Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients with Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Change in blood glucose concentrations
研究概览
简要总结
The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.
详细描述
The goal of this clinical trial is to evaluate the effects of the time in which food intake is restricted (morning or evening hours or no restriction in time) on glucose metabolism and liver steatosis in the context of a hypocaloric diet plan in 54 patients with non-alcoholic fatty liver disease (NAFLD). The participants will be divided into 3 groups of 18 individuals each and will be randomly assigned to one of the 3 dietary interventions. In the first group (control group), participants will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week) with the instruction to consume their meals throughout the day, without time restriction. In the second group (early eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 07:00-09:00 and 17:00-19:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. In the third group (late eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 11:00-13:00 and 21:00-23:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours.
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
- •Body Mass Index >25 kg/m2
- •Liver steatosis with Magnetic Resonance Elastography (MRE)
排除标准
- •Other chronic liver diseases
- •Alcohol consumption >20 g/day (female) and >30 g/day (male)
- •Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
- •Changes in body weight ± 3 % in the last 3 months
- •Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
- •Unstable glucose-lowering medications in the last 6 months
- •Body weight lowering medications and/or history of bariatric surgery
- •Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
- •Uncontrolled type 2 diabetes mellitus defined as HbA1c value > 9.0% or insulin depending type 1 and 2 diabetes mellitus
- •Pregnancy
- •Lactation
- •Immunologic or inflammatory diseases
- •Depression and other psychiatric diseases
- •Patients working in shifts
结局指标
主要结局
Change in blood glucose concentrations
时间窗: 12 weeks
Clinically significant change in blood glucose concentrations (mg/dL)
次要结局
- Change in body weight(12 weeks)
- Change in blood insulin concentrations(12 weeks)
- Change in Controlled Attenuation Parameter (CAP)(12 weeks)
- Change in blood lipids levels(12 weeks)
- Change in Chronic Liver Disease Questionnaire (CLDQ)(12 weeks)
研究者
Aimilia Papakonstantinou
Assistant Professor
Agricultural University of Athens