Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- assessment of Non-alcoholic fatty liver using ultrasonography
研究概览
简要总结
This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.
详细描述
Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.
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
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
- •All patients are sedentary lifestyle with little or no exercise.
- •High lipid profile (total cholesterol > 200, LDL > 130, TAGs > 150) patients by laboratory investigation.
- •High fasting insulin level > 20mlU/mL & high fasting Glucose level >100, HbA1c > 5.7 & high HOMA- IR > 2.5 patients by Laboratory investigation.
- •High inflammatory markers (IL6) patients.
- •Age ranged from 30 to 40 years old.
排除标准
- •Alcoholic fatty liver patients.
- •Cirrhosis patients.
- •Diabetes patients.
- •Cognitive impaired patients.
- •History of epilepsy patients.
- •Cardiac pacemaker patients.
- •Anemic patients
- •pregnancy
研究组 & 干预措施
Intermittent fasting group
intermittent fasting time-restricted feeding (TRF) subjects consumed 100 % of their energy needs in an 8 hours period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. schedule (8-hr daily eating period, The remaining 16 hours per 24-hour period made up the fasting period)
干预措施: Intermittent fasting (Other)
Diet group
the dietary approach to stop hypertension (DASH) subjects consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. (12-hr eating period).
干预措施: Dietary approach to stop hypertension (DASH) (Other)
结局指标
主要结局
assessment of Non-alcoholic fatty liver using ultrasonography
时间窗: at baseline at after two months
usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease
次要结局
- assessment of change of lab profile using laboratory investigations(at baseline at after two months)
- assessment of change of body mass index(at baseline at after two months)
- assessment of macronutrients distribution(at baseline at after two months)
研究者
Aya Gamal Khattab Omer
principal investigator
Cairo University