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

Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study

This study is testing if eating within an 8-hour window along with a healthy diet and exercise can help reduce liver fat in people with non-alcoholic fatty liver disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Weill Medical College of Cornell University (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05332613 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a BMI over 25 and a baseline liver fat content of at least 10%.

Not a fit: Patients with unclear liver disease etiology or other significant liver conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a novel dietary intervention to improve liver health and reduce the burden of NAFLD.

How similar studies have performed: While the concept of time-restricted eating is gaining traction, this specific application in NAFLD is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

New York, New York

• 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

Conditions Non-Alcoholic Fatty Liver Disease