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.
Cardiovascular 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.



The 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.



Studies 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.



ClinicalTrials.gov Identifier: NCT02202265 (registered on 18 July 2014: first version).
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Vera Lucia
VL
Portal
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Melissa Medeiros
MM
Markoski
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Alexandre Schaan de
AS
Quadros
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Sílvia
S
Garofallo
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Julia Lorenzon Dos
JL
Santos
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Aline
A
Oliveira
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Camila
C
Wechenfelder
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Viviane Paiva de
VP
Campos
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Priscilla Azambuja Lopes de
PA
Souza
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Luana
L
Machado
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil. alinemo@ufcspa.edu.br.|Department of Nutrition, Federal University of Health Sciences of Porto Alegre (UFCSPA), 245 Sarmento Leite Street, Porto Alegre, RS, 90050-170, Brazil. alinemo@ufcspa.edu.br.
Aline
A
Marcadenti
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001938:Brazil; D018955:CD36 Antigens / Q000235:genetics*; D031325:Carya; D008078:Cholesterol, LDL / Q000097:blood; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000097:blood / Q000175:diagnosis / Q000178:diet therapy* / Q000235:genetics*; D038441:Diet, Mediterranean; D005260:Female; D059647:Gene-Environment Interaction; D005838:Genotype; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D009754:Nuts; D000069463:Olive Oil; D010641:Phenotype; D020641:Polymorphism, Single Nucleotide; D012107:Research Design; D050796:STAT3 Transcription Factor / Q000235:genetics*; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D018955:CD36 Antigens; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D018836:Inflammation Mediators; D007328:Insulin; D000069463:Olive Oil; D050796:STAT3 Transcription Factor; C494086:STAT3 protein, human; C517652:hemoglobin A1c protein, human
Biological markers; Coronary artery disease; Genetic; Nuts; Olive oil; Polymorphism; Randomized clinical trial