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

Non-Alcoholic Fatty Liver Disease

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

Inclusion Criteria4

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

Exclusion Criteria20

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)

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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.