Composition for reducing body fat mass of human body and uses thereof

Abstract

Provided are a composition including the microorganism Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP) as an active ingredient for use in reducing body fat weight (BF) without reducing lean body mass (LBM) of the human body, and uses thereof.

Description

Composition for reducing body fat in the human body and use thereof

[0001] A composition containing microorganisms for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body and its use.

[0002] Recent research suggests that gut bacteria may play a role in regulating health conditions associated with obesity. This regulation can be achieved by introducing probiotic microorganisms into foods.

[0003] WO 2006 / 019222 discloses that Lactobacillus rhamnosus strain PL60 KCCM-10654P has body-fat reducing activity producing t10c12-octadecanoic acid. WO 2009 / 02449 discloses that Lactobacillus rhamnosus strain CGMCC 1.3724 or NCC407 is used for preventing or treating metabolic diseases. The microorganism-containing composition regulates intestinal Proteobacteria.

[0004] Meanwhile, obese or overweight animals are at increased risk for many chronic diseases, including heart disease, diabetes, high blood pressure, stroke, dyslipidemia, certain types of cancer, sleep apnea, and osteoarthritis. Therefore, losing excess weight is essential for overweight and obese animals, including humans, to maintain health and quality of life. However, excessive weight loss often leads to muscle loss, which involves losing muscle along with body fat. Muscles burn calories, and as muscle mass decreases, the basal metabolic rate gradually decreases, which can lead to adverse effects such as the so-called "yo-yo effect," or rebound weight loss. Therefore, healthy weight loss involves reducing body fat while maintaining muscle mass as much as possible. However, this typically involves reducing carbohydrate intake, which causes the brain to use muscle as an energy source, leading to muscle loss. Furthermore, reduced protein intake also contributes to muscle loss, making it difficult to achieve.

[0005] Therefore, there remains a need for compositions and uses thereof that reduce body fat mass without reducing lean body mass in the human body to maintain a healthy body weight.

[0006] Meanwhile, Korean Patent No. 10-1670048 confirmed through in vitro testing that the culture filtrate and / or cell extract of Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP) is involved in adipocyte differentiation and lipogenesis-related enzymes. The patent also confirmed in an animal experiment that when live Lactobacillus plantarum LMT1-48 was administered to a mouse model induced to be obese by a high-fat diet, the expression of genes related to adipocyte differentiation was reduced, and Micro-CT confirmed that the area of ​​abdominal viscera and subcutaneous fat was reduced. However, the effect of freeze-drying and consuming the above-mentioned bacteria on reducing body fat in an obese population has not been confirmed to date.

[0007] One aspect provides a composition for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body, comprising a microorganism, Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP), as an active ingredient, and a pharmaceutically or food-wise acceptable excipient, diluent, or carrier.

[0008] Another aspect provides a method for reducing body fat weight (BF) in a human body without reducing lean body mass (LBM), comprising administering to the human body the composition.

[0009] Another aspect provides the use of a microorganism, Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP), in the preparation of a composition for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body.

[0010] One aspect provides a composition for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body, comprising a microorganism, Lactobacillus plantarum LMT1-48 (accession number KCTC13024BP), as an active ingredient, and a pharmaceutically or food-wise acceptable carrier.

[0011] The above microorganism may have been isolated from kimchi and deposited at the Korean Collection for Type Cultures (KCTC) at the Korea Research Institute of Bioscience and Biotechnology on May 13, 2016.

[0012] In the above composition, the microorganism may be freeze-dried. The freeze-drying may be performed at a temperature of -70°C to -30°C, for example, -70°C to -40°C. The freeze-drying may be performed by freezing under cooling conditions for 3 to 48 hours, for example, 6 to 36 hours, for example, 12 to 24 hours, and then thawing in a freeze dryer to remove moisture.

[0013] The above microorganism may be viable. The above microorganism may exhibit a survival rate of 10% or more, 15% or more, 20% or more, 25% or more, 30% or more, 35% or more, 60% or more, 65% or more, 70% or more, 75% or more, 80% or more, 85% or more, 90% or more, or 95% or more compared to the initial storage level after storage for 2 weeks at 40°C. The above microorganism may exhibit a survival rate of 10% or more, 15% or more, 20% or more, 25% or more, 30% or more, 35% or more, 60% or more, 65% or more, 70% or more, 75% or more, 80% or more, 85% or more, 90% or more, or 95% or more compared to the initial storage level after storage for 4 weeks at 40°C.

