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

Description

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.

Conditions

Non-Alcoholic Fatty Liver Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non-Alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Weill Medical College of Cornell University,

Sonal Kumar, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2025-12-31