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Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease

RecruitingNAAges 18 Years - 65 YearsAllWeill Medical College of Cornell University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • TRE plus SOC
  • SOC
  • TRE
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Where

1 site
Weill Cornell Medicine
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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