Status:
RECRUITING
Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05332613
Start Date
April 27 2022
End Date
December 31 2025
Last Update
March 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medicine
New York, New York, United States, 10021