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Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study
Who can join
Ages 18 to 65 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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) of significant alcohol consumption. For men, significant consumption is defined as \>30g of alcohol per day. For women, it is defined as \>20g of alcohol per day. * Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded. * Reduction in weight by ≥ 5% within the prior 90 days * Current fasting for ≥ 12 hours per day on the majority of days each week * Pregnant females * Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain * Inability to perform MRI-PDFF and/or study as defined below * Inability to medically perform prolonged fasting (i.e. insulin regimen)
About the study
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.
What is being tested
- TRE plus SOC (behavioral)
- SOC (behavioral)
- TRE (behavioral)
Sponsor: Weill Medical College of Cornell University · Participants: 40 · Started: Apr 27, 2022
Contact the study team
- Sonal Kumar, MD · Phone: 646-962-5483
- Lara Phipps · Phone: 646-962-5483
Official record on ClinicalTrials.gov — NCT05332613
Locations in the U.S.
| New York | Weill Cornell Medicine, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.