Lactobacillus paracasei NB23 strain and method of using the same to increase muscle mass and to prevent metabolic syndrome

Lactobacillus paracasei NB23 strain addresses muscle loss and metabolic syndrome by enhancing muscle protein synthesis and reducing inflammation, offering a treatment for sarcopenia and associated conditions.

JP2025079316AActive Publication Date: 2025-05-21NEW BELLUS ENTERPRISES
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Patent Information

Application Number
JP2024169647
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-09
Filing Date
2024-09-27
Publication Date
2025-05-21
Estimated Expiration
2044-09-27

AI Technical Summary

Technical Problem

Current clinical practices lack effective treatments for sarcopenia and metabolic syndrome, primarily due to the difficulty in maintaining exercise and dietary habits, leading to muscle mass loss and associated health issues.

Method used

The use of Lactobacillus paracasei NB23 strain, which promotes muscle protein synthesis, inhibits muscle protein degradation, and has anti-inflammatory properties, is administered to increase muscle mass and treat metabolic syndrome.

Benefits of technology

Lactobacillus paracasei NB23 strain effectively increases muscle mass, reduces inflammation, and improves metabolic indicators, thereby treating or preventing sarcopenia and related diseases.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a Lactobacillus paracasei NB23 strain and its uses for increasing muscle mass and preventing metabolic syndrome.SOLUTION: The present invention discloses a Lactobacillus paracasei NB23 strain and its uses for increasing muscle mass and preventing metabolic syndrome. The Lactobacillus paracasei NB23 strain is deposited at the Food Industry Research and Development Institute in Hsinchu City, Taiwan, under the deposit number BCRC911201. By administering the Lactobacillus paracasei NB23 strain or a metabolite thereof to an individual, the effect of effectively treating or preventing diseases associated with muscle loss or insufficient muscle mass, metabolic syndrome, and diseases related thereto can be achieved.SELECTED DRAWING: Figure 1
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Description

[Technical field]

[0001] The present invention relates to a novel probiotic strain and its uses, in particular to Lactobacillus paracasei NB23 and its uses in increasing muscle mass and anti-metabolic syndrome. [Background technology]

[0002] Muscles make up about 40-50% of the human body's weight, and the amount of muscle mass and strength are closely related to the metabolism and ability to maintain activity. Research has shown that after the age of 30, muscle mass decreases year by year, and the rate of decline increases with age, with muscle mass decreasing by about 10-20% at age 40-50 compared to that at age 30. The loss of muscle mass is not only related to age, but also to exercise and eating habits. A decrease in muscle mass not only affects the silhouette of the person's appearance, but also affects the behavior and ability to act of the individual, such as making the lower back and back more susceptible to pain, being unable to lift heavy objects, becoming slower, and having a poorer memory.

[0003] In current clinical practice, there is no treatment for sarcopenia caused by loss of muscle mass, and patients can only be advised to improve their diet and exercise habits. This means that to improve the symptoms of sarcopenia, it is necessary to ingest high protein and increase the time of load-bearing exercise. However, most patients find it difficult to continue improving their exercise and dietary habits, so sarcopenia remains one of the difficult conditions to treat. Therefore, it can be understood that the development of a composition that can help treat or improve muscle mass deficiency and related diseases is an important challenge. Summary of the Invention [Problem to be solved by the invention]

[0004] The main objective of the present invention is to provide Lactobacillus paracasei NB23 strain and its use for increasing muscle mass and anti-metabolic syndrome. The Lactobacillus paracasei NB23 strain disclosed in the present invention is a probiotic that is safe for the human body, and has various physiological activities including promoting muscle protein synthesis and mass increase, promoting muscle cell proliferation and hypertrophy, anti-inflammation, antioxidant, etc., so that the Lactobacillus paracasei NB23 strain can be developed into a lactic acid bacteria-related product. [Means for solving the problem]

[0005] In order to achieve the above-mentioned objectives, the present invention discloses Lactobacillus paracasei NB23 and its use in increasing muscle mass and anti-metabolic syndrome. The Lactobacillus paracasei NB23 strain was deposited at the Food Industry Development Research Institute, Hsinchu Foundation, Taiwan on October 4, 2023, with the deposit number BCRC911201.

