Evaluation of HB05P for Muscle Strength Improvement in Older Adults

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.

NCT Number	NCT07402278
Lead Sponsor	Healthbiome Inc
Conditions	Age-Related Muscle Weakness
Enrollment	80 participants
Start Date	2024-09-02
Primary Completion	2025-03-26 (estimated)
Study Completion	2025-03-26 (estimated)
Updated on ClinicalTrials.gov	2026-02-12