Diet or drugs? new study tests if fasting beats pills for fatty liver disease
NCT ID NCT06845345
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a Mediterranean diet combined with intermittent fasting can reduce liver scarring (fibrosis) better than the weight-loss medication naltrexone/bupropion. About 70 adults with overweight or obesity and heart or metabolic risks (like type 2 diabetes or high blood pressure) will be followed for six months. The goal is to see if the diet approach is a safer or more effective way to manage fatty liver disease and prevent long-term liver damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * BMI \> 30 kg/m2 or BMI \> 27 kg/m2 and at least one cardiometabolic risk factor (T2D, hypertension, dyslipidaemia) * Moderate to severe liver fibrosis, measured as liver stiffness by transient elastography (LSM \> 7.0 kPa and \< 13.6 kPa) * Aged 18-75 years * Written informed consent Exclusion Criteria: * An insufficient comprehension of the Dutch language (spoken and written) * Female who is pregnant, breast-feeding or intends to become pregnant * Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson's disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease * History of liver transplant, or current placement on a liver transplant list * History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding * Participants with active HIV infection and/or treatment * Participants with diagnosed malignancies with or without active treatment * Participants with history or pre-existing renal disease (eGFR \<30 mL/min/1.73 m2) * Participants with corticosteroid induced diabetes (while still using corticosteroids) * Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose * Participants using MAO-inhibitors, opioids and/or methadone (due to contraindication) * Known or suspected excessive alcohol consumption (\>30 grams/day for males or \>20 grams/day for females. One drink is equivalent to 10 grams of alcohol) * Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient's weight, in the opinion of the investigator, are allowed. * Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Franciscus
Rotterdam, 3045 PM, Netherlands
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Other studies related to the condition(s) this trial covers.
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