A 2 Week, Crossover Trial of Dietary Nitrate in HTN
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|ClinicalTrials.gov Identifier: NCT02597010|
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Dietary Nitrate for Resistant Hypertension: A Randomized, Placebo-controlled, Crossover Trial|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Nitrate rich beetroot juice
Concentrated, beetroot juice is a rich source of dietary nitrate.
Dietary Supplement: Dietary nitrate
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Other Name: Beetroot juice
Placebo Comparator: Nitrate depleted placebo beetroot juice
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Dietary Supplement: Placebo
140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Other Name: Nitrate depleted beetroot juice
- Change in day ambulatory blood pressure [ Time Frame: Day 1, day 15, day 29 ]
- Change in plasma nitrate [ Time Frame: Day 1, day 15, day 29 ]
- Change in 24h ambulatory blood pressure [ Time Frame: Day 1, day 15, day 29 ]
- Change in night ambulatory blood pressure [ Time Frame: Day 1, day 15, day 29 ]
- Change in cardiac biomarkers [ Time Frame: Day 1, day 15, day 29 ]Assessed by serum lipids.
- Change in plasma nitrite [ Time Frame: Day 1, day 15, day 29 ]
- Change in inflammatory biomarkers. [ Time Frame: Day 1, day 15, day 29 ]Assessed by serum C-reactive protein.