WO2025258565A1 - Composition destinée à être administrée par voie orale - Google Patents

Composition destinée à être administrée par voie orale

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Publication number
WO2025258565A1
WO2025258565A1 PCT/JP2025/020861 JP2025020861W WO2025258565A1 WO 2025258565 A1 WO2025258565 A1 WO 2025258565A1 JP 2025020861 W JP2025020861 W JP 2025020861W WO 2025258565 A1 WO2025258565 A1 WO 2025258565A1
Authority
WO
WIPO (PCT)
Prior art keywords
water
oral composition
dietary fiber
soluble dietary
bifidobacteria
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2025/020861
Other languages
English (en)
Japanese (ja)
Inventor
悠平 馬場
直樹 東
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ezaki Glico Co Ltd
Original Assignee
Ezaki Glico Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ezaki Glico Co Ltd filed Critical Ezaki Glico Co Ltd
Publication of WO2025258565A1 publication Critical patent/WO2025258565A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • 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
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • C12Q1/689—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria

Definitions

  • the present invention relates to an oral composition that can improve basal metabolic rate.
  • the amount of energy consumed by a person in a day consists of basal metabolic rate (REE, resting energy expenditure), physical activity, and diet-induced thermogenesis, of which basal metabolic rate accounts for approximately 60%. Therefore, in order to efficiently increase energy expenditure, it is desirable to increase basal metabolic rate.
  • basal metabolic rate resting energy expenditure
  • physical activity physical activity
  • diet-induced thermogenesis of which basal metabolic rate accounts for approximately 60%. Therefore, in order to efficiently increase energy expenditure, it is desirable to increase basal metabolic rate.
  • a low basal metabolic rate makes people more susceptible to obesity and can be a factor in triggering lifestyle-related diseases.
  • Patent Document 1 discloses that basal metabolic rate improved when mice were given Bifidobacterium breve.
  • Patent Document 2 discloses that basal metabolism can be increased by continuously ingesting lactic acid bacteria that increase TLR2 activity by a certain amount.
  • the present invention therefore aims to provide an oral composition that can improve basal metabolic rate.
  • Item 1 An oral composition comprising bifidobacteria and water-soluble dietary fiber, wherein the intake or administration amount of the water-soluble dietary fiber is set to 4.5 g or more per day.
  • Item 2. An oral composition containing bifidobacteria and water-soluble dietary fiber, which is used to improve basal metabolic rate.
  • Item 3. An oral composition for improving basal metabolic rate, which contains bifidobacteria and is to be ingested or administered in combination with water-soluble dietary fiber.
  • Item 4. An oral composition for improving basal metabolic rate, which contains water-soluble dietary fiber and is to be ingested or administered in combination with bifidobacteria.
  • Item 6. The oral composition according to any one of Items 1 to 5, wherein the amount of water-soluble dietary fiber is 4.5 g or more per 1.0 x 10 10 cfu of the bifidobacteria.
  • Item 7. The oral composition according to any one of Items 1 to 6, wherein the water-soluble dietary fiber is inulin.
  • Item 8 The oral composition according to any one of Items 1 to 7, wherein the bifidobacterium is Bifidobacterium lactis.
  • the water-soluble dietary fiber is divided into a single dose in a container, Item 3.
  • the oral composition according to Item 1 or 2 wherein the water-soluble dietary fiber is ingested or administered n times per day (n is an integer), and the bifidobacteria and (4.5/n) g or more of the water-soluble dietary fiber are contained in the container.
  • n is an integer
  • bifidobacteria and (4.5/n) g or more of the water-soluble dietary fiber are contained in the container.
  • a kit comprising an oral composition containing bifidobacteria and a water-soluble dietary fiber as separately provided,
  • the water-soluble dietary fiber is divided into single-dose portions in a container,
  • the kit comprises a container containing at least (4.5/n) g of the water-soluble dietary fiber, the container containing the water-soluble dietary fiber being ingested or administered n times per day (n is an integer).
