An interventional study of Beetroot Extract (Nitrate-rich) and Placebo in Hypertension and Hypertension (HTN), sponsored by São Paulo State University. Recruiting at 1 site in Brazil. Open to female participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by São Paulo State University · Not applicable, Interventional, and Basic science
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →São Paulo State University is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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) · Dietary Supplement: Placebo · Behavioral: Exercise · Other: Rest (Control Condition)
Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate.
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.
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).
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.
Systolic and Diastolic Blood Pressure
Assessed using a validated automatic or semi-automatic device. Results measured in millimeters of mercury (mmHg).
Time frame: Baseline (Rest), during intervention (at 10 and 20 minutes), immediately post-intervention (at 30 minutes), and 10 minutes post-intervention recovery.
Muscle Oxygen Saturation
Assessed via Near-Infrared Spectroscopy (NIRS) placed on the vastus lateralis muscle. Measured in percentage (%).
Time frame: Continuously recorded during the 30-minute exercise session.
Oxidative Stress Markers (SOD, CAT, GPx, MDA)
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).
Time frame: Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).
Plan to share: Undecided — 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.
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São Paulo State University