Trials / Enrolling By Invitation
Enrolling By InvitationNCT07058922
Acute Effects of Powdered Beetroot Extract Supplementation on the Microcirculation of Resistant Hypertensive Individuals
- Status
- Enrolling By Invitation
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- National Institute of Cardiology, Laranjeiras, Brazil · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-07-10
- Last updated
- 2025-07-23
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT07058922. Inclusion in this directory is not an endorsement.