  • a kit comprising an oral composition containing water-soluble dietary fiber and the attached bifidobacteria, the oral composition is divided into containers each containing a single dose of the water-soluble dietary fiber;
  • the kit comprises a container containing at least (4.5/n) g of the water-soluble dietary fiber, the container containing the water-soluble dietary fiber being ingested or administered n times per day (n is an integer).
  • Item 13 Use of a combination of bifidobacteria and a water-soluble food for producing an oral composition for improving basal metabolic rate.
  • Item 14 Use of bifidobacteria for producing an oral composition for improving basal metabolic rate, to be ingested or administered in combination with water-soluble dietary fiber.
  • Item 19 Use of a combination of bifidobacteria and water-soluble dietary fiber for the treatment of diseases associated with low basal metabolic rate.
  • Item 20 Use of bifidobacteria in the treatment of diseases associated with low basal metabolic rate by administering the bacteria in combination with water-soluble dietary fiber.
  • Item 21 Use of water-soluble dietary fiber for the treatment of diseases associated with low basal metabolic rate by administering it in combination with bifidobacteria.
  • Item 22 The use according to any one of Items 13 to 21, wherein the intake or administration amount of the water-soluble dietary fiber is set to 4.5 g or more per day.
  • Item 23 The use according to any one of Items 13 to 22, wherein the amount of water-soluble dietary fiber used is 4.5 g or more per 1.0 ⁇ 10 10 cfu of bifidobacteria used.
  • Item 24 The use according to any one of Items 13 to 22, wherein the amount of water-soluble dietary fiber used is 4.5 g or more per 1.0 ⁇ 10 10 cfu of bifidobacteria used.
  • basal metabolic rate can be improved by combining bifidobacteria with water-soluble dietary fiber.
  • the oral composition of the present invention is characterized by being configured to be ingested or administered in combination with bifidobacteria and water-soluble dietary fiber.
  • the oral composition of the present invention includes oral compositions according to first to fourth embodiments.
  • the first embodiment of the oral composition of the present invention contains bifidobacteria and water-soluble dietary fiber, and the intake or administration amount of the water-soluble dietary fiber is set to 4.5 g or more per day.
  • the second embodiment of the oral composition of the present invention contains bifidobacteria and water-soluble dietary fiber and is used to improve basal metabolic rate.
  • the third embodiment of the oral composition of the present invention is intended for improving basal metabolic rate, contains bifidobacteria, and is intended for ingestion or administration in combination with water-soluble dietary fiber.
  • the fourth embodiment of the oral composition of the present invention is intended for improving basal metabolic rate, contains water-soluble dietary fiber, and is intended for ingestion or administration in combination with bifidobacteria.
  • the oral compositions according to the first to fourth embodiments are also collectively referred to as the oral compositions of the present invention. The oral compositions of the present invention are described in detail below.
  • Bifidobacteria are not particularly limited as long as they are bacteria belonging to the genus Bifidobacterium.
  • Specific examples of bifidobacteria include Bifidobacterium animalis (e.g., Bifidobacterium animalis subsp. Lactis, etc.), Bifidobacterium pseudocatenulatum, Bifidobacterium catenulatum (e.g., Bifidobacterium catenulatum subsp. Catenulatum, etc.), Bifidobacterium longum (e.g., Bifidobacterium longum subsp. Longum, Bifidobacterium longum subsp.
  • Bifidobacterium breve Bifidobacterium bifidum.
  • Bifidobacterium angulatum Bifidobacterium kashiwanohense
  • Bifidobacterium dentium Bifidobacterium faecale
  • Bifidobacterium adolescentis Bifidobacterium adolescentis
  • one of these bifidobacteria may be used alone, or two or more may be used in combination.
  • Bifidobacterium animalis is preferred, Bifidobacterium animalis subsp. lactis is more preferred, and Bifidobacterium animalis subsp. lactis GCL2505 (FERM P-21918) is particularly preferred.
  • live bifidobacteria are used.
  • the amount of bifidobacteria per 100 g of the oral composition of the present invention is not particularly limited, and may be, for example, 1.0 ⁇ 10 cfu/100 g or more, preferably 3.0 ⁇ 10 cfu/100 g or more, more preferably 5.0 ⁇ 10 cfu/100 g or more, even more preferably 8.0 ⁇ 10 cfu/100 g or more, and particularly preferably 1.0 ⁇ 10 cfu/100 g or more.
