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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: TRE plus SOC; Behavioral: SOC; Behavioral: TRE

Detailed Description

Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for MASLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of MASLD on top of standard of care diet and lifestyle modifications.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonal Kumar, MD; Phone Number: 646-962-5483; Email: sok9028@med.cornell.edu
• Study Contact Backup: Name: Lara Phipps; Phone Number: 646-962-5483; Email: lap4015@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: Sonal Kumar, MD
      • Contact: Sonal Kumar, MD; Phone Number: 6469625483; Email: sok9028@med.cornell.edu
      • Contact: Lara Phipps; Phone Number: 6469625483; Email: lap4015@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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).
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.	Behavioral: SOC; Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks	Evaluate the mean change of quality of life score from SF-36 from baseline to 12 weeks. Scores range from 0-100. Higher scores indicate better health status, while lower scores indicate a poorer health status. A mean score of 50 has been articulated as the normative value of all scales.	Baseline, 12 weeks
Mean Change from Baseline in Weight at 12 weeks		Baseline, 12 weeks
Mean Change from Baseline in BMI at 12 weeks	Evaluate the mean change of body mass index from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks	Evaluate the mean change in liver stiffness as measured by (FibroScan®) from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in Body Composition Measurements at 12 weeks	Evaluate the mean change of body composition measurements as measure by InBody Body	Baseline, 12 weeks
Mean Change from Baseline in aspartate transglutaminase at 12 weeks	Evaluate the mean change in aspartate transglutaminase from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in alanine transglutaminase at 12 weeks	Evaluate the mean change in alanine transglutaminase from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in total bilirubin at 12 weeks	Evaluate the mean change in total bilirubin from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in direct bilirubin at 12 weeks	Evaluate the mean change direct bilirubin from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in albumin at 12 weeks	Evaluate the mean change in albumin from baseline to 12 weeks.	Baseline, 12 weeks
Mean Change from Baseline in total protein at 12 weeks	Evaluate the mean change in total protein from baseline to 12 weeks.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Sonal Kumar, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Disaccharidases; Trehalase
• Other Study ID Numbers: 21-10024103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No