Impact of Meal Timing on Liver Fat in Patients with Non-Alcoholic Fatty Liver Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of time-restricted eating (TRE) combined with standard lifestyle recommendations on liver fat content in patients with non-alcoholic fatty liver disease (NAFLD). Participants will follow an 8-hour eating window each day while adhering to a hypocaloric Mediterranean diet and engaging in regular exercise. The study aims to determine if TRE provides additional benefits beyond standard care in reducing liver fat, as measured by magnetic resonance imaging. The findings could enhance treatment strategies for NAFLD, a condition that can lead to serious health complications.

Why it matters

Who can join: the full rules

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)

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sonal Kumar, MD — Weill Medical College of Cornell University
• Study coordinator: Sonal Kumar, MD
• Email: sok9028@med.cornell.edu
• Phone: 646-962-5483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.