NCT06845345

Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors (MEDFAST-study)

Effect of Mediterranean Diet Combined With Intermittent Fastingon Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Carmen Dietvorst · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In the Netherlands, there are many people with cardiometabolic diseases. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Losing weight can be done with medication such as naltrexone/bupropion (Mysimba®), which is often prescribed to people with cardiometabolic diseases, but losing weight can also be done with diet. In this study, the investigators want to combine a Mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. In addition participants are not allowed to eat after the evening meal. The investigators will compare this with a group of participants receiving Mysimba®, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with cardiometabolic diseases.

Conditions

• Diabetes Mellitus, Type 2
• Liver Fibrosis
• Liver Steatoses
• Hepatic Steatosis
• Hepatic Fibrosis
• Overweight or Obesity
• MASLD
• MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Cardio-metabolic Risk
• Cardio-metabolic Health
• Hypertension
• Dyslipidaemia

Interventions

Type	Name	Description
OTHER	early time restricted Mediterranean diet	Participants will start with a calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) for a period of six months. Participants are asked to stop eating at 6PM. This results in a daily fasting window of approximately 14 hours. A daily caloric intake of 500 kcal compared to the calculated energy requirement is assumed to stimulate weight loss.
DRUG	Mysimba	Participants will take Mysimba twice daily at a total dose of 32 mg/360 mg naltrexone/bupropion per day for a duration of six months. The dosage will be built up in the first month following the stepped care approach used in the SmPC. Participants receive usual care, including the advice of 60 minutes of exercise per day and standard dietary recommendations according to the guidelines for the Dutch population.

Timeline

• Start date: 2025-04-14
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-02-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: Netherlands