Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual analogue scale for appetite (VAS)
研究概览
简要总结
This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.
详细描述
Nonalcoholic fatty liver disease (NAFLD), also termed metabolic dysfunction-associated fatty liver disease, is one of the most common chronic liver diseases worldwide. The development of NAFLD is fueled by a sedentary lifestyle, low frequency of physical activity, unhealthy diet and excessive calorie intake. NAFLD is characterized by fat accumulation in the liver accounting for >5% of hepatic tissue weight (fatty liver), as well as liver inflammation, which is not caused by alcohol abuse.
NAFLD prevalence is on the rise, mainly due to the presence of the obesity epidemic. Nowadays, NAFLD has been suggested to affect approximately 25% of the population worldwide. they have found a greater increase among men than women regarding the prevalence of NAFLD. Moreover, its mortality is projected to approach an increase of 65% to 100% by 2030 in Asian-Pacific regions.
Globally, NAFLD prevalence averages 24.1%, ranging from 13.5% in Africa to 31.8% in the Middle East. Despite limited data on the extent of NAFLD in Egypt, the available data indicate a prevalence of nearly 32% among Egyptians, compared to a global prevalence of 25% Egypt ranks among the top ten countries with the highest obesity rates in the world.
Lifestyle modifications are the cornerstone of NAFLD management. A Mediterranean diet (MD), rich in whole grains, vegetables, fruits, nuts, and olive oil, is proven to improve liver health by reducing inflammation and fat accumulation.
Transcutaneous electrical stimulation (TENS) of T6 dermatome on the abdomen generates impulses which are carried to the spinal cord via afferent pathways, in turn, efferent impulses pass through the vagus nerve, and effects are induced similar to the gastric stimulator .This somato-autonomic reflex helps in decreasing appetite.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The age will range from 35-45 years old.
- •BMI (Body Mass Index 30-34.9 kg/m2.)
- •With fatty liver infiltration confirmed by abdominal ultrasound
- •Elevated of liver enzymes as a primary marker
- •All patients are psychologically stable.
排除标准
- •History of cardiovascular or respiratory disease.
- •If any known endocrine diseases e.g. Hypothyroidism (which elevates liver enzymes and effects on appetite)
- •Any acute or chronic illness causing elevated liver enzymes other than fatty liver e.g. Hepatitis b, Hepatitis c
- •Any neurological illness or impairment can effect on sensation
- •Patients associated with infections, mental or malignant conditions.
- •Patients who have undergone any gastric surgery e.g. Bariatric surgery
- •Taking dietary supplement for weight reduction.
- •Patients who participating in any other exercise program.
研究组 & 干预措施
TENS + Mediterranean Diet
This group will consist of 25 patients, who will receive TENS treatment at T6 dermatome for 30 minutes, 3 times per week for 12 weeks, in addition to following Mediterranean diet for 12 weeks.
干预措施: Transcutaneous electrical stimulation (TENS) (Device)
TENS + Mediterranean Diet
This group will consist of 25 patients, who will receive TENS treatment at T6 dermatome for 30 minutes, 3 times per week for 12 weeks, in addition to following Mediterranean diet for 12 weeks.
干预措施: Mediterranean Diet (Other)
Mediterranean Diet
This group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks.
干预措施: Mediterranean Diet (Other)
结局指标
主要结局
Visual analogue scale for appetite (VAS)
时间窗: 12 weeks
This method is used to evaluate the appetite level of fatty liver patients before and after treatment procedures. This method usually consists of a set of questions assessing hunger, fullness/satisfaction, desire to eat and prospective food intake the question is presented with a 100 mm horizontal line scale.
Levels of liver transaminases aspartate transaminase (AST)
时间窗: 12 weeks
It will be measured pre and post-treatment for all participants in both groups.
Levels of liver alanine transaminase (ALT)
时间窗: 12 weeks
It will be measured pre and post-treatment for all participants in both groups.
次要结局
- Fatigue Severity Scale (FSS)(12 weeks)
- Relative fat mass (RFM)(12 weeks)
- Body mass index (BMI)(12 weeks)
研究者
Doaa Anwar Mohamed
Principal Investigator
Cairo University
