A 2 Week, Crossover Trial of Dietary Nitrate in HTN

November 3, 2015 updated by: Royal College of Surgeons, Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically stable,
  • Uncontrolled hypertension

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Nitrate depleted beetroot juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in day ambulatory blood pressure
Time Frame: Day 1, day 15, day 29
Day 1, day 15, day 29

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

University College Dublin
Connolly Hospital Blanchardstown

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic NO3- in HTN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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