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Diet and Meal Timing for Metabolic Dysfunction Associated Steatotic Liver Disease

This study is looking at how different eating patterns, specifically time-restricted eating (TRE), can help people with non-alcoholic fatty liver disease (MASLD). MASLD is a condition where too much fat builds up in the liver. Researchers want to see if TRE, which involves eating only during an 8-hour window each day, combined with standard diet and exercise advice, can reduce liver fat more effectively. You might be able to join if you are between 18 and 65 years old, have a BMI over 25, and at least 10% liver fat. The main goal is to see how many participants achieve at least a 30% reduction in liver fat after 12 weeks. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 40 participants. It compares different behavioral interventions: time-restricted eating (TRE) with standard care, standard care alone, and TRE with additional dietitian visits and scans.
What's involved
Participants will undergo time-restricted eating daily for 12 weeks, or receive lifestyle recommendations for diet and exercise. Some participants will have 4 extra visits with a registered dietitian and repeat scans (Fibroscan, InBody, MRI-PDFF).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, indicating the duration of the main assessment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05332613

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

Recruiting
NAAges 18–65InterventionalPrevention
Weill Medical College of Cornell University
~40 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:TRE plus SOCSOCTRE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks
Measured over 12 weeks

Conditions

Non-Alcoholic Fatty Liver Disease

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NCT05332613

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sonal Kumar, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Sonal Kumar, MD
[email protected]
646-962-5483
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks12 weeks

    Evaluate the percentage of patients with baseline MASLD (MRI-PDFF greater than or equal to 10%) who achieve clinically significant improvement in hepatic fat, as defined by greater than or equal to 30% reduction from baseline liver fat on MRI-PDFF, while adopting a time-restricted eating pattern (fasting 16 hours per day) along with standard of care management as compared to patients with only standard of care NAFLD management.