Dietary Nitrate for Resistant Hypertension: 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
- 20
- 主要终点
- Change in day ambulatory 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 including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.
详细描述
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.
The investigators hypothesize that chronic nitrate consumption might decrease blood pressure in hypertensives who are suboptimally controlled on at least one blood pressure medication 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 and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated followed by 7 days 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,
- •Uncontrolled hypertension
排除标准
- •Pulmonary hypertension
- •Active CVD
- •Taking vasodilators
- •Diabetes mellitus
结局指标
主要结局
Change in day ambulatory blood pressure
时间窗: Day 1, day 15, day 29
次要结局
- Change in plasma nitrate(Day 1, day 15, day 29)
- Change in plasma nitrite(Day 1, day 15, day 29)
- Change in 24h ambulatory blood pressure(Day 1, day 15, day 29)
- Change in cardiac biomarkers(Day 1, day 15, day 29)
- Change in night ambulatory blood pressure(Day 1, day 15, day 29)
- Change in inflammatory biomarkers.(Day 1, day 15, day 29)
