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A 2 Week, Crossover Trial of Dietary Nitrate in HTN

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02597010
Enrollment
20
Registered
2015-11-04
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

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.

Interventions

DIETARY_SUPPLEMENTDietary 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.

DIETARY_SUPPLEMENTPlacebo

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.

Sponsors

University College Dublin
CollaboratorOTHER
Connolly Hospital Blanchardstown
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Clinically stable, * Uncontrolled hypertension

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in day ambulatory blood pressureDay 1, day 15, day 29

Secondary

MeasureTime frameDescription
Change in 24h ambulatory blood pressureDay 1, day 15, day 29
Change in night ambulatory blood pressureDay 1, day 15, day 29
Change in plasma nitrateDay 1, day 15, day 29
Change in plasma nitriteDay 1, day 15, day 29
Change in inflammatory biomarkers.Day 1, day 15, day 29Assessed by serum C-reactive protein.
Change in cardiac biomarkersDay 1, day 15, day 29Assessed by serum lipids.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026