WO2016044167A1 - Procédés d'accroissement de la force musculaire et de la mobilité chez des sujets subissant une inactivité physique significative à l'aide d'acide gamma-linolénique - Google Patents

Procédés d'accroissement de la force musculaire et de la mobilité chez des sujets subissant une inactivité physique significative à l'aide d'acide gamma-linolénique Download PDF

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Publication number
WO2016044167A1
WO2016044167A1 PCT/US2015/049990 US2015049990W WO2016044167A1 WO 2016044167 A1 WO2016044167 A1 WO 2016044167A1 US 2015049990 W US2015049990 W US 2015049990W WO 2016044167 A1 WO2016044167 A1 WO 2016044167A1
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Prior art keywords
oil
subject
protein
mobility
linolenic acid
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PCT/US2015/049990
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English (en)
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Suzette Pereira
Neile Edens
Stephen Demichele
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Abbott Laboratories
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Publication of WO2016044167A1 publication Critical patent/WO2016044167A1/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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

Definitions

  • the present disclosure relates to methods for increasing muscle strength and mobility in a subject experiencing significant physical inactivity by administering nutritional compositions containing gamma linolenic acid to the subject.
  • the methods include
  • a nutritional composition comprising at least one of protein and carbohydrate in addition to the fat.
  • Administration of the nutritional composition to the subject increases muscle strength and mobility of the subject by increasing levels of peroxisome proliferator- activated receptor ⁇ coactivator- ⁇ (PGC-l ) in muscle of the subject.
  • the disclosure provides a method of increasing muscle strength and mobility in an elderly individual.
  • the method includes administering 500 mg to 5 gm of gamma linolenic acid to the elderly individual per day as part of a nutritional composition comprising at least one of protein and carbohydrate in addition to fat.
  • the methods of the present disclosure involve administering
  • compositions containing gamma linolenic acid to an inactive individual to improve muscle strength and mobility in the individual.
  • the "nutritional composition” is suitable for enteral administration to a subject.
  • inactivity refers to infrequent movement of the limbs or body. “Inactivity” can result from hospitalization, restriction of movement by others, self-imposed restriction, mental or physical disease, or other condition. "Significant” inactivity as used herein, unless otherwise specified, refers to a period of inactivity of two or more days.
  • subject and “individual” as used herein, unless otherwise specified, refers to a mammal, including, but not limited to, a human (e.g., a toddler, child, or an adult), a domesticated farm animal (e.g., a cow, horse, or pig), or a pet (e.g., a dog or cat).
  • a human e.g., a toddler, child, or an adult
  • a domesticated farm animal e.g., a cow, horse, or pig
  • a pet e.g., a dog or cat
  • yielderly refers to a subject or individual at or above an age that is associated with frequent inactivity.
  • the various embodiments of the nutritional compositions used in the methods of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining composition still contains all of the required ingredients or features as described herein.
  • the term "substantially free” means that the selected 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 compositions and methods 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 composition applications.
  • the nutritional compositions including gamma linolenic acid which are useful in the methods of the present disclosure, may be formulated in any known or otherwise suitable product form for enteral administration, including oral administration.
  • Oral product forms are generally preferred and include any solid, liquid, or powder formulation suitable for use herein, provided that such a formulation allows for safe and effective oral delivery of the essential and other selected ingredients from the selected product form.
  • Non-limiting examples of solid nutritional composition forms suitable for use in the methods herein include snack and meal replacement products, including those formulated as bars; sticks; cookies, breads, cakes, or other baked goods; frozen liquids; candy; breakfast cereals; powders, granulated solids, or other particulates; snack chips or bites; frozen or retorted entrees; and so forth.
  • liquid product forms suitable for use herein 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, enteral feeding compositions, and so forth.
  • compositions are most typically formulated as suspensions or emulsions, but can also be formulated in any other suitable forms such as clear liquids, substantially clear liquids, solutions, liquid gels, and so forth.
  • suitable oral product forms include semi-solid or semi-liquid compositions (e.g., puddings, gels), as well as more
