| CTRI Number |
CTRI/2024/08/071921 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [DIETARY INTERVENTION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Indo-mediterranean diet on fatty liver |
|
Scientific Title of Study
|
To compare the effect of Indo-Mediterranean Diet with continuous energy restriction diet on hepatic steatosis and fibrosis, body composition, and metabolic parameters in adults with non-alcoholic fatty liver disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Naval K Vikram |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 8, SRB LAB, 3rd Floor Teaching Block, All India Institute of Medical Sciences, New Delhi, India
South
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Naval K Vikram |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTUTUTE OF MEDICAL SCIENCES,NEW DELHI |
| Address |
ROOM NO 8, SRB LAB, 3rd FLOOR TEACHING BLOCK,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
South
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Naval K Vikram |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTUTUTE OF MEDICAL SCIENCES,NEW DELHI |
| Address |
ROOM NO 8, SRB LAB, 3rd FLOOR TEACHING BLOCK,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA
South
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (DHR), IRCS Building,2nd Floor,1, Red Cross Road, New Delhi-110001, India |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF HEALTH RESEARCH DHR |
| Address |
1, Red Cross Road, Gokul Nagar, Sansad Marg Area, New Delhi-110001 |
| 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 NAVAL K VIKRAM |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
ROOM NO 8, SRB LAB, 3rd FLOOR, TEACHING BLOCK, AIIMS, NEW DELHI
South
DELHI |
01126593678
navalvikram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, DELHI |
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 |
CONTROL GROUP |
Participants in this group will be given a Continuous Energy Restriction diet. To promote weight loss, it is important to reduce the energy intake to achieve weight loss. A calorie restriction of 500 Kcal/day from the recommended dietary allowances of adults results in weight loss of 0.5 kg/week and 5% weight loss in 3 months. |
| Intervention |
Indo Mediterranean diet (IMD) GROUP |
One arm consists of subjects who will be put on an IMD diet. In this diet, energy is provided as required by an individual based on ideal body weight as recommended by dietary allowance to Indian[2] but the composition of the food will be modified with a higher quantity of whole grains, herbs, spices, mustard oil, almonds and walnuts and in addition to fruits and vegetables and fish to non-vegetarians. Thus, the major constituents of the Indo-Mediterranean diet are more whole grains, such as millet, porridge, beans, brown rice, spices (coriander, turmeric, fenugreek, cumin, and cinnamon), peppers, onion, garlic, curd, and buttermilk, and lack of animal foods, except fish. This diet will also help in promoting the use of indigenous food grains like millet, vegetables, and fruits. The Indo-Mediterranean diet has no animal foods (except fish), lower saturated fat and total fat, sugar, and salt, and high omega-3 fatty acids and flavonoids. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18-60 years will be included.
2. Patients enrolled in the study need to be diagnosed with non-alcoholic fatty liver disease.
3. Patients should have a Body Mass Index (BMI) of ≥ 25 kg/m2.
4. Adult patients will be willing to participate and ensure cooperation in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing the treatment or recently diagnosed diabetes mellitus.
2. Participants who have undergone any recent (in the last three months) major surgery.
3. Patients with any acute or chronic infectious illness are excluded.
4. Patients with a history of pancreatitis or other diseases who require any dietary modifications/restrictions.
5. Patients with chronic heart and kidney disease and advanced end-organ damage are excluded from the study.
6. Patients who have chronic hepatitis are excluded.
7. Any Pregnant and lactating women are excluded from the study.
8. Presence of seropositivity for Hepatitis B, C, and Human Immunodeficiency Virus (HIV) patients are excluded.
9. Patients who consume excessive alcohol (>20 g/day for women and >30 g/day for men).
10. Currently (in the last three months) enrolled or have been a part of any other intervention program study are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), body weight, body composition, and metabolic parameters in NAFLD patients |
Changes in CAP, Liver Stiffness Measurement (LSM), and metabolic parameters in NAFLD patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to assess the improvement in biomarkers, energy expenditure, sleep quality, any subclinical inflammation, & quality of life. It also include the assessment of adherence to the dietary regime provided in the study. |
BASELINE, 6 WEEKS (1.5 months), 12 WEEKS (3 months) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
13/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Non-alcoholic fatty liver
disease (NAFLD) is emerging as the most common chronic liver disease. [1] Currently, there is no consensus concerning the
pharmacological treatment of NAFLD. However, lifestyle interventions based on
exercise and a balanced diet for quality and quantity, are considered the
cornerstone of NAFLD management.
Research question: The research question here is, does
the IMD is better than CER in improving liver steatosis,
fibrosis, body composition and metabolic parameters. It is also important to compare
the impact of these diets on other NAFLD related biomarkers. At last, apart from above mentioned parameters the study
will also compare the effect of IMD and CER on, sleep quality, quality of life
and adherence to the diet.
Methodology: 150 NAFLD patients will be included in the study and divided into
2 groups 75 in each group. Patients will be assessed at baseline for the liver
steatosis and fibrosis, clinical, anthropometric, biochemical and metabolic
parameters. They will be provided with the intervention and the outcomes will
be assessed at 1.5 months and final outcomes at 3 months.
Proposed outcome: It is expected that after 3 months of intervention improvement in
liver steatosis and fibrosis, clinical, anthropometric, biochemical and metabolic
parameters will be observed in the intervention group. |