Gut health and gym: new combo tackles fatty liver
NCT ID NCT06563921
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether combining a probiotic supplement with resistance exercise can help people with metabolic fatty liver disease (MAFLD/NAFLD). Researchers will measure changes in liver fat using MRI over 12 weeks. The goal is to find out which patients benefit most based on their gut bacteria and nervous system activity.
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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 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2036
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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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD/MAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods. Inclusion criteria: * Diagnosis of NAFLD/MAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy) * Age 18-60 years * Ability to understand the study procedures and provide informed consent. * Stable clinical condition for at least 3 months prior to study initiation. Exclusion criteria: * Lack of fluency in English or Polish * Significant (structural) limitation of upper and/or lower limb mobility * Pregnancy or breastfeeding * Inability to understand instructions * Shift work * Participation in any study or research project within the last 3 months * Participation in an interventional drug study within the last 3 months * Participants with hepatic steatosis and regular alcohol consumption \> 30 g/day * Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic/genetic diseases (e.g., Wilson's disease)) * Anticoagulant/antiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \< 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment * Use of medications such as steroids, methotrexate, metformin * Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid) * Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \[e.g., cervical\] or benign skin cancer), unless complete remission has been achieved * Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment * Known allergy to probiotics * History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry * Previous surgery (bariatric surgery, gastric or intestinal resection) * Parenteral nutrition (TPN) within the last 6 months * Insulin therapy * Uncontrolled diabetes * Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance) * Nervous system disorders * Cognitive impairment and dementia * Osteoporosis/osteopenia * Active thyroid disease * Cushing's syndrome * Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)
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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 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.
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Other studies related to the condition(s) this trial covers.
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