  • the quantity of the nutritional composition for providing an effective amount of gamma linolenic acid to the targeted user may be contained in one or a plurality of individual dosage forms that may be administered in single or multiple dosages per day, per week, per month, or over another periodic basis determined to be appropriate for the individual.
  • the nutritional compositions may be administered as a sole (4-6 servings or 1-1.5 liters per day), primary, or supplemental (1-2 servings per day) source of nutrition.
  • the nutritional compositions include a protein source.
  • the protein source can be any protein source known in the art that can be used in a nutritional composition as disclosed herein.
  • Exemplary, non-limiting protein sources include whey protein concentrates, whey protein isolates, whey protein hydrolysates, acid caseins, sodium casemates, calcium casemates, potassium casemates, casein
  • 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, fungal proteins, insect proteins, algal proteins, and proteins expressed by microorganisms.
  • the nutritional compositions include one or more essential amino acids (i.e., isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine) provided as free amino acids.
  • essential amino acids i.e., isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine
  • freeform essential amino acids which may be included in the nutritional compositions include L-leucine, L-valine, L-isoleucine, and L-tryptophan.
  • the nutritional compositions include a carbohydrate.
  • the carbohydrate can include any carbohydrate known in the art that can be used in a nutritional composition as disclosed herein.
  • Exemplary, non-limiting carbohydrates 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, maltitol, erythritol, sorbitol, glycerine, sucrose, glucose, fructose, lactose, isomaltulose, sucromalt, pullulan, potato starch, and other slowly- digested carbohydrates, oligosaccharides including fructo-oligosaccharides, 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 acacia, chitosan, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low
  • the nutritional compositions include a fat.
  • the fat can include any fat known in the art that can be used in a nutritional composition as disclosed herein.
  • Exemplary, non-limiting fats include borage oil, coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, medium chain triglyceride oil, high gamma linolenic acid safflower oil, sunflower oil, high oleic sunflower oil, palm oil, palm kernel oil, palm olein, canola oil, marine oils, algal oils, cottonseed oils, evening primrose oil, interesterified oils, and transesterified oils.
  • the fat includes an oil which is enriched in gamma linolenic acid.
  • Oils enriched in gamma linolenic acid include those oils with at least 20%, including at least 30%, and including at least 40% gamma linolenic acid, by weight of the oil.
  • Exemplary, non-limiting oils enriched in gamma linolenic acid suitable for use in the nutritional compositions disclosed herein include borage oil, and high gamma linolenic acid safflower oil.
  • Gamma linolenic acid for use as described herein can also be obtained from plants or cells genetically engineered to produce oils enriched in gamma linolenic acid.
  • the nutritional compositions containing gamma linolenic acid and macronutrients may also contain other optional ingredients that may modify the physical, nutritional, chemical, hedonic, or processing characteristics of the products or serve as pharmaceutical or additional nutritional components when used in a targeted population.
  • optional ingredients are known or otherwise suitable for use in nutritional compositions and may be used in the nutritional compositions 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.
  • preservatives antioxidants, emulsifying agents, buffers, fructooligosaccharides, pharmaceutical actives, additional nutrients as described herein, colorants, flavors, thickening agents and stabilizers, and so forth.
  • the nutritional compositions 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 nutritional compositions may further comprise additional minerals, non-limiting examples of which include phosphorus, magnesium, calcium, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
  • the nutritional compositions may also include one or more other compounds which contribute to muscle health.
  • the nutritional compositions include one or more of beta-hydroxy-beta-methylbutyrate (HMB), metabolites of leucine (alpha-ketoisocaproic acid, HICA), docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), green tea polyphenols, curcumin, and polyphenols from cocoa and fruit extracts.
  • HMB beta-hydroxy-beta-methylbutyrate
  • HICA metabolites of leucine
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • green tea polyphenols curcumin
  • curcumin polyphenols from cocoa and fruit extracts.
  • the nutritional compositions may be manufactured by any known or otherwise suitable method for making nutritional compositions, including nutritional liquids such as emulsions.
  • a nutritional liquid is prepared using at least three separate slurries, including a protein-in-fat (PIF) slurry, a
