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CTRI Number  CTRI/2025/03/083070 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Indian Hepatoprotective Diet]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Indian Hepatoprotective Diet (IHPD) on hepatic steatosis, features of metabolic syndrome in patients with NAFLD and healthy individuals on a Western diet. 
Scientific Title of Study   Effects of Indian Foods and Ayurvedic drugs on healthy and diseased liver; Effect of Indian hepatoprotective diet in reversibility of NAFLD.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S K Sarin 
Designation  Sr. Professor of Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 22065, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.

South West
DELHI
110070
India 
Phone  01146300000  
Fax    
Email  shivsarin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S K Sarin 
Designation  Sr. Professor of Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 22065, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.

South West
DELHI
110070
India 
Phone  01146300000  
Fax    
Email  shivsarin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S K Sarin 
Designation  Sr. Professor of Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 22065, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.

South West
DELHI
110070
India 
Phone  01146300000  
Fax    
Email  shivsarin@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH Government of India B Block, GPO Complex, Barapullah Rd, Aviation Colony, INA Colony, New Delhi, Delhi 110023, India  
 
Primary Sponsor  
Name  Ministry of AYUSH Government of India 
Address  Bhawan, B-Block, GPO Complex, INA, New Delhi-110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S K Sarin  Institute of Liver and Biliary Sciences  Room No. 22065, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI 
01146300000

shivsarin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ILBS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Healthy individuals with Western Diet (This is not a comparison; it is a parallel group under the same study).  Desserts/Sweets,Processed meats,Red Meats,Highly processed foods,Dairy products includes high fat ,refined grains,potato,wholegrains,vegetables,legumes,fruit. Duration: 7 days 
Intervention  Indian Hepatoprotective 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 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. Only egg whites are allowed as the non-vegetarian source. Milk products used are only Milk, buttermilk and curd (paneer is excluded). Major source of oil is mustard oil only. Route: Oral Duration: 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Recently diagnosed (less than 3 months) consenting adults with NAFL (steatotosis) of grades 2 and 3 diagnosed on the basis of liver transient eleastography (controlled attenuation parameter: CAP more than 250)
2.BMI more than18
3.Age 18 to 55 years 
 
ExclusionCriteria 
Details  1.Intake of antibiotics within last month
2.Viral hepatitis
3.Significant alcohol consumption (regular consumption of more than 10g per day for females and more than 20g per day in males)
4.Chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded.
6.Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
7.Seriously ill and bed ridden patients
8.Pregnant & lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of IHPD on hepatic steatosis in patients with NAFLD and healthy individuals on Western diet.  pre post (28 days) 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in reducing body weight in patients with NAFLD and healthy individuals on Western diet in 28 days.  pre post (28 days) 
To study the effectiveness of IHPD on features of metabolic syndrome i.e. Hyperglycemia (Fasting blood sugar, HbA1c levels, central obesity (waist circumference, visceral fat), hypertension (BP), and hypertriglyceridemia (serum triglyceride and HDL cholesterol levels) in patients with NAFLD   pre post (28 days) 
To study the effectiveness of IHPD on gut microbiota in patients with NAFLD and healthy individuals on Western diet.  pre post (28 days) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Rationale

With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, is recognized as a common liver disease in many countries and comprises a spectrum of diseases, ranging from simple steatosis of the liver to fibrosis and cirrhosis. It has been reported that NAFLD is associated with an increased risk of cardiovascular disease (CVD). This study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor [1].

Diet and lifestyle management is the cornerstone of therapy for NAFLD. It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Our cereals should be from the more refined to the more complex ones being rich in fiber, with more emphasis on intake of fruits and vegetables of various colours. High proteins of the plant origin and of the lean meats and eggs are preffered than the processed meats and the red meat. The quality of the fats and oils used in the diet also make a difference as they are the most concentrated source of energy. Good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be on the consumption of high fiber cereals, low in simple carbohydrates, curds having the probiotic properties, vegetables that have hepatoprotective effect, chana and moong sprouts which besides being a good source of proteins have an individual hepatoprotective effect also, which even have the potential to modulate the intestinal bacterial ecology to a more favorable type thus helping in intensifying the effects of overall dietary modifications. 

 
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