Clinical trial

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)

Invitation only · Phase 4 · 1 countries · Registry ID NCT06845345

Invitation onlyPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes 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

Full registry criteria

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

Treatments and study arms

early time restricted Mediterranean diet

Other

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 calorie restriction of 500 kcal will be applied, based on the estimated energy requirement calculated using the WHO equation for participants with a BMI ≤ 30 and the Harris-Benedict equation for those with a BMI \> 30.

Mysimba

Drug

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 Summary of Product Characteristics (SmPC), up to maximally tolerated doses. Compliance with N/B intake is monitored by pill counting at the three and six-month visits. 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.

Primary outcomes

Between-group difference in absolute change in liver fibrosis during six monthsChange from baseline to 6 months

Measured as liver stiffness in kilopascals (kPa) by transient elastography with FibroScan. For a value between 0 and 8 kPa, no liver fibrosis is assumed. Anything above 8 kPa means liver fibrosis. The highest possible result is 75 kPa.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Franciscus🇳🇱 Rotterdam, Netherlands

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