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Enrolling by Invitation

NCT Number: NCT07058922

Acute Effects of Powdered Beetroot Extract Supplementation on the Microcirculation of Resistant Hypertensive Individuals

Arterial hypertension is a major public health issue and is considered to be a new epidemic due to its high mortality and morbidity rates. Elevated blood pressure levels increase the risk of coronary artery disease, heart failure, stroke, chronic kidney disease and death. Dietary nitrate supplementation in the form of beetroot powder extract may offer a more accessible way to increase systemic nitric oxide availability and consequently promote vasodilation in these patients. However, studies are needed to assess its benefits in patients with hypertension.

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Key information

Conditions

Resistant Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

National Institute of Cardiology

Rio de Janeiro, 20397-230, Brazil

About this study

Methods and Analyses: This is a double-blind, placebo-controlled clinical trial in which patients with hypertension will be randomly assigned to two groups to receive either nitrate powder supplementation or placebo for a duration of 60 days. The primary outcome will be the reduction in blood pressure levels. Secondary outcomes will include systemic microvascular reactivity and quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Resistant hypertensive patients, with a diagnosis documented in medical records, without any change in medication or increase in dosage in the past 30 days.

Exclusion criteria

  • Patients will be excluded from the study if they have: neoplasms, heart failure, are using medications containing nitrate in their formulation, or have undergone renal denervation.

Treatment and study plan

evaluation of systemic microvascular reactivity

Diagnostic Test

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.

ABPM

Diagnostic Test

Ambulatory blood pressure measuring: systolic, diastolic and mean arterial pressures

beetroot supplement

Dietary Supplement

A powdered beetroot extract supplement containing 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g.

Primary outcomes

  1. Blood pressure

    Time frame: 60 days of tratment

    ABPM - measurement of systolic, diastolic and mean arterial pressure.

Secondary outcomes

  1. Systemic microvascular reactivity

    Time frame: 60 days treatment

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 23, 2025

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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