NCT05332613 · Weill Medical College of Cornell University
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
What this study is about
This study will assess the impact of time-restricted eating (8 hours of eating each day) with the usual treatment 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- 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)
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations