Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD

NCT05696808 | Unknown DMC

• 1 other identifier: ILBS-NAFLD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (6)

• 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 hypertension (BP) 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 in reducing body weight in patients with NAFLD

  1 month

Study Arms (2)

Indian hepatoprotective diet (IHPD)

EXPERIMENTAL

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

Western Diet

ACTIVE COMPARATOR

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

Interventions

IHPD DIETARY_SUPPLEMENT

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.

Indian hepatoprotective diet (IHPD)

Western Diet DIETARY_SUPPLEMENT

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.

Western Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Interventions

Diet, Western

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Prof. Shiv Kr Sarin, MD, DM, FNA

  Institute of Liver and Biliary Sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Shiv Kr Sarin, MD, DM, FNA

CONTACT

011-46300000; shivsarin@gmail.com

Dr. Jaya Benjamin, PhD

CONTACT

011-46300000; jayabenjaminilbs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the variables would be studied before and after intervention with indian hepatoprotective diet (IHPD) in 60 patients with NAFLD and 60 healthy individuals on Western diet.

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 25, 2023
• Study Start: January 16, 2023
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)