HypertensionNCT07444138
Effects of Beetroot Extract on Blood Pressure and Exercise in Hypertensive Older Women
A study testing Beetroot Extract (Nitrate-rich) and Exercise in people with Hypertension and Hypertension (HTN), run by São Paulo State University at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hypertension (HTN)
- What is being tested?
- Beetroot Extract (Nitrate-rich) and Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
São Paulo State University (UNESP)
Bauru, São Paulo, 17011-041
Anderson S Zago, Professor, anderson.zago@unesp.br, anderson.zago@unesp.br
About this study
Official 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
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.
Read the 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.
- Conditions
- Hypertension, Hypertension (HTN)
- Being tested
- Beetroot Extract (Nitrate-rich), Placebo, Exercise, Rest (Control Condition)
- Keywords
- Dietary Nitrate, Beetroot Extract, Aerobic Exercise, Nitric Oxide, Older Adults, Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary 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.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Beetroot Extract