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Enrolling by invitation NCT07058922

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

Early Phase I Interventional Resistant Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: evaluation of systemic microvascular reactivity, ABPM, beetroot supplement.
Who it may be relevant to
Registry conditions: Resistant Arterial Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test evaluation of systemic microvascular reactivity
    Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.
  • Diagnostic test ABPM
    Ambulatory blood pressure measuring: systolic, diastolic and mean arterial pressures
  • Dietary supplement beetroot 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 outcome measures

  • Blood pressure [Time frame: 60 days of tratment]
Secondary outcome measures (1)
  • Systemic microvascular reactivity [Time frame: 60 days treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • National Institute of Cardiology — Rio de Janeiro

Identifiers

NCT: NCT07058922 · CAAE70847523.9.0000.5272

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