  • the PIF slurry is formed by heating and mixing the selected oils (e.g. , canola oil, corn oil, and fish oil) and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein (e.g. , milk protein concentrate) with continued heat and agitation.
  • oils e.g. , canola oil, corn oil, and fish oil
  • an emulsifier e.g., lecithin
  • fat soluble vitamins e.g., lecithin
  • a portion of the total protein e.g., milk protein concentrate
  • the CHO-MIN slurry is formed by adding, with heated agitation, to water: minerals (e.g., potassium citrate, dipotassium phosphate, and sodium citrate), trace and ultra trace minerals (TM/UTM premix), and thickening or suspending agents (e.g., Avicel, gellan, and carrageenan).
  • minerals e.g., potassium citrate, dipotassium phosphate, and sodium citrate
  • trace and ultra trace minerals TM/UTM premix
  • thickening or suspending agents e.g., Avicel, gellan, and carrageenan
  • the PIW slurry is then formed by mixing remaining protein (e.g., sodium caseinate and soy protein concentrate) with heat and agitation into water.
  • remaining protein e.g., sodium caseinate and soy protein concentrate
  • 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, flavors 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 emulsion, or the composition is added to retort stable containers and then subjected to retort sterilization to form retort sterilized nutritional emulsions.
  • the nutritional solid such as a spray dried nutritional powder or dry- mixed nutritional powder, may be prepared by any collection of known or otherwise effective techniques, suitable for making and formulating a nutritional powder.
  • the spray drying step may likewise include any spray drying technique that is known for or otherwise suitable for use in the production of nutritional powders. Many different spray drying methods and techniques are known for use in the nutrition field, all of which are suitable for use in the manufacture of the spray dried nutritional powders herein.
  • One method of preparing the spray dried nutritional powder comprises forming and homogenizing an aqueous slurry or liquid comprising fat containing gamma linolenic acid, protein, and carbohydrate, and then spray drying the slurry or liquid to produce a spray dried nutritional powder.
  • the method may further comprise the step of spray drying, dry mixing, or otherwise adding additional nutritional ingredients, including any one or more of the ingredients described herein, to the spray dried nutritional powder.
  • the nutritional compositions including gamma linolenic acid are administered orally to an individual as needed to improve muscle strength and mobility.
  • the compositions can be administered to any individual who could benefit from improved muscle strength and mobility.
  • Such individuals include any individual undergoing a significant period of inactivity.
  • the individuals can be healthy or already suffer from one or more diseases or conditions such as sarcopenia, diabetes, insulin resistance, and obesity.
  • Other individuals who can benefit from the use of the compositions and methods disclosed herein include, without limitation, individuals who have experienced or are currently experiencing sickness, injury, bed rest and/or immobilization, surgery, recovery and/or rehabilitation, stress induced muscle wasting, catabolic conditions such as cancer, chronic obstructive pulmonary disease (COPD), and end-stage renal disease (ESRD).
  • COPD chronic obstructive pulmonary disease
  • ESRD end-stage renal disease
  • the individuals can be of any age group, in some embodiments, the methods are used with elderly individuals and other groups of individuals who may be at an increased risk of developing disease from inactivity.
  • Such increased risk may arise not only due to age, but also, e.g., due to genetic or environmental predispositions that lead to greater susceptibility to disease from inactivity.
  • individuals with increased risk due to a genetic predisposition will include individuals with genetic mutations in genes associated with muscle health, including PGC-l and MafBx, as disclosed herein, and/or with mutations in genes which regulate the expression of genes associated with muscle health.
  • individuals to be benefited from the methods disclosed herein are those who are specifically "in need of increased muscle strength, mobility, or both. Such individuals will include those individuals with elevated risks of a disease or condition from inactivity as well as those individuals currently manifesting a disease or condition resulting from inactivity.
  • compositions containing gamma linolenic acid modulates the expression of genes whose expression is associated with muscle health. Specifically, supplementation of the diet with gamma linolenic acid increases the expression of PGC-l , and decreases the expression of MafBx. As PGC-l expression is correlated with improved muscle strength and mobility, and MafBx expression is correlated with increased muscle breakdown (proteolysis), consumption of gamma linolenic acid is expected to increase muscle strength and mobility by increasing the level of PGC-la , decreasing the level of MafBx, or both. Furthermore, low levels of PGC-la expression are correlated with insulin resistance and the development of diabetes. Thus, in some embodiments, by increasing the level of PGC-la, improved insulin sensitivity is also expected.
