Effect of Consumption of Millets Based Diet on, Clinical Characteristics, Metabolic Profile, and Gut Microbiome in Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)
研究概览
简要总结
With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, 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.
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. Managing our cereals from being refined to the more complex ones being rich in fibre, protein and 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 in increasing the consumption of cereals that are not only high in fibre, low in carbohydrates but also that have the potential to modulate the intestinal bacterial ecology to a more favourable type thus helping in intensifying the effects of overall dietary modifications.
Gut microbiota is currently explored for its role in NAFLD and there are gaps in knowledge which preclude having therapeutic strategies through its modulation. Millets, which were once considered to be poor man’s diet are now becoming a part of the plate more frequently, especially for its unique nutritive content, with increased fiber, low carbohydrates, high protein and good quality fats. The processing methods may alter glycemic responses. Thus, the present study is proposed to look into the effect of millet based diets in reduction of hepatic steatosis and the resultant alterations in the gut microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Recently diagnosed consenting adults with NAFL (steatotosis) of any grade with or without features of metabolic syndrome.
排除标准
- •Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months Those with intake of antibiotics within last month Seriously ill and bed ridden patients Patients with viral hepatitis Pregnant & lactating women Patients with significant alcohol consumption Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded Patients with NAFLD with associated hypertriglyceridemia that requires administration of statins.
结局指标
主要结局
Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)
时间窗: 3 months
次要结局
- Change in lipid parameters as assessed by blood lipid profile test(3 months)
- Change in blood sugar as assessed by blood fasting glucose, serum insulin & HbA1c(3 months)
- Change in liver enzymes as assessed by liver function tests(3 months)
- Change in Nutritional status as assessed using bioelectrical impedence analysis(3 months)
- Change in gut microbiota(3months)
研究者
Nida athar
Institute of Liver & Biliary Sciences