Composition for increasing and / or inhibiting the decrease of muscle mass

Abstract

The object of the present invention is to provide a composition that exhibits an effect of increasing or inhibiting the decrease in muscle mass. [Solution] The present inventors have conducted extensive research to solve the above problems and have found that by designing the daily intake of corosolic acid to be 0.2 to 20 mg / day, an excellent effect of increasing or suppressing the decrease in muscle mass can be obtained, thus completing the present invention.

Description

Technical Field

[0001] The present invention relates to a composition for increasing and / or suppressing the decrease in muscle mass, which is designed such that the daily intake of cholanic acid is 0.2 to 20 mg / day.

Background Art

[0002] In recent years, with the development of transportation means such as cars and trains and the changes in lifestyle such as telework, the opportunity for exercise has decreased, and thus the decrease in muscle mass has become a problem for all generations. As a means to increase or maintain muscle mass, exercise such as muscle training is effective. However, there are cases where exercise is difficult due to time or physical constraints, or where the physical burden is too large to continue exercise. Therefore, there is a demand for the development of functional foods that support the increase and maintenance of muscle mass and can be easily ingested. As such a functional food, a muscle mass increasing agent containing panaxatriol or panaxadiol is known (Patent Document 1). However, since panaxadiol and panaxatriol have strong astringent and bitter tastes, there are consumers who do not prefer to ingest them. Therefore, there has been a demand for the development of new functional foods that support the increase and maintenance of muscle mass.

[0003] One of the most challenging aspects of developing functional foods that support muscle growth and maintenance is determining the effective dosage. Even if an ingredient has shown efficacy in cell or animal studies, the optimal dosage for humans cannot be determined without conducting clinical trials. However, clinical trials are extremely expensive, so if the effective dosage in humans is already known from research papers, it is common practice to follow that dosage. On the other hand, if the effective dosage in humans is unknown, it is necessary to conduct clinical trials to determine it. In such cases, it is common practice to administer a dosage to humans that is expected to be effective based on the results of already known animal studies and conduct clinical trials. However, because the biological structures of animals and humans differ, a dosage that is expected to be effective based on animal studies may not be effective in humans, frequently resulting in wasted clinical trial costs.

[0004] Incidentally, corosolic acid is a compound found in the leaves of banaba (scientific name Lagerstroemia speciosa) and is known to possess various physiological activities. Examples of corosolic acid's physiological activities include its effect of suppressing blood glucose elevation (Patent Document 2) and its anti-periodontal disease effect (Patent Document 3). However, there is no knowledge regarding the effect of administering corosolic acid to humans on increasing or inhibiting muscle mass decrease, and the effective dose in humans was also unknown. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Japanese Patent Publication No. 2015-059102 [Patent Document 2] Japanese Patent Publication No. 2000-169384 [Patent Document 3] Japanese Patent Publication No. 2013-010715 [Overview of the project] [Problems that the invention aims to solve]

[0006] The object of the present invention is to provide a composition that exhibits an effect of increasing or inhibiting the decrease in muscle mass. [Means for solving the problem]

[0007] The inventors of this invention have conducted extensive research to solve the above problems and have found that by designing the daily intake of corosolic acid to be 0.2 to 20 mg / day, excellent effects of increasing or suppressing muscle mass can be obtained, thus completing the present invention.

[0008] In other words, the outline of the present invention is as follows: [1] A composition for increasing and / or inhibiting muscle mass, designed to provide a daily intake of 0.2 to 20 mg / day of corosolic acid. [2] A composition for increasing and / or inhibiting muscle loss, designed to provide a daily intake of 0.2 to 20 mg / day of corosolic acid. [3] An oral composition containing corosolic acid as an active ingredient, It is designed so that the daily intake of corosolic acid is 0.2 to 20 mg / day. An oral composition that is labeled as having one or more functions selected from among increasing muscle mass, inhibiting or maintaining muscle mass decline, increasing muscle strength, and inhibiting or maintaining muscle strength decline. [4] The composition according to any one of claims 1 to 3, wherein the composition is a functional food or a food for specified health uses. [5] A composition according to any one of [1] to [4], designed to provide a daily intake of corosolic acid of 0.3 to 15 mg / day. [6] A composition according to any one of [1] to [4], designed to provide a daily intake of corosolic acid of 0.5 to 10 mg / day. [7] A composition according to any one of [1] to [4], designed to provide a daily intake of 1 to 8 mg of corosolic acid. [8] A composition according to any one of [1] to [4], designed to provide a daily intake of 1.5 to 5 mg of corosolic acid per day. [9] A composition according to any one of [1] to [4], designed to provide a daily intake of 1.8 to 3 mg of corosolic acid per day.