[0006] In one embodiment of the present invention, the composition disclosed comprises an effective amount of the Lactobacillus paracasei NB23 strain or a metabolite thereof, wherein the composition can be a food, a dietary supplement, a pharmaceutical composition, etc.

[0007] For example, when the composition is a food product, the composition comprises an effective amount of the Lactobacillus paracasei NB23 strain and a food-acceptable ingredient, or when the composition is a pharmaceutical composition, the composition comprises an effective amount of the Lactobacillus paracasei NB23 strain and a pharma- ceutically acceptable ingredient.

[0008] In the following embodiment of the present invention, the Lactobacillus paracasei NB23 strain has the activity of inhibiting NF-κB and Fox-O, and therefore can prevent the degradation of muscle proteins or apoptosis of muscle cells. Therefore, a composition containing the Lactobacillus paracasei NB23 strain or its metabolites can be used for the treatment and / or prevention of sarcopenia or its associated symptoms such as muscle atrophy, muscle weakness, difficulty in movement, and lack of grip strength.

[0009] In another embodiment of the present invention, the Lactobacillus paracasei NB23 strain can activate IGF-1 (insulin-like growth factor) and insulin, thereby activating the PI-3K / Akt / mTOR pathway and promoting protein synthesis in muscle cells. Therefore, by administering the Lactobacillus paracasei NB23 strain or a composition containing its metabolites to an individual, the muscle synthesis rate can be improved, thereby improving the muscle mass of the individual, and achieving the effects of increasing muscle mass and improving related diseases caused by muscle deficiency.

[0010] In yet another embodiment of the present invention, the use of Lactobacillus paracasei NB23 strain in the preparation of a composition for treating or improving metabolic syndrome is provided. Specifically, Lactobacillus paracasei NB23 strain can lower blood pressure, triglyceride, fasting blood glucose level, and increase HDL cholesterol, so that the effect of preventing or treating metabolic syndrome and its related diseases can be achieved by administering the composition containing Lactobacillus paracasei NB23 strain or its metabolites to an individual.

[0011] In one embodiment of the present invention, the use of Lactobacillus paracasei NB23 strain in preparing a composition for treating or improving cardiovascular disease is disclosed. Lactobacillus paracasei NB23 strain has the activity of reducing anti-inflammatory and cytotoxicity indicators, and at the same time, has the activity of controlling cardiovascular sclerosis indicators, so that the composition containing Lactobacillus paracasei NB23 strain or its metabolites can be administered to an individual to achieve the effect of preventing or treating cardiovascular disease.

[0012] Among them, cardiovascular diseases are caused by hardening of blood vessels.

[0013] Among these, cardiovascular sclerosis indicators include LDL cholesterol, HDL cholesterol, total cholesterol / LDL cholesterol (ratio), LDL cholesterol / HDL cholesterol (ratio), vitamin D, etc.

[0014] Among these, cytotoxicity indicators include CRP (C-reactive protein), LDH (lactate dehydrogenase), TNFα, IL-6, and the like. [Brief description of the drawings]

