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临床试验/CTRI/2024/09/073565
CTRI/2024/09/073565招募中3 期

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

Indian Council of Medical Research India1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
140
试验地点
1
主要终点
To evaluate change in DII from baseline values in patients on IAMD versus usual dietary care

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Not willing to undertake a formal dietary intervention
  • Patients on a formal dietary intervention plan
  • Patients with comorbidities requiring special dietary interventions like CKD
  • Patients with other serious coexisting illnesses like cancers, thyroid diseases, rheumatic/chronic inflammatory diseases
  • Patients with clinical heart failure
  • 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).

结局指标

主要结局

To evaluate change in DII from baseline values in patients on IAMD versus usual dietary care

时间窗: at 6 months follow up of the patients.

次要结局

  • Secondary Outcome(To assess any correlation between DII at baseline with cardiovascular and inflammatory biomarkers)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Ambuj Roy

AIIMS, New Delhi

研究点 (1)

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