跳至主要内容
临床试验/NCT01262521
NCT01262521已完成不适用

Physiological Effects of Oral Nitrate on Vascular Function

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Circulating angiogenic cells

研究概览

简要总结

An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate and nitrite are abundant in our everyday diet.

Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and thus regenerative processes in cardiovascular medicine is not known. Thus, in the present study, we tested whether oral application of nitrate leads to an enhanced number of circulating angiogenic cells and whether this is associated with an improvement in endothelial function.

详细描述

Administration of a single dose of nitrate intervention or water alone to healthy volunteers. Before and up to 4 hours (short-term)/6 days (long-term) after ingestion, marker of vascular function are measured in plasma and by using high-resolution ultrasound.

Measurements are taken before and up to 4 h after double blind cross-over per os administration of a single dose of nitrate intervention (150 ml tab water with 150 umol/kg sodium-nitrate) or water control (100 ml Chapelle mineral water) to healthy volunteers. Circulating angiogenic cells are measured as CD34+/KDR+ and CD133+/KDR+ mononuclear cells in blood by flow cytometry and plasma is analyzed for nitrate and nitrite, as well as mobilization markers and cytokines including stromal cell derived factor, vascular endothelial growth factor and stem cell factor. All measurements are performed after >12h overnight fasting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age > 20 years
  • refrain from nitrate containing food ingestion during trial

排除标准

  • > 36 years
  • poor endothelial function
  • acute infection
  • any chronic heart or pulmonary disease
  • arrhythmias
  • acute or chronic renal failure
  • cardio-vascular risk factors: diabetes mellitus, hypertension, hyperlipidemia
  • intake of nutrition supplements (l-arginine, creatinine)

结局指标

主要结局

Circulating angiogenic cells

时间窗: 4 hours

次要结局

  • Endothelial function(4 hours)
  • Cytokines(4 hours)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Christian Meyer, MD

Heinrich-Heine University, Duesseldorf

研究点 (2)

Loading locations...

相似试验