| CTRI Number |
CTRI/2025/01/079451 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary Intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Indianized Version of Mediterranean Diet (Type of diet) versus Low Fat Diet in MASLD (Liver Disease). |
|
Scientific Title of Study
|
Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06768216 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashray S Patel |
| Designation |
Senior Resident,Department of pediatric hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3326, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
patel1995ash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Alam |
| Designation |
Professor & Head, Department of Pediatric Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3326, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
seema_alam@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Alam |
| Designation |
Professor & Head, Department of Pediatric Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3326, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
seema_alam@hotmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,vasant kunj, New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,vasant kunj, New Delhi-110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashray S Patel |
Institute of Liver and Biliary Sciences |
Room No. 3326, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
patel1995ash@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 |
Indianized version of Mediterranean Diet with Physical Activity |
Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking).
DURATION: 6 months |
| Intervention |
Low Fat Diet with Physical Activity |
Low fat diet will have 50-60% carbohydrate, 20-30% fat (with 10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than 30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet.
DURATION: 6 months |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 8 to 18 years
2. BMI more than 85th centile
3. CAP more than 236 |
|
| ExclusionCriteria |
| Details |
Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the proportions of patients achieving normal CAP values (less than 236db per m) after 180 days of IMD versus LFD in children and adolescent with MASLD. |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD |
180 days |
| To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups. |
180 days |
| To compare the changes in CAP value in PNPLA3 mutant children. |
180 days |
| To compare the changes in following parameters in both study groups: Weight,BMI,HOMA-IR & Lipid Profile. |
180 days |
| To compare the adherence to IMD, with the help of Modified KIDMED score. |
180 days |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
28/01/2025 |
| 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="2"
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
|
NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD. |