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

NCT07058922 | Enrolling By Invitation Early Phase 1

• 1 other identifier: CAAE70847523.9.0000.5272
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resistant Arterial Hypertension

Keywords

arterial hypertension; systemic microcirculation; beetroot extract

Outcome Measures

Primary Outcomes (1)

• Blood pressure

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

  60 days of tratment

Secondary Outcomes (1)

• Systemic microvascular reactivity

  60 days treatment

Study Arms (2)

beetroot powder extract supplement

EXPERIMENTAL

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.

Diagnostic Test: evaluation of systemic microvascular reactivity; Diagnostic Test: ABPM; Dietary Supplement: beetroot supplement

placebo control

PLACEBO COMPARATOR

An isocaloric, colored, and flavored supplement composed of maltodextrin will be orally administered.

Diagnostic Test: evaluation of systemic microvascular reactivity; Diagnostic Test: ABPM

Interventions

evaluation of systemic microvascular reactivity DIAGNOSTIC_TEST

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.

beetroot powder extract supplement; placebo control

ABPM DIAGNOSTIC_TEST

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

beetroot powder extract supplement; placebo control

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.

beetroot powder extract supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, Rio de Janeiro, 20397-230, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior researcher

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

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

BR (1)