Recruiting

Diet & Meal Timing

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05332613

Conditions

Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

TRE plus SOC

SOC

TRE

Study Details

Brief summary:

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study ID

NCT05332613

Start date

Apr 27, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: TRE plus SOC

Participants will be required to fast each day for 12 weeks and will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. The RD will collect the participant's normal diet and exercise routine. Counseling will involve instructing the participant to choose an eight-hour eating window (e.g., 10:00am - 6:00pm) during which the participant will be able to eat. During the 16-house fasting window (e.g., 6:00pm - 10:00 am), the participant is able to drink regular water and black coffee or tea. The RD will be available to answer any questions the participants may have pertaining to the regimen and will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise.

active comparator: SOC

lifestyle modifications and weight management. Participants will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. A baseline dietary record will be assessed prior to fasting initiation with the RD in person. The RD will also collect the subject's normal diet and exercise routine. The RD will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise.

experimental: Crossover to TRE

Participants who have not lost weight or have lost less than or equal to 5% of their body weight, they will be given the option to crossover to the TRE arm. Following the initial 12-week period and end of study MRI, participants would restart another identical 12-week cycle but adhering to the exact steps of the TRE arm including another 4 visits with the registered dieticians (RDs) and an end of study visit with repeat Fibroscan, InBody 770 body composition scan, and MRI-PDFF.

Interventions

TRE plus SOC

Participants will undergo time restricted eating (TRE) each day for 12 weeks and will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).

SOC

Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).

TRE

Participants will undergo time restricted eating (TRE) each day for 12 weeks plus 4 extra visits with the registered dietician and repeat Fibroscan, InBody composition scan, and MRI-PDFF.

Primary outcome measure

  • Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Sonal Kumar, MD

646-962-5483sok9028@med.cornell.edu

Lara Phipps

646-962-5483lap4015@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Sonal Kumar, MD

6469625483sok9028@med.cornell.edu

Lara Phipps

6469625483lap4015@med.cornell.edu

Principal Investigator:

Sonal Kumar, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-02-27.