Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study

NCT ID: NCT05332613

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2025-12-31

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.

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. Non-alcoholic fatty liver disease (NAFLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for NAFLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of NAFLD on top of standard of care diet and lifestyle modifications.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TRE plus SOC

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

TRE

Intervention Type: BEHAVIORAL

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.

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).

Intervention Type: BEHAVIORAL

SOC

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonal Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonal Kumar, MD

Role: CONTACT

sok9028@med.cornell.edu

646-962-5483

Lindsay Rogers

Role: CONTACT

lkr4002@med.cornell.edu

646-962-5483

Facility Contacts

Sonal Kumar, MD

Role: primary

sok9028@med.cornell.edu

646-962-5483

Lindsay Rogers

Role: backup

lkr4002@med.cornell.edu

6469625483

Other Identifiers

21-10024103

Identifier Type: -

Identifier Source: org_study_id