Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD — NAFLDNutrition  

Metabolic Syndrome Clinical Trial

Official title: Effects of Indian Foods and Ayurvedic Drugs on Healthy and Diseased Liver

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-Alcoholic Fatty Liver Disease

• NCT number: NCT05696808
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Prof. Shiv Kr Sarin, MD, DM, FNA
• Phone: 011-46300000
• Email: shivsarin@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Completion date: January 13, 2024