Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Between-group difference in absolute change in liver fibrosis during six months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pharmacological arm
32 mg/360 mg naltrexone/bupropion (Mysimba)
干预措施: Mysimba (Drug)
Dietary arm
Calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating)
干预措施: early time restricted Mediterranean diet (Other)
结局指标
主要结局
Between-group difference in absolute change in liver fibrosis during six months
时间窗: Change 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.
次要结局
- Between group difference in absoulte change in liver steatosis during six months(Change from baseline to 6 months)
- Between-group difference in waist circumference during six months(Change from baseline to 6 months)
- Between-group difference in weight during six months(Change from baseline to 6 months)
- Between-group difference in height during six months(Change from baseline to 6 months)
- Between-group difference in body composition during six months(Change from baseline to 6 months)
- Between-group difference in grip strength during six months(Change from baseline to 6 months)
- Between-group difference in glycaemic regulation during six months(Change from baseline to 6 months)
- Between-group differences in cholesterol during six months(Change from baseline to 6 months)
- Between-group differences in lipoproteins during six months(Change from baseline to 6 months)
- Between-group difference in blood pressure during six months(Change from baseline to 6 months)
- Between-group difference in liver enzymes during six months(Change from baseline to 6 months)
- Between-group difference in renal function during six months(Change from baseline to 6 months)
- Between-group difference in blood count during six months(Change from baseline to 6 months)
- Between-group difference in physical activity during six months(Change from baseline to 6 months)
- Between-group difference in lifestyle factors during six months(Change from baseline to 6 months)
- Between-group difference in quality of life during six months(Change from baseline to 6 months)
研究者
Carmen Dietvorst
MSc.
Franciscus Gasthuis