Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Interleukin-6 (IL-6)
研究概览
简要总结
Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.
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 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
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
- •patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
- •willing to participation in the study
排除标准
- •Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month
- •َChronic kidney disease stage 5
- •Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
结局指标
主要结局
Interleukin-6 (IL-6)
时间窗: 6 week
change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6
次要结局
- plasma lipid profile(6 week)
- Interleukin-10 (IL-10)(6 week)
- C reactive protein (CRP)(6 week)
- plasma liver enzymes (SGOT & SGPT)(6 week)
研究者
Javad Nasrollahzadeh
Investigator in Clinical Nutrition
Shahid Beheshti University