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Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study)

Study acronym: MEDFAST
StatusEnrolling by Invitation
PhasePhase 4
Started2025-04-14
View on ClinicalTrials.gov ↗
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, 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 naltrexone/bupropion, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with cardiometabolic diseases.

Amendment record

Amended 3 times since 2025-02-24; most recent filed 2026-04-16. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-04-16
Amendment Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v3
2025-12-03
Amendment RecruitingEnrolling by Invitation Study Identification, Study Status, Oversight, Study Description, Conditions, Eligibility, Contacts/Locations v2
2025-07-07
Amendment Study Identification, Study Status, Study Description, Conditions v1
2025-02-24
Original filing
Trial Details
NCT Number NCT06845345
Lead Sponsor Carmen Dietvorst
Conditions Diabetes Mellitus, Type 2, Liver Fibrosis, Liver Steatoses, Hepatic Steatosis, Hepatic Fibrosis, Overweight or Obesity, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease +4 more
Enrollment 70 participants
Start Date 2025-04-14
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-21