[10] A composition according to any one of [1] to [4], designed to provide a daily intake of 2 to 2.5 mg of corosolic acid per day.

[11] A composition according to any one of [1] to

[10] , wherein the period of intake is at least 4 weeks.

[12] A composition according to any one of [1] to

[10] , wherein the period of intake is at least 6 weeks.

[13] The composition according to any one of [1] to

[10] , wherein the period of intake is at least 12 weeks.

[14] The composition according to any one of [1] to

[13] , wherein the composition is a food or beverage.

[15] The composition according to any one of [1] to

[14] , wherein the composition is a functional food or a food for specified health uses.

[16] A composition described in any one of items [1] to

[15] , intended for use by middle-aged and elderly persons. [Effects of the Invention]

[0009] The composition of the present invention exhibits excellent effects in increasing or inhibiting the decrease of muscle mass. [Modes for carrying out the invention]

[0010] The present invention will be described in detail below. However, the present invention is not limited to the embodiments described below.

[0011] 1. Corosolic acid The composition of the present invention contains corosolic acid. Corosolic acid is a kind of triterpene and is represented by the following structural formula (1). As the corosolic acid used in the present invention, those concentrated or purified from plants, those chemically synthesized, or commercially available products can be used. Also, plants containing corosolic acid may be used. As plants containing corosolic acid, for example, banaba (scientific name: Lagerstroemia speciosa) of the Lythraceae family is known. From the viewpoint of particularly excellent muscle strengthening or reduction inhibitory action and safety, those extracted from plants are preferable, and those extracted from banaba are particularly preferable.

[0012]

Chemical formula

[0013] When corosolic acid is obtained by extraction from a plant, the extraction solvent is not particularly limited. For example, solvents such as water, alcohol (e.g., methanol, ethanol, n-propanol, n-butanol, etc.), and acetone can be mentioned. Preferably, water and / or ethanol, etc. can be used. The temperature of the solvent when obtaining the extract is not particularly limited, and can be appropriately selected from normal temperatures such as about room temperature to below the boiling point of the solvent. Also, when obtaining an extract powder, it can be obtained by removing the solvent of the extract by methods usually used by those skilled in the art, such as vacuum drying or spray drying.

[0014] When using banaba as the plant containing corosolic acid, it is preferable to use banaba leaves because they are rich in corosolic acid. Banaba leaves can be used in various forms, such as pulverized material, juice, or extract. Examples of pulverized material include dried powder (banaba leaf powder) and dried pulverized material. Juice and extract may be in liquid form, but can also be used as a paste or dried powder (juice powder, extract powder). Examples of solvents used for extraction include water; lower alcohols such as methanol, ethanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. Among these, water, ethanol, or aqueous ethanol are preferred from the viewpoint of more effectively exhibiting the effects of the present invention, and ethanol or aqueous ethanol are particularly preferred. The temperature of each solvent can be appropriately set from room temperature to below the boiling point.

[0015] When using banaba extract as corosolic acid, the corosolic acid content in the banaba extract is not particularly limited and can be appropriately selected within the range that produces the desired effect. For example, a banaba extract containing 1% by mass or more of corosolic acid on a dry weight basis can be used, preferably containing 5% by mass or more, more preferably containing 7% by mass or more, and even more preferably containing 9% by mass or more. Furthermore, the temperature of each solvent can be set as appropriate, ranging from room temperature to below its boiling point.