[0014] The composition may comprise 1% to 20%, 5% to 20%, 1% to 15%, 1% to 10%, 1% to 7.5%, 2.5% to 7.5%, 3% to 7%, 4% to 6%, or about 5% of the microorganism by weight of the total composition. The composition may comprise 80% to 99%, 80% to 95%, 85% to 99%, 90% to 99%, 92.5% to 99%, 92.5% to 97.5%, 93% to 97%, 94% to 96%, or about 95% of the excipient by weight of the total composition.

[0015] The above composition is 1x10 3 1x10 11 CFU For example, 1x105 1x10 11 CFU, 1x10 7 1x10 11 CFU, 1x10 9 1x10 11 CFU, 5x10 9 5x10 10 CFU, or 9x10 9 5x10 10 It may contain the above microorganisms in CFU.

[0016] The composition may be formulated for oral administration. The composition may be enteric coated or microencapsulated. The composition may be formulated for administration in the form of a solid dosage form. The solid dosage form may be formulated in the form of a capsule, powder, pill, tablet, etc. The solid dosage form may contain 1x10 5 1x10 12 CFU, 1x10 7 1x10 11 CFU, 1x10 9 1x10 11 CFU, 5x10 9 1x10 11 CFU, 6x10 9 1x10 11 CFU, 7x10 9 1x10 11 CFU, 8x10 9 1x10 11 CFU, 9x10 9 1x10 11 CFU, 9x10 9 1x10 10 CFU, 9x10 9 2x10 10 CFU, 1x10 10 2x10 10 CFU, 1x10 10 3x10 inland 10 CFU, 5x10 9 1.5x10 10CFU, 5x10 9 2x10 10 CFU, or 9.5x10 10 1.5x10 10 It may contain the above microorganisms in CFU.

[0017] The composition may further comprise a prebiotic, a preservative or a stabilizer.

[0018] The composition may further comprise a carbohydrate. The carbohydrate may be a sugar substitute. The carbohydrate may be a monosaccharide, a disaccharide, an oligosaccharide, a polysaccharide, or a combination thereof. The carbohydrate may be trehalose, sucrose, glucose, fructose, lactose, maltose, maltooligosaccharide, fructooligosaccharide, maltodextrin, starch, cellulose, or a combination thereof.

[0019] The above maltodextrin may be digestible maltodextrin. The above maltodextrin may be a solid obtained by processing plant starch. The above digestible maltodextrin is rapidly digested and provides glucose, and is used as a food additive.

[0020] The maltodextrin may also be digestion-resistant maltodextrin. The digestion-resistant maltodextrin, when fermented in the colon, produces short-chain fatty acids, which may contribute to intestinal health and may thus be defined as a nutritional food additive. The digestion-resistant maltodextrin may be a solid derived from the processing of plant starch. The processing may render the resulting maltodextrin particularly resistant to digestion. The digestion-resistant maltodextrin may be used as a low-calorie sweetener ingredient.

[0021] Additionally, the maltodextrin may be a mixture of digestible maltodextrin and indigestible maltodextrin.

[0022] The composition may comprise 1% to 20%, 5% to 20%, 1% to 15%, 1% to 10%, 1% to 7.5%, 2.5% to 7.5%, 3% to 7%, 4% to 6%, or about 5% of the microorganism, based on the weight of the microorganism and the carbohydrate. The composition may comprise 80% to 99%, 80% to 95%, 85% to 99%, 90% to 99%, 92.5% to 99%, 92.5% to 97.5%, 93% to 97%, 94% to 96%, or about 95% of the carbohydrate, based on the weight of the microorganism and the carbohydrate.

[0023] The above dosage is 1x10 per day 3 1x10 11 CFU For example, 1x10 5 1x10 11 CFU, 1x10 7 1x10 11 CFU, 1x10 9 1x10 11 CFU, 1x10 9 1x10 10 CFU, 2x10 9 8x10 9 CFU, 3x10 9 7x10 9 CFU, 4x10 9 6x10 9 CFU, 5x10 9 5x10 10 CFU, or 9x10 9 5x10 10 It could be CFU.

