Evaluation of HB05P for Muscle Strength Improvement in Older Adults

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of Oral Intake of HB05P on Improving Muscle Strength

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Muscle Weakness
• Intervention / Treatment: Dietary supplement: HB05P (Pasteurized Akkermansia muciniphila); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• 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)
• Pregnant or lactating women, or women planning to become pregnant during the study period
• Known allergy to any component of the study product
• History of alcohol abuse
• Asthma or obstructive/restrictive pulmonary disease that may affect lung volume
• Uncooperative attitude or any condition that, in the investigator's judgment, would make the participant unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB05P; Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks	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).
Placebo Comparator: Placebo; Placebo capsule containing crystalline cellulose, once daily for 12 weeks	Dietary supplement: Placebo; Matching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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 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 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 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

Collaborators and Investigators

• Sponsor: Healthbiome Inc
• Investigators: Principal Investigator: Hyunlee Shin, MD, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2404-009-597

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No