Dietary Nitrate for COPD: a 14d, 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
- 8
- 试验地点
- 2
- 主要终点
- Change in incremental shuttle walk test distance
研究概览
简要总结
Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.
详细描述
Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in OSAS has not been reported.
The investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of life and pulmonary function.
This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable,
- •Diagnosed with COPD
- •Ambulatory out-patients
排除标准
- •Long term oxygen therapy
- •Pulmonary hypertension
- •Active cardiovascular disease
- •Active skeletal conditions
- •Taking vasodilators
- •Diabetes mellitus
结局指标
主要结局
Change in incremental shuttle walk test distance
时间窗: Day 1, day 15 and day 29
次要结局
- Change in plasma nitrate(Day 1, day 15 and day 29)
- Change in forced expiratory volume(Day 1, day 15 and day 29)
- Change in forced vital capacity(Day 1, day 15 and day 29)
- Change in ambulatory blood pressure(Day 1, day 15 and day 29)
- Change in quality of life(Day 1, day 15 and day 29)
- Change in plasma nitrate and nitrite(Day 1, day 15 and day 29)
- Change in inflammatory markers(Day 1, day 15 and day 29)