[0015] [Figure 1] This shows the results of an analysis of PIK protein expression levels in muscle cells after co-culturing muscle cells with different strains of lactic acid bacteria. [Diagram 2] This is the result of an analysis of mTOR protein expression levels in muscle cells after co-culturing muscle cells with different strains of Lactobacillus. [Diagram 3] This is the result of an analysis of the amount of AKT protein expression in muscle cells after co-culturing muscle cells with different strains of lactic acid bacteria. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The present invention discloses Lactobacillus paracasei NB23 and its use in increasing muscle mass and anti-metabolic syndrome. Specifically, the Lactobacillus paracasei NB23 strain disclosed in the present invention has the ability to activate PI3K / Akt / mTOR, which is a signal transduction pathway of IGF-1, to lower CRP (C-reactive protein), LDH (lactate dehydrogenase), TNFα, and IL-6, which are indicators of inflammation and cytotoxicity, to lower LDL-C (LDL cholesterol), TC / HDL-C (total cholesterol / HDL cholesterol), and LDL-C / HDL-C ratio, which are indicators of cardiovascular sclerosis, and to improve HDL-C (HDL cholesterol) and vitamin D, which are indicators of cardiovascular disease. At the same time, the Lactobacillus paracasei NB23 strain or its metabolites have the activity to control metabolic syndrome indicators, such as lowering systolic blood pressure, lowering triglycerides, lowering fasting blood glucose, and increasing HDL-C. Therefore, by administering an effective amount of the Lactobacillus paracasei NB23 strain or its metabolites to an individual, it is possible to effectively achieve the effect of treating or preventing metabolic syndrome and related diseases caused by muscle loss or insufficient muscle mass, and related diseases thereof.

[0017] The Lactobacillus paracasei NB23 strain disclosed in the present invention was deposited at the Food Industry Development Research Institute, Hsinchu Foundation, Taiwan on October 4, 2023, with the deposit number BCRC911201.

[0018] Among them, the Lactobacillus paracasei NB23 strain disclosed in the present invention is a Gram-positive bacterium isolated from pickled vegetables, and its culture conditions are Lactobacilli MRS Broth, a growth temperature of 37°C, and an anaerobic environment.

[0019] The term "effective amount" refers to the administration of a probiotic or a metabolite thereof that can achieve relief or amelioration of one or more symptoms of the disease being treated, reduction in the discomfort of one or more symptoms, or slowing the progression of the disease.

[0020] The term "composition" refers to a composition containing the Lactobacillus paracasei NB23 strain or its metabolites disclosed in the present invention, which is the main active ingredient, and can be prepared into various dosage forms based on factors such as the subject of use and the method of use, and can also contain excipients, vehicles, and other ingredients acceptable in the pharmaceutical or food industry. For example, the composition can be a pharmaceutical product, a dietary supplement, a food, or a therapeutic preparation.

[0021] The term "metabolites" refers to by-products produced during the cultivation of the Lactobacillus paracasei NB23 strain disclosed in the present invention and may be present in the culture medium.

[0022] The term "administration" refers to the act or method of administering the Lactobacillus paracasei NB23 strain disclosed in the present invention, its metabolites, or compositions containing the above-mentioned strains or their metabolites to an individual, for example orally, by implantation, etc.

[0023] In the following, in order to explain the technical features of the present invention and the effects that can be achieved by it, several embodiments will be described in detail with reference to the drawings.

[0024] Cells such as C2C12 myoblasts used in the following examples are biological materials that can be easily obtained by those skilled in the art, and therefore do not need to be deposited.

[0025] All human testing content and procedures disclosed in the following examples comply with ethical standards.

[0026] Example 1: Muscle cell culture

[0027] C2C12 muscle cells were placed in the medium and cultured under the conditions of 5% CO2 and 37℃, and the growth medium required for the growth of muscle cells was provided in a timely manner during the culture process. The medium used was DMEM medium containing 5% fetal bovine serum, and the growth medium contained 1% 4mM L-glutamine, 1.5g / L sodium bicarbonate, 4.5g / L glucose, 100μg / mL streptomycin, 10unit / mL penicillin, and its pH value was 7.1~7.4.

[0028] Example 2: Antioxidant Testing

[0029] The lactic acid bacteria shown in Table 1 were prepared and cultured, and the culture supernatants of each strain of lactic acid bacteria were crushed and diluted 16, 50, and 200 times to obtain samples of different dilutions of each lactic acid bacteria. C2C12 muscle cells were treated with each sample, and the absorbance of each group of cells was analyzed, and the DPPH radical scavenging ability of each strain of lactic acid bacteria was calculated. The results are shown in Table 2.

