A 2 Week, Crossover Trial of Dietary Nitrate in HTN

Not Applicable

Completed

• Conditions: Hypertension

• 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-07
• Status Verified: 2015-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted QC: 2015-11-03
• Last Update Submitted: 2015-11-03
• Study First Posted: 2015-11-04
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinically stable,
• Uncontrolled hypertension

Exclusion Criteria

• Pulmonary hypertension
• Active CVD
• Taking vasodilators
• Diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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 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.
Change in plasma nitrite	Day 1, day 15, day 29