  • the upper limit of the bifidobacteria content is not particularly limited, and may be, for example, 1.0 ⁇ 10 cfu/100 g or less, 1.0 ⁇ 10 cfu/100 g or less, 1.0 ⁇ 10 cfu/100 g or less, or 1.0 ⁇ 10 cfu/100 g or less.
  • a more specific range for the content of bifidobacteria can be set by arbitrarily combining the above upper and lower limits, but is preferably 1.0 ⁇ 10 9 to 1.0 ⁇ 10 12 cfu/100g, more preferably 5.0 ⁇ 10 9 to 1.0 ⁇ 10 11 cfu/100g.
  • cfu stands for colony forming unit, and in this specification, the value is measured using MUP-added TOS propionic acid agar medium (ISO29981/IDF220TOS), which is a propionic acid agar medium adopted as an international standard medium and is made by adding 5% of an aqueous solution of mupirocin (1 mg/ml), in accordance with the "Guidelines for fermented milk and lactic acid bacteria drinks using bifidobacteria" issued by the National Fermented Milk and Lactic Acid Bacteria Drinks Association in March 2014.
  • MUP-added TOS propionic acid agar medium ISO29981/IDF220TOS
  • mupirocin 1 mg/ml
  • Water-soluble dietary fiber There are no particular limitations on the water-soluble dietary fiber, but any fiber that generally serves as a substrate for intestinal bacteria in the large intestine can be used. Specific examples of water-soluble dietary fiber include inulin, gums (thickening polysaccharides such as guar gum, locust bean gum, tara gum, carob gum, tamarind seed gum, and gum arabic), glucomannan, pectin, hemicellulose, lignin, alginic acid, polydextrose, resistant dextrin, resistant starch, fucoidan, pullulan, and psyllium.
  • gums thickening polysaccharides such as guar gum, locust bean gum, tara gum, carob gum, tamarind seed gum, and gum arabic
  • glucomannan glucomannan
  • pectin hemicellulose
  • lignin alginic acid
  • polydextrose resistant dextrin
  • resistant starch resistant dextrin
  • one of these water-soluble dietary fibers may be used alone, or two or more may be used in combination.
  • inulin is preferred.
  • the inulin may be straight-chain inulin or branched-chain inulin.
  • the origin of the inulin is also not particularly limited.
  • Inulin may be derived from, for example, chicory, agave, Jerusalem artichoke, onion, chive, garlic, burdock, sweet potato, banana, etc.
  • inulin When inulin is used as dietary fiber in the oral composition of the present invention, one of these inulins may be used alone, or two or more may be used in combination.
  • the inulin preferably contains straight-chain inulin, and inulin derived from chicory is more preferred.
  • the ratio of the content or amount of bifidobacteria to water-soluble dietary fiber used is not particularly limited, but for example, the amount of water-soluble dietary fiber per 1.0 x 10 cfu of bifidobacteria is 4.5 g or more, preferably 4.6 g or more, more preferably 4.7 g or more, even more preferably 4.8 g or more, and even more preferably 4.9 g or more.
  • the upper limit of the amount of water-soluble dietary fiber per 1.0 x 10 cfu of bifidobacteria is not particularly limited, but from the viewpoint of side effects such as abdominal discomfort caused by water-soluble dietary fiber, it is preferably 15 g or less, more preferably 10 g or less, even more preferably 8.0 g or less, even more preferably 6.0 g or less, and even more preferably 5.5 g or less.
  • a more specific range of the amount of water-soluble dietary fiber per 1.0 x 10 cfu of bifidobacteria can be set by arbitrarily combining the above-mentioned upper and lower limits, and may be, for example, 4.5 g to 15 g, preferably 4.6 to 10 g, more preferably 4.7 to 8.0 g, even more preferably 4.8 to 6.0 g, still more preferably 4.9 to 5.5 g, and most preferably 5.0 g.
