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Evaluation of HB05P for Muscle Strength Improvement in Older Adults

NCT07402278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-12

No results posted yet for this study

Summary

This study aims to clinically and scientifically evaluate the safety of HB05P intake as a functional ingredient for health functional foods, as well as its efficacy in improving muscle strength.

This study is designed as a randomized, double-blind, placebo-controlled trial. Subjects who voluntarily agree to participate in the study by providing written informed consent will be screened according to the inclusion and exclusion criteria. Subjects who are taking health functional foods or medications that are judged not to affect the study outcomes may continue their use during the study. Eligible subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group.

Randomized subjects will be instructed to perform walking and resistance (muscle-strengthening) exercises at least three times per week, for 30 minutes to 1 hour per session, until the end of the study period. Subjects will be required to complete an exercise diary. They will also receive the investigational product and a daily intake diary, and will consume the study product once daily according to the instructed method.

The quality of life questionnaire (EQ-5D-5L), exercise diary, and dietary intake assessed using the 24-hour recall method will be evaluated and compared between baseline and post-intervention. Efficacy and safety assessment variables will be measured and tested at Day 0 and Day 84, and the collected data will be statistically analyzed.

Conditions

  • Age-Related Muscle Weakness

Interventions

DIETARY_SUPPLEMENT

HB05P (Pasteurized Akkermansia muciniphila)

Pasteurized Akkermansia muciniphila HB05P capsule containing 150mg HB05P (3×10¹⁰ cells/day). One capsule taken orally once daily after breakfast for 12 weeks (84 days).

DIETARY_SUPPLEMENT

Placebo

Matching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days).

Sponsors & Collaborators

  • Healthbiome Inc

    lead INDUSTRY

Principal Investigators

  • Hyunlee Shin, MD, Ph.D. · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • South Korea

Study Locations

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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 NCT07402278 on ClinicalTrials.gov