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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  
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 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  
Status 
Not Applicable 
 
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

 
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