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HB05P on Muscle Health

NCT07749118 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-10

No results posted yet for this study

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 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).

Conditions

Interventions

DIETARY_SUPPLEMENT

HB05P

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.

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.

Sponsors & Collaborators

  • Pusan National University Yangsan Hospital

    lead OTHER

Principal Investigators

  • Sang Yeoup Lee, MD, PhD · Pusan National University Yangsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-06-29
Completion
2027-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749118 on ClinicalTrials.gov