Effects of Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Vascular Endothelial Function and Some Biochemical Indicators Related to Atherosclerosis in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Flow Mediated Dilatation (FMD)
研究概览
简要总结
Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.
详细描述
A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
- •willing to participation in the study
排除标准
- •cigarette Smoking
- •continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
- •consumption of flaxseed or any omega-3 supplement at the beginning of the study
- •َadvanced renal disease
- •unwillingness to continuance
- •any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
研究组 & 干预措施
Flaxseed
Daily consumption of 30 grams flaxseed for 3 months
干预措施: Flaxseed (Other)
Flaxseed and the Mediterranean-like diet
Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months
干预措施: Flaxseed (Other)
Flaxseed and the Mediterranean-like diet
Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months
干预措施: the Mediterranean-like diet (Other)
Placebo
Daily consumption of Placebo for 3 months
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Flow Mediated Dilatation (FMD)
时间窗: 3 month
Change in dilatation of the brachial artery from baseline at 3 month
次要结局
- carotid intima-media thickness (c-IMT)(3 month)
- plasma level of high sensitive C reactive protein (hs-CRP)(3 month)
- plasma lipid profile(3 month)
- asymmetric di-methyl arginine (ADMA)(3 month)
研究者
Javad Nasrollahzadeh
Director
Shahid Beheshti University