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临床试验/NCT05696808
NCT05696808招募中不适用

Effects of Indian Foods and Ayurvedic Drugs on Healthy and Diseased Liver

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in hepatic steatosis in patients with NAFLD index in patients with NAFLD

研究概览

简要总结

The modality of lifestyle modification including low calorie diets along with normal protein and moderate physical activity is the safest standard medical treatment for NAFLD in general. There are many benefits of weight loss to the patients with NAFLD. Besides the improvement in the features of metabolic syndrome, weight loss with IHPD would certainly improve the overall vitality and well being of the patients. The results of study will help to delineate a protocolized care for the management of NAFLD with metabolic syndrome thus helping other patients also in the future.

详细描述

There is a strong link between food items, gut microbiota (GM), liver fat and development of various non-communicable diseases (NCDs). The incidence of NCDs is rapidly increasing globally. The GM is considered an organ by itself and any alterations in its composition or functioning are likely to be associated with different NCDs, including cancers. The core to most of the NCDs is increased fat in the liver and the non-alcoholic fatty liver disease (NAFLD). The highly variable natural history of NAFLD reflects the current incomplete understanding of the pathobiology of the disease. The strongest risk factors for NAFLD/NASH are unhealthy food items and their metabolites which affect the host and the gut microbiota.

Traditional Indian food items are known to have strong influence on liver and production of healthy bile, the 'Pitta'. The influence and health worthiness of various indigenous food items has not been scientifically evaluated. Their role in health and disease would not only help in prevention but also management of multiple non-communicable diseases. This information could also make a change in the social and behavioural attitudes of Indians

The proposed project would, therefore, undertake work on the following broad areas:

  1. Effects of conventional Indian foods as hepatoprotective agents, producers of 'healthy' bile and stimulating liver regeneration.
  2. Food constituents as therapeutic agents by changing dysbiotic gut microbiota to healthy microbiota, reduction in hepatic fat and inflammation, improving metabolic health (reducing sugar, cholesterol, etc.) and reduction in liver fibrosis

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients recently diagnosed (<3 months)diagnosed on the basis of ultrasound and /or liver transient eleastography (controlled attenuation parameter; CAP >250)
  • Having components of metabolic syndrome like Hyperglycemia, central obesity, hypertension, hypertriglyceridemia, and low HDL cholesterol levels).

排除标准

  • Pregnant & lactating women
  • Age <18 and >55 years
  • 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
  • Patients with significant alcohol consumption (regular consumption of > 10g per day for females and > 20g/d in males),
  • Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
  • Patients with NAFLD with associated hypertriglyceridemia requiring administration of statins.

结局指标

主要结局

To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in hepatic steatosis in patients with NAFLD index in patients with NAFLD

时间窗: 1 month

Hepatic steatosis index will be assessed by controlled attenuation parameter (CAP) score.

次要结局

  • To study the effectiveness of IHPD in reducing body weight in patients with NAFLD(1 month)
  • To study the effectiveness of IHPD on hypertension (BP) in patients with NAFLD(1 month)
  • To study the effectiveness of IHPD on Hyperglycemia (Fasting blood sugar) in patients with NAFLD(1 month)
  • To study the effectiveness of IHPD on central obesity (waist circumference) in patients with NAFLD(1 month)
  • To study the effectiveness of IHPD on hypertriglyceridemia in patients with NAFLD(1 month)
  • To study the effectiveness of IHPD on gut microbiota in patients with NAFLD(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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