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OpenTrials
Completed

NCT Number: NCT02597010

A 2 Week, Crossover Trial of Dietary Nitrate in HTN

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable,
  • Uncontrolled hypertension

Exclusion criteria

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

Treatment and study plan

Dietary nitrate

Dietary Supplement

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 names: Beetroot juice

Placebo

Dietary Supplement

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 names: Nitrate depleted beetroot juice

Primary outcomes

  1. Change in day ambulatory blood pressure

    Time frame: Day 1, day 15, day 29

Secondary outcomes

  1. Change in plasma nitrate

    Time frame: Day 1, day 15, day 29

  2. Change in 24h ambulatory blood pressure

    Time frame: Day 1, day 15, day 29

  3. Change in night ambulatory blood pressure

    Time frame: Day 1, day 15, day 29

  4. Change in cardiac biomarkers

    Time frame: Day 1, day 15, day 29

    Assessed by serum lipids.

  5. Change in plasma nitrite

    Time frame: Day 1, day 15, day 29

  6. Change in inflammatory biomarkers.

    Time frame: Day 1, day 15, day 29

    Assessed by serum C-reactive protein.

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Connolly Hospital Blanchardstown
  • University College Dublin

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2015
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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