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

Weill Medical College of Cornell University · NCT05332613

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
1
Study start
April 27, 2022
Record last updated
February 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TRE plus SOC; SOC; TRE

Conditions: Non-Alcoholic Fatty Liver Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Weill Cornell Medicine

    New York, NY 10021

    Site contact: Sonal Kumar, MD · 6469625483 · sok9028@med.cornell.edu

Study contacts (from the official record)

  • Sonal Kumar, MD · 646-962-5483 · sok9028@med.cornell.edu
  • Lara Phipps · 646-962-5483 · lap4015@med.cornell.edu
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Diet and Meal Timing in Patients With Metabolic Dysfunction… (NCT05332613) | Bored Studies