Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Change in Incremental Shuttle Walk Test Distance
研究概览
简要总结
The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.
详细描述
Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink.
This study is a randomized, double-blind placebo-controlled, crossover trial.
Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Information consenting out-patients with a previous physician diagnosis of COPD
- •Clinically stable
- •Ambulatory
排除标准
- •Subjects who required supplemental oxygen for exercise
- •Subjects with pulmonary hypertension and angina
- •Intolerant to beetroot
- •Insulin dependent diabetes
- •Thyroid disease
结局指标
主要结局
Change in Incremental Shuttle Walk Test Distance
时间窗: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h
The change between day 1, time 0 and day 1, time 3h will be compared to the changes between day 8, time 0 and day 8, time 3h.
次要结局
未报告次要终点