[0024] The above human body can be male, female, or both. The above human body has a body mass index (BMI) of 23 kg / m 2 More than 25 kg / m 2 Less than 25kg / m 2 More than 30kg / m 2 Less than 30 kg / m 2 More than 35 kg / m 2 Less than 35 kg / m2 More than 40 kg / m 2 Less than 23 kg / m 2 More than 40 kg / m 2 Less than 23 kg / m 2 Above, 25 kg / m 2 Above 30 kg / m 2 Above, 35 kg / m 2 or more than 40 kg / m 2 The above human body may have a waist circumference of 80 cm or more, 90 cm or more, for example, 90.2 cm to 99.1 cm, 88.29 cm to 100.13 cm, or 88.29 cm to 100.13 cm.

[0025] The human body may have a thigh circumference of 52.98 cm to 61.88 cm, 53.88 cm to 60.9 cm, or 52.98 cm to 61.98 cm. The human body may have a hip circumference of 100.13 cm to 107.69 cm, 100 cm to 108.82 cm, or 100 cm to 108.82 cm. In addition, the waist-hip ratio of the human body may be 0.84 to 0.96, 0.85 to 0.97, or 0.84 to 0.97. The human body may have an arm circumference of 28.6 cm to 33.18 cm, 27.4 cm to 32.14 cm, or 27.4 cm to 33.18 cm.

[0026] The above human body may be between 19 and 70 years of age, for example, between 31.78 and 57.5, between 30.55 and 50.89, or between 30.55 and 57.5 years of age.

[0027] The above human body may be a person with a disease or condition associated with a loss of muscle mass. The disease or condition associated with a loss of muscle mass may be sarcopenia, muscle atrophy including skeletal muscle atrophy, muscle weakness including age-related muscle weakness, muscle loss including cases associated with sarcopenia or cachexia, cachexia, osteoporosis, or diabetes. The person with a disease or condition associated with a loss of muscle mass may not be obese.

[0028] The composition may be administered for at least 6 weeks, for example, at least 12 weeks, or at least 24 weeks.

[0029] The above composition may be administered once or multiple times daily. The administration may be once or twice daily.

[0030] The composition may be such that it causes a change in lean body mass of 1.5% or less, for example, 1.0% or less, 0.5% or less, or 0% or less, at 12 weeks relative to the baseline. Furthermore, the composition may be such that it causes a decrease in lean body mass of 1.5% or less, for example, 1.0% or less, 0.5% or less, or 0% or less, at 12 weeks relative to the baseline. Furthermore, the composition may be such that it causes an increase in lean body mass of 0.5% or more, 1.0% or more, or 1.5% or more, at 12 weeks relative to the baseline.

[0031] When administered to a human body, the composition may reduce body fat weight (BF) without reducing lean body mass (LBM). The lean body mass (LBM) represents the value obtained by subtracting body fat (BF) from total body weight (BW).

[0032] In the above composition, the carrier may include an excipient or a diluent. The carrier may be a carbohydrate. The carbohydrate is as described above. In addition, the carrier may be one commonly used in formulations, and may be trehalose, maltodextrin, lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia gum, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, or mineral oil. In addition to the above components, the composition may further include a lubricant, a wetting agent, a sweetener, a flavoring agent, an emulsifier, a suspending agent, a stabilizer, a preservative, etc. The carrier may be present in an amount of from 0.01% to 50%, for example, from 0.01% to 20%, from 0.01% to 10%, from 0.1% to 50%, from 0.1% to 20%, from 0.1% to 10%, from 1.0% to 50%, from 1.0% to 20%, from 5.0% to 20%, or from 1.0% to 10%, based on the total weight of the composition.

[0033]

[0034] The composition may contain or be administered together with a prebiotic. The prebiotic is a non-digestible ingredient that helps the growth of beneficial bacteria in the intestines and serves as a nutrient source for probiotics, thereby helping to improve the intestinal environment. The prebiotic may be an oligosaccharide. The oligosaccharide may be GOS, FOS, polyfructose, inulin, short chain FOS, a GOS / FOS mixture, a GOS / scFOS mixture, FOS / inulin, BMOS, N-acetyl oligosaccharide, galactooligosaccharide, silyl oligosaccharide, or a combination thereof.

[0035] The above composition may be a food or pharmaceutical composition. The food may be a dietary supplement, dietary supplement, health food, or health functional food.

[0036]

[0037] Another aspect provides a method for reducing body fat weight (BF) in a human body without reducing lean body mass (LBM), comprising administering to the human body the composition. The lean body mass may be the total body weight minus the body fat mass, i.e., including muscle, water, minerals, and cell membranes.

