphorus, magnesium, iron, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, zinc, and combinations thereof.
  • the various embodiments of the nutritional compositions disclosed herein may also be substantially free of any optional ingredient or feature described herein, provided that the remaining nutritional composition still contains all of the required ingredients or features as described herein.
  • the term "substantially free” means that the selected nutritional compositions contain less than a functional amount of the optional ingredient, typically less than 0.5% by weight solids of such optional ingredient based on the total weight of the nutritional composition, including less than 0.1% and also including zero, by weight solids of such optional ingredient based on the total weight of the nutritional composition.
  • Tables 2 and 3 Exemplary formulations of liquid nutritional compositions in accordance with embodiments disclosed herein are provided below in Tables 2 and 3. All ingredient amounts listed in Tables 2 and 3 are listed as kilogram per 1000 kg batch of product, unless otherwise indicated.
  • Table 2 shows an exemplary formulation of a decaffeinated emulsion-type liquid nutritional composition containing fat, protein, and carbohydrates and has a pH in the range of 6.6-7. Assuming a density of 1.075 g/mL and a serving size of about 237 mL (about 8 fl. oz.), a nutritional composition made according to the formulation shown in Table 2 has about 177 mg of EGCg per serving.
  • Table 3 shows an exemplary formulation of a decaffeinated clear-type liquid nutritional composition that is substantially free of fat and has a pH in the range of 3-3.5. Assuming a density of 1.05 g/mL and a serving size of about 296 mL (about 10 fl. oz.), a nutritional composition made according to the formulation shown in Table 3 has about 188 mg of EGCg per serving.
  • Antifoam processing aid non-silicone 0.060
  • 1 SUNPHENON® 90D which is a decaffeinated green tea extract that contains approximately 50% by weight of EGCg, i.e., 1.212 kg of green tea extract contains approximately 0.606 kg EGCg.
  • Vitamin premix includes one or more of the following: dl-Alpha-Tocopheryl Acetate, Vitamin A Palmitate, Phylloquinone, Vitamin D3, Niacinamide, d-Calcium Pantothenate, Thiamine Chloride Hydrochloride, Pyridoxine Hydrochloride, Riboflavin, Folic Acid, Biotin, Cyanocobalamin, etc.
  • the various embodiments of the nutritional composition disclosed herein may be prepared by any process or suitable method (now known or known in the future) for making the selected product form, such as a liquid or semi-liquid nutritional composition.
  • a suitable manufacturing process for preparing the emulsion-type liquid nutritional compositions ⁇ e.g., such as the composition listed in Table 2 above), for example, at least three separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate- mineral (CHO-MIN) slurry, and a protein-in-water (PIW) slurry.
  • PPF protein-in-fat
  • CHO-MIN carbohydrate- mineral
  • PIW protein-in-water
  • the PIF slurry is formed by heating and mixing an oil ⁇ e.g., soy oil, canola oil, corn oil, etc) and then adding an emulsifier ⁇ e.g., lecithin), fat soluble vitamins, and a portion of the total protein ⁇ e.g., milk protein concentrate, etc.) with continued heat and agitation.
  • the CHO-MIN slurry is formed by adding with heated agitation to water: minerals ⁇ e.g., potassium citrate, dipotassium phosphate, sodium citrate, etc), including trace and ultra trace minerals (TM/UTM premix), and thickening or viscosity agents ⁇ e.g., cellulose gel, gellan, carrageenan).
  • 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 the carbohydrates ⁇ e.g., sucrose, corn syrup, etc.).
  • additional minerals e.g., potassium chloride, magnesium carbonate, potassium iodide, etc
  • the carbohydrates e.g., sucrose, corn syrup, etc.
  • the three slurries are blended together with heat and agitation and the pH is adjusted to the desired range, e.g., from 6.6 to 7, after which the composition is subjected to high-temperature short-time (“HTST") processing.
  • the composition is heat treated, emulsified, homogenized, and cooled during HTST.
