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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
Sponsor:
Collaborators:
University College Dublin
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in day ambulatory blood pressure [ Time Frame: Day 1, day 15, day 29 ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically stable,
  • Uncontrolled hypertension

Exclusion Criteria:

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

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02597010     History of Changes
Other Study ID Numbers: Chronic NO3- in HTN
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases