Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To compare the proportions of patients achieving normal CAP values (less than 236db per m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
研究概览
简要总结
NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD.
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
- 8.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 8 to 18 years
- •BMI more than 85th centile
- •CAP more than 236.
排除标准
- •Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.
结局指标
主要结局
To compare the proportions of patients achieving normal CAP values (less than 236db per m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
时间窗: 180 days
次要结局
- To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD(180 days)
- To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.(180 days)
- To compare the changes in CAP value in PNPLA3 mutant children.(180 days)
- To compare the changes in following parameters in both study groups: Weight,BMI,HOMA-IR & Lipid Profile.(180 days)
- To compare the adherence to IMD, with the help of Modified KIDMED score.(180 days)
研究者
Dr Ashray S Patel
Institute of Liver and Biliary Sciences