An Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile — RISMED  

Coronary Artery Disease Clinical Trial

Official title: A Randomized Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether a Mediterranean Diet, personalized in terms of total calories, total lipids and balanced in terms of saturated, mono- and poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary advice.

Clinical Trial Description

Geographical differences in the incidence of CardioVascular Disease (CVD) show a lower risk in countries of south Europe compared with north and east Europe and USA. The Mediterranean Diet (MD) has been the most frequently invoked factor to explain these differences, but the underlying mechanisms are still unclear. On the other hand, blood fatty acid (FA) composition has been shown to be strongly related to cardiovascular risk, presumably through changes in oxidative stress and inflammatory pathways, two mechanisms involved in the pathogenesis of atherothrombosis. Preliminary data from our group suggest that patients with Coronary Heart Disease (CHD) adhere less to features of MD and exhibit a different fatty acid profile compared to healthy subjects. We speculate that MD may reduce oxidative stress and inflammatory markers, and reverse the unfavorable blood fatty acid profile observed in patients with CHD. Even though single MD components (wine, olive oil, vegetables, fish, etc) have shown beneficial effects on oxidative stress, inflammation and CardioVascular (CV) risk, evidence indicates that these effects are mostly related to the extent of compliance with the whole MD, which comprises possible synergism between food components. For this reason, the present study will consider the whole MD and not single components.

Design: randomized, parallel groups, open-label, intervention trial. Intervention: an intensively advised MD (fatty fish at least 3 times/week; legumes 2-3 times/ week; vegetables twice a day; fruits twice/day; 30-45g olive oil/day; 1-2 glasses of red wine/day, not more than 150g red meat/week), personalized in terms of calories, total lipids and balanced in terms of saturated, mono- and poly-unsaturated lipids (n= 75) vs. usual low-fat dietary advice (n=75) for 3 months. Participants: males and females, age 30-75, with a recent history of coronary revascularization, randomized after clinical stabilization (at least 60 days after any coronary procedure or event).

At baseline and after intervention in both groups:

Dietary assessment: using the EPIC questionnaire, a well validated dietary recall tool.

Blood, urinary and fecal samples: routine biochemical determinations, blood fatty acid composition by gas-chromatography, C reactive protein and oxidative stress markers (urinary isoprostanes, whole blood reduced and oxidized glutathione by Liquid Chromatography- Mass Spectrometry (LC-MS/MS), plasma alpha- and gamma-tocopherol by High Performance Liquid Chromatography (HPLC) with fluorimetric detector), gene expression and/or epigenome in peripheral whole blood cells (as an index of global changes of inflammation/immune response), intestinal microbiome.

Statistical analysis: Principal component analysis to characterize fatty acid patterns. Score of Trichopoulou to assess adherence to MD. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT02578329
• Study type: Interventional
• Source: Centro Cardiologico Monzino
• Contact: Fabrizio Veglia, PhD
• Phone: +39 025800
• Email: fabrizio.veglia@ccfm.it
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Completion date: February 2018