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临床试验/NCT03101904
NCT03101904已完成不适用

The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia

Bangor University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年2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
23
试验地点
1
主要终点
Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.

研究概览

简要总结

The study will aim to describe and evaluate the effect of chronic beetroot juice supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It is hypothesized that beetroot supplementation will decrease acute mountain sickness and increase exercise performance.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Women only: Regular menstrual cycle or post-menopausal

排除标准

  • •Stayed at altitude above 2500m in the last 6 months
  • •Traveled to altitude above 2500m in the last 2 months
  • •Unable to give informed consent
  • •Unstable medical condition.

研究组 & 干预措施

Nitrate then Placebo

Experimental

Participants will consume a daily a beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

Following a minimum of ten days wash out, participants will then consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

干预措施: Beetroot Juice (Dietary Supplement)

Nitrate then Placebo

Experimental

Participants will consume a daily a beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

Following a minimum of ten days wash out, participants will then consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

干预措施: Placebo (Dietary Supplement)

Placebo then Nitrate

Placebo Comparator

Participants will consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

Following a minimum of ten days wash out, participants will then consume a daily beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

干预措施: Beetroot Juice (Dietary Supplement)

Placebo then Nitrate

Placebo Comparator

Participants will consume a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

Following a minimum of ten days wash out, participants will then consume a daily beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK).

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.

时间窗: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia

Acute Cerebral Mountain Sickness score (AMS-C) calculated from the 11-item Environmental Symptoms Questionnaire (ESQ; Sampson et al., 1994). Participants rate the severity of each item from zero to five, and the ratings were multiplied by their factorial loadings and summed. Unabbreviated scale title: Acute Cerebral Mountain Sickness Abbreviated title: AMS-C Unit of measure: Scores on a scale Minimum value: 0 Maximum value: 5 Interpretation: Higher scores mean a worse outcome

次要结局

  • Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.(Measured on the sixth day of supplementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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