Effects of Indian Foods and Ayurvedic drugs on healthy and diseased liver; Effect of Indian hepatoprotective diet in reversibility of NAFLD.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To study the effectiveness of IHPD on hepatic steatosis in patients with NAFLD and healthy individuals on Western diet.
研究概览
简要总结
Rationale
With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, is recognized as a common liver disease in many countries and comprises a spectrum of diseases, ranging from simple steatosis of the liver to fibrosis and cirrhosis. It has been reported that NAFLD is associated with an increased risk of cardiovascular disease (CVD). This study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor [1].
Diet and lifestyle management is the cornerstone of therapy for NAFLD. It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Our cereals should be from the more refined to the more complex ones being rich in fiber, with more emphasis on intake of fruits and vegetables of various colours. High proteins of the plant origin and of the lean meats and eggs are preffered than the processed meats and the red meat. The quality of the fats and oils used in the diet also make a difference as they are the most concentrated source of energy. Good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be on the consumption of high fiber cereals, low in simple carbohydrates, curds having the probiotic properties, vegetables that have hepatoprotective effect, chana and moong sprouts which besides being a good source of proteins have an individual hepatoprotective effect also, which even have the potential to modulate the intestinal bacterial ecology to a more favorable type thus helping in intensifying the effects of overall dietary modifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Recently diagnosed (less than 3 months) consenting adults with NAFL (steatotosis) of grades 2 and 3 diagnosed on the basis of liver transient eleastography (controlled attenuation parameter: CAP more than 250) 2.BMI more than18 3.Age 18 to 55 years.
排除标准
- •1.Intake of antibiotics within last month 2.Viral hepatitis 3.Significant alcohol consumption (regular consumption of more than 10g per day for females and more than 20g per day in males) 4.Chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded.
- •6.Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months 7.Seriously ill and bed ridden patients 8.Pregnant & lactating women.
结局指标
主要结局
To study the effectiveness of IHPD on hepatic steatosis in patients with NAFLD and healthy individuals on Western diet.
时间窗: pre post (28 days)
次要结局
- To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in reducing body weight in patients with NAFLD and healthy individuals on Western diet in 28 days.(pre post (28 days))
- To study the effectiveness of IHPD on features of metabolic syndrome i.e. Hyperglycemia (Fasting blood sugar, HbA1c levels, central obesity (waist circumference, visceral fat), hypertension (BP), and hypertriglyceridemia (serum triglyceride and HDL cholesterol levels) in patients with NAFLD(pre post (28 days))
- To study the effectiveness of IHPD on gut microbiota in patients with NAFLD and healthy individuals on Western diet.(pre post (28 days))
研究者
Dr S K Sarin
Institute of Liver and Biliary Sciences