  • water-soluble dietary fiber contained per 100 g of the oral composition of the present invention, but examples include 4.5 g to 15 g, preferably 4.6 to 10 g, more preferably 4.7 to 8.0 g, even more preferably 4.8 to 6.0 g, even more preferably 4.9 to 5.5 g, and most preferably 5.0 g.
  • the oral composition of the present invention may consist of bifidobacteria and/or water-soluble dietary fiber, and may further contain additives and/or bases depending on the formulation.
  • the additives and bases that may or may not be contained in the oral composition of the present invention are not particularly limited as long as they are pharmaceutically acceptable, and examples include excipients, binders, disintegrants, lubricants, isotonicity agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV protection agents, preservatives, flavoring agents, fragrances, powders, thickeners, pigments, and chelating agents.
  • these additives and/or bases may be used alone or in combination of two or more.
  • the content of these additives and bases is determined appropriately depending on the types of additives and bases used, the formulation form of the oral composition, and other factors.
  • the oral composition of the present invention when it is a food or beverage, it may further contain ingredients commonly used in food or beverage products in addition to bifidobacteria and/or water-soluble dietary fiber.
  • ingredients include milk, dairy products, seaweed, fish, meat, eggs, beans, bean products, vegetables, fruits, oils and fats, grains, sugar, etc.
  • the content of these ingredients is set appropriately depending on the type of ingredients used and the type of food or beverage.
  • the form of the oral composition of the present invention is not particularly limited as long as it can be orally ingested or administered, and examples thereof include solid preparations such as powders, fine granules, granules (including dry syrup), tablets, pills, capsules (soft capsules, hard capsules), etc.; semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, syrups, etc.
  • Product classifications of oral compositions include oral medicines, oral quasi-drugs, and foods and beverages.
  • the oral composition of the present invention when in the form of a food or drink, it may be in any form, such as liquid, paste, gel, solid, or powder, and specific forms include tablet confectionery; liquid food; wheat flour products such as bread, macaroni, spaghetti, noodles, cake mix, fried chicken flour, and breadcrumbs; instant noodles, cup noodles, retort/prepared foods, canned foods, microwaveable foods, instant soups/stews, instant miso soup/cleaning liquids, canned soups, freeze-dried foods, and other foods.
  • Instant foods and other instant foods include processed agricultural products such as canned agricultural products, canned fruit, jams and marmalades, pickles, boiled beans, dried agricultural products, and cereals (processed grain products); processed seafood products such as canned seafood, fish ham and sausages, fish paste products, seafood delicacies, and tsukudani (simmered fish dishes); processed livestock products such as canned livestock products and pastes, and livestock ham and sausages; processed milk, milk drinks, yogurt, lactic acid bacteria drinks, cheese, ice cream, infant formula, cream, and other milk products.
  • milk and dairy products fats and oils such as butter, margarine, vegetable oil; basic seasonings such as soy sauce, miso, sauces, processed tomato seasonings, mirin, vinegars, spices; specialized seasonings such as cooking mixes, curry roux, sauces, dressings, noodle soup, and other compound seasonings; frozen foods such as frozen ingredients, semi-cooked frozen foods, and cooked frozen foods; sweets such as caramel, candy, chewing gum, chocolate, cookies, biscuits, cakes, pies, snacks, crackers, Japanese sweets, rice crackers, bean snacks, dessert sweets, jelly, and other sweets; beverages such as carbonated drinks, natural fruit juice, fruit juice drinks, soft drinks with fruit juice, fruit pulp drinks, fruit drinks with fruit particles, vegetable drinks, soy milk, soy milk drinks, coffee drinks, tea drinks, powdered drinks, concentrated drinks, sports drinks, energy drinks, alcoholic drinks, and other beverages; other commercially available foods such as baby food, furikake, and ochazuke nori seaweed.
  • basic seasonings such
  • a preferred product category for foods and beverages is functional food.
