| CTRI Number |
CTRI/2024/09/073565 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diet] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of the benefit of Indian adaptation of Mediterranean diet in patients with heart disease |
|
Scientific Title of Study
|
Impact of Indian Adaptation of Mediterranean Diet on Dietary Inflammatory Index in Patients with Coronary Artery Disease- A Randomised Clinical Trial |
| 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 Ambuj Roy |
| Designation |
Professor of Cardiology |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 20 7th Floor Department of Cardiology C N Center AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9810992822 |
| Fax |
|
| Email |
drambujroy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ambuj Roy |
| Designation |
Professor of Cardiology |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 20 7th Floor Department of Cardiology C N Center AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9810992822 |
| Fax |
|
| Email |
drambujroy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ambuj Roy |
| Designation |
Professor of Cardiology |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 20 7th Floor Department of Cardiology C N Center AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9810992822 |
| Fax |
|
| Email |
drambujroy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Grant by Indian Council of Medical Research, AIIMS Campus Temple, Ansari Nagar East, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research India |
| Address |
NCD Division ICMR New Delhi, AIIMS Campus Temple, Ansari Nagar East, New Delhi 110029 |
| 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 Ambuj Roy |
All India Institute of Medical Sciences, New Delhi |
Room no 20 7 floor CN center AIIMS New Delhi New Delhi DELHI |
9810992822
drambujroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indian Adaptive Mediterranean Diet |
The intervention is a dietary package comprising a 7-day cyclical menu based on the principles of the Mediterranean diet, called the IAMD, that will be customised considering the dietary preferences of the patient. The menu will be supported by information materials and patient counselling sessions. |
| Comparator Agent |
Standard diet care |
The control arm will receive a dietary package administered by the in-house dietician in the department of cardiology to patients diagnosed with CAD as part of the usual care protocol.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of CAD (old MI/angiography proven CAD with more than 50 percent diameter stenosis in more than 1 coronary artery/ Previous PCI or CABG) or high risk for CAD (INTERHEART Score more than 15) on stable dose of cardiovascular medicines (esp statins) for at least one month |
|
| ExclusionCriteria |
| Details |
Not willing to undertake a formal dietary intervention
2. Patients on a formal dietary intervention plan
3. Patients with comorbidities requiring special dietary interventions like CKD
4. Patients with other serious coexisting illnesses like cancers, thyroid diseases, rheumatic/chronic inflammatory diseases
5. Patients with clinical heart failure
6. Patients with eating disorders (behavioral conditions characterized by severe and persistent disturbance in eating behaviors including anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder, other specified feeding and eating disorders, pica and rumination disorder).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate change in DII from baseline values in patients on IAMD versus usual dietary care |
at 6 months follow up of the patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
To assess any correlation between DII at baseline with cardiovascular and inflammatory biomarkers
2.To assess any correlation between change in DII in interventional arm with IAMD adherence
3.To assess any correlation between change in DII in interventional arm with cardiovascular and inflammatory biomarkers. |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Coronary Artery Disease (CAD) occurs
at a younger age and is associated with severe and extensive atherosclerosis in
Indians. One of the
established risk factors of CAD is an unhealthy diet, which is also related to
CAD risk factors- hypertension, Type 2 Diabetes Mellitus, central obesity and
dyslipidemia. Indian diets are high in carbohydrates with low energy from
proteins and low fruit and vegetable consumption. This dietary profile may
contribute to increased CAD risk differently from Western diets where a
saturated fat diet, processed food and sugar-sweetened beverages drive the CAD
risk. This underscores a need for a detailed analysis of the diet among
patients with CAD. One of the recently validated diet indexes, the Dietary
Inflammatory Index (DII), has been shown to have a strong association with
cardiovascular disease and mortality. The Mediterranean Diet, with its low DII,
has been shown to be cardioprotective in clinical trials. In Phase I of the
study we developed a diet with ingredients with commonalities or substitutes of
the Mediterranean Diet. A 7-day cyclical menu was developed based on a
modification of commonly eaten food items in a North Indian Diet with very low
(high anti-inflammatory) DII scores. In this Phase II study, we aim to study
the impact of this culturally adapted, individually customized,
anti-inflammatory diet- Indian Adaptation of Mediterranean Diet versus usual
diet prescribed as per current guidelines in patients of stable CAD and see its
impact on DII, cardiovascular and inflammatory biomarkers |