Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Dise
This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.
| Condition(s) | Non-Alcoholic Fatty Liver Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging. |
| Who can participate | Inclusion Criteria: * Age ≥ 18 and \< 65 years old * Must provide signed written informed consent and agree to comply with the study protocol * BMI \>25 kg/m² * Baseline liver fat content of at least 10% as measured by MRI-PDFF Exclusion Criteria: * Unclear etiology of liver disease * Competing etiologies for hepatic steatosis * Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to: * Positive hepatitis B surface antigen * Positive hepatitis C virus RNA * Suspicion of drug-induced liver disease * Alcoholic liver disease * Autoimmune hepatitis * Wilson's disease * Hemochromatosis * Primary biliary cholangitis or primary sclerosing cholangitis * Known or suspected hepatocellular carcinoma * Current or recent history (\<5 years) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Weill Medical College of Cornell University |
| Locations | New York, New York, United States |
| Start date | 2022-04-27 |
| NCT ID | NCT05332613 |
| Official listing | https://clinicaltrials.gov/study/NCT05332613 |