| 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
|
|
|
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
|
|
|
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. |