Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Abstract

BackgroundCardiovascular disease has become a major health problem, and it has been associated with both environmental and genetic factors. Studies have shown that the Mediterranean Diet (MeDiet), or its components such as nuts and olive oil, may be strongly associated with the improvement of cardiovascular risk factors in specific populations. The purpose of the GENUTRI study is to investigate the interaction of genetics with cardiovascular risk factors in a non-Mediterranean population with coronary artery disease (CAD) according to three different diets: rich in pecan nuts, in extra-virgin olive oil or a control diet.Methods/designThe GENUTRI study is a single-center, randomized, open-label, parallel-group, 12-week pragmatic clinical trial conducted in patients aged 40 to 80 years and diagnosed with CAD. A standardized questionnaire will be applied to data collection and a blood sample will be obtained for lipid, glycemic and inflammatory profile evaluation. Polymorphisms in the CD36 and STAT3 genes will be detected using the TaqMan® SNP Genotyping Assay. Patients will be allocated in three groups: group 1: 30 g/day of pecan nuts; group 2: 30 ml/day of olive oil; and group 3: control diet. The primary outcome will consist of changes in LDL-cholesterol (in mg/dl) after 12 weeks of intervention.DiscussionStudies have shown the beneficial effects of diets rich in nuts and olive oil mainly in the Mediterranean population. GENUTRI is a clinical trial focusing on the effects of nuts or olive oil supplementation in Brazilian individuals. Additionally, we will try to demonstrate that genetic polymorphisms linked to cardiovascular disease may modulate the effects of different diets on biochemical and inflammatory markers among these subjects.Trial registrationClinicalTrials.gov Identifier: NCT02202265 (registered on 18 July 2014: first version).

Correlations between Traditional and Nontraditional Indicators of Adiposity, Inflammation, and Monocyte Subtypes in Patients with Stable Coronary Artery Disease

“…This was a cross-sectional study conducted using baseline data from a randomized clinical trial including patients >40 years who were diagnosed with CAD by cineangiocoronariography and were clinically stable (more than 60 days without new symptoms, hospitalization, or emergency visit due to cardiovascular disease or new cardiovascular events) [20]. Patients were enrolled from the Interventional Cardiology Service of the Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC, Porto Alegre, Brazil) as well as from public call.…”

Effects of supplementing a healthy diet with pecan nuts or extra-virgin olive oil on inflammatory profile of patients with stable coronary artery disease: a randomised clinical trial

“…In the initial assessment, participants were submitted to a standardized questionnaire that included sociodemographic, clinical (current and past), lifestyle data and level of physical activity (25) . The medical diagnoses of dyslipidemia, hypertension and type 2 diabetes mellitus (T2DM) were defined according to the current guidelines at the beginning of the study (25) . Body weight (kg), height (cm), waist circumference (cm) were obtained, and BMI (kg/m 2 ) was calculated.…”

“…The nutritional composition of the three diets prescribed, its similarities and differences are described in Table 1. The fatty acids and total polyphenols composition of the pecan and olive oil offered in the study, and details about the origin and methods for conservation and daily consumption of the foods were previously published in details (25,26) .…”

Methodological challenges to evaluating the health economic impact of nutritional interventions

“…Studies are underway to begin to understand the interaction between genetic factors and the effectiveness of dietary interventions (Portal, Markoski et al 2016, Rizzi, Conti et al 2016; knowing more about the genetic profile of the population and how certain genetic variants interact with foods and their components could increase the accuracy of projections about the effectiveness of dietary interventions. Data on genetic or other factors that may affect the apportionment of benefit or risk, so far, are rarely available at a sufficient level of detail and degree of scientific certainty to inform population-level nutrition economic models.…”