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

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.

Eligibility

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)

Conditions2

Locations1 site

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