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Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD

NCT05696808 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-14

No results posted yet for this 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.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

IHPD

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

Western Diet

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.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Prof. Shiv Kr Sarin, MD, DM, FNA · Institute of Liver and Biliary Sciences, New Delhi, India

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-01-13
Completion
2024-01-13

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696808 on ClinicalTrials.gov