[0038] In the above method, the composition is as described above.

[0039] The above administration may be oral. The administration may be administered before, after, or simultaneously with a meal. The administration may be administered in an amount effective to reduce body fat weight (BF) without reducing lean body mass (LBM). The administration may be administered alone or in combination with another component. The other component may be a food or meal. The administration may be administered before, simultaneously with, or after a meal.

[0040] The above dose is 1x10 per day 3 1x10 11 CFU For example, 1x10 5 1x10 11 CFU, 1x10 7 1x10 11 CFU, 1x10 9 1x10 11 CFU, 1x10 9 1x10 10 CFU, 2x10 9 8x10 9 CFU, 3x10 9 7x109 CFU, 4x10 9 6x10 9 CFU, 5x10 9 5x10 10 CFU, or 9x10 9 5x10 10 It may be administered in doses of CFU.

[0041] The above administration may be administered for more than 6 weeks, for example, more than 12 weeks, or more than 24 weeks.

[0042] The above administration may be administered as a single or multiple doses daily. The above administration may be administered at intervals of 4 to 48 hours, for example, 6 to 48 hours, 4 to 24 hours, or 12 to 24 hours.

[0043] Another aspect provides the use of a microorganism, Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP), in the preparation of a composition for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body.

[0044] The composition, human body, and administration are as described above.

[0045] The composition according to one aspect can be used to reduce body fat weight (BF) without reducing lean body mass (LBM) in a human body.

[0046] A method for reducing body fat weight (BF) without reducing lean body mass (LBM) in the human body according to different aspects can effectively reduce body fat weight (BF) without reducing lean body mass (LBM) in the human body.

[0047] According to the purpose of the microorganism Lactobacillus plantarum LMT1-48 (Accession No. KCTC13024BP) in the preparation of a composition for use in reducing body fat weight (BF) in a human body without reducing lean body mass (LBM) according to different aspects, it can be used to effectively reduce body fat weight (BF) in a human body without reducing lean body mass (LBM).

[0048] Figure 1 shows the change in body fat mass (g) measured by DEXA at ​​weeks 0 and 12.

[0049] Figure 2 shows the change in body fat percentage (%) measured by DEXA at ​​weeks 0 and 12.

[0050] Figure 3 shows the change in lean body mass (g) measured by DEXA at ​​weeks 0 and 12.

[0051] The present invention will be described in more detail below through examples. However, these examples are intended to exemplify the present invention and the scope of the present invention is not limited to these examples.

[0052] Example 1. Preparation of LMT1-48 Microorganism-Containing Formulation and Results of Clinical Trial on Adult Men and Women

[0053] In this example, the strain Lactobacillus plantarumLMT1-48 (accession number KCTC13024BP) was administered to humans and its body fat reduction effect was confirmed. The specific experimental process is as follows.

[0054] 1. Selection of research subjects

[0055] After receiving a detailed explanation of the purpose and research methods of this study, those who gave written consent were screened and selected based on their eligibility and exclusion criteria. The specific selection criteria are as follows, and the final selection included 106 overweight adult men and women. The information on the selected subjects is presented in Table 1.

[0056] Selection criteria: Adult men and women aged 19 to 70 years, with a body mass index (BMI) of 25 kg / m 2 More than 30kg / m 2 Overweight adult men and women below 18 kg / m2.

[0057] Exclusion criteria: comorbidities of chronic diseases (e.g., diabetes and cardiovascular disease), consumption of products containing antibiotics or probiotics, use of medications that may affect body weight (e.g., anorexics, antidepressants, beta-blockers, diuretics, hormonal contraceptives, and steroids), participation in a diet control program, and weight change of more than 10% in 3 months.

[0058] Test group (LMT1-48) n=53 Control group (placebo) n=53 Gender (male) 2118 Gender (female) 3235 Age (years) Mean ± standard deviation 44.64 ± 12.86 40.72 ± 10.17

[0059] 2. Research design

[0060] This study was designed and conducted as a randomized, double-blind, placebo-controlled, parallel-group trial in compliance with the International Conference on Harmonized Clinical Trials (ICH GCP), the Korean Good Clinical Practice (KGCP), and the Declaration of Helsinki. Participants were selected from among human trial subjects who voluntarily signed a consent form. After an on-site evaluation to determine whether they met the inclusion / exclusion criteria, only eligible human trial subjects were randomly assigned to either the experimental or control group in the order of registration. The experimental protocol was approved by the Institutional Review Board (IRB) of the Global Medical Research Center and the clinical trial code was MT13-KR23OWT703.

