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Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD (NAFLDNutrition)

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
IHPD
Western Diet
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indian hepatoprotective diet (IHPD)

Western Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To study the effectiveness of IHPD on Hyperglycemia (Fasting blood sugar) in patients with NAFLD
Hyperglycemia will checked by fasting blood sugar>110mg/dl
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
To study the effectiveness of IHPD on hypertension (BP) in patients with NAFLD
Hypertension will be checked by observing blood pressure>120/80
To study the effectiveness of IHPD on hypertriglyceridemia in patients with NAFLD
Hypertriglyceridemia will be checked by raised cholestrol and triglycerides.
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
To study the effectiveness of IHPD on gut microbiota in patients with NAFLD
Gut microbiota will be assessed by 16S

Full Information

First Posted
January 14, 2023
Last Updated
February 11, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05696808
Brief Title
Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD
Acronym
NAFLDNutrition
Official Title
Effects of Indian Foods and Ayurvedic Drugs on Healthy and Diseased Liver
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
January 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indian hepatoprotective diet (IHPD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Western Diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
IHPD
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Western Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in hepatic steatosis in patients with NAFLD index in patients with NAFLD
Description
Hepatic steatosis index will be assessed by controlled attenuation parameter (CAP) score.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To study the effectiveness of IHPD on Hyperglycemia (Fasting blood sugar) in patients with NAFLD
Description
Hyperglycemia will checked by fasting blood sugar>110mg/dl
Time Frame
1 month
Title
To study the effectiveness of IHPD on central obesity (waist circumference) in patients with NAFLD
Description
Central obesity will be measured by waist circumference in cm
Time Frame
1 month
Title
To study the effectiveness of IHPD on hypertension (BP) in patients with NAFLD
Description
Hypertension will be checked by observing blood pressure>120/80
Time Frame
1 month
Title
To study the effectiveness of IHPD on hypertriglyceridemia in patients with NAFLD
Description
Hypertriglyceridemia will be checked by raised cholestrol and triglycerides.
Time Frame
1 month
Title
To study the effectiveness of IHPD in reducing body weight in patients with NAFLD
Description
Weight will be checked in kg with the help of weihing machine
Time Frame
1 month
Title
To study the effectiveness of IHPD on gut microbiota in patients with NAFLD
Description
Gut microbiota will be assessed by 16S
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Shiv Kr Sarin, MD, DM, FNA
Phone
011-46300000
Email
shivsarin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Jaya Benjamin, PhD
Phone
011-46300000
Email
jayabenjaminilbs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Shiv Kr Sarin, MD, DM, FNA
Organizational Affiliation
Institute of Liver and Biliary Sciences, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Shiv Kr Sarin, MD, DM, FNA
Phone
01146300000
Email
shivsarin@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Jaya Benjamin, PhD
Phone
01146300000
Email
jayabenjaminilbs@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD

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