HB05P on Muscle Health

The purpose of this pilot study is to evaluate whether HB05P, a health functional food ingredient containing pasteurized Akkermansia muciniphila HB05, improves muscle strength, and to evaluate its safety. This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study. A total of 80 adults aged 50 to under 80 years who meet the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia or possible sarcopenia will be randomly assigned in a 1:1 ratio to the test group or the control group. Participants will take one 430 mg hard capsule once daily with water after breakfast for 168 days (24 weeks). The test capsule contains 150 mg of HB05P (3 x 10\^10 cells per day); the control capsule contains microcrystalline cellulose and is identical in appearance and packaging. All participants are asked to perform 30 to 60 minutes of walking and resistance exercise at least 3 times per week throughout the study and to keep an exercise diary and an intake diary. The primary outcome is the change from baseline in peak torque per body weight (Nm/kg) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second and averaged across the left and right sides. Secondary outcomes include muscle power, muscle mass measured by dual-energy X-ray absorptiometry, handgrip strength, Short Physical Performance Battery scores, muscle-related blood markers, and quality of life. Efficacy and safety are assessed at Day 0, Day 84, and Day 168.

Inclusion Criteria: * Men or women aged 50 to under 80 years who meet all inclusion criteria and none of the exclusion criteria * Meeting the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia (low muscle mass and low handgrip strength) or possible sarcopenia (low muscle mass with either low handgrip strength or low physical performance), defined as follows: * Muscle mass, measured as ASM/height\^2 by bioelectrical impedance analysis: age 50 to 64 years, less than 7.6 kg/m\^2 for men and less than 5.7 kg/m\^2 for women; age 65 years or older, less than 7.0 kg/m\^2 for men and less than 5.7 kg/m\^2 for women * Handgrip strength, maximum value of the dominant hand: age 50 to 54 years, 34.5 kg or less for men and 22.0 kg or less for women; age 55 to 59 years, 33.5 kg or less for men and 21.5 kg or less for women; age 60 to 64 years, 31.0 kg or less for men and 20.0 kg or less for women; age 65 to 69 years, 29.0 kg or less for men and 19.0 kg or less for women; age 70 to 74 years, 27.5 kg or less for men and 18.0 kg or less for women; age 75 to 79 years, 26.0 kg or less for men and 16.8 kg or less for women * Physical performance, 5-time chair stand test of the Short Physical Performance Battery: more than 10 seconds for age 50 to 64 years, more than 12 seconds for age 65 years or older * Not having participated in a commercial exercise program or performed regular resistance exercise 2 or more times per week within the 3 months before study participation * Physically able to participate in the standardized resistance exercise program provided from the start of the study at least 3 times per week, and willing to comply with it * Having received a full explanation of the purpose and procedures of the study and having voluntarily provided written informed consent Exclusion Criteria: * Short Physical Performance Battery total score of 3 or less * Cachexia or unintentional weight loss of 5 percent or more within the past 3 months * History of fracture or musculoskeletal surgery within the past 6 months * Musculoskeletal or functional limitation that precludes isokinetic strength testing or performance of the standardized exercise program (for example, severe osteoarthritis or rheumatoid arthritis) * Uncontrolled or clinically unstable endocrine disease (for example, Cushing syndrome or adrenal insufficiency) * Severe respiratory disease (COPD GOLD stage III to IV or long-term oxygen therapy) * Uncontrolled hypertension (systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher), uncontrolled diabetes mellitus (fasting glucose 160 mg/dL or higher), or uncontrolled thyroid disease * Major cardiovascular or cerebrovascular event within the past 6 months (acute myocardial infarction, stroke, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting) * History of malignancy within 3 years before screening or currently receiving anticancer treatment, except malignancies with negligible risk of metastasis or death such as adequately treated non-melanoma skin cancer or carcinoma in situ * AST or ALT greater than 3 times the upper limit of normal at screening * Serum creatinine greater than 2 times the upper limit of normal at screening * History of gastrointestinal surgery or gastrointestinal disease that may affect absorption of the study food, except simple appendectomy or hernia repair * Known hypersensitivity to the active ingredient or any component of the study food * Use of systemic antibiotics or bowel preparation agents within 2 weeks before screening * Intake of probiotics, prebiotics, or lactic acid bacteria or fermented milk products 4 or more times per week within 2 weeks before screening, excluding fermented foods included in a regular diet * Continuous use of protein supplements or muscle-related health functional foods within 1 month before screening * Use of medications that may affect muscle mass or muscle strength within 3 months before screening, including systemic corticosteroids (oral or injectable), testosterone, growth hormone preparations, selective androgen receptor modulators, and anti-obesity drugs * Severe alcohol use disorder according to DSM-5 diagnostic criteria * Continuous use of psychiatric medication for schizophrenia, bipolar disorder, or severe major depressive disorder, excluding intermittent medication for sleep disturbance * Participation in another clinical trial within 3 months before screening, or current participation in another clinical trial * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period * Any other condition that, in the judgment of the principal investigator, may affect the safety of the participant or the integrity of the study results