Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients

April 7, 2026 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Effect of Nitrate Supplementation on Blood Pressure and Systemic Microvascular Function of Resistant Hypertensive Patients

Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eduardo Tibirica, MD, PhD
  • Phone Number: +55-21-99914-6075
  • Email: etibi@uol.com.br

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • Recruiting
        • National Institute of Cardiology
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.

Exclusion Criteria:

  • neoplasms
  • heart failure
  • use of medications with nitrate in their formula
  • patients undergoing renal denervation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.
Dietary supplement: Placebo
The placebo will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.
Active Comparator: Beetroot extract
Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.
Dietary supplement: Beetroot extract
Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of blood pressure evolution
Time Frame: 60 days
Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures
60 days

Collaborators and Investigators

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

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

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 (Actual)

November 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70847523.9.0000.5272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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