The Impact of Indian Adapted Mediterranean Diet (IAMD) on Dietary Inflammatory Index in Patients with Coronary Artery Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND

South Asians experience a higher incidence and earlier onset of coronary artery disease (CAD). Diet is a key modifiable cardiometabolic risk factor with anti-inflammatory diet shown to be protective against CAD. Although the Mediterranean Diet has demonstrated anti-inflammatory and cardioprotective effects, its cultural acceptability and feasibility in India remain limited. The Indian Adapted Mediterranean Diet (IAMD) is a regionally tailored, culturally appropriate dietary pattern designed to reduce dietary inflammation using locally available foods.

METHODS

In this single-center, open-label randomized controlled trial, 140 adults with stable CAD or moderate to high cardiovascular risk (INTERHEART score ≥ 10) will be randomized 1:1 to receive either IAMD-based intervention or standard dietary advice and followed for six months. The primary outcome is the change in Dietary Inflammatory Index (DII) and energy-adjusted DII (E-DII) from baseline to six months. Secondary outcomes include changes in inflammatory biomarkers (c-reactive protein [CRP], interleukin-4 [IL-4], interleukin-6 [IL-6], and interleukin-10 [IL-10]), cardiometabolic risk factors (fasting plasma glucose, glycated hemoglobin [HbA1c], fasting insulin, lipid profile, uric acid, and serum fatty acid composition), and anthropometric parameters. Exploratory endpoints include changes in metabolic hormones adiponectin, leptin, ghrelin, resistin, and glucagon-like peptide-1 (GLP-1) levels.

DISCUSSION: This trial will evaluate the efficacy of the culturally contextualized IAMD in reducing dietary inflammation among Indians with CAD or at high cardiovascular risk. By quantifying dietary inflammatory potential and its metabolic correlates, the IAMD Trial aims to generate evidence for a scalable, region-specific dietary strategy to mitigate cardiovascular risk in South Asians. The findings are expected to guide dietary recommendations and inform public health nutrition policies for cardiovascular disease prevention in low- and middle-income settings.

TRIAL REGISTRATION: CTRI: REF/2024/07/088698.