Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function of Patients With Stable Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Olivomed and OlivomedSmart effects on endothelial function.
研究概览
简要总结
Olive extracts are considered to have antioxidant properties. The investigators will study the effect of olive extracts containing hydroxytyrosol (HT)-olivomed and combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - olivomedSmart on endothelial, cardiac and vascular function in patients with coronary artery disease .
详细描述
30 patients with stable angiographically documented coronary artery disease will be randomized to receive olive extracts with high concentration of hydroxytyrosol (5 mg po twice per day included in Olivomed capsules) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month.
30 patients with stable angiographically documented coronary artery disease will be randomized to receive OlivomedSmart - olive extracts with Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) (OL:HT:OC 2:1:3) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month.
the same quantity of hydroxytyrosol was contained in two supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <70 years
- •Stable coronary heart disease
- •Patients with acute coronary syndrome who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), 2 months must have passed since the incident
- •High LDL levels, low HDL, high triglycerides
排除标准
- •Age> 70 years
- •Patient with diabetes
- •Patient with hypertension
- •Patient with liver disease
- •Patient with thyroid disease
- •Patient with active malignancy
- •Patient with a disease that affects inflammatory markers (rheumatic diseases, etc.)
- •Patient with chronic renal failure (creatinine> 2 mg / dl)
- •Patient treated chronically with corticosteroids
- •Patient who has joined a weight loss program or any dietary intervention or intensive exercise programme within the previous 2 months or consumes multivitamin preparations with antioxidant properties.
结局指标
主要结局
Olivomed and OlivomedSmart effects on endothelial function.
时间窗: one month
Olivomed and OlivomedSmarteffects on endothelial function. Endothelial function is assessed by measuring Flow Mediated Vasodilation (FMD) of the brachial artery using ultrasonography. During FMD test, vasodilation occurs following an acute increase in blood flow, typically induced via circulatory arrest in the arm (supra-systolic cuff occlusion) for 5 minutes. FMD is the percent of increase of the brachial artery diameter during hyperemia after release of the occlusion.
Olivomed and OlivomedSmarteffects on coronary function.
时间窗: one month
Olivomed and OlivomedSmart effects on coronary function as assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.
Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness.
时间窗: one month
Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Darkfield (SDF) imaging
Olivomed and OlivomedSmart effects on left ventricular function.
时间窗: one month
Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.
Olivomed and OlivomedSmart effects on arterial stiffness
时间窗: one month
Olivomed and OlivomedSmart effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
次要结局
未报告次要终点
研究者
Ignatios Ikonomidis
Professor of Cardiology
University of Athens