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

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.

Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for MASLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of MASLD on top of standard of care diet and lifestyle modifications.

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)