[0016] The corosolic acid content in a composition can be measured using a liquid chromatograph-mass spectrometer. Specifically, the corosolic acid content in a sample can be measured by the following method. First, a standard solution is prepared by dissolving a corosolic acid standard in methanol. Next, the sample is heated and refluxed with water and methanol, then centrifuged, and the resulting supernatant is diluted with methanol to prepare a test solution. The obtained standard solution and test solution are injected into a liquid chromatograph-mass spectrometer, and the corosolic acid in the test solution is identified (qualitatively) from the peak retention time of corosolic acid in the standard solution, and the peak height is measured. Subsequently, a calibration curve is created from the measured peak height of the standard solution and the concentration of the standard solution, and the corosolic acid content in the test solution can be measured by determining the concentration of corosolic acid in the test solution from the peak height obtained from the test solution and the calibration curve. The operating conditions for the liquid chromatograph-mass spectrometer may be, for example, as follows.

[0017] [Liquid Chromatograph-Mass Spectrometer Operating Conditions] Analytical column: Inertsil ODS-2, φ2.1mm × 150mm, particle size 5μm Column temperature: 40℃ Mobile phase: Mixture of acetonitrile and 1% acetic acid (6:4) Injection volume: 5μL Flow rate: 0.2mL / min Ionization method: Electrospray (negative ion detection mode) Set mass number (m / z): 471.5

[0018] The composition of the present invention is characterized by being designed so that the daily intake of corosolic acid is 0.2 to 20 mg / day. "Designed so that the daily intake of corosolic acid is 0.2 to 20 mg / day" means that if the oral composition is taken according to the daily intake amount stated on the package or instruction manual, 0.2 to 20 mg of corosolic acid can be taken per day. The effects of the present invention are efficiently exerted by taking 0.2 to 20 mg of corosolic acid per day. If the daily intake is less than 0.2 mg, a sufficient increase in muscle mass or inhibition of muscle loss will not be exerted. Furthermore, if the daily intake exceeds 20 mg, the increase in muscle mass or inhibition of muscle loss will not be further increased, and in fact, a decrease in the increase in muscle mass or inhibition of muscle loss may be observed, so it cannot be said that the increase in muscle mass or inhibition of muscle loss is efficiently exerted in relation to the dose of corosolic acid.

[0019] The daily intake of corosolic acid is not particularly limited as long as it is in the range of 0.2 to 20 mg, but from the viewpoint of exerting a sufficient effect of increasing or inhibiting the decrease in muscle mass, and from the viewpoint of maximizing the effect of increasing or inhibiting the decrease in muscle mass per dose of corosolic acid, 0.3 to 15 mg / day is preferred, 0.5 to 10 mg / day is more preferred, 1 to 8 mg / day is even more preferred, 1.5 to 5 mg / day is even more preferred, 1.8 to 3 mg / day is particularly preferred, and 2 to 2.5 mg / day is most preferred.

[0020] The composition of the present invention may be appropriately designed so that the daily intake of corosolic acid falls within the above range, and may be consumed in one dose or in multiple doses. That is, for example, it can be contained in one packaging container or divided into two to four packaging containers to represent one day's supply.

[0021] The packaging form is not particularly limited and can be selected as appropriate depending on the dosage form, etc., but examples include blister packs such as PTP; strip packaging; heat seal; aluminum pouch; film packaging using plastic or synthetic resin; glass containers such as vials; plastic containers such as ampoules, etc.

[0022] While there are no particular limitations on the duration of intake of the composition of the present invention, from the viewpoint of exhibiting the effects of the present invention more significantly, the intake period is preferably at least 4 weeks, more preferably at least 6 weeks, and most preferably at least 12 weeks. By taking a low dose over a long period of time, an excellent effect of increasing or inhibiting muscle mass decline can be expected. However, even if the daily intake amount exceeds the particularly preferred range described in this application when the intake period is 4 weeks or more, 6 weeks or more, or 12 weeks or more, the effect of increasing or inhibiting muscle mass decline will not improve beyond the level when the daily intake amount is within the particularly preferred range described in this application.

[0023] There are no particular restrictions on who can consume the composition of the present invention; it can be consumed by children, young adults, and middle-aged and elderly individuals. In particular, it is especially preferable to target middle-aged and elderly individuals aged 40 and over, as they are prone to muscle loss.

[0024] 2. Oral composition The oral composition of the present invention may contain other components besides corosolic acid. Examples of such other components include sugars, vitamins, minerals, proteins, dietary fiber such as insoluble dietary fiber, plants or processed plant products, yeast, etc. Furthermore, it may contain, if necessary, sweeteners, acidulants, colorants, thickeners, glazing agents, lubricants, excipients, anticaking agents, nutritional supplements, binders, lubricants, stabilizers, diluents, bulking agents, emulsifiers, food additives, seasonings, etc., which are commonly used in the food industry.

