Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD

Phase

N/A

Condition

Diabetes Prevention

Metabolic Disorders

Liver Disease

Treatment

N/A

Clinical Study ID

NCT05696808

ILBS-NAFLD

Ages 18-60
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Pregnant & lactating women
Age <18 and >55 years
Individuals who had been hospitalised with complications of Diabetes mellitus, ChronicKidney 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 dayfor females and > 20g/d in males),
Patients having chronic inflammatory bowel disease or any chronic and autoimmunediseases will be excluded
Patients with NAFLD with associated hypertriglyceridemia requiring administration ofstatins.

Study Design

January 16, 2023

January 13, 2024

Study 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:

Effects of conventional Indian foods as hepatoprotective agents, producers of 'healthy' bile and stimulating liver regeneration.
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

Connect with a study center

Institute of Liver and Biliary Sciences
New Delhi, Delhi 110070
India
Active - Recruiting

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