  • the above-described benefits can be obtained by administering about 100 mg to about 5 gm of gamma linolenic acid to a subject per day. Dosing ranges at the higher or lower ends of the spectrum can be used, based on the age and size of the subject. For example, for human adults and elderly humans a dose of about 500 mg to about 5 gm of gamma linolenic acid per day is preferred. Other exemplary doses include 100 mg to 500 mg per day, 500 mg to 1 gm per day, and 2 gm to 5 gm per day.
  • the desired dosing can be achieved by orally administering a nutritional composition containing any amount of gamma linolenic acid that results in the recipient receiving a dose within the desired range.
  • a desired dosage of gamma linolenic acid in an individual can be achieved by varying the quantity of the administered nutritional composition and the frequency at which the nutritional composition is administered to the individual.
  • the administration regimen to achieve a desired dosage of gamma linolenic acid for a particular individual is determined by identifying an administration regimen which is sufficient to keep the level of PGC-la in a biological sample taken from the individual after extended ⁇ e.g., 2, 3, 4, 5, 6, 7, or more days) inactivity at or above the level of PGC-la in a biological sample taken from the individual prior to beginning inactivity.
  • the level of PGC- ⁇ in the individual prior to and after inactivity can be determined by methods known in the art, e.g., by measuring gene or protein expression levels.
  • the administration regimen to achieve a desired dosage of gamma linolenic acid for a particular individual can be determined by identifying an administration regimen which is sufficient to keep the level of MafBx in a biological sample taken from the individual after extended ⁇ e.g., 2, 3, 4, 5, 6, 7, or more days) inactivity at or below the level of MafBx in a biological sample taken from the individual prior to beginning inactivity.
  • the level of MafBx in the individual prior to and after inactivity can be determined by methods known in the art, e.g., by measuring gene or protein expression levels.
  • Biological samples used can include any biological samples from which PGC- ⁇ and/or MafBx expression can be measured, including bodily fluids and tissues. In some embodiments, the biological samples are samples of muscle tissue.
  • An administration regimen can be continued for any period of time necessary to overcome or lessen the effects of inactivity on the individual's muscle strength and mobility. This can include administration for a period of days, weeks, months, or years and may depend on the extent and period of inactivity as well as other factors including the individual's susceptibility to muscle weakness or immobility as a result of the inactivity.
  • the administration regimen can be continued for any amount of time during and after the period of inactivity occurs. In some embodiments, e.g., where the individual is an elderly individual, administration may begin in anticipation of an ensuing period of inactivity.
  • Example 1 Gamma linolenic acid (GLA) supplementation regulates the expression of PGC-la and MafBx in rats.
  • GLA Gamma linolenic acid
  • a chronic feeding study (8 week) was carried out in aged (20 month) Sprague Dawley rats. Rats (n 10/group) were fed a control diet (modified AIN-93M containing 10% fat from soybean oil; Composition: 12.4% protein, 62.4% carbohydrate, and 10% fat) or a test diet (a modified AIN93M diet which was the same as the control diet except that the source of fat was from a GLA oil blend where the GLA oil blend contained 47% GLA-safflower oil, 27% soybean oil, and 26% safflower oil). The final dose of GLA delivered to the animals was equivalent to 1 gm GLA/kg of bodyweight/day.
  • PGC-l Peroxisome proliferator-activated receptor ⁇ coactivator- ⁇
  • RT-PCR reverse-transcriptase polymerase chain reaction
  • Mafbx protein expression was determined by western blot analysis of protein from the muscle tissue. Rats on the test diet exhibited about a 30% decrease in Mafbx protein expression (expressed 0.7 times the amount of Mafbx protein) relative to rats on the control diet (p-value of 0.10).
  • GLA-supplementation of diet both increases the expression of genes whose expression is beneficial to muscle health and decreases the expression of genes whose expression negatively affects muscle health.
  • genes like PGC- ⁇
  • administration of nutritional compositions containing GLA to an individual is expected to lead to preventing progression of muscle atrophy during aging, maintaining neuromuscular junction (NMJ) integrity, and preventing development of diabetes with age in the individual.
  • NMJ neuromuscular junction
  • administration of nutritional compositions containing GLA to an individual is expected to lead to downregulation of muscle protein degradation that increases during catabolic conditions (e.g., during inactivity) and which can cause muscle atrophy in the individual.