  • Functional foods refer to foods that have a certain functionality for the living body, and examples include functional health foods such as foods for specified health uses (including conditional FOSHUs [foods for specified health uses]) and foods with nutrient functions, foods with functional claims, foods for special dietary uses, nutritional supplements, health supplements, supplements (in various dosage forms such as tablets, coated tablets, sugar-coated tablets, capsules, and liquids), and beauty foods (such as diet foods and beverages).
  • functional foods may be special-purpose foods and beverages such as foods and beverages for the sick, powdered milk for pregnant and nursing women, infant formula, foods and beverages for the elderly, and foods and beverages for caregivers.
  • the oral composition according to the first embodiment of the present invention may be divided into containers each containing a single dose of water-soluble dietary fiber.
  • n is an integer, for example, an integer from 1 to 3, an integer from 1 to 2, or 1
  • the oral composition may contain bifidobacteria and (4.5/n) g or more of water-soluble dietary fiber and be contained in a container.
  • the oral composition contained in the container according to this embodiment can be provided as a set of n pieces.
  • the oral composition according to the third embodiment may be, for example, in a form in which the oral composition containing bifidobacteria is accompanied by instructions to be taken or administered in combination with water-soluble dietary fiber as an intake or administration method for improving basal metabolic rate, or in a form in which the oral composition containing bifidobacteria is packaged as a kit together with separately provided water-soluble dietary fiber (the separate attachment may consist solely of water-soluble dietary fiber, or may contain water-soluble dietary fiber and the other components described above), and accompanied by instructions to be taken or administered in combination with water-soluble dietary fiber as an intake or administration method for improving basal metabolic rate.
  • the separately provided water-soluble dietary fiber may be individually divided into containers containing single doses of water-soluble dietary fiber.
  • n is an integer, for example, an integer from 1 to 3, an integer from 1 to 2, or 1
  • the separately provided water-soluble dietary fiber may be contained in a container in amounts of (4.5/n) g or more, and further, when n>1, the separately provided water-soluble dietary fiber contained in a container in this form can be provided as a set of n pieces.
  • the oral composition according to the fourth embodiment may be, for example, a form in which the oral composition containing water-soluble dietary fiber bacteria is accompanied by instructions to be taken or administered in combination with bifidobacteria as an intake or administration method for improving basal metabolic rate, or the oral composition containing water-soluble dietary fiber bacteria may be packaged as a kit together with separately attached bifidobacteria (the separately attached material may consist solely of bifidobacteria, or may contain bifidobacteria and the other components described above), and may be in a form in which the oral composition containing water-soluble dietary fiber bacteria is packaged as a kit together with instructions to be taken or administered in combination with bifidobacteria as an intake or administration method for improving basal metabolic rate.
  • the oral composition containing water-soluble dietary fiber bacteria may be packaged as a kit together with separately attached bifidobacteria (the separately attached material may consist solely of bifidobacteria, or may
  • the oral composition containing water-soluble dietary fiber bacteria may be divided into containers containing single doses of water-soluble dietary fiber.
  • n is an integer, for example, an integer from 1 to 3, an integer from 1 to 2, or 1
  • the oral composition may contain (4.5/n) g or more of water-soluble dietary fiber and be housed in a container; further, when n>1, n pieces of the oral composition housed in the container according to this form may be provided as a set.
  • the oral composition of the present invention can improve basal metabolic rate by taking or ingesting it. Therefore, the oral composition of the present invention can be used to improve basal metabolic rate.
  • the basal metabolic rate is specifically resting energy expenditure (REE) and is calculated using the formula (1) described below.
  • the oral composition of the present invention is designed to be ingested or administered in combination with bifidobacteria and water-soluble dietary fiber, thereby improving basal metabolic rate. Therefore, the oral composition of the present invention can be used for a variety of purposes through the improvement of basal metabolic rate, such as anti-obesity, weight loss, body fat reduction, and visceral fat reduction.
  • the oral composition of the present invention can be applied not only to obese individuals (e.g., those with a BMI of 25 or more, preferably a BMI of 25 or more but less than 30) but also to non-obese individuals.
  • the oral composition of the present invention is highly effective in improving basal metabolic rate, so it can effectively improve basal metabolic rate without concurrent exercise. Therefore, the oral composition of the present invention can also be used in subjects who do not engage in exercise to increase their basal metabolic rate.
