HB05P on Muscle Health

Sponsor
Pusan National University Yangsan Hospital
Study ID
NCT07749118
Status
Recruiting
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Conditions

  • Possible Sarcopenia
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
50 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

  • HB05P — DIETARY_SUPPLEMENT
    Hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05), microcrystalline cellulose, silicon dioxide, and magnesium stearate. One capsule once daily with water after breakfast for 168 days, providing 3 x 10\^10 cells per day. Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit.
  • Placebo — DIETARY_SUPPLEMENT
    Hard capsule of 430 mg containing microcrystalline cellulose, silicon dioxide, and magnesium stearate, without HB05P. One capsule once daily with water after breakfast for 168 days. Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit.

Study Details

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 Dates

First listed
Aug 6, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jun 29, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Test group: HB05P
    Participants receive one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05, 3 x 10\^10 cells per day) once daily with water after breakfast for 168 days (24 weeks). In addition, participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week throughout the study period.
  • Placebo Comparator: Control group: Placebo
    Participants receive one hard capsule of 430 mg without HB05P, once daily with water after breakfast for 168 days (24 weeks). The capsule is identical to the test capsule in internal and external appearance and packaging. In addition, participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week throughout the study period.

Primary Outcome Measure

Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right) [ Time Frame: Baseline, Week 12 (Day 84), and Week 24 (Day 168) ]

Central Contacts

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