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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06169241

Arterial Hypertension Resistant Hypertension Microvascular Function +1 more

RECRUITING EARLY_PHASE1

Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients

NCT04020796

Hypertension

COMPLETED NA

The Chronic Effects of Beetroot Juice in Hypertensive Subjects

NCT01405898

Hypertension

COMPLETED NA

The Acute Effect of Beetroot Juice in Normal and Hypertensive Subjects

NCT01236872

Hypertension

COMPLETED NA

Investigation of Dietary Nitrate Effects in Hypertension-induced Target Organ Damage

NCT03088514

Hypertension

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resistant Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

beetroot powder extract 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.

Group Type EXPERIMENTAL

evaluation of systemic microvascular reactivity

Intervention Type DIAGNOSTIC_TEST

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.

ABPM

Intervention Type DIAGNOSTIC_TEST

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

beetroot supplement

Intervention Type 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.

placebo control

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

Group Type PLACEBO_COMPARATOR

evaluation of systemic microvascular reactivity

Intervention Type DIAGNOSTIC_TEST

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.

ABPM

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

evaluation of systemic microvascular reactivity

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.

Intervention Type DIAGNOSTIC_TEST

ABPM

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No