Dietary Nitrate for OSAS: a 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
- 10
- 试验地点
- 2
- 主要终点
- Difference in ambulatory nocturnal blood pressure
研究概览
简要总结
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
详细描述
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice.
This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance 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,
- •Untreated OSAS out-patients
排除标准
- •Using continuous positive airways pressure therapy
- •Pulmonary hypertension
- •Active CVD
- •Active musculo-skeletal conditions
- •Taking vasodilators
- •Diabetes mellitus
结局指标
主要结局
Difference in ambulatory nocturnal blood pressure
时间窗: Day 1, day 15, day 29
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
次要结局
- Difference in OSAS symptomatology(Day 1, day 15, day 29)
- Difference in 2h post OGT glucose(Day 1, day 15, day 29)
- Difference in exhaled nitric oxide(Day 1, day 15, day 29)
- Difference in vigilance scores derived from the Conner's Continuous Performance Test.(Day 1, day 15, day 29)
- Difference in 24h blood pressure(Day 1, day 15, day 29)
- Difference in plasma nitrate and nitrite(Day 1, day 15, day 29)
- Difference in fasting glucose(Day 1, day 15, day 29)
- Difference in overnight oximetry(Day 1, day 15, day 29)