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

National Institute of Cardiology, Laranjeiras, Brazil

Status and phase: Invitation-only; Early Phase 1

Conditions: Resistant Arterial Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07058922

CAAE70847523.9.0000.5272

Details and patient eligibility

About

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.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

beetroot powder extract supplement

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ABPM

Diagnostic Test: evaluation of systemic microvascular reactivity

placebo control

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: ABPM

Diagnostic Test: evaluation of systemic microvascular reactivity