[0025] Examples of the oral composition of the present invention include tablets, capsules, powders, granules, liquids, granular preparations, rod-shaped preparations, plate-shaped preparations, block-shaped preparations, solid preparations, round preparations, paste-like preparations, cream-like preparations, caplet-like preparations, gel-like preparations, chewable preparations, stick-shaped preparations, and the like. Among these forms, tablets, capsules, powders, granules, and liquid preparations are preferred from the viewpoint of ease of administration.

[0026] The oral composition of the present invention can take the form of a pharmaceutical product (including quasi-drugs) or a food or beverage. Among these, a food or beverage is particularly preferred because it can be easily consumed in daily life.

[0027] Examples of foods and beverages of the present invention include general foods, nutritional functional foods, functional foods whose efficacy has been approved by a designated institution, and so-called health foods such as foods for specified health uses. Foods that display efficacy are sometimes collectively referred to as "health functional foods" or "functional foods." When the oral composition of the present invention is a food or beverage, it is particularly preferable that it be a functional food or a food for specified health uses, from the viewpoint of being able to communicate the effects of the present invention to consumers.

[0028] The present invention does not particularly limit the food and beverages, but examples include: milk and dairy products; beverages such as soft drinks, fruit juices, milk beverages, alcoholic beverages, sports drinks, and nutritional drinks; seasonings; alcoholic beverages; processed agricultural and forestry products; confectionery and bread; flour and noodles; processed marine products; processed livestock products; oils and fats; frozen prepared foods; retort foods; instant foods; food ingredients; and supplements. Examples of supplement forms include tablets, capsules, powders, granules, and liquids.

[0029] 3. Oral compositions used for purposes such as increasing or inhibiting muscle mass decrease. The oral composition of the present invention has the effect of increasing and / or inhibiting the decrease of muscle mass, and increasing and / or inhibiting the decrease of muscle strength, and can therefore be used as a composition for increasing and / or inhibiting the decrease of muscle mass, and a composition for increasing and / or inhibiting the decrease of muscle strength. In the present invention, inhibition of decrease means inhibiting the decrease of muscle mass or muscle strength, and is a concept that includes maintenance.

[0030] The compositions for increasing muscle mass or muscle strength in this invention are not particularly limited as long as the daily intake of corosolic acid is within a specific range and the product can be distinguished from other products in that it is used to increase muscle mass or muscle strength. For example, any product in which the main body, packaging, instructions, or promotional materials of the present invention indicate that it has functions such as increasing muscle mass, increasing muscle weight, increasing muscle cross-sectional area, increasing muscle density, increasing muscle strength, enhancing muscle synthesis, improving muscle quality, or increasing power is included in the scope of this invention. For example, the active ingredient may not be specified. Furthermore, even general foods (so-called health foods) that are manufactured and sold with the indication that they can be used to increase muscle mass or muscle strength are included in the scope of this invention. For example, foods that are sold with testimonials on websites etc. mentioning an increase in muscle mass or muscle strength as a personal opinion of the person who consumed them are also included in the scope of this invention. Furthermore, functional foods that use papers etc. showing an increase in muscle mass or muscle strength as the scientific basis for their functionality and have corosolic acid as the functional ingredient are also included in the scope of this invention.

[0031] The composition for inhibiting the decline of muscle mass or muscle strength in the present invention is not particularly limited as long as the daily intake of corosolic acid is within a specific range and the product can be distinguished from other products in that it is used to inhibit the decline of muscle mass or muscle strength. For example, any product in the body, packaging, instructions, or promotional materials of the present invention that displays that it has functions such as maintaining / inhibiting the decline of muscle mass, maintaining / inhibiting the decline of muscle weight, maintaining / inhibiting the decline of muscle cross-sectional area, maintaining / inhibiting the decline of muscle density, maintaining / inhibiting the decline of muscle strength, maintaining / inhibiting the decline of muscle synthesis, maintaining / inhibiting the decline of muscle quality, or maintaining / inhibiting the decline of power is included in the scope of the present invention. For example, the active ingredient may not be specified. Furthermore, even general foods (so-called health foods) that are manufactured and sold with the suggestion of use in inhibiting the decline of muscle mass or muscle strength are included in the scope of the present invention. For example, foods that are sold with testimonials on a website or elsewhere that mention the maintenance / inhibition of the decline of muscle mass or muscle strength as personal impressions of people who have consumed them are also included in the scope of the present invention. Furthermore, the scope of this invention also includes functional foods that use corosolic acid as a functional ingredient, based on scientific evidence of functionality such as papers demonstrating the maintenance or suppression of muscle mass or muscle strength. [Examples]