[0030] Table 1: Lactic acid bacteria samples and sample origin JPEG2025079316000002.jpg233153JPEG2025079316000003.jpg11153

[0031] Table 2: DPPH radical scavenging ability of each lactic acid bacteria strain JPEG2025079316000004.jpg202126

[0032] As can be seen from the results in Table 2, overall, the higher the sample dilution ratio of the lactic acid bacteria samples, the lower their DPPH radical scavenging ability. Among these, the 8-fold dilution concentration had the best antioxidant effect, followed by the 16-fold dilution concentration.

[0033] Furthermore, the NB42 strain was the only one that did not reach 50% or more at 8-fold dilution, and the DPPH radical scavenging rate at 50-fold and 200-fold dilution did not reach 40% at either of them. At 16-fold dilution, the NB17 strain had a DPPH radical scavenging rate of 71.82%, and the strains with the best DPPH radical scavenging effect at 50-fold and 200-fold dilution were NB34, NB17, and NB23, respectively.

[0034] Example 3: Cell viability test

[0035] The lactic acid bacteria shown in Table 1 were prepared and cultured, and the culture supernatants of each lactic acid bacteria strain were crushed and diluted 16, 50, and 200 times to obtain samples of each lactic acid bacteria at different dilutions. C2C12 muscle cells were treated with each sample, and the viability of the C2C12 muscle cells treated with the lactic acid bacteria samples at different dilutions was examined by MTT analysis. The results are shown in Table 3 below.

[0036] Table 3: Viability of muscle cells after treatment with different dilutions of Lactobacillus strains. JPEG2025079316000005.jpg208170

[0037] As can be seen from the results in Table 3, the lactic acid bacteria samples had dose- and time-dependent effects on C2C12 muscle cells at a 16-fold dilution. The higher the concentration of the lactic acid bacteria samples, the lower the survival rate of the muscle cells, and the longer the duration of action, the lower the survival rate. After culturing each lactic acid bacteria sample with muscle cells at a 16-fold dilution for 72 hours, the survival rates of the strains numbered NB04, 10, 18, 20, 30, 36, 42, and 43 all exceeded 100%. However, in reality, the above eight strains tend to remain at the bottom of the 96-well plate and cannot be removed by filtration. The main reason for this is that the cell membrane characteristics of these strains are easily bound to muscle cells. Therefore, although the measured survival rates were high, they were not useful, and the above eight strains were excluded from subsequent tests.

[0038] Example 3: Analysis of protein expression in muscle cells

[0039] Based on the results of Tables 2 and 3, and taking into consideration the feasibility of quantifying each strain, the following lactic acid bacteria numbers NB07, NB17, NB23, and NB34 were selected, and each of the selected lactic acid bacteria was cultured with C2C12 muscle cells for 12 hours and 24 hours. After 24 hours of co-culture, the protein content of the C2C12 muscle cells treated with each of the above-mentioned lactic acid bacteria and the expression levels of PI3K, Akt, and mTOR proteins, which are proteins related to muscle growth in the cells, were examined by Western blotting. The results are shown in Table 4 and Figures 1 to 3 below. Among them, the gene protein concentrations shown in Figures 1 to 3 are values ​​quantified using ImageJ software from the results (shades of band colors) obtained by Western blotting.

[0040] Table 4: Protein content after co-cultivation of each Lactobacillus strain with muscle cells. JPEG2025079316000006.jpg105146

[0041] As can be seen from the results of Table 4 and Figures 1 to 3, the lactic acid bacteria strains with the best effect of improving muscle cell mass were NB23, NB07, NB34, and NB17, in that order.

[0042] As can be seen from the results of Examples 2 to 4, the Lactobacillus paracasei NB23 strain disclosed in the present invention can not only eliminate radicals in muscle cells, but also maintain the proliferation and viability of muscle cells, and at the same time, can achieve the effect of increasing muscle proliferation and hypertrophy by improving the expression level of PI3K and AKT proteins, and can achieve the effect of promoting muscle synthesis and increase by improving the expression level of mTOR protein. In other words, the Lactobacillus paracasei NB23 strain disclosed in the present invention has the activity of treating or improving muscle mass deficiency and its related diseases. This means that by administering an effective amount of the Lactobacillus paracasei NB23 strain, its metabolites, or a composition containing any of the above-mentioned substances to an individual, the muscle mass and strength of the individual can be effectively increased, thereby achieving the effect of treating or preventing sarcopenia and its related symptoms.

