An interventional study of IHPD and Western Diet in Non-Alcoholic Fatty Liver Disease and Metabolic Syndrome, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
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:
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 25 Kcal/Kg BW/day, with a protein intake of 1 gm/Kg BW/day i.e., around 15 % of total calories from protein, 35% from fats and 50% from carbohydrates. Major portion of the carbohydrates is vegetables, fruits and then cereals (high fiber cereals), more amount of tomato and amla at least 200 gm in a day, protein requirements are met by mainly legumes like chick pea black - (kala chana) and moong sprouts besides dals. Lean meats and egg whites would be allowed as the non-vegetarian source. Milk products used are only milk and buttermilk, curd (excluding paneer). Major source of oil would be mustard oil only.
Dietary Supplement: IHPD
The intervention is planned with a goal of restricting the calorie intake to 40 Kcal/Kg BW/day, around 10-15 % of total calories from protein, 30-35% from fats and 55-60% from carbohydrates. Major portion of the carbohydrates is Western fast food comprising of pizza and burger, French fries, sweets, muffins, cakes, chocolates, sugar sweetened beverages.
Dietary Supplement: Western Diet
The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 25 Kcal/Kg BW/day, with a protein intake of 1 gm/Kg BW/day i.e., around 15 % of total calories from protein, 35% from fats and 50% from carbohydrates. Major portion of the carbohydrates is vegetables, fruits and then cereals (high fiber cereals), more amount of tomato and amla at least 200 gm in a day, protein requirements are met by mainly legumes like chick pea black - (kala chana) and moong sprouts besides dals. Lean meats and egg whites would be allowed as the non-vegetarian source. Milk products used are only milk and buttermilk, curd (excluding paneer). Major source of oil would be mustard oil only.
The intervention is planned with a goal of restricting the calorie intake to 40 Kcal/Kg BW/day, around 10-15 % of total calories from protein, 30-35% from fats and 55-60% from carbohydrates. Major portion of the carbohydrates is Western fast food comprising of pizza and burger, French fries, sweets, muffins, cakes, chocolates, sugar sweetened beverages.
To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in hepatic steatosis in patients with NAFLD index in patients with NAFLD
Hepatic steatosis index will be assessed by controlled attenuation parameter (CAP) score.
Time frame: 1 month
To study the effectiveness of IHPD on Hyperglycemia (Fasting blood sugar) in patients with NAFLD
Hyperglycemia will checked by fasting blood sugar\>110mg/dl
Time frame: 1 month
To study the effectiveness of IHPD on central obesity (waist circumference) in patients with NAFLD
Central obesity will be measured by waist circumference in cm
Time frame: 1 month
To study the effectiveness of IHPD on hypertension (BP) in patients with NAFLD
Hypertension will be checked by observing blood pressure\>120/80
Time frame: 1 month
To study the effectiveness of IHPD on hypertriglyceridemia in patients with NAFLD
Hypertriglyceridemia will be checked by raised cholestrol and triglycerides.
Time frame: 1 month
To study the effectiveness of IHPD in reducing body weight in patients with NAFLD
Weight will be checked in kg with the help of weihing machine
Time frame: 1 month
To study the effectiveness of IHPD on gut microbiota in patients with NAFLD
Gut microbiota will be assessed by 16S
Time frame: 1 month
Plan to share: No
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Institute of Liver and Biliary Sciences, India