Age-Related Muscle WeaknessNCT07402278
Evaluation of HB05P for Muscle Strength Improvement in Older Adults
A study testing HB05P (Pasteurized Akkermansia muciniphila) in people with Age-Related Muscle Weakness, run by Healthbiome Inc at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Age-Related Muscle Weakness
- What is being tested?
- HB05P (Pasteurized Akkermansia muciniphila)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Sep 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- HB05P (Pasteurized Akkermansia muciniphila), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboDietary supplement
Matching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days).
| Study group | Role | What they receive |
|---|---|---|
| HB05P | Experimental | Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks Receives: Dietary Supplement: HB05P (Pasteurized Akkermansia muciniphila) |
| Placebo | Placebo comparator | Placebo capsule containing crystalline cellulose, once daily for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 12
Secondary outcomes (12)
Change in Isokinetic Muscle Power
Change from baseline in muscle power measured by Biodex dynamometer at angular velocity of 60°/s
Measured: 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)
Measured: Baseline and Week 12
Change in Skeletal Muscle Mass Index (SMMI)
Change from baseline in skeletal muscle mass index (ASM/height²) measured by DEXA
Measured: Baseline and Week 12
Change in Body Fat Percentage
Change from baseline in total and trunk body fat percentage measured by DEXA
Measured: Baseline and Week 12
Change in Lower Extremity Muscle Mass
Change from baseline in lower extremity muscle mass measured by DEXA
Measured: Baseline and Week 12
Change in Handgrip Strength
Change from baseline in handgrip strength measured by hand dynamometer
Measured: 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)
Measured: Baseline and Week 12
Change in Serum IGF-1 Level
Change from baseline in serum insulin-like growth factor-1 (IGF-1) concentration
Measured: Baseline and Week 12
Change in Serum Myostatin Level
Change from baseline in serum myostatin concentration
Measured: Baseline and Week 12
Change in Serum Follistatin Level
Change from baseline in serum follistatin concentration
Measured: Baseline and Week 12
Change in Serum Nutritional Markers
Change from baseline in serum albumin, prealbumin, and total protein concentrations
Measured: 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)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start2 Sep 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthbiome Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyunlee Shin, MD, Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402278
- Sponsor's protocol ID
- 2404-009-597
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of Oral Intake of HB05P on Improving Muscle Strength
- ClinicalTrials.gov ID
- NCT07402278
- Acronym / sponsor ID
- 2404-009-597
- Conditions
- Age-Related Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Healthbiome IncIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB05P | Experimental | Dietary Supplement: HB05P (Pasteurized Akkermansia muciniphila)Pasteurized Akkermansia muciniphila HB05P, 3×10¹⁰ cells/day, once daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule containing crystalline cellulose, once daily for 12 weeks |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | HB05P |
| PlaceboMatching placebo capsule containing crystalline cellulose. One capsule taken orally once daily after breakfast for 12 weeks (84 days). | Dietary supplement | Placebo |
Primary outcome
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
12 secondary outcomes
Change in Isokinetic Muscle Power
Time frame: Baseline and Week 12
Change in Appendicular Skeletal Muscle Mass (ASM)
Time frame: Baseline and Week 12
Change in Skeletal Muscle Mass Index (SMMI)
Time frame: Baseline and Week 12
Change in Body Fat Percentage
Time frame: Baseline and Week 12
Change in Lower Extremity Muscle Mass
Time frame: Baseline and Week 12
Change in Handgrip Strength
Time frame: Baseline and Week 12
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline and Week 12
Change in Serum IGF-1 Level
Time frame: Baseline and Week 12
Change in Serum Myostatin Level
Time frame: Baseline and Week 12
Change in Serum Follistatin Level
Time frame: Baseline and Week 12
Change in Serum Nutritional Markers
Time frame: Baseline and Week 12
Change in Health-Related Quality of Life
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Age-Related Muscle Weakness
Recruiting
Effects of Rehabilitative Exergame Training on Foot Muscle Activity, Balance, and Mobility in Older Adults
Aging, Foot Muscle Dysfunction
RecruitingPhase 1/2
CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy
Age-related Muscle Decline
Not yet recruiting
Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults (IMT-3)
Frailty Syndrome, Geriatric Health
Recruiting
Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults
Age-Related Muscle Weakness
Active, not recruiting
Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training in Frail Older Adults
Frailty Syndrome, Respiratory Muscle Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunlee Shin, MD, Ph.D. principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB05P (Pasteurized Akkermansia muciniphila) in people with Age-Related Muscle Weakness, run by Healthbiome Inc at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Isokinetic Knee Extension and Flexion Strength (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.