[0061] 3. Research process

[0062] 3.1. Products for clinical trials

[0063] The clinical trial product contained 5% (w / w) Lactobacillus plantarum LMT1-48 and 95% (w / w) maltodextrin and was provided as yellow capsules without flavor or off-flavor. The placebo contained 100% (w / w) maltodextrin and was provided as yellow capsules without flavor or off-flavor. The clinical trial product contained 2.5 x 10 9 Contains LMT1-48 CFU.

[0064] 3.2. Manufacturing of clinical trial products

[0065] LMT1-48 capsules were prepared as follows. Lactobacillus plantarum LMT1-48 strain was cultured in 420 ml of sterilized MRS liquid medium (BD, Difco, MI, USA) at 34°C for 14 h. The culture was taken at 0.01 g / ml and transferred to a 420 L bulk fermenter containing MRS liquid medium (BD, Difco, MI, USA) and cultured in bulk at 34°C for 17 h. The culture was then separated in a separator, the supernatant was discarded, and only the lactic acid bacteria were recovered. The recovered lactic acid bacteria were mixed with a cryoprotectant (trehalose 50%, xanthan gum 0.20%, K2HPO4 1.15%, KH2PO4 1.1%, carboxymethylcellulose 0.20%, purified water 47.35%) at a weight ratio of 1:1 while stirring, and then rapidly freeze-dried at -50℃. Subsequently, the freeze-dried bacteria were ground and powdered using a mixer to obtain freeze-dried lactic acid bacteria powder. The freeze-dried LMT1-48 cells and maltodextrin were mixed at a weight ratio of 5:95, and the mixture was placed inside a yellow capsule that had no flavor or off-odor. Placebo capsules were manufactured by the same process except that 100% maltodextrin was used instead of the freeze-dried LMT1-48 cells and maltodextrin at a weight ratio of 5:95. The capsules were packaged and provided as a single unit. The package including the above capsules was to be stored in an airtight container under refrigeration, i.e., at 2 to 8°C.

[0066] 3.3. Amount, method, and duration of intake of clinical trial products

[0067] The clinical trial product LMT1-48 or placebo was taken once a day for 12 weeks, 2 capsules per time, with water. One capsule of the clinical trial product LMT1-48 contains 2.5x10 9 Contains LMT1-48 CFU. Therefore, the dose per single administration is 5x10 9LMT1-48 cells were CFU. Compliance with the protocol was strictly monitored by counting the number of remaining capsules at each visit.

[0068] 3.4. Energy intake and physical activity (GPAQ) survey

[0069] From the beginning to the end of the study, participants were instructed to maintain a healthy lifestyle by adhering to the published guidelines. A dietary questionnaire was distributed to participants and collected at weeks 0, 6, and 12. Food intake records were analyzed using the Can Pro program of the Korean Nutrition Society to determine average daily energy intake. Additionally, the Global Physical Activity Questionnaire (GPAQ) was used to assess participants' physical activity levels by domain at week 0, 6, and 12.

[0070] 3.5. Body measurements (weight, body mass index (BMI))

[0071] Weight and body mass index (BMI, kg / m) 2 ) were measured in an 8-hour fasting state at weeks 0, 6, and 12. Body weight was measured and rounded to the nearest 0.1 kg.

[0072] 3.6. Thigh, arm, waist, hip circumference, and waist / hip ratio

[0073] At weeks 0, 6, and 12, thigh, arm, waist, and hip circumferences, as well as the waist-to-hip ratio (W / H ratio), were measured after an 8-hour fast. Measurements of thigh, arm, waist, and hip circumferences were taken using anthropometric tape while the participants stood on a flat surface. Measurements were taken three times and averaged, and the values ​​were recorded to the nearest 0.1 cm.

[0074] 3.7. Dual Energy X-ray Absorptiometry (DEXA)

[0075] Body fat mass (g), body fat percentage (%), and lean body mass (g) were measured using Dual Energy X-ray Absorptiometry (DEXA) in an 8-hour fasting state at weeks 0, 6, and 12. DEXA works by measuring the difference in the radiolucency (absorption amount) of a penetrating substance when radiation passes through the body, thereby calculating the density of the penetrating substance, and has the advantage of high accuracy. The DEXA measurements were performed using a HORIZON-WI (BHR-10-140) device.

