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

NCT07444138 | Recruiting

• 2 other identifiers: 7.865.40088887.174291/2025-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Hypertension (HTN)

Keywords

Dietary Nitrate; Beetroot Extract; Aerobic Exercise; Nitric Oxide; Older Adults; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Systolic and Diastolic Blood Pressure

  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 Outcomes (2)

• Muscle Oxygen Saturation

  Continuously recorded during the 30-minute exercise session.

• Oxidative Stress Markers (SOD, CAT, GPx, MDA)

  Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).

Study Arms (1)

Experimental Group (All Participants)

EXPERIMENTAL

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)

Interventions

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.

Experimental Group (All Participants)

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.

Experimental Group (All Participants)

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).

Experimental Group (All Participants)

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.

Experimental Group (All Participants)

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• São Paulo State University: lead

Study Sites (1)

São Paulo State University (UNESP)

Bauru, São Paulo, 17011-041, Brazil

RECRUITING

Related Publications (6)

• Guimaraes DA, Batista RIM, Tanus-Santos JE. Nitrate and nitrite-based therapy to attenuate cardiovascular remodelling in arterial hypertension. Basic Clin Pharmacol Toxicol. 2021 Jan;128(1):9-17. doi: 10.1111/bcpt.13474. Epub 2020 Aug 28.

  PMID: 32772466 BACKGROUND

• van der Avoort CMT, van Loon LJC, Verdijk LB, Poyck PPC, Thijssen DTJ, Hopman MTE. Acute Effects of Dietary Nitrate on Exercise Tolerance, Muscle Oxygenation, and Cardiovascular Function in Patients With Peripheral Arterial Disease. Int J Sport Nutr Exerc Metab. 2021 Sep 1;31(5):385-396. doi: 10.1123/ijsnem.2021-0054. Epub 2021 Jul 20.

  PMID: 34284348 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.

  PMID: 11153730 BACKGROUND

• Caldwell JT, Sutterfield SL, Post HK, Craig JC, Baumfalk DR, Copp SW, Ade CJ. Impact of Acute Dietary Nitrate Supplementation during Exercise in Hypertensive Women. Med Sci Sports Exerc. 2019 May;51(5):1014-1021. doi: 10.1249/MSS.0000000000001857.

  PMID: 30531488 BACKGROUND

• Benjamim CJR, Lopes da Silva LS, Valenti VE, Goncalves LS, Porto AA, Tasinafo Junior MF, Walhin JP, Garner DM, Gualano B, Bueno Junior CR. Effects of dietary inorganic nitrate on blood pressure during and post-exercise recovery: A systematic review and meta-analysis of randomized placebo-controlled trials. Free Radic Biol Med. 2024 Mar;215:25-36. doi: 10.1016/j.freeradbiomed.2024.02.011. Epub 2024 Feb 23.

  PMID: 38403254 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Anderson S Zago, Professor

CONTACT

+55 14 98199-9293; anderson.zago@unesp.br

Lucas K Carvalho, Master's student

CONTACT

+55 14 99799-2971; lk.carvalho@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 2, 2026
• Study Start: October 8, 2025
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

BR (1)