HB05P on Muscle Health

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Sarcopenia, Possible Sarcopenia

In brief

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 average power, muscle strength, 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 baseline (Day 0), Week 12 (Day 84), and Week 24 (Day 168).

Key facts

Study ID: NCT07749118
Run by: Pusan National University Yangsan Hospital
People needed: 80
Starts: 2026-09-01
Expected to finish: 2027-06-30
Last updated by the study team: 2026-08-10

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men or women aged 50 to under 80 years
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). Low muscle mass is defined as ASM/height\^2 measured by bioelectrical impedance analysis below 7.6 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 50 to 64 years, and below 7.0 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 65 years or older. Low handgrip strength is defined as the maximum value of the dominant hand at or below the following thresholds: 34.5 kg for men and 22.0 kg for women aged 50 to 54 years; 33.5 kg for men and 21.5 kg for women aged 55 to 59 years; 31.0 kg for men and 20.0 kg for women aged 60 to 64 years; 29.0 kg for men and 19.0 kg for women aged 65 to 69 years; 27.5 kg for men and 18.0 kg for women aged 70 to 74 years; 26.0 kg for men and 16.8 kg for women aged 75 to 79 years. Low physical performance is defined as more than 10 seconds on the 5-time chair stand test of the Short Physical Performance Battery for participants aged 50 to 64 years, and more than 12 seconds for those aged 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

You may not qualify if…

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

Where it is running

Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)

Full record on ClinicalTrials.gov

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