Effects of Beetroot Extract on Blood Pressure and Exercise in Hypertensive Older Women

February 27, 2026 updated by: Lucas Kowalewski Carvalho, São Paulo State University

Acute Effects of Beetroot Extract Supplementation on Blood Pressure, Oxidative Stress, and Muscle Oxygen Saturation in Hypertensive Older Women Submitted to an Aerobic Exercise Session

The goal of this clinical trial is to learn about the acute effects of beetroot extract in older women with high blood pressure. The main questions it aims to answer are:

Does beetroot extract affect blood pressure during exercise? Does it change oxygen levels in the muscles? Participants will take a beetroot supplement and perform an aerobic exercise session to check how their bodies respond.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Note: Although registered as Single Group/Open Label for data entry purposes, this study is strictly double-blind and randomized regarding the order of interventions (crossover design).

Hypertension is a major risk factor for cardiovascular disease in older adults. Dietary nitrate, found in beetroot extract, has been shown to improve vascular health and exercise tolerance. However, its specific effects on older women with hypertension during exercise require further investigation.

This clinical trial aims to analyze the acute impact of beetroot extract supplementation on cardiovascular and metabolic parameters. Specifically, the study will measure blood pressure responses, oxidative stress markers, and muscle oxygen saturation (assessed via NIRS) in hypertensive older women submitted to a single session of aerobic exercise. The goal is to determine if nitrate supplementation can attenuate the cardiovascular stress of exercise and improve muscle oxygenation in this population.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lucas K Carvalho, Master's student
  • Phone Number: +55 14 99799-2971
  • Email: lk.carvalho@unesp.br

Study Locations

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17011-041
        • Recruiting
        • São Paulo State University (UNESP)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female sex: Older women aged between 60 and 70 years.
  • Physical capability: Absence of health conditions that could compromise performance in the required physical exercise tests.

Exclusion Criteria:

  • Smoking: Current smokers.
  • Alcohol use: History of alcohol abuse or excessive alcohol consumption.
  • Cardiovascular Disease: Diagnosis of cardiovascular diseases (other than the primary condition of hypertension).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (All Participants)
All participants will undergo four experimental sessions in a randomized, counterbalanced order: 1) Resting with Placebo; 2) Resting with Nitrate Supplementation; 3) Aerobic Exercise with Placebo; and 4) Aerobic Exercise with Nitrate Supplementation. A washout period of at least 2 days will be respected between sessions.
Dietary supplement: Beetroot Extract (Nitrate-rich)
Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate.
Dietary supplement: Placebo
Capsules identical in appearance, color, and size to the experimental supplement, but containing an inert substance (starch). This intervention is used to maintain the double-blind design of the study.
Behavioral: Exercise
Participants will perform a single aerobic exercise session on a treadmill. The protocol consists of a 7-minute warm-up followed by 30 minutes of continuous exercise at an intensity corresponding to 60-80% of maximum heart rate (HRmax), estimated using Tanaka's formula (208 - 0.7 * age). Rate of Perceived Exertion (RPE) will be monitored periodically using the Borg scale (6-20).
Other: Rest (Control Condition)
Participants will remain seated for 30 minutes (matching the exercise session duration). During this time, a researcher will administer a Food Frequency Questionnaire (FFQ) in an interview format. This activity serves to assess dietary habits and simulates a routine, low-exertion daily activity (similar to a conversation), acting as a time-matched control for the exercise session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure
Time Frame: Baseline (Rest), during intervention (at 10 and 20 minutes), immediately post-intervention (at 30 minutes), and 10 minutes post-intervention recovery.
Assessed using a validated automatic or semi-automatic device. Results measured in millimeters of mercury (mmHg).
Baseline (Rest), during intervention (at 10 and 20 minutes), immediately post-intervention (at 30 minutes), and 10 minutes post-intervention recovery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Oxygen Saturation
Time Frame: Continuously recorded during the 30-minute exercise session.
Assessed via Near-Infrared Spectroscopy (NIRS) placed on the vastus lateralis muscle. Measured in percentage (%).
Continuously recorded during the 30-minute exercise session.
Oxidative Stress Markers (SOD, CAT, GPx, MDA)
Time Frame: Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).
Analysis of Superoxide Dismutase (SOD), Catalase (CAT), Glutathione Peroxidase (GPx), and Malondialdehyde (MDA) levels in blood plasma. Results measured in nanomoles per minute per gram of protein (nmol/min/g).
Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

São Paulo State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7.865.400 (Other Identifier: Plataforma Brasil - CEP UNESP)
  • 88887.174291/2025-00 (Other Identifier: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data sharing policy has not yet been established. The research team will evaluate the feasibility and necessary ethical approvals for sharing individual participant data after the conclusion of the study and publication of the primary results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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