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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 and \< 65 years old - Must provide signed written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

BEHAVIORAL

TRE plus SOC

Participants will undergo time restricted eating (TRE) each day for 12 weeks and will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).

BEHAVIORAL

SOC

Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).

BEHAVIORAL

TRE

Participants will undergo time restricted eating (TRE) each day for 12 weeks plus 4 extra visits with the registered dietician and repeat Fibroscan, InBody composition scan, and MRI-PDFF.

Locations (1)

Weill Cornell Medicine
New York, New York, United States