Lifestyle changes to treat non-alcoholic fatty liver disease.
Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease
This study tests whether personalized lifestyle counseling can help people with non-alcoholic fatty liver disease improve their liver health better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT05816915 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of personalized lifestyle counseling versus standard care on patients with non-alcoholic fatty liver disease (NAFLD) and metabolic syndrome. The study aims to evaluate changes in liver fat content and other health parameters over a one-year period. Participants will receive tailored cognitive behavioral therapy to promote lifestyle modifications, while researchers will also assess factors like gut microbiota that may influence the disease's progression or regression.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with NAFLD who also have metabolic syndrome.
Not a fit: Patients with liver disease caused by factors other than NAFLD or those with uncontrolled cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients with NAFLD and metabolic syndrome.
How similar studies have performed: While lifestyle modification has been suggested for NAFLD management, this specific approach of tailored counseling has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with NAFLD and metabolic syndrome Exclusion Criteria: * Etiology of liver disease other than NAFLD. * Presence of malignant disease. * Uncontrolled cardiovascular disease * Pregnancy.
Where this trial is running
Prague
- General University Hospital — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Radan Bruha, Prof. — General University Hospital, Prague
- Study coordinator: Radan Bruha, Prof.
- Email: bruha@cesnet.cz
- Phone: +420224962506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.