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Abstract

L'invention concerne des procédés d'accroissement de la force musculaire et de la mobilité chez un sujet subissant une inactivité physique significative, ledits procédés comprenant l'administration d'acide gamma-linolénique au sujet en tant que partie d'une composition nutritionnelle contenant de la matière grasse et au moins une protéine et un hydrate de carbone. L'administration de la composition nutritionnelle au sujet accroît la force musculaire et la mobilité du sujet en augmentant les taux de récepteur gamma activé par les proliférateurs des peroxysomes coactivateur-1 alpha (PGC-1 alpha) dans les muscles du sujet.
PCT/US2015/049990 2014-09-15 2015-09-14 Procédés d'accroissement de la force musculaire et de la mobilité chez des sujets subissant une inactivité physique significative à l'aide d'acide gamma-linolénique WO2016044167A1 (fr)

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WO2017202939A1 (fr) * 2016-05-27 2017-11-30 Nestec S.A. Composition nutritionnelle pour le traitement ou la prévention de la diminution de la mobilité
CN107621399A (zh) * 2016-07-14 2018-01-23 北京三元食品股份有限公司 一种检测母乳中低聚糖的方法
WO2019223819A1 (fr) * 2018-05-25 2019-11-28 Kratochvil Roman Composition nutritionnelle

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Cited By (8)

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Publication number Priority date Publication date Assignee Title
WO2017202939A1 (fr) * 2016-05-27 2017-11-30 Nestec S.A. Composition nutritionnelle pour le traitement ou la prévention de la diminution de la mobilité
CN109152749A (zh) * 2016-05-27 2019-01-04 雀巢产品技术援助有限公司 用于治疗或预防移动性受损的营养组合物
JP2019518744A (ja) * 2016-05-27 2019-07-04 ネステク ソシエテ アノニム 運動障害を治療又は予防するための栄養組成物
US11123407B2 (en) 2016-05-27 2021-09-21 Societe Des Produits Nestle S.A. Nutritional composition for treating or preventing impaired mobility
AU2017270131B2 (en) * 2016-05-27 2023-03-09 Société des Produits Nestlé S.A. Nutritional composition for treating or preventing impaired mobility
CN107621399A (zh) * 2016-07-14 2018-01-23 北京三元食品股份有限公司 一种检测母乳中低聚糖的方法
CN107621399B (zh) * 2016-07-14 2021-04-27 北京三元食品股份有限公司 一种检测母乳中低聚糖的方法
WO2019223819A1 (fr) * 2018-05-25 2019-11-28 Kratochvil Roman Composition nutritionnelle

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