Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
研究概览
简要总结
The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.
详细描述
The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- 40 to 65 years old
- •non-smokers
- •Specific inclusion criteria for healthy subjects :
- •Healthy subjects should not take antihypertensive or statin.
- •Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.
- •Specific inclusion criteria for subjects with metabolic syndrome :
- •- subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.
排除标准
- •treatment vasodilator nitric oxide liberating,
- •diabetes and coronary artery disease,
- •chronic alcoholism,
- •severe hepatic impairment,
- •end stage renal failure or dialysis,
- •neurological tremor,
- •cancer, mental illness or other severe disease which can impact informed consent and / or results,
- •Refusal to be registered in the National File of Volunteers
- •Person in exclusion of the National Volunteer File
结局指标
主要结局
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
时间窗: at 150 mn after the product intake
Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: \- Flow Mediated Dilatation (FMD) (reference) Compared to: * Hyperemic Velocity Time Integral (VTI) * Endothelial microparticles (MPE)
次要结局
- Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)(at 150 mn after the product intake)