[0032] The present invention will be described below based on examples. However, the present invention is not limited to the following examples. Unless otherwise specified, "parts" below refers to "parts by mass" and "%" refers to "percentage by mass".

[0033] 1. Clinical Trials The clinical trials described below confirmed that corosolic acid has an effect of suppressing (increasing) muscle mass loss when the daily intake is within a specific range.

[0034] 1-1. Subjects and Methods 1) Experimental design This study was conducted as a randomized, double-blind, placebo-controlled, parallel-group comparative trial (allocation ratio: 1:1) lasting a total of 13 weeks, consisting of a pre-observation period (1 week) and an intake period (12 weeks).

[0035] 2) Subjects and setting This study included healthy adults who met the following selection criteria and did not violate any exclusion criteria. Prior to the start of the study, participants were given a thorough explanation of the study and provided written consent. Selection criteria: (1) Healthy Japanese men and women aged 40 to under 75 on the date of obtaining consent; (2) Individuals who do not exercise regularly and are aware that their muscle strength has declined compared to before; (3) Individuals with a BMI of less than 30; (4) Individuals who have received a full explanation of the purpose and content of this study, have the capacity to give consent, fully understand it, voluntarily volunteer to participate, and give written consent to participate in the study. Exclusion Criteria: (1) Individuals who regularly use medications related to muscle or lipid metabolism; (2) Individuals with a history of serious liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, other metabolic diseases, skeletal muscle diseases, or tendon diseases; (3) Individuals who are currently undergoing or may undergo surgical treatment for joints; (4) Individuals who use cardiac pacemakers or artificial joints; (5) Individuals who have suffered severe injuries to the musculoskeletal system, such as fractures, tendon ruptures, or muscle tears, in the past year; (6) Individuals with severe physical disabilities such as lower back pain or knee pain that interfere with exercise. (7) Individuals who, based on self-reporting, may be suffering from idiopathic chronic fatigue or chronic fatigue syndrome; (8) Individuals with a history of digestive disorders or surgery that affect digestion and absorption; (9) Individuals who cannot stop taking supplements or health foods (including foods for specified health uses and foods with functional claims) during the study period; (10) Individuals prohibited from exercising by a doctor; (11) Individuals who have reported having an allergy to food; (12) Individuals who cannot abstain from alcohol for screening tests or two days prior to each test; (13) Individuals who consume 20% or more pure alcohol equivalent for four or more days a week. (14) Individuals who have a habit of consuming more than g / day of alcohol, (15) Individuals who work in shifts or night shifts, (16) Individuals with a history of drug or alcohol dependence, (17) Individuals deemed unsuitable as research subjects by the principal investigator based on clinical tests performed during screening, (18) Individuals who have had blood drawn or donated more than 200 mL within one month of obtaining consent, or more than 400 mL within three months, (19) Pregnant individuals, individuals who intend to become pregnant during the research period, or breastfeeding individuals, (10) Individuals currently participating in or intending to participate in research involving the intake of other foods, the use of pharmaceuticals, or the application of cosmetics, etc., (11) Others deemed unsuitable as research subjects by the principal investigator.

[0036] 3) Intervention During the intake period, the intervention consisted of consuming the test food and performing exercise. The test food (Example 1) was a tablet made by mixing banaba leaf extract (manufactured by Toyo Shinyaku Co., Ltd.) with reduced maltose, cellulose, calcium stearate, and silicon dioxide. The control food (Comparative Example 1) was a food in which the banaba leaf extract in the test food was replaced with caramel coloring and the amount of reduced maltose was adjusted so that it could not be distinguished from the test food by appearance. The daily intake for both the test food and the control food was designed to be 250 mg x 1 tablet. During the intake period, subjects ingested one sachet (1 tablet) of the test food (test food group received the test food, and the control food group received the control food) once a day with water or lukewarm water. Table 1 shows the energy and nutritional values ​​per daily intake of the test food. The amount of corosolic acid derived from banaba leaves contained in the test food was 2.2 mg per daily intake.

