CD36和STAT3基因多态性对冠心病患者不同饮食干预的影响：一项随机对照试验的研究方案
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.
作者信息
Portal Vera Lucia, Markoski Melissa Medeiros, Quadros Alexandre Schaan de, Garofallo Sílvia, Santos Julia Lorenzon Dos, Oliveira Aline, Wechenfelder Camila, Campos Viviane Paiva de, Souza Priscilla Azambuja Lopes de, Machado Luana, Marcadenti Aline
机构信息
Postgraduate Program in Health Sciences: Cardiology, Institute of Cardiology of the Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.
Department of Nutrition, Federal University of Health Sciences of Porto Alegre (UFCSPA), 245 Sarmento Leite Street, Porto Alegre, RS, 90050-170, Brazil.
出版信息
Trials. 2016 Sep 5;17(1):437. doi: 10.1186/s13063-016-1564-1.
BACKGROUND
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.
METHODS/DESIGN: 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.
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02202265 (registered on 18 July 2014: first version).
背景
心血管疾病已成为一个主要的健康问题，它与环境和遗传因素都有关联。研究表明，地中海饮食（MeDiet），或其组成部分如坚果和橄榄油，可能与特定人群中心血管危险因素的改善密切相关。GENUTRI研究的目的是根据三种不同饮食：富含山核桃、特级初榨橄榄油或对照饮食，调查非地中海人群冠心病（CAD）中基因与心血管危险因素的相互作用。
方法/设计：GENUTRI研究是一项单中心、随机、开放标签、平行组、为期12周的实用临床试验，在年龄40至80岁且诊断为CAD的患者中进行。将应用标准化问卷进行数据收集，并采集血样用于血脂、血糖和炎症指标评估。将使用TaqMan®SNP基因分型检测法检测CD36和STAT3基因中的多态性。患者将被分为三组：第1组：每天30克山核桃；第2组：每天30毫升橄榄油；第3组：对照饮食。主要结局将包括干预12周后低密度脂蛋白胆固醇（mg/dl）的变化。
讨论
研究表明富含坚果和橄榄油的饮食主要对地中海人群有有益作用。GENUTRI是一项关注巴西个体补充坚果或橄榄油效果的临床试验。此外，我们将试图证明与心血管疾病相关的基因多态性可能调节这些受试者中不同饮食对生化和炎症标志物的影响。
试验注册
ClinicalTrials.gov标识符：NCT02202265（于2014年7月18日注册：第一版）
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