  • Water soluble vitamins and ascorbic acid are added (if applicable), the pH is again adjusted (if necessary), flavors are added and any additional water can be added to adjust the solids content to the desired range.
  • the decaffeinated green tea extract is prepared as a solution ⁇ e.g., 1% w/w) by adding to water and agitating for 0-24 hours.
  • the solution of decaffeinated green tea extract is added to the composition containing the other ingredients and is agitated for a period of time, e.g., 5-60 minutes, to ensure homogeneous distribution of the green tea extract in the composition.
  • the agitation associated with the preparation of the solution containing the decaffeinated green tea extract, as well as the agitation associated with the addition of such decaffeinated green tea extract solution to the other ingredients, may take place at 4° C to 50° C.
  • the liquid nutritional composition may optionally be packaged and sterilized according to any suitable sterilization technique ⁇ e.g. , aseptic, retort, hot- fill, chemical, radiation, and filtering sterilization techniques).
  • the decaffeinated green tea extract solution is then added to the kettle containing the other ingredients and is agitated for a period of time, e.g., 5-60 minutes, to ensure homogeneous distribution of the decaffeinated green tea extract in the composition.
  • the agitation associated with the preparation of the solution containing the decaffeinated green tea extract, as well as the agitation associated with the addition of such decaffeinated green tea extract solution to the other ingredients may take place at 4° C to 50° C.
  • the liquid nutritional composition may optionally be packaged and sterilized according to any suitable sterilization technique (e.g. , aseptic, retort, hot- fill, chemical, radiation, and filtering sterilization techniques).
  • the methods disclosed herein maintain or increase bodyweight of a subject.
  • bodyweight refers to the mass of the subject (e.g., measured in pounds, kilograms, etc.).
  • the bodyweight of the subject does not decrease, but instead is maintained (e.g., stays the same) or increases.
  • the maintenance or increase in the bodyweight may occur with varying corresponding body compositional profiles.
  • adipose tissue mass which also may be referred to as body fat
  • lean muscle mass profiles may vary, as long as the overall bodyweight stays the same (i.e., is maintained) or increases.
  • the methods disclosed herein result in maintaining or increasing the bodyweight of the subject by maintaining or increasing at least the lean muscle mass of the subject.
  • Those skilled in the art would understand how to measure the bodyweight of the subject.
  • Those skilled in the art would also understand how to measure the amount of lean muscle mass, the amount of adipose tissue, and the relative amounts thereof in the subject.
  • the decaffeination of the green tea extract has provided an unexpected effect of the green tea extract, which primarily contains EGCg (e.g., as discussed above, greater than 30% by weight solids EGCg based on the total weight of the green tea extract), in maintaining or increasing bodyweight of a subject.
  • Caffeinated green tea extract has been often shown to contribute to decreased bodyweight in subjects due to synergy between caffeine and EGCg in reducing adipose tissue (body fat).
  • the decaffeinated green tea extract disclosed herein when used in accordance with the methods disclosed herein, in contrast to that of a caffeinated green tea extract, either maintains or increases the bodyweight of the subject.
  • the methods disclosed herein maintain or increase bodyweight of a subject without a concomitant increase in food intake by the subject.
  • the subject maintains or increases his or her bodyweight without simultaneously increasing his or her food intake on top of, or in addition to, the administration of the decaffeinated green tea extract according to the methods disclosed herein.
  • food intake refers to the weight (mass) of food consumed by the subject.
  • the subject can maintain or increase his or her bodyweight without adjusting the total amount of food (by weight) consumed in addition to the administration of the decaffeinated green tea extract as disclosed herein.
  • the increase in bodyweight (see Figure 1) from the administration of decaffeinated green tea extract was associated with the decreased expression of intramuscular 19S protein (of the ubiquitin proteasome pathway involving muscle protein degradation) and myostatin (a negative regulator of muscle anabolism) in aged rats fed with a diet containing decaffeinated green tea extract.
