Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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
Locations
United States
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Sonal Kumar, MD
sok9028@med.cornell.edu
646-962-5483
Backup
Lindsay Rogers
lkr4002@med.cornell.edu
646-962-5483
Time Frame
Start Date: 2022-04-27
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University