A Randomised Controlled Exercise Intervention in Subjects With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Gut microbiota changes
研究概览
简要总结
Non-Alcoholic Fatty Liver Disease is the most common cause of chronic liver diseases. The benign non-alcoholic fatty liver, characterized by excessive fat accumulation, can evolve into non-alcoholic steatohepatitis and liver cancer.
The recommendation nowadays is a lifestyle change with physical exercise and diet to reduce liver fat and improve inflammation. Besides this, a leaky gut and dysbiosis have an impact on the liver, and exercise ameliorates the diversity of gut microbiota and permeability of the intestine.
The aim of this study is to find out a link between exercise and the gut-liver axis regarding the stage of liver adiposity and define exercise-responsive gut microbiome in NAFLD patients
详细描述
For this 12-week randomised controlled intervention 60 subjects between 18 and 70 years old, diagnosed with NAFLD and body mass index under 35 kg/m2 will be recruited. They will be randomly assigned in a high-intensity aerobic interval training (n=30) and a control group with a sedentary lifestyle (n=30). The intervention group follows a supervised high-intensity aerobic interval training two times per week and additionally, an individualised home workout program to have 3 hours of aerobic training per week. Blood samples, adipose tissue biopsy, 24h-urine and faecal samples will be collected at the baseline, midway (only stool) and at the end of the study. Dietary intake will be analysed at weeks 0, 6, 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed NAFLD
- •BMI:25 - 35 kg/m^2
排除标准
- •acute illness or current evidence of acute or chronic inflammatory or infective diseases
- •liver disease (e.g. Wilsons disease/alpha-1-antitrypsin deficiency, Hepatitis B and C, hemochromatosis)
- •bleeding disorder, anticoagulation medication
- •subjects with diagnosed type 1 diabetes or diagnosed type 2 diabetes with insulin or Glucagon-like peptide-1 agonist treatment
- •diagnosed depression and mental illness
- •any condition preventing physical activity
- •alcohol abuse (daily consumption ≥ 30 g for men and ≥ 20 g for women)
研究组 & 干预措施
Control-group
Subjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.
Exercise-group
This group with diagnosed NAFLD patients will perform a high-intensity aerobic interval exercise training without changing their diets.
干预措施: high-intensity aerobic interval training (Behavioral)
结局指标
主要结局
Gut microbiota changes
时间窗: 12 weeks (baseline and endpoint)
Changes in the composition and richness of gut microbiota through metagenomic analyses
Changes in liver fat content
时间窗: 12 weeks (baseline and endpoint)
Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)
次要结局
- Changes in low-grade inflammation(12 weeks (baseline and endpoint))
- Changes in metabolomics(12 weeks (baseline and endpoint))
- Changes in glucose profile(14 weeks (two weeks preceding the intervention and during the last weeks of the intervention))
- The effect on body composition(12 weeks (baseline and endpoint))
- Changes in protein expression in adipose tissue(12 weeks (baseline and endpoint))