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New treatment option for Non-Alcoholic Fatty Liver Disease
Official title Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
ClinicalTrials.gov ID: NCT05332613
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full 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 (\ 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.