[0043] Example 5: Human testing

[0044] Subjects were randomly divided into two groups and the study period was 12 weeks.

[0045] The placebo group received 3 g of placebo (maltodextrin starch) every day after breakfast and dinner.

[0046] The NB23 group took one bag (3 g / bag) containing the Lactobacillus paracasei NB23 strain with a viable cell count of 50 billion CFU every day after breakfast and dinner.

[0047] Example 6: Analysis of blood pressure, body fat percentage and skeletal muscle percentage

[0048] The subjects in each group in Example 5 were subjected to the following tests.

[0049] At weeks 0 and 12, the skeletal muscle and body fat percentages of the subjects in each group were examined using a commercially available body fat scale.

[0050] Muscle strength and function were evaluated at weeks 0 and 12. Grip strength was evaluated using a hand dynamometer (TTM, Tokyo, Japan) to evaluate upper limb muscle strength. The number of times a one-minute chair sit-to-stand test was measured to evaluate lower limb muscle strength.

[0051] Analyses were conducted based on the above test results, and the results are shown in Tables 5 to 10 below.

[0052] As can be seen from the results of Tables 5 to 6, there was no difference in the body fat percentage and skeletal muscle percentage of the subjects in each group at the 0th week of the study, and at the 12th week of the study, the skeletal muscle percentage-trunk and chair sitting and standing times per minute of the subjects in the NB23 group were all significantly increased compared to the placebo group. Also, as can be seen from the results of Table 7, the subjects in the NB23 group had significantly greater improvement effects than the placebo group in the items of minimum blood pressure, body fat percentage, skeletal muscle percentage-both legs, skeletal muscle percentage-both arms, skeletal muscle percentage-trunk, skeletal muscle percentage-average, and chair sitting and standing times per minute. Among them, items such as skeletal muscle percentage-both legs, skeletal muscle percentage-both arms, skeletal muscle percentage-trunk, skeletal muscle percentage-average, and chair sitting and standing times per minute were significantly improved compared to the placebo group, and other items were lower than the placebo group.

[0053] As can be seen from the results in Table 8, the total body skeletal muscle ratio, both arm skeletal muscle ratio, trunk skeletal muscle ratio, average skeletal muscle ratio, and chair sit-to-stand count per minute of the female subjects in the NB23 group were all increased compared to the female subjects in the placebo group, and the decrease in body fat percentage of the female subjects in the NB23 group was significantly greater than that of the female subjects in the placebo group, and the decrease in systolic blood pressure of the male subjects in the NB23 group was greater than that of the female subjects.

[0054] As can be seen from the results in Table 9, the increase in trunk skeletal muscle ratio in subjects aged 40-60 in the NB23 group was significantly higher than that in subjects aged 20-40. As can be seen from the results in Table 10, in the NB23 group, subjects with BMI<24kg / m 2The subjects in the NB23 group had significantly higher increases in trunk skeletal muscle ratio, average skeletal muscle ratio, and chair sit-to-stand times per minute, as well as decreases in minimum blood pressure, body fat percentage, and average grip strength than the subjects in the placebo group. 2 The mean increase in grip strength in subjects with a BMI < 24 kg / m 2 was larger than that of the subjects.

[0055] Table 5: Analysis of blood pressure, body fat and skeletal muscle percentage in week 0 of the study for subjects in each group JPEG2025079316000007.jpg174148

[0056] Table 6: Analysis of blood pressure, body fat and skeletal muscle percentage for subjects in each group at week 12 of the study JPEG2025079316000008.jpg169148

[0057] Table 7: Analysis of differences in blood pressure, body fat and skeletal muscle percentage between weeks 0 and 12 of the study for subjects in each group JPEG2025079316000009.jpg164149

[0058] Table 8: Difference analysis of blood pressure, body fat and skeletal muscle percentage between weeks 0 and 12 of the study for subjects of different genders JPEG2025079316000010.jpg174148

[0059] Table 9: Difference analysis of blood pressure, body fat and skeletal muscle percentage between weeks 0 and 12 of the study for subjects of different age groups JPEG2025079316000011.jpg175148

[0060] Table 10: Difference analysis of blood pressure, body fat and skeletal muscle percentage between subjects with different BMIs at week 0 and week 12 of the study JPEG2025079316000012.jpg179147

[0061] Example 7: Blood biochemical value testing and analysis

[0062] At the 0th and 12th weeks of the test, the subjects of each group of Example 5 were examined for blood biochemical values. The results are shown in Tables 11 to 15 below. Among them, TG stands for triglyceride, TC stands for total cholesterol, LDL-C stands for LDL cholesterol, HDL-C stands for HDL cholesterol, BUN stands for blood urea nitrogen, GOT stands for aspartate aminotransferase, GPT stands for alanine aminotransferase, TP stands for total protein, CRP stands for C-reactive protein, and LDH stands for lactate dehydrogenase.

[0063] As can be seen from the results in Table 11, the cardiovascular sclerosis index factors (TC, LDL-C, LDL-C / HDL-C), renal function index factors (BUN, uric acid), and myocardial infarction / liver function / muscle damage factor-GOT values ​​of the subjects in the NB23 group were significantly lower at week 12 of the study than at week 0 of the study. As can be seen from the results in Table 12, the blood vitamin D levels of the subjects in the NB23 group were significantly higher than those of the female subjects in the placebo group, and the values ​​of the index items TG, TC, LDL-C, TC / HDL-C, LDL-C / HDL-C, BUN, creatinine, uric acid, GOT, fasting blood glucose, HbA1C, insulin, and fibrinogen were also significantly lower than those of the placebo group.

[0064] According to the results in Table 11, 12 weeks after administration of Lactobacillus paracasei NB23 strain, the TG, LDL-C, and BUN values ​​of the subjects in the NB23 group were significantly lower than those in the placebo group. As can be seen from the results in Table 12, the subjects in the NB23 group had significantly lower cardiovascular sclerosis indicators (plasma TC, LDL-C, LDL-C / HDL-C), renal function indicators (BUN, uric acid), and myocardial infarction / liver function / muscle damage (GOT) 12 weeks after administration of Lactobacillus paracasei NB23 strain than before the test (week 0), but the placebo group had no significant differences in any of the indicators in the blood biochemical tests before and after the test.

[0065] As can be seen from the results in Table 13, 12 weeks after administration of Lactobacillus paracasei NB23 strain, the male subjects in the NB23 group showed significantly greater reductions in plasma TG, TC, LDL-C, LDL-C / HDL-C, LDH levels, as well as serum creatinine, uric acid, GOT, albumin, and insulin than the placebo group, while the female subjects in the NB23 group showed significantly greater reductions in indicators such as TC, LDL-C, LDL-C / HDL-C, uric acid, TG, and HbA1c than the placebo group.

[0066] As can be seen from the results in Table 14, subjects aged 20-40 years in the NB23 group showed significantly greater decreases in indicators such as plasma TC, LDL-C, LDL-C / HDL-C, and serum creatinine than the placebo group. 12 weeks after administration of Lactobacillus paracasei NB23 strain, subjects aged 20-40 years in the NB23 group showed significantly greater decreases in indicators such as plasma TG, TC / HDL-C, serum uric acid, fasting blood glucose, and insulin than the placebo group, and the increase in serum fibrinogen was also greater than the placebo group. Subjects aged 40-60 years in the NB23 group showed significantly greater decreases in indicators such as plasma LDL-C, uric acid, TG, TC, and LDL-C / HDL-C than the placebo group. Furthermore, the reductions in plasma TC / HDL-C and LDL-C / HDL-C, which are cardiovascular sclerosis factors, in subjects aged 20 to 40 years in the NB23 group were significantly greater than those in subjects aged 40 to 60 years in the NB23 group, but the results for plasma TP levels were the opposite.

