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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB05P | Experimental | Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo capsule containing crystalline cellulose, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB05P (Pasteurized Akkermansia muciniphila) | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Isokinetic Knee Extension and Flexion Strength | Change from baseline in isokinetic muscle strength of quadriceps and hamstrings (both left and right) measured by Biodex dynamometer at angular velocity of 60°/s | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Isokinetic Muscle Power | Change from baseline in muscle power measured by Biodex dynamometer at angular velocity of 60°/s | Baseline and Week 12 |
| Change in Appendicular Skeletal Muscle Mass (ASM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyunlee Shin, MD, Ph.D. | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea |
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| Placebo | Dietary Supplement | Matching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days). |
|
Change from baseline in appendicular skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA)
| Baseline and Week 12 |
| Change in Skeletal Muscle Mass Index (SMMI) | Change from baseline in skeletal muscle mass index (ASM/height²) measured by DEXA | Baseline and Week 12 |
| Change in Body Fat Percentage | Change from baseline in total and trunk body fat percentage measured by DEXA | Baseline and Week 12 |
| Change in Lower Extremity Muscle Mass | Change from baseline in lower extremity muscle mass measured by DEXA | Baseline and Week 12 |
| Change in Handgrip Strength | Change from baseline in handgrip strength measured by hand dynamometer | Baseline and Week 12 |
| Change in Short Physical Performance Battery (SPPB) Score | Change from baseline in Short Physical Performance Battery (SPPB) total score (range 0-12; higher scores indicate better physical performance) and subscores: balance (0-4), gait speed (0-4), and chair stand (0-4) | Baseline and Week 12 |
| Change in Serum IGF-1 Level | Change from baseline in serum insulin-like growth factor-1 (IGF-1) concentration | Baseline and Week 12 |
| Change in Serum Myostatin Level | Change from baseline in serum myostatin concentration | Baseline and Week 12 |
| Change in Serum Follistatin Level | Change from baseline in serum follistatin concentration | Baseline and Week 12 |
| Change in Serum Nutritional Markers | Change from baseline in serum albumin, prealbumin, and total protein concentrations | Baseline and Week 12 |
| Change in Health-Related Quality of Life | Change from baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) index score (range -0.5 to 1.0; higher scores indicate better health-related quality of life) | Baseline and Week 12 |