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临床试验/NCT04103736
NCT04103736已完成不适用

The Effect of Dietary Nitrates on Physical Performance and Vascular Function in Chronic Kidney Disease

University of Delaware2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis

研究概览

简要总结

The purpose of this study is to examine the effect of acute ingestion of a concentrated beetroot juice supplement on vascular function and exercise capacity in patients with moderate to severe chronic kidney disease

详细描述

People with Chronic Kidney Disease (CKD) are at an increased risk of cardiovascular disease. Blood vessel dysfunction and exercise intolerance are common in CKD. Blood vessel dysfunction has been shown to predict future cardiovascular events and decreased physical activity can contribute to an increased risk of cardiovascular disease. Therefore, this study investigates if dietary nitrate from beetroot juice, which has been shown to improve blood vessel function and exercise capacity in other cardiovascular disease pathologies, could be effective at improving these measures in patients with CKD. In a controlled, double blinded trial, stage 3-5 CKD patients will be randomly assigned to receive either beetroot beverage or a placebo and then complete measures of blood vessel function and an exercise test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage 3-5 Chronic Kidney Disease

排除标准

  • History of cardiovascular disease
  • Current pregnancy
  • Uncontrolled hypertension
  • Uncontrolled hyperlipidemia
  • Current hormone replacement therapy
  • Current use of tobacco products
  • Current autoimmune disease
  • Current hyperkalemia
  • Diagnosis of a deep vein thrombosis (DVT) within the last 6 months

研究组 & 干预措施

Beet Juice Supplement

Experimental

A single, acute dose of Beet It Sport Shot containing ~12.6mmol naturally occurring dietary nitrates.

干预措施: Beet It Sport Shot (Dietary Supplement)

Placebo juice

Placebo Comparator

A single, acute dose of nitrate-depleted Beet It Sport Shot

干预措施: Nitrate-depleted placebo (Dietary Supplement)

结局指标

主要结局

Microvascular Function, assessed by laser Doppler flowmetry coupled with intradermal microdialysis

时间窗: 2.5 hours post ingestion of juice

Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis

次要结局

  • Pulse wave analysis(2.5 hours post ingestion of juice)
  • Arterial stiffness(2.5 hours post ingestion of juice)
  • Blood pressure(Change from pre-ingestion baseline to 2.5 hours post ingestion of juice)
  • Peak aerobic capacity(2.5 hours post ingestion of juice)
  • Endothelial function(2.5 hours post ingestion of juice)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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