A 2 Week, Crossover Trial of Dietary Nitrate in HTN
- Conditions
- Hypertension
- Interventions
- Dietary Supplement: Dietary nitrateDietary Supplement: Placebo
- Registration Number
- NCT02597010
- Lead Sponsor
- Royal College of Surgeons, Ireland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Clinically stable,
- Uncontrolled hypertension
- Pulmonary hypertension
- Active CVD
- Taking vasodilators
- Diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nitrate rich beetroot juice Dietary nitrate Concentrated, beetroot juice is a rich source of dietary nitrate. Nitrate depleted placebo beetroot juice Placebo Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
- Primary Outcome Measures
Name Time Method Change in day ambulatory blood pressure Day 1, day 15, day 29
- Secondary Outcome Measures
Name Time Method 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 Assessed by serum lipids.
Change in plasma nitrate 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 Assessed by serum C-reactive protein.