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Study of the benefit of Indian adaptation of Mediterranean diet in patients with heart disease

Impact of Indian Adaptation of Mediterranean Diet on Dietary Inflammatory Index in Patients with Coronary Artery Disease- A Randomised Clinical Trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073565
Enrollment
140
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: 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

Sponsors

Indian Council of Medical Research India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
To evaluate change in DII from baseline values in patients on IAMD versus usual dietary careTimepoint: at 6 months follow up of the patients.

Secondary

MeasureTime frame
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.Timepoint: 6 Months

Countries

India

Contacts

Public ContactDr Ambuj Roy

AIIMS, New Delhi

drambujroy@gmail.com9810992822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026