[0067] The results in Table 15 show that 12 weeks after administration of Lactobacillus paracasei NB23 strain, the BMI of the NB23 group was <24 kg / m 2 The subjects in the NB23 group showed significantly greater reductions in plasma TC, LDL-C, TC / HDL-C, LDL-C / HDL-C, serum creatinine, HbA1c, and other indicators than the placebo group, and the increase in serum vitamin D was also significantly greater than in the placebo group. 2The subjects in the 10-mg / kg / day group also showed more significant decreases in plasma TG, TC, LDLC, LDL-C / HDL-C, BUN, uric acid, albumin, and other indicators than the placebo group, and the increases in serum fibrinogen were also greater than in the placebo group.

[0068] As can be seen from the above results, by administering the Lactobacillus paracasei NB23 strain disclosed in the present invention for 12 consecutive weeks, it can reduce the expression of inflammation and cell damage index (LDH) in subjects, and at the same time reduce cardiovascular sclerosis index factors (LDL-C, TC / HDL-C, LDL-C / HDL-C ratio), and improve cardiovascular disease index (HDL-C, vitamin D) and metabolic syndrome index (maximum blood pressure, triglyceride, fasting blood glucose are reduced, and HDL-C is increased). In other words, the Lactobacillus paracasei NB23 strain disclosed in the present invention or its metabolites can be used for the treatment or prevention of metabolic syndrome and cardiovascular-related diseases.

[0069] Table 11: Analysis of blood biochemistry values ​​of subjects in each group at weeks 0 and 12 of the study JPEG2025079316000013.jpg153154

[0070] Table 12: Blood biochemical analysis before and after lactobacillus supplementation JPEG2025079316000014.jpg112144

[0071] Table 13: Differential analysis of blood biochemical values ​​in subjects of different genders JPEG2025079316000015.jpg188148

[0072] Table 14: Differential analysis of blood biochemical values ​​in subjects of different age groups JPEG2025079316000016.jpg190148

[0073] Table 15: Differential analysis of blood biochemical values ​​of subjects with different BMI JPEG2025079316000017.jpg188148

[0074] Example 8: Analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation

[0075] At week 0 and week 12, the inflammation indicators TNF-α, IL-6, PARP, the cellular protein degradation indicators NF-κB, Fox-O, MyoD (cell differentiation and maturation factor), and the cellular protein synthesis indicators PI3K, Akt, mTOR (myogenic regulatory factor), insulin, and IGF-1 (insulin-like growth factor) were examined for each subject in Example 5. The results are shown in Tables 16 to 20.

[0076] As can be seen from the results in Table 16, 12 weeks after administration of Lactobacillus paracasei NB23 strain, the MyoD and expression levels of subjects in the NB23 group were significantly higher than those in the placebo group, and the expression levels of muscle protein degradation regulators TNFα, NF-κB, and FoxO were also significantly lower than those in the placebo group. Furthermore, after 12 weeks of the study, subjects in the NB23 group showed a significant increase in the expression level of mTOR, a myogenic regulator, but there was no significant difference in the placebo group.

[0077] As can be seen from the results in Table 17, 12 weeks after administration of Lactobacillus paracasei NB23 strain, the subjects in the NB23 group had significantly lower serum insulin levels than the placebo group, and the levels of TNFα and IL-6 were significantly decreased, and the expression levels of mTOR and MyoD were significantly increased compared to the subjects in the placebo group.

[0078] The results in Table 18 show that 12 weeks after administration of Lactobacillus paracasei NB23 strain, the decreased serum TNFα and serum mTOR content were higher in both male and female subjects than in the placebo group, and the serum MyoD level in female subjects was significantly higher than in the placebo group. In addition, the decreased serum TNFα level in female subjects in the NB23 group was significantly higher than that in male subjects.

