HB05P on Muscle Health

Study design This is a randomized, double-blind, placebo (comparator food)-controlled, parallel-group, single-center exploratory (pilot) clinical trial of a health functional food ingredient. Eligible participants who provide written informed consent are randomly assigned 1:1 to the test group or the control group.

Sample size 64 participants (32 per group) are required for efficacy evaluation. Allowing for a 20 percent dropout rate, 80 participants (40 per group) will be enrolled.

Study population Adults aged 50 to under 80 years who meet the 2025 AWGS criteria for sarcopenia or possible sarcopenia. Muscle mass is assessed as ASM/height^2 by bioelectrical impedance analysis, handgrip strength as the maximum value of the dominant hand, and physical performance by the 5-time chair stand test of the Short Physical Performance Battery.

Investigational products Test food: one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05), microcrystalline cellulose, silicon dioxide, and magnesium stearate. Control food: one hard capsule of 430 mg containing microcrystalline cellulose, silicon dioxide, and magnesium stearate, without HB05P. Both capsules are manufactured to be indistinguishable in internal and external appearance and are supplied in identical packaging.

Dosing One capsule once daily with water after breakfast for 168 days (24 weeks). Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit. Intake is recorded by the participant in an intake diary, and compliance is checked at Visit 3 and Visit 4.

Blinding Randomization code assignment is kept sealed by the principal investigator and is not disclosed until the end of the study. If emergency unblinding is required for a serious adverse reaction, only the assignment of the individual participant can be opened, using participant-specific sealed envelopes. The randomization code is opened for efficacy analysis after study completion.

Visit schedule Visit 1, screening, Day -14 to Day 0: informed consent, eligibility assessment, demographics, medical and medication history, physical examination, eligibility tests, vital signs, clinical laboratory tests.

Visit 2, baseline, Day 0: eligibility assessment, physical examination, clinical laboratory tests, efficacy assessments, questionnaires, concomitant medication check, dispensing of study food.

Visit 3, Day 84 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check, dispensing of study food.

Visit 4, Day 168 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check.

Efficacy assessments (Visit 2, Visit 3, Visit 4) Isokinetic dynamometry at 60 degrees per second: peak torque per body weight of the quadriceps and hamstrings (average, left, right), average power (average, left, right), and muscle strength (left, right). Dual-energy X-ray absorptiometry: absolute skeletal muscle mass, ASM/height^2, ASM/weight x 100, skeletal muscle mass/height^2, lower-limb muscle mass, and body fat percentage (total, trunk). Handgrip strength (left, right). Short Physical Performance Battery total score and subscores. Blood markers: creatinine, total protein, albumin, prealbumin, C-reactive protein, creatine kinase, insulin-like growth factor 1, follistatin, and myostatin. Quality of life by EQ-5D-5L, a 24-hour dietary recall, and an exercise diary.

Safety assessments Adverse events, vital signs, physical examination, and clinical laboratory tests are collected at the scheduled visits and evaluated for severity and causal relationship to the study food.

Concomitant exercise All participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week until the end of the study and record it in an exercise diary.

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