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)

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 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
• Препарат 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 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 di

Первичные конечные точки

• Between-group difference in absolute change in liver fibrosis during six months [Срок оценки: Change from baseline to 6 months]

Вторичные конечные точки (12)

• Between group difference in absoulte change in liver steatosis during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in weight during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in height during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in waist circumference during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in body composition during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in grip strength during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in glycaemic regulation during six months [Срок оценки: Change from baseline to 6 months]
• Between-group differences in cholesterol during six months [Срок оценки: Change from baseline to 6 months]
• Between-group differences in lipoproteins during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in blood pressure during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in liver enzymes during six months [Срок оценки: Change from baseline to 6 months]
• Between-group difference in renal function during six months [Срок оценки: Change from baseline to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Franciscus — Rotterdam

Публикации

• Dietvorst CAW, Konings LAM, Saidi AN, Noordermeer T, van Wenum M, Peeters RP, Berk KA, Castro Cabezas M. 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: study protocol for a randomised controlled trial (MEDFAST trial). BMJ Open. 2026 Jun 25;16(6):e113058. doi PMID 42350004

Идентификаторы

NCT: NCT06845345 · 2024-519774-40-00 · 2024-519774-40-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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