Age-Related Muscle Weakness
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTHB05P (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_SUPPLEMENTPlacebo
Matching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days).
Sponsors
Healthbiome Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 60 years or older and younger than 80 years (male or female) who meet the inclusion criteria and do not meet any
Exclusion criteria
* Body Mass Index (BMI) between 18.5 and 30.0 kg/m² * Skeletal muscle mass less than 110% of standard value measured by Bioelectrical Impedance Analysis (BIA) * Reduced handgrip strength in the dominant hand based on age- and sex-specific criteria: (Ages 60-69) Males ≤38.5 kg, Females ≤24.1 kg; (Ages 70-79) Males ≤33.2 kg, Females ≤20.9 kg * Capable of normal physical activity and voluntarily providing written informed consent to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Isokinetic Knee Extension and Flexion Strength | Baseline and Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Isokinetic Muscle Power | Baseline and Week 12 | Change from baseline in muscle power measured by Biodex dynamometer at angular velocity of 60°/s |
| Change in Appendicular Skeletal Muscle Mass (ASM) | Baseline and Week 12 | Change from baseline in appendicular skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA) |
| Change in Skeletal Muscle Mass Index (SMMI) | Baseline and Week 12 | Change from baseline in skeletal muscle mass index (ASM/height²) measured by DEXA |
| Change in Body Fat Percentage | Baseline and Week 12 | Change from baseline in total and trunk body fat percentage measured by DEXA |
| Change in Lower Extremity Muscle Mass | Baseline and Week 12 | Change from baseline in lower extremity muscle mass measured by DEXA |
| Change in Handgrip Strength | Baseline and Week 12 | Change from baseline in handgrip strength measured by hand dynamometer |
| Change in Short Physical Performance Battery (SPPB) Score | Baseline and Week 12 | 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) |
| Change in Serum IGF-1 Level | Baseline and Week 12 | Change from baseline in serum insulin-like growth factor-1 (IGF-1) concentration |
| Change in Serum Myostatin Level | Baseline and Week 12 | Change from baseline in serum myostatin concentration |
| Change in Serum Follistatin Level | Baseline and Week 12 | Change from baseline in serum follistatin concentration |
| Change in Serum Nutritional Markers | Baseline and Week 12 | Change from baseline in serum albumin, prealbumin, and total protein concentrations |
| Change in Health-Related Quality of Life | Baseline and Week 12 | 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) |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyunlee Shin, MD, Ph.D.
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Outcome results
None listed