Effect of Polymorphisms in CD36 and STAT3 Genes on Different Dietary Interventions Among Patients With Coronary Artery Disease: a Randomized Clinical Trial With a Nutrigenetic Approach
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- LDL
研究概览
简要总结
Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated with increased consumption of total fat. The transcription factor STAT3 is released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is associated with abdominal obesity and higher intake of saturated fat. Studies have been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and these dietary patterns have been often studied with nutrigenetic approach; these studies, however, are often limited to European populations, making it difficult to generalize to different populations.
Hypothesis: Different dietary approaches may similarly influence in modifying metabolic, inflammatory and anthropometric profile, especially among patients with coronary arterial disease (CAD). The genetic interaction with environmental factors such as the nutrient intake, and the prescription of a different diet according to individual genotype, could influence the development and/or the treatment of cardiovascular diseases.
Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and anthropometric profile in patients with CAD and possible interactions with polymorphisms in CD36 and STAT3 genes.
详细描述
A randomized clinical trial with a nutrigenetic approach among patients ≥ 40 years diagnosed with CAD. Randomization will be made in blocks from a list of random numbers generated by site www.randomization.org (sealed opaque envelopes). A questionnaire with demographic and clinical data will be applied; systolic and diastolic blood pressure, waist, hip and neck circumferences, height and weight will be assessed. Nutrients intake will be assessed through a food diary. Laboratory evaluation will consist of lipid profile (LDL-cholesterol, HDL-cholesterol and total cholesterol, serum triglycerides), glycemic profile (fasting plasma glucose, glycated hemoglobin) and inflammatory profile (high-sensitivity C-reactive protein, fibrinogen, TNF-alpha, interleukin-6 and interleukin-10). Genotyping will be made by TaqMan SNP Genotyping Assay®. Patients will be randomized in three groups: Group 1 Intervention [Supplementation with nuts (SN)]: standard dietary guidelines + 30g of nuts a day; Group 2 Intervention [Supplementation with olive oil (SAO)]: standard dietary guidelines + 30ml of olive oil a day; Group 3 [Control diet (CO)]: standard dietary guidelines. Patients will be followed for three months (12 weeks) and the primary endpoint will be the change in LDL-cholesterol. The follow-up visits will be made at 30 days, 60 days and 90 days (final visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with coronary arterial disease.
排除标准
- •Psychiatric disease;
- •Morbid obesity (BMI ≥ 40mg/m2);
- •Expectancy of life less than 6 months;
- •Pregnancy or lactation;
- •Renal failure (in dialysis);
- •Congestive heart failure;
- •Prior organ transplantation;
- •Patients in wheelchair;
- •Use of vitamin/nutritional supplements;
- •Chronic use of non steroidal anti-inflammatory drugs;
- •Participation in another experimental study.
研究组 & 干预措施
Control diet (standard dietary)
Patients will receive a control diet based on standard dietary guidelines
干预措施: Control diet (Dietary Supplement)
Nuts (30g a day)
Patients will receive a control diet based on standard dietary guidelines plus 30g of nuts a day
干预措施: Nuts (Dietary Supplement)
Olive oil (30ml a day)
Patients will receive a control diet based on standard dietary guidelines + 30ml of olive oil a day
干预措施: Olive oil (Dietary Supplement)
结局指标
主要结局
LDL
时间窗: twelve weeks
LDL-cholesterol, in mg/dL
次要结局
- BMI(twelve weeks)
- TC(twelve weeks)
- BW(twelve weeks)
- TG(twelve weeks)
- NHDL(twelve weeks)
- HDL(twelve weeks)
- TyG index(twelve weeks)
- HbA1C(twelve weeks)
- FG(twelve weeks)
- Insulin(twelve weeks)
- HOMA-IR(twelve weeks)
- inflammatory profile(twelve weeks)
- WC(twelve weeks)
- NC(twelve weeks)
- LAP index(twelve weeks)
- DAAT index(twelve weeks)
- VAI index(twelve weeks)
- PFA(twelve weeks)
- Mon(twelve weeks)
- rs1761667 G>A(baseline)
- rs8069645 A>G(baseline)
- Interaction diet * genotype(twelve weeks)