[0079] As can be seen from the results in Table 19, 12 weeks after administration of Lactobacillus paracasei NB23 strain, subjects aged 20-40 years in the NB23 group showed significantly higher decreases in serum TNFα and insulin than the placebo group, and also showed larger increases in serum MyoD, IGF-1, mTOR, and other indicators than the placebo group. In the NB23 group, subjects aged 20-40 years showed significantly higher decreases in serum TNF than the placebo group, and also showed larger increases in serum PI3K and mTOR than the placebo group. In addition, as can be seen by comparing subjects of different age groups in the NB23 group, 12 weeks after administration of Lactobacillus paracasei NB23 strain, subjects aged 20-40 years showed significantly higher decreases in serum TNFα than subjects aged 40-60 years. From these results, it can be seen that regardless of the age group of the subjects, 12 weeks after administration of the Lactobacillus paracasei NB23 strain disclosed in the present invention, the content of inflammatory factors such as TNFα in the serum can be reduced and the content of mTOR, a muscle protein synthesis regulator, can be increased.

[0080] As can be seen from the results in Table 20, in the NB23 group, BMI < 24 kg / m 2 The subjects in the 100 mg group had significantly greater increases in serum MyoD, IGF-1, mTOR, and other indicators than the placebo group, and the decreases in serum TNFα were also significantly greater than those in the placebo group. 2 The subjects in the NB23 group also showed significantly higher decreases in serum TNFα and insulin than the placebo group, and significantly higher increases in serum mTOR than the placebo group. 2 The subjects with a BMI < 24 kg / m2 showed a significant reduction in serum FoxO indices. 2 was significantly larger than that of the subjects.

[0081] The above results show that the Lactobacillus paracasei NB23 strain disclosed in the present invention can reduce the content of inflammatory factors such as TNFα in the serum of subjects, and improve the activity of muscle protein synthesis factors such as mTOR in the serum. This means that by administering an effective amount of the Lactobacillus paracasei NB23 strain disclosed in the present invention or its metabolites to an individual, it can effectively improve the inflammatory response of the individual and its associated diseases, and at the same time, it can increase the muscle synthesis activity of the individual, thereby achieving the effect of treating or improving the symptoms caused by muscle deficiency.

[0082] Table 16: Analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation in subjects of each group at weeks 0 and 12 of the study. JPEG2025079316000018.jpg119160

[0083] Table 17: Differential analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation before and after the test in subjects of each group JPEG2025079316000019.jpg67145

[0084] Table 18: Differential analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation before and after the test in subjects of different genders. JPEG2025079316000020.jpg119150

[0085] Table 19: Differential analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation before and after the test in subjects of different age groups JPEG2025079316000021.jpg120150

[0086] Table 20: Differential analysis of factors regulating muscle protein synthesis, degradation, and cell differentiation and maturation before and after the test in subjects with different BMI values JPEG2025079316000022.jpg119150

Claims

1. Lactobacillus paracasei NB23 strain, deposited at the Food Industry Development Research Institute, Hsinchu Foundation, Taiwan on October 4, 2023, with the deposit number BCRC911201.

2. A composition comprising at least an effective amount of the Lactobacillus paracasei NB23 strain or a metabolite thereof according to claim 1.

3. A composition for treating or preventing sarcopenia and its associated symptoms, comprising the Lactobacillus paracasei NB23 strain described in claim 1.

4. The composition according to claim 3, wherein the Lactobacillus paracasei NB23 strain is used to inhibit NF-κB and Fox-O.

5. A composition for increasing muscle mass comprising the Lactobacillus paracasei NB23 strain of claim 1.

6. The composition according to claim 5, wherein the Lactobacillus paracasei NB23 strain is used to activate the IGF-1 (insulin-like growth factor-1) signaling pathway.

7. A composition for treating or ameliorating metabolic syndrome, comprising the Lactobacillus paracasei NB23 strain described in claim 1.

8. The composition of claim 7, wherein the metabolic syndrome is associated with an imbalance in at least one of the risk factors: blood pressure, blood glucose, LDL cholesterol, and triglycerides.

9. A composition for treating or ameliorating cardiovascular disease, comprising the Lactobacillus paracasei NB23 strain described in claim 1.

10. The composition according to claim 9 , wherein the cardiovascular disease is caused by hardening of blood vessels.