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Behavioral Intervention

Diet and Meal Timing for Non-Alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Sonal Kumar, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 and < 65 years old
Be older than 18 years old
Must not have
Reduction in weight by ≥ 5% within the prior 90 days
Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will study the effect of time-restricted eating on liver fat in people with prediabetes.

Who is the study for?
This study is for adults aged 18-64 with a BMI over 25 and at least 10% liver fat content, who can follow the protocol. It's not for those with other liver diseases, significant alcohol use, recent weight loss of more than 5%, or conditions preventing MRI tests or fasting.Check my eligibility
What is being tested?
The trial examines time-restricted eating (eating within an 8-hour window) combined with standard care (low-calorie Mediterranean diet and exercise) versus standard care alone on liver fat reduction in non-alcoholic fatty liver disease patients.See study design
What are the potential side effects?
Potential side effects may include hunger during fasting periods, possible nutritional deficiencies if the diet isn't well-balanced, fatigue due to calorie restriction, and stress from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lost 5% or more of my weight in the last 3 months.
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I am mentally capable of understanding and following the study's requirements.
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I have a liver condition not caused by cancer.
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I have cirrhosis or NASH with severe liver scarring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks
Secondary outcome measures
Mean Change from Baseline in BMI at 12 weeks
Mean Change from Baseline in Body Composition Measurements at 12 weeks
Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TRE plus SOCExperimental Treatment1 Intervention
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 II: Crossover to TREExperimental Treatment1 Intervention
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 III: SOCActive Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include dietary interventions like time-restricted eating (TRE), which limits the eating window to 8 hours daily. This approach can improve metabolic efficiency by aligning food intake with circadian rhythms, thereby enhancing insulin sensitivity and reducing caloric intake. Additionally, TRE can decrease liver inflammation and fat accumulation without significant weight loss, making it a promising strategy for managing NAFLD. Other lifestyle modifications, such as adopting a hypocaloric Mediterranean diet and regular exercise, also play a crucial role in reducing liver fat and improving overall metabolic health. These treatments are essential for NAFLD patients as they target the underlying metabolic dysfunctions, potentially preventing disease progression and associated complications.
Two-Week Isocaloric Time-Restricted Feeding Decreases Liver Inflammation without Significant Weight Loss in Obese Mice with Non-Alcoholic Fatty Liver Disease.A single daily meal at the beginning of the active or inactive period inhibits food deprivation-induced fatty liver in mice.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,146 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
61 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sonal Kumar, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
48 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

TRE plus SOC (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05332613 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: TRE plus SOC, SOC, Crossover to TRE
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: TRE plus SOC Highlights & Side Effects. Trial Name: NCT05332613 — N/A
TRE plus SOC (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05332613 — N/A
~6 spots leftby Dec 2024