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

Early Phase 1

Recruiting

• Conditions: Nitrate Supplementation; Resistant Hypertension; Microvascular Function; Arterial Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Beetroot extract

• Registration Number: NCT06169241
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Brief Summary

Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.

Exclusion Criteria

• neoplasms
• heart failure
• use of medications with nitrate in their formula
• patients undergoing renal denervation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.
Beetroot extract	Beetroot extract	Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.

Primary Outcome Measures

Name	Time	Method
Assessment of blood pressure evolution	60 days	Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures

Trial Locations

Locations (1)

National Institute of Cardiology; 🇧🇷 Rio de Janeiro, Brazil