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Completed

NCT Number: NCT07402278

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.

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Key information

Conditions

Age-Related Muscle Weakness

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in Isokinetic Knee Extension and Flexion Strength

    Time frame: 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 outcomes

  1. Change in Isokinetic Muscle Power

    Time frame: Baseline and Week 12

    Change from baseline in muscle power measured by Biodex dynamometer at angular velocity of 60°/s

  2. Change in Appendicular Skeletal Muscle Mass (ASM)

    Time frame: Baseline and Week 12

    Change from baseline in appendicular skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA)

  3. Change in Skeletal Muscle Mass Index (SMMI)

    Time frame: Baseline and Week 12

    Change from baseline in skeletal muscle mass index (ASM/height²) measured by DEXA

  4. Change in Body Fat Percentage

    Time frame: Baseline and Week 12

    Change from baseline in total and trunk body fat percentage measured by DEXA

  5. Change in Lower Extremity Muscle Mass

    Time frame: Baseline and Week 12

    Change from baseline in lower extremity muscle mass measured by DEXA

  6. Change in Handgrip Strength

    Time frame: Baseline and Week 12

    Change from baseline in handgrip strength measured by hand dynamometer

  7. Change in Short Physical Performance Battery (SPPB) Score

    Time frame: 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)

  8. Change in Serum IGF-1 Level

    Time frame: Baseline and Week 12

    Change from baseline in serum insulin-like growth factor-1 (IGF-1) concentration

  9. Change in Serum Myostatin Level

    Time frame: Baseline and Week 12

    Change from baseline in serum myostatin concentration

  10. Change in Serum Follistatin Level

    Time frame: Baseline and Week 12

    Change from baseline in serum follistatin concentration

  11. Change in Serum Nutritional Markers

    Time frame: Baseline and Week 12

    Change from baseline in serum albumin, prealbumin, and total protein concentrations

  12. Change in Health-Related Quality of Life

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Healthbiome Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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