[0076] 3.8. Blood lipids

[0077] Obesity occurs when excess energy left over after energy metabolism is converted into fat and stored in adipose cells located in the viscera or subcutaneous layer. When this fat cell accumulation reaches saturation, excessive insulin secretion leads to an increase in blood lipids. Numerous studies in obese or overweight individuals have confirmed that weight loss reduces total cholesterol, LDL cholesterol, and triglyceride levels.

[0078] Blood was collected in an 8-hour fasting state at weeks 0 and 12, and triglycerol levels among blood lipids were analyzed.

[0079] 3.9. Adiponectin

[0080] Adiponectin is a protein expressed in adipose tissue and circulating in the blood when body fat increases. It participates in fat catabolism. When body fat accumulates excessively, adiponectin expression and blood concentration decrease, making it a useful indicator of body fat accumulation.

[0081] Blood was collected in an 8-hour fasting state at weeks 0 and 12, and then an adiponectin test was performed.

[0082] 3.10. Fecal microflora

[0083] On day 0, participants were distributed a CJ fecal sampling kit (GutInside fecal collection kit), and stool samples were collected on day 0 and week 12. The fecal flora was analyzed using next-generation sequencing (NGS).

[0084] Specifically, DNA was extracted from fecal samples, the 16s rRNA gene was amplified, and a genetic library was constructed. Next, NGS was performed to identify the bacterial flora composition based on the sequence information.

[0085] 4. Statistical Analysis

[0086] Statistical analysis was performed using SAS® (Version 9.4, SAS Institute, Cary, North Carolina, USA). Data on efficacy, demographic and nutritional analyses, and safety were analyzed using a two-sided test with a significance level of 0.05. All p-values ​​were presented to four decimal places, and a p-value <0.05 was considered significant. For numerical values ​​such as means, standard deviations, and percentages, rounded to two decimal places were presented.

[0087] The data obtained from this test were presented by calculating the mean and standard deviation, and the significance of the difference was verified at the p<0.05 level using a two-tailed test.

[0088] Comparison between groups was performed using a normality test (Shapiro-Wilk) and a two-sample t-test when both the test group and the control group satisfied normality at a p-value of 0.05. If normality was not satisfied in even one group, the Wilcoxon rank sum test was used for comparison and analysis.

[0089] 5. Results

[0090] One hundred and twenty subjects were randomly assigned to the LMT1-48 and placebo groups. During the study period, 7 and 7 subjects dropped out of the LMT1-48 and placebo groups, respectively, leaving 106 subjects (53 in the LMT1-48 group and 53 in the placebo group) who ultimately completed this RCT.

[0091] 5.1. Physical indicators

[0092] Table 2 shows the body index values ​​measured at baseline (week 0), weeks 6, and 12.

[0093] Index group Week 0 Week 6 Week 12 Difference value p value 1 p value 2 Weight (kg) LMT1-48 75.48±8.15 74.58±8.4 174.07±8.24-1.41±1.79<.00010.45 27(T) Placebo 75.34±9.5 574.78±9.8 174.21±9.91-1.13±2.06 0.0002 BMI (kg / m²) LMT1-48 27.25±1.28 26.91±1.37 26.74±1.32-0.52±0.67<.00010.42 05(T) Placebo 27.00±1.31 26.80 ±1.5126.59±1.62-0.41±0.750.0002Waist circumference (cm)LMT1-4894.50±4.6093.84±4.5793.48±4.53-1.02±1.42<.00010.4518(W)Placebo94.21±5.9293.80±5.9493.34±6.22-0.87±1.620.0003Thigh circumference (cm)LMT1-4857.43±4.4557.31±4.3857.34±4.33-0.09±0.460. 16620.6593(W) Placebo57.39±3.5157.39±3.4557.36±3.38-0.03±0.630.7446Arm circumference(cm)LMT1-4830.89±2.2930.77±2.2930.65±2.30-0.24±0.36<.00010.3421(W) Placebo30.27±1.8730.20±1.8730.12±1.83-0.16±0.480.0225Hip circumference(cm)LMT1-48103.91±3.7810 3.53±3.60103.25±3.52-0.66±1.200.00020.5480(W)Placebo104.41±4.41104.24±4.27104.00±4.24-0.41±1.350.0338Waist-to-hip ratioLMT1-480.90±0.060.90±0.060.89±0.05-0.01±0.030.1030.7739(W)Placebo0.91±0.060.90±0.060.90±0.06-0.01±0.040.0959

