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NCT Number: NCT07444138

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Hypertension (HTN) Vascular Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

São Paulo State University (UNESP)

Bauru, São Paulo, 17011-041, Brazil

Location status: Recruiting

Location contact

Anderson S Zago, Professor

CONTACT

[email protected]

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Beetroot Extract (Nitrate-rich)

Dietary Supplement

Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate.

Placebo

Dietary Supplement

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.

Exercise

Behavioral

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).

Rest (Control Condition)

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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 (%).

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anderson S Zago, Professor

CONTACT

[email protected]

+55 14 98199-9293

Lucas K Carvalho, Master's student

CONTACT

[email protected]

+55 14 99799-2971

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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