RecruitingNot ApplicableNCT05332613

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


Sponsor

Weill Medical College of Cornell University

Enrollment

40 participants

Start Date

Apr 27, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study explores how diet and the timing of meals affect fatty liver disease (now called Metabolic Dysfunction Associated Steatotic Liver Disease or MASLD). Researchers want to know if eating within certain windows of time can reduce liver fat. You may be eligible if: - You are between 18 and 65 years old - Your BMI is greater than 25 - Your liver fat content is at least 10% as measured by MRI You may NOT be eligible if: - You have another cause of liver disease (such as hepatitis B or C, alcoholic liver disease, autoimmune hepatitis, or cirrhosis) - You have lost 5% or more of your body weight in the last 90 days - You are already fasting 12 or more hours per day on most days - You are pregnant - You currently take insulin that prevents you from fasting safely - You have a significant alcohol intake history (over 30g/day for men or 20g/day for women in the last 5 years) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTRE 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).

BEHAVIORALSOC

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

BEHAVIORALTRE

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.


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT05332613


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