[0094] In Table 2, values ​​are means ± standard deviations. The analysis was based on data obtained from the full analysis (n = 106) (FA set). The difference represents the difference obtained by subtracting the data at week 0 from the data at week 12. The p value 1 is the p value for the paired t-test (P) for the comparison between week 0 and week 12 within the group. The p value 2 is the p value for the two-sample t-test (T) or Wilcoxon rank sum test (W) for the comparison between the groups at week 12. As shown in Table 2, the LMT1-48 group and the placebo group showed significant decreases in body weight, BMI, waist circumference, arm circumference, and hip circumference within the group (see p value 1). There were no statistically significant differences in body parameters between the LMT1-48 group and the placebo group (see p value 2).

[0095] 5.2. DEXA

[0096] Table 3 shows the results of analyzing changes in body fat mass and lean body mass measured by DEXA at ​​baseline (week 0) and week 12.

[0097] Index group reference value Week 12 p value 1 p value 2 DEXA: Fat (g) LMT 1 -48 29,952.32 ± 4,405.97 28,326.31 ± 4,127.17 -1,626.00 ± 1,868.99 < .000 10.00 86 (W) Placebo 29,030.87 ± 4,440.7 129,030.87 ± 4,440.71 -711.91 ± 2,161.7 10.02 0 1 DEXA: Fat(%)LMT1-4840.85±6.8139.40±6.34-1.45±1.99<.00010.0036(W)Placebo39.66±5.8039.31±5.78-0.35±2.110.2288DEXA: Lean(g)LMT1-4841,929.95±8,469.1742,102.22±8,086.95172.27±1,440.780.38810.0257(W)Placebo42,508.82±8,221.8342,153.64±8,435.45-355.18±1,347.720.0605

[0098] In Table 3, values ​​are the mean ± standard deviation. The analysis was based on data from the full analysis (n=106) (FA set). The difference represents the difference obtained by subtracting the 0-week data from the 12-week data. The p-value 1 is the p-value for the paired t-test (P) for comparisons within groups. The p-value 2 is the p-value for the Wilcoxon rank sum test (W) for comparisons between groups. In the analysis of changes in body fat mass using DEXA, after 12 weeks of intake, the LMT1-48 group decreased by 1,626.00±1,868.99 g (p<0.0001), while the placebo group decreased by 711.91±2,161.71 g (p=0.0201), showing a statistically significant difference between intake groups (p=0.0086(W), Fig. 1). In the analysis of changes in body fat percentage using DEXA, after 12 weeks of intake, the LMT1-48 group decreased by 1.45±1.99% (p<0.0001), while the placebo group decreased by 0.35±2.11% (p=0.2288), showing a statistically significant difference between intake groups (p=0.0036(W), Fig. 2).

[0099] In the analysis of changes in lean body mass using DEXA, the LMT1-48 group increased by 172.27±1,440.78 g after 12 weeks of intake (p=0.3881), while the placebo group decreased by 355.18±1,347.72 g (p=0.0605), showing a statistically significant difference between the intake groups (p=0.0257(W), Fig. 3).

[0100] In summary, the LMT1-48 composition reduced body fat but increased lean body mass (LBM). This suggests that administration of LMT1-48 not only significantly suppressed lean body mass loss compared to the placebo group, but also increased lean body mass. Considering that conventional weight loss typically involves a decrease in lean body mass, this effect is a surprising and unexpected outcome for those skilled in the art.

[0101] 5.3. Blood lipid and adiponectin analysis

[0102] Table 4 shows the results of blood lipid and adiponectin analyses measured at baseline (week 0) and week 12.

[0103] Index group Week 0 Week 12 Difference p value 1 p value 2 Triglyceride (mg / dL) LMT1-48 136.94±136.78 105.62±68.20-31.32±112.49 0.047 80.99 50 (W) Placebo 111.09±57.35 94.32±51.11-16.77±42.65 0.006 Adiponectin (pg / mL) LMT1-48 4.08±0.84 4.85±0.56 0.78±1.21 <.000 10.53 99 (W) Placebo 4.11±0.81 4.87±0.52 0.76±1.03 <.000 1

[0104] In Table 4, the values ​​are the mean ± standard deviation. The analysis was based on data obtained from the full analysis (n = 106) (FA set). The difference represents the difference value obtained by subtracting the 0-week data from the 12-week data. The p value 1 is the p value for the Paired t-test (P) for comparison within the group. The p value 2 is the p value for the Wilcoxon rank sum test (W) for comparison between the groups. In the analysis of the change in triglycerides, the LMT1-48 group decreased by 31.32 ± 112.49 mg / dL after 12 weeks of intake compared to week 0, showing a statistically significant difference within the intake group (p = 0.0478). On the other hand, the placebo group decreased by 16.77 ± 42.65 mg / dL compared to week 0, showing no statistically significant difference within the intake group (p = 0.0060).

