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RECRUITING
NCT07749118
NA

HB05P on Muscle Health

Sponsor: Pusan National University Yangsan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: The Effect of HB05P Supplementatioon on Muscle Strength Improvement: A Randomized, Double-blind, Controlled Preliminary Clinical Trial (HB05P-Muscle Trial)

Key Details

Gender

All

Age Range

50 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-09-01

Completion Date

2027-12-31

Last Updated

2026-08-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

HB05P

Hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05, 3 x 10\^10 cells per day), microcrystalline cellulose, silicon dioxide, and magnesium stearate. 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.

DIETARY_SUPPLEMENT

Placebo

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.

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea