High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- assessment of short chain free fatty acids butyrate and acetate
研究概览
简要总结
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
详细描述
non- Alcoholic Fatty Liver disease affects approximately 25% of the global population, with its prevalence increasing due to lifestyle changes such as poor diet and sedentary behavior. non- Alcoholic Fatty Liver disease is often associated with metabolic disorders, including insulin resistance, obesity, and type 2 diabetes. Emerging evidence suggests that alterations in gut microbiota may contribute to the pathophysiology of non- Alcoholic Fatty Liver disease, influencing liver function, inflammation, and metabolic regulation. However, there is limited research exploring the effects of interventions such as exercise and dietary changes on gut microbiota composition in non- Alcoholic Fatty Liver disease patients The findings of this study could have important clinical implications, particularly for developing tailored lifestyle interventions for non- Alcoholic Fatty Liver disease patients. As gut microbiota dysbiosis is increasingly recognized as a key player in the development and progression of non- Alcoholic Fatty Liver disease, interventions targeting microbiota balance could offer novel therapeutic approaches for managing this prevalent and potentially severe condition
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
- •Body mass index will range from 30 to 34.9 kg/m².
- •Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
- •Patients who have taken no regular exercise in the last year (<3 times/week and 30 min/time.
- •No antibiotic or probiotic use for at least last 3 months.
- •Medical drugs such as metformin, sulfonylureas, statins, and blood pressure medication were eligible, as well as stable.
排除标准
- •History of liver cirrhosis or other chronic liver diseases.
- •Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
- •Recent gastrointestinal infections or surgeries.
- •Diabetes Mellitus type 1 or uncontrolled type
- •Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
- •Active smokers.
- •Pregnancy or breastfeeding.
- •Uncontrolled hypertension.
- •Communication disorders.
- •Bleeding disorders.
研究组 & 干预措施
high intensity interval training and Mediterranean diet
This study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet.
干预措施: High intensity interval training (Other)
high intensity interval training and Mediterranean diet
This study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet.
干预措施: Mediterranean diet (Other)
moderate intensity continous training and Mediterranean diet
This group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet.
干预措施: moderate intensity continuous training (Other)
moderate intensity continous training and Mediterranean diet
This group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet.
干预措施: Mediterranean diet (Other)
Mediterranean Diet
It is characterized by a high consumption of plant-based foods, such as vegetables, fruits, whole grains, seeds, nuts and legumes, and moderate consumption of protein-source foods such as fish and poultry. This diet is rich in monounsaturated fatty acids primarily from olive oil and olives, reduced fat dairy products and low red meat intake.
干预措施: Mediterranean diet (Other)
结局指标
主要结局
assessment of short chain free fatty acids butyrate and acetate
时间窗: at baseline and after 12 weeks
For short chain free fatty acids analyses, fecal sample will be separated. Applying four analytes, including total Short Chain Fatty Acids, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids from fecal samples
assessment of lipid profile
时间窗: at baseline and after 12 weeks
Fasting blood samples were collected after an overnight fast, and serum lipid levels were analyzed using standard enzymatic methods with an automated biochemical analyzer. The lipid profile included triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol to assess lipid metabolism and cardiovascular risk.
次要结局
- assessment of quality of life(at baseline and after 12 weeks)
研究者
Heba Yasser
Principal Investigator
Horus University