  • the decrease in expression of the intramuscular 19S protein and myostatin indicates that the decaffeinated green tea extract has a protective effect on muscle tissue and body composition. Furthermore, as shown in the Examples the administration of the decaffeinated green tea extract to aged rats resulted in increased bodyweight of the rats without increasing the food intake (by weight), (see Figure 2).
  • the methods disclosed herein maintain or increase bodyweight of a subject without a concomitant increase in physical exercise by the subject.
  • physical exercise refers to any physical activity that results in strengthening, building, or maintaining lean muscle mass in the subject.
  • the subject is not always capable or willing to exercise.
  • the subject maintains or increases his or her bodyweight without undergoing or enduring an increase in the amount of physical activity that would otherwise strengthen, build, or maintain lean muscle in the subject.
  • SUNPHENON® 90D containing 50% EGCg was dissolved in water (100 mg/mL).
  • This decaffeinated green tea extract solution was added to AIN-93M diet as a liquid in a manner so as to result in 400 mg/kg by weight of the total diet of decaffeinated green tea extract for diet B, i.e., 100 ml of the above solution was added per kg diet, which provides an equivalent of 10 g decaffeinated green tea extract per kg of diet to deliver a dose of 400 mg/kg by weight of the total diet of decaffeinated green tea extract per day.
  • the amount of EGCg present in the aforementioned decaffeinated green tea extract solution used to prepare the diet was measured to be 5 g/lOOg of solution.
  • the amount of ECg present in the aforementioned decaffeinated green tea extract solution used to prepare the diet was measured to be 0.86 g/lOOg of solution.
  • the change in the control group was not normally distributed where, on average, the bodyweights of the rats decreased 6.75 g (with a median: increase of 7.5 g).
  • the decaffeinated green tea extract group gained in bodyweight on average of 40.5 g and showed significantly (P ⁇ 0.05) greater weight gain over the course of the 8 weeks than the control group (diet A).
  • Figure 2 shows the weekly food intake of the Sprague Dawley rats over the 8 week period.
  • the total food intake was not significantly different between groups, i.e., 1241 and 1326 grams for the control (diet A) and the decaffeinated green tea extract (diet B) groups, respectively.
  • consumption was less in the control group as compared to the decaffeinated green tea extract group, however, cumulatively, there was no significant difference in food intake between the two groups over the 8 week period.
  • Table 4 The values shown in Table 4 represent the 19S and myostatin expression in skeletal muscle of the rats, as measured by western blotting with GAPDH loading normalization (arbitrary units), at the conclusion of the 8 week treatment. As shown in Table 4, the expression of the 19S and myostatin were lower in the decaffeinated green tea extract treatment group (diet B) as compared to the control group (diet A).
  • the improved energy utilization and compartmentalization in addition or as an alternative to, an improvement in nutrient use, is particularly evident in the context of increased bodyweight in the rats (shown in Figure 1) that were administered the decaffeinated green tea extract as compared to the control, while all of the rats (i.e., those fed the control and decaffeinated green tea extract treatments) consumed approximately the same amount of nutrients (i.e. , there is no significant difference in diet/food intake by the rats shown in Figure 2).

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Abstract

L'invention concerne des méthodes pour maintenir ou augmenter le poids corporel chez un sujet susceptible de présenter un amaigrissement involontaire. Les méthodes comprennent une étape d'administration d'au moins une portion par jour d'une composition comprenant de 20 à 2000 mg d'un extrait de thé vert décaféiné par portion au sujet.
PCT/US2014/069092 2013-12-18 2014-12-08 Méthodes pour maintenir ou augmenter le poids corporel à l'aide d'extrait de thé vert décaféiné Ceased WO2015094767A1 (fr)

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WO2016044272A1 (fr) * 2014-09-16 2016-03-24 Abbott Laboratories Procédés de conservation de la force musculaire au cours d'une période d'inactivité musculaire par administration de bêta-hydroxy-bêta-méthylbutyrate et d'un extrait de thé vert
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