[0037] [Table 1]

[0038] Exercise load consisted of resistance training performed 4-5 times a week at a sports club or at home. For sports club exercises, participants performed 1-2 times a week at a designated sports club during the intake period. At the first exercise session, participants received instruction on equipment usage from an exercise therapist, and their RM (repetition maximum) was measured. Each subsequent exercise was performed at 60-80% of that intensity. The exercises performed were leg press, leg extension, and leg curl. Warm-up stretches were performed before exercise, and no other exercises were performed. The intensity varied depending on the stage of exercise: 60% for 8 repetitions x 2 sets from week 0 onwards, 60% for 10 repetitions x 2 sets from week 3 onwards, 70% for 10 repetitions x 3 sets from week 6 onwards, and 80% for 10 repetitions x 3 sets from week 9 onwards. During the intake period, participants were instructed to perform either Set A or Set B at home 3-4 times per week. Set A consisted entirely of dumbbell exercises: (1) squats, (2) front lunges (alternating left and right), (3) calf raises, and (4) side lunges (alternating left and right), all performed on days separate from their workouts at the sports club. The exercise load was 8 reps x 2 sets (male: 2kg x 2, female: 1kg x 2) ((2) and (4) 4 reps each, alternating left and right) from week 0 onwards, 10 reps x 2 sets (male: 2kg x 2, female: 1kg x 2) ((2) and (4) 5 reps each, alternating left and right) from week 3 onwards, 8 reps x 3 sets (male: 3kg x 2, female: 2kg x 2) ((2) and (4) 4 reps each, alternating left and right) from week 6 onwards, and 10 reps x 3 sets (male: 3kg x 2, female: 2kg x 2) ((2) and (4) 5 reps each, alternating left and right) from week 9 onwards. Set B consisted of (1) push-ups, (2) back kicks, and (3) dumbbell arm curls (alternating left and right), all performed with the understanding that they would overlap with exercise days at the sports club. The exercise load was 8 reps x 2 sets (male: 2kg x 2, female: 1kg x 2) ((3) 4 reps alternating left and right) from week 0 onwards, 10 reps x 2 sets (male: 2kg x 2, female: 1kg x 2) ((3) 5 reps alternating left and right) from week 3 onwards, 8 reps x 3 sets (male: 3kg x 2, female: 2kg x 2) ((3) 4 reps alternating left and right) from week 6 onwards, and 10 reps x 3 sets (male: 3kg x 2, female: 2kg x 2) ((3) 5 reps alternating left and right) from week 9 onwards. The weight of the dumbbells used in Sets A and B was adjusted to suit the individual participant. The exercise intensity was approximately 3.5 METs.

[0039] 4) Examination items Whole-body muscle mass and leg muscle mass were evaluated a total of three times: before intake (hereinafter referred to as "pre-intake"), 6 weeks after the start of intake (hereinafter referred to as "6 weeks after intake"), and 12 weeks after the start of intake (hereinafter referred to as "12 weeks after intake"). Muscle mass was measured using Dual Energy X-ray Absorptiometry (DXA), and the sum of the muscle mass of both legs was used for evaluation of leg muscle mass. Participants were given a food diary and a participant diary, and were instructed to fill out the following survey items daily, starting one week before the intake period and continuing throughout the intake period. Survey items: (1) Intake status of test foods (during intake period only) (2) Presence or absence of changes in physical condition (3) Bedtime (4) Presence or absence of changes in lifestyle (5) Use of pharmaceuticals (excluding nutritional drinks, newly designated quasi-drugs, and newly defined quasi-drugs) (6) Whether or not exercise is performed at a sports club or at home, and the duration of exercise (7) Dietary content (including meals, snacks, prohibited foods, supplements, health foods, drinks, alcohol, etc.)

[0040] 5) Number of cases The target number of cases in this study was set at 30 patients per group (60 patients in total).

