A 2 Week, Crossover Trial of Dietary Nitrate in HTN

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Nitrate for Resistant Hypertension: A Randomized, Placebo-controlled, Crossover Trial

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Dietary nitrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically stable, Uncontrolled hypertension Exclusion Criteria: Pulmonary hypertension Active CVD Taking vasodilators Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrate rich beetroot juice<br>Concentrated, beetroot juice is a rich source of dietary nitrate. | Dietary Supplement: Dietary nitrate<br>* 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.<br>* Other names: Beetroot juice;|
| Placebo Comparator: Nitrate depleted placebo beetroot juice<br>Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content. | Dietary Supplement: Placebo<br>* 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.<br>* Other names: Nitrate depleted beetroot juice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in day ambulatory blood pressure |  | Day 1, day 15, day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma nitrate |  | Day 1, day 15, day 29 | 
| Change in 24h ambulatory blood pressure |  | Day 1, day 15, day 29 | 
| Change in night ambulatory blood pressure |  | Day 1, day 15, day 29 | 
| Change in cardiac biomarkers | Assessed by serum lipids. | Day 1, day 15, day 29 | 
| Change in plasma nitrite |  | Day 1, day 15, day 29 | 
| Change in inflammatory biomarkers. | Assessed by serum C-reactive protein. | Day 1, day 15, day 29 |