High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
2026年7月5日 更新者：Heba Yasser、Horus University
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
研究概览
地位
尚未招聘
条件
详细说明
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
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Heba Yasser Bihery, Assistant lecturer
- 电话号码：01065015529
- 邮箱：hyasser@horus.edu.eg
学习地点
-
-
-
Cairo、埃及
- out-patient clinic, faculty of physical therapy, Horus university
-
接触：
- Heba Yasser Bihery, Assistant lecturer
- 电话号码：01065015529
- 邮箱：hyasser@horus.edu.eg
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 2.
- Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
- Active smokers.
- Pregnancy or breastfeeding.
- Uncontrolled hypertension.
- Communication disorders.
- Bleeding disorders.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
Patients will engage in high-intensity interval training using heart rate reserve (HRR) to determine exercise intensity.
The program includes three sessions per week for 12 weeks, featuring three 3-minute high-intensity intervals at 70-90% HRR, with 2 minutes of active recovery in between.
Each 30-minute session will be treadmill-based under supervision, incorporating warm-up and cool-down periods.
Participants will also follow a Mediterranean diet.
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%).
Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%.
Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
|
|
实验性的：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.
|
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%).
Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%.
Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
The program will be in form of:
|
|
有源比较器：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.
|
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%).
Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%.
Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assessment of short chain free fatty acids butyrate and acetate
大体时间：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
|
at baseline and after 12 weeks
|
|
assessment of lipid profile
大体时间：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.
|
at baseline and after 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assessment of quality of life
大体时间：at baseline and after 12 weeks
|
The short form-12 was scored using the standard scoring algorithm, which converts participants' responses into two norm-based summary measures: the Physical Component Summary and the Mental Component Summary.
Each score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
The scores were calculated according to the official short form -12 scoring guidelines.
|
at baseline and after 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月10日
初级完成 (估计的)
2026年9月10日
研究完成 (估计的)
2026年10月10日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月5日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月5日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.