[0105] In the analysis of adiponectin changes, the LMT1-48 group increased by 0.78±1.21 pg / mL compared to week 0 after 12 weeks of intake (p<0.0001), and the placebo group increased by 0.76±1.03 pg / mL compared to week 0 (p<0.0001), so there was a statistically significant difference within the intake groups in both the LMT1-48 group and the placebo group.

[0106] In summary, ingestion of the LMT1-48 composition decreased blood triglycerides and increased adiponectin in the human body. This indicates that the LMT1-48 composition significantly reduces body fat.

[0107] 5.4. Fecal microbiota analysis

[0108] Table 5 lists the bacterial genera that showed significant differences in the bacterial flora before and after ingestion of the LMT1-48 group and the placebo group among the bacterial flora analyzed from fecal samples at weeks 0 and 12.

[0109] Bacteria-genus species p 값LMT1-48 species DALDAp_Firmicutes_C; g_Phascolarctobacterium_A3.160.049p_Proteobacteria; g_Parasutterella3,140,004p_Firmicutes_A; g_Eubacterium_G2,860,028p_Cyanobacteria; f_Gastranaerophilaceae; g_CAG_1962.470.042p_Firmicutes_A; f_Acutalibacteraceae; g_UBA59052.280.033p_Firmicutes_A; g_Eubacterium_O_2582702.270.004p_Actinobacterium; g_Adlercreutzia_4042572.190.026p_Firmicutes_A; f_Lachnospiraceae; g_CAG_952.020.042p_Proteobacteria; f_Enterobacteriaceae_A; g_Hafnia0.0232.39p_Firmicutes_A; g_Anaerococcus0.0422.81p_Firmicutes_D; g_Lactiplantibacillus0.0003.41p_Firmicutes_A; g_Lachnospira0.0363.55p_Bacteroidote; g_Expression_A_8580040.0224.13

[0110] In Table 5 above, when the linear discriminant analysis (LDA) score is expressed in the placebo group, it indicates a significant increase in the placebo group compared to the LMT1-48 group. When the LDA score is expressed in the LMT1-48 group, it indicates a significant increase in the LMT1-48 group compared to the placebo group. The results of fecal microbiota analysis showed that Lactiplantibacillus, Phocaeicola (existing Bacteroides strain), and Anaerococcus, which are known to be beneficial bacteria, increased in the LMT1-48 group compared to the placebo group. This confirms that administration of LMT1-48 can enhance the intestinal dominance competitiveness of beneficial bacteria.

Claims

1. A composition for use in reducing body fat weight (BF) without reducing lean body mass (LBM) in a human body, comprising a microorganism, Lactobacillus plantarum LMT1-48 (accession number KCTC13024BP), as an active ingredient, and a pharmaceutically or food-wise acceptable carrier.

2. A composition according to claim 1, wherein the microorganism is freeze-dried.

3. In claim 1, 1x10 3 1x10 11 A composition comprising a CFU of microorganisms.

4. A composition according to claim 1, further comprising a carbohydrate.

5. A composition according to claim 4, wherein the carbohydrate is trehalose, sucrose, glucose, fructose, lactose, maltose, maltooligosaccharide, fructooligosaccharide, maltodextrin, starch, cellulose or a combination thereof.

6. A composition according to claim 4, comprising 1 to 20% of the microorganism and carbohydrate weight basis.

7. In claim 1, the human body has a body mass index (BMI) of 23 kg / m 2 A composition that is ideal.

8. A composition according to claim 1, wherein the composition is administered for 6 weeks or longer.

9. A composition according to claim 1, which causes a change in lean body mass of 1.5% or less at 12 weeks from the baseline.

10. A composition according to claim 1, wherein the administration is performed once a day to twice a day.

11. A composition according to claim 1, which is a food.

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