What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include time-restricted eating, hypocaloric Mediterranean diet, and regular exercise. Time-restricted eating may lead to side effects such as hunger, irritability, and reduced energy levels, especially during the initial adjustment period. A hypocaloric Mediterranean diet is generally well-tolerated but may cause gastrointestinal discomfort, such as bloating or constipation, due to increased fiber intake. Regular exercise is beneficial but can result in muscle soreness, fatigue, and, in rare cases, injury if not performed correctly. Overall, these treatments are considered safe and effective for managing NAFLD when monitored by healthcare professionals.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) mentioned in the provided context. However, lifestyle interventions such as time-restricted eating, which limits the eating window to 8 hours, are being studied for their potential to reduce liver fat by improving metabolic efficiency and reducing caloric intake. These approaches focus on dietary modifications and exercise to manage NAFLD.

What other types of research exist?

Promising alternatives to Time-Restricted Eating for NAFLD patients include: 1) Mediterranean Diet: This diet has shown significant reduction in intrahepatic lipid content without energy restriction. 2) Hypocaloric Diets: Diets high in unsaturated fats have been effective in reducing hepatic steatosis. 3) Exercise Training: Regular aerobic exercise, such as treadmill running, has been shown to improve liver conditions in animal models. 4) Fenofibrate Nanoliposome: This treatment has demonstrated significant reduction in hepatic lipid content in mice. These alternatives can be considered in consultation with a healthcare provider.

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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

No Placebo-Only Group

Summary

This trial will test if a specific eating pattern can help patients with fatty liver disease more than just following a healthy diet and exercise plan. The goal is to see if this eating pattern can improve liver health by aiding weight loss and better blood sugar control.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks

Secondary study objectives

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TRE

2023

N/A

~50

0 / 5Eligibility criteria met

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.