[0041] 6) Test Method In this study, the principal investigator enrolled participants according to inclusion and exclusion criteria, and a statistical analyst assigned participants using a block randomization method (block size 4) with computer-generated random numbers, adjusting for protein intake (FFQg), BMI, sex, and age. The two assigned groups were then divided into a test food group and a control food group by controllers who were not directly involved in the study. Furthermore, the controllers created and sealed a table (key code) containing the assignment results and kept it sealed until the key code was disclosed after the analysis participants were determined, thereby ensuring blinding to anyone other than the controllers. In addition, the test food was distributed to participants in individual plain aluminum bags, ensuring blinding to both participants and those implementing the intervention. Furthermore, during the study period, participants were instructed to avoid excessive drinking (maximum daily amount: less than 20 g of pure alcohol per day), not to drink alcohol before exercise, to refrain from using or consuming supplements or health foods (including foods for specified health uses and foods with functional claims), to maintain the same lifestyle as before the study, to perform resistance exercises using dumbbells, etc., at home 3-4 days a week unless they have health problems, to perform only the specified exercises at a designated sports club 1-2 times a week, to refrain from consuming alcohol for 2 days prior to all tests, to refrain from strenuous exercise the day before all tests, to go to bed early the day before all tests and not to stay up late, to go to bed by around midnight as a general rule and get enough sleep, to refrain from smoking from the time of waking up until the completion of all tests on the day of all tests, to refrain from eating or drinking from the time of waking up until the completion of clinical tests for those undergoing tests in the morning and to fast for at least 8 hours from the previous night, and to finish eating at least 6 hours before coming to the hospital if they are undergoing tests in the afternoon. In addition, subjects were required to obtain permission from the principal investigator or co-investigator before using any medication, except in emergency situations.

[0042] 1-2.Results 1) Participants in the analysis The study initially enrolled 60 participants (40 males and 20 females), and there were no dropouts after randomization, so the study began with 60 participants. During the study period, it was discovered that one participant (male) in the test food group was unable to perform the prescribed exercise load, and the principal investigator decided to discontinue the study. As a result, the number of participants who completed the study was reduced to 59. After the study, one participant (male) in the test food group who showed a significant change in dietary habits compared to before the study was excluded, leaving 58 participants (38 males and 20 females) for analysis. The analysis was performed for each group according to the original allocation.

[0043] 2) Analysis results Table 2 shows the average values ​​of muscle mass (measured values ​​and changes). In the test food group, the decrease in muscle mass was suppressed compared to the control food group.

[0044] [Table 2]

[0045] 2. Tablets containing corosolic acid After mixing the raw materials listed in Table 3, tablets (250 mg) for Examples 2-14 were produced by compressing them using a rotary tablet press. The resulting tablets were designed so that the daily intake would be 4 tablets (1000 mg). The daily intake of corosolic acid in each example is shown in Table 3. All of the resulting tablets exhibited effects in increasing and inhibiting muscle mass, but the tablets with a daily intake of 1-5 mg of corosolic acid (Examples 5-10) showed particularly excellent effects in increasing and inhibiting muscle mass relative to the dose of corosolic acid. Among these, the tablets with a daily intake of 1.5-3 mg of corosolic acid (Examples 6-9) showed the best effect in increasing and inhibiting muscle mass relative to the dose of corosolic acid.

[0046] [Table 3] [Industrial applicability]

[0047] The composition of the present invention is industrially useful because it exhibits effects that increase and suppress the decrease of muscle mass, and can therefore be used as a health food such as a functional food or a food for specified health uses.

Claims

1. A composition for increasing and / or inhibiting the decrease of muscle mass, designed to provide a daily intake of 0.2 to 20 mg / day of corosolic acid.

2. A composition for increasing and / or inhibiting muscle loss, designed to provide a daily intake of 0.2 to 20 mg of corosolic acid.

3. An oral composition containing corosolic acid as an active ingredient, It is designed so that the daily intake of corosolic acid is 0.2 to 20 mg / day. An oral composition that is labeled as having one or more functions selected from among increasing muscle mass, inhibiting or maintaining muscle mass decline, increasing muscle strength, and inhibiting or maintaining muscle strength decline.

4. The composition according to any one of claims 1 to 3, wherein the composition is a functional food or a food for specified health uses.

Images