  • the target population is preferably adults (18 years of age or older), more preferably 25 to 61 years of age.
  • the intake or administration amount of bifidobacteria can be set to, for example, 1.0 x 10 cfu/100 g or more per day. More specific ranges for the intake or administration amount of bifidobacteria include preferably 1.0 x 10 to 1.0 x 10 cfu/100 g, and preferably 5.0 to 10 to 1.0 x 10 cfu/100 g per day. This intake or administration amount is applicable to one human.
  • the intake or administration amount of water-soluble dietary fiber of the oral composition of the present invention be set at 4.5 g or more per day. More specific ranges for the intake or administration amount of water-soluble dietary fiber include preferably 4.5 to 15 g per day, more preferably 4.6 to 10 g, even more preferably 4.7 to 8.0 g, and even more preferably 4.9 to 5.5 g. This intake or administration amount can be applied to one human.
  • the oral composition of the present invention has a daily intake or administration amount of water-soluble dietary fiber of, for example, 0.025 g/kg or more, preferably 0.030 to 0.223 g/kg, more preferably 0.045 to 0.148 g/kg, and even more preferably 0.056 g/kg to 0.095 g/kg.
  • the oral composition of the present invention can be taken, for example, 1 to 3 times, 1 to 2 times, or once a day to achieve the intake or dosage described above. There are no particular restrictions on the timing of administration, and it may be taken before, during, after, or between meals, although after meals is preferred.
  • the oral composition of the present invention be taken or ingested continuously, and the period of taking or ingesting the composition may be, for example, one week or more, preferably two weeks or more, more preferably three weeks or more, and even more preferably four weeks or more.
  • the inclusion criteria were: (1) healthy individuals, (2) individuals with a BMI of 25 kg/ m2 or greater but less than 30 kg/ m2 , (3) individuals with a body fat percentage of 15% or greater for men and 25% or greater for women, and (4) the top 44 individuals with the lowest resting energy metabolism among individuals who met inclusion criteria (1) to (3) but did not meet any exclusion criteria.
  • the exclusion criteria were: (1) individuals currently receiving treatment for or with a history of malignant tumors, heart failure, or myocardial infarction; (2) individuals with an implanted pacemaker or implantable cardioverter defibrillator; (3) individuals currently receiving treatment for arrhythmia, liver damage, kidney damage, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases; (4) individuals taking a specified health food or a functional food; (5) individuals taking medicines (including herbal medicines) or supplements; (6) individuals with allergies (to medicines or foods related to the test food); (7) individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period; (8) individuals who have participated in other clinical trials within the 28 days prior to obtaining consent, or who plan to participate during the study period; (9) individuals who have taken antibiotics within the 28 days prior to obtaining consent; and (10) individuals who the principal investigator otherwise deems unsuitable for participation in this study.
  • Subject Management (1) Subjects consumed the designated diet for breakfast and lunch the day before each test. Other than the designated diet, they were only allowed to consume water. (2) Subjects stayed at the designated accommodation facility from the evening before the test. Subjects consumed the designated dinner at the accommodation facility no later than 12 hours before the start of the test the next day. Other than the designated diet, they were only allowed to consume water. (3) Upon visiting the hospital, subjects' physical condition was ascertained through a medical interview. (4) During the study period, the subjects' intake of the test food and whether they were menstruating (females only) were recorded daily in a diary designated by the contracted clinical trial organization.
  • Subjects were required to strictly adhere to the following points during their study participation: (a) Intake of the test food according to the prescribed dosage and administration. Daily intake of inulin was 5 g (0.056 g/kg to 0.095 g/kg). (b) During the study period, subjects were to consume the test food continuously for a total of 80% or more of the total target intake days. (c) From the date of obtaining the consent form for the study until the final test (test 4 weeks after intake), avoid overeating and do not change your previous lifestyle habits. (d) Avoid drinking alcohol or excessive exercise from 3 days before each test until the end of the test on the day. (e) If any changes in your physical condition occur during the study period, immediately contact the contracted clinical trial organization and ask for instructions on how to proceed.
  • test foods As test foods for the examples, an oral composition was prepared containing Bifidobacterium animalis subsp. lactis GCL2505 (1.0 x 10 cfu/100 g) and chicory-derived inulin (Orafti® GR ) (5.0 g/100 g) in a milk drink containing skim milk powder, high-fructose corn syrup, sucrose, yeast extract, acidulant, stabilizer, and flavoring. As a placebo, a milk drink was prepared that did not contain Bifidobacterium animalis subsp.
  • lactis GCL2505 or chicory-derived inulin but instead contained food-grade acetic acid and lactic acid to adjust the flavor and pH to be equivalent to those of the test foods for the examples. Details of the ingredients and nutritional composition of these test foods are shown in Table 1.
  • Study design This study was conducted as a randomized, placebo-controlled, double-blind, parallel-group comparative study. The allocation ratio for each group was 1:1, and randomization was performed using a block randomization method with random block size.
  • Subjects in the example group and placebo group ingested 100g of the test food (milk drink) once a day for four consecutive weeks.
  • the daily inulin intake for the example group was 5g.
  • the double-blind study was carried out by labeling the test food only with an identification number. Evaluation items included resting energy metabolism at weeks 2 and 4, body weight, BMI, body fat percentage, and muscle mass at weeks 2 and 4, and fecal bifidobacteria count at week 4.
  • Muscle mass was measured using a body composition analyzer.
  • PCR Real-time polymerase chain reaction
  • the primer sequences used were GATTCTGGCTCAGGATGAACGC (SEQ ID NO: 1) for the sense primer and CTGATAGGACGCGACCCCAT (SEQ ID NO: 2) for the antisense primer.
  • Each PCR reaction mixture contained 20 pmol of each primer, 5 ⁇ L of SYBR® Premix Ex taq (Takara Bio), and 1 ⁇ L of DNA solution in a total volume of 10 ⁇ L.
  • the mean structure of the model except for BMI, included time, group (active or placebo), sex, baseline value, baseline BMI value, and interactions between time and group and between baseline value and time.
  • a completely unstructured variance-covariance matrix was assumed for the error term.
  • Fecal bifidobacterium counts were compared within groups using a paired t-test, and between groups using covariate analysis with baseline (week 0) values as the covariate.

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Abstract

Le but de la présente invention est de fournir une composition destinée à être administrée par voie orale capable d'améliorer le taux métabolique basal. La présente invention peut améliorer le taux métabolique basal en combinant des bifidobactéries avec des fibres alimentaires hydrosolubles.
PCT/JP2025/020861 2024-06-10 2025-06-09 Composition destinée à être administrée par voie orale Pending WO2025258565A1 (fr)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024507187A (ja) * 2021-02-10 2024-02-16 中科微智（北京）生物科技有限公司 ビフィドバクテリウム・ラクティス及びその使用

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024507187A (ja) * 2021-02-10 2024-02-16 中科微智（北京）生物科技有限公司 ビフィドバクテリウム・ラクティス及びその使用

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DATABASE Mintel GNPD 1 November 2019 (2019-11-01), PROTEIN WORLD: "Chocolate Flavour The Slender Blend Meal Replacement Shake", XP093382289, Database accession no. 7056749 *
GLICO EZAKI: "The BifiX Yogurt Fruit Series, powered by the ability to produce short-chain fatty acids, is back with a delicious new taste! Enjoy the rich flavor and texture of real fruit in this large-capacity yogurt.", PR TIMES, 29 September 2020 (2020-09-29), pages 1 - 4, XP093382249, Retrieved from the Internet <URL:https://prtimes.jp/main/html/rd/p/000000316.000001124.html%3E> *
SHIMBUN ASAHI: "Health from the gut: Focus on "tansa [shortchain] fatty acids" to boost your basal metabolism and create a body that's less prone to weight gain.", ASAHI.COM, 25 March 2024 (2024-03-25), pages 1 - 8, XP093382285, Retrieved from the Internet <URL:https://www.asahi.com/ads/tu/15202400> *

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