Gut bacteria may hold key to stronger muscles in aging
NCT ID NCT07749118
First seen Aug 06, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This trial tests whether a daily capsule containing pasteurized Akkermansia muciniphila HB05, a type of gut bacteria, can improve muscle strength in adults aged 50 to 80 with sarcopenia or possible sarcopenia. Participants take the supplement or a placebo for 24 weeks while doing regular walking and resistance exercise. The study measures changes in leg muscle strength, muscle mass, and physical performance to see if the probiotic offers a benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pasteurized Akkermansia muciniphila HB05 (a probiotic supplement)
- What this could lead to
- If it works, this could point toward a simple daily supplement to help older adults maintain muscle strength and independence.
- What could go wrong
- This is a small early-stage trial, so results may not apply broadly. The supplement may not improve muscle strength, and its long-term safety is not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or women aged 50 to under 80 years * Meeting the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia (low muscle mass and low handgrip strength) or possible sarcopenia (low muscle mass with either low handgrip strength or low physical performance). Low muscle mass is defined as ASM/height\^2 measured by bioelectrical impedance analysis below 7.6 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 50 to 64 years, and below 7.0 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 65 years or older. Low handgrip strength is defined as the maximum value of the dominant hand at or below the following thresholds: 34.5 kg for men and 22.0 kg for women aged 50 to 54 years; 33.5 kg for men and 21.5 kg for women aged 55 to 59 years; 31.0 kg for men and 20.0 kg for women aged 60 to 64 years; 29.0 kg for men and 19.0 kg for women aged 65 to 69 years; 27.5 kg for men and 18.0 kg for women aged 70 to 74 years; 26.0 kg for men and 16.8 kg for women aged 75 to 79 years. Low physical performance is defined as more than 10 seconds on the 5-time chair stand test of the Short Physical Performance Battery for participants aged 50 to 64 years, and more than 12 seconds for those aged 65 years or older. * Not having participated in a commercial exercise program or performed regular resistance exercise 2 or more times per week within the 3 months before study participation * Physically able to participate in the standardized resistance exercise program provided from the start of the study at least 3 times per week, and willing to comply with it * Having received a full explanation of the purpose and procedures of the study and having voluntarily provided written informed consent Exclusion Criteria: * Short Physical Performance Battery total score of 3 or less * Cachexia or unintentional weight loss of 5 percent or more within the past 3 months * History of fracture or musculoskeletal surgery within the past 6 months * Musculoskeletal or functional limitation that precludes isokinetic strength testing or performance of the standardized exercise program (for example, severe osteoarthritis or rheumatoid arthritis) * Uncontrolled or clinically unstable endocrine disease (for example, Cushing syndrome or adrenal insufficiency) * Severe respiratory disease (COPD GOLD stage III to IV or long-term oxygen therapy) * Uncontrolled hypertension (systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher), uncontrolled diabetes mellitus (fasting glucose 160 mg/dL or higher), or uncontrolled thyroid disease * Major cardiovascular or cerebrovascular event within the past 6 months (acute myocardial infarction, stroke, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting) * History of malignancy within 3 years before screening or currently receiving anticancer treatment, except malignancies with negligible risk of metastasis or death such as adequately treated non-melanoma skin cancer or carcinoma in situ * AST or ALT greater than 3 times the upper limit of normal at screening * Serum creatinine greater than 2 times the upper limit of normal at screening * History of gastrointestinal surgery or gastrointestinal disease that may affect absorption of the study food, except simple appendectomy or hernia repair * Known hypersensitivity to the active ingredient or any component of the study food * Use of systemic antibiotics or bowel preparation agents within 2 weeks before screening * Intake of probiotics, prebiotics, or lactic acid bacteria or fermented milk products 4 or more times per week within 2 weeks before screening, excluding fermented foods included in a regular diet * Continuous use of protein supplements or muscle-related health functional foods within 1 month before screening * Use of medications that may affect muscle mass or muscle strength within 3 months before screening, including systemic corticosteroids (oral or injectable), testosterone, growth hormone preparations, selective androgen receptor modulators, and anti-obesity drugs * Severe alcohol use disorder according to DSM-5 diagnostic criteria * Continuous use of psychiatric medication for schizophrenia, bipolar disorder, or severe major depressive disorder, excluding intermittent medication for sleep disturbance * Participation in another clinical trial within 3 months before screening, or current participation in another clinical trial * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period * Any other condition that, in the judgment of the principal investigator, may affect the safety of the participant or the integrity of the study results
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pusan National University Yangsan Hospital
RECRUITINGYangsan, 50612, South Korea
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