Evaluation of HB05P for Muscle Strength Improvement in Older Adults

NCT07402278 | Completed DMC

• 1 other identifier: 2404-009-597
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Change in Isokinetic Muscle Power

  Baseline and Week 12

• Change in Appendicular Skeletal Muscle Mass (ASM)

  Baseline and Week 12

• Change in Skeletal Muscle Mass Index (SMMI)

  Baseline and Week 12

• Change in Body Fat Percentage

  Baseline and Week 12

• Change in Lower Extremity Muscle Mass

  Baseline and Week 12

Study Arms (2)

HB05P

EXPERIMENTAL

Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks

Dietary Supplement: HB05P (Pasteurized Akkermansia muciniphila)

Placebo

PLACEBO COMPARATOR

Placebo capsule containing crystalline cellulose, once daily for 12 weeks

Dietary Supplement: Placebo

Interventions

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).

HB05P

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• History of bone fracture within the past 1 year
• Serum creatinine greater than 2 times the upper limit of normal at the study site
• AST (GOT) or ALT (GPT) greater than 2 times the upper limit of normal at the study site
• Current diabetes mellitus or fasting blood glucose ≥126 mg/dL
• Uncontrolled hyperthyroidism or hypothyroidism
• Uncontrolled hypertension (blood pressure ≥160/100 mmHg)
• Currently taking medication for psychiatric disorders (except for intermittent use for sleep disorders)
• Participation in another drug clinical trial within 1 month prior to screening
• Regular consumption (≥4 times/week) of probiotics or fermented dairy products (yogurt, cheese, etc.) within 2 weeks prior to screening
• Use of medications or health functional foods related to muscle function within 1 month prior to screening (refer to prohibited concomitant medications)
• History of gastrointestinal resection surgery (except appendectomy)

Sponsors & Collaborators

• Healthbiome Inc: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Officials

• Hyunlee Shin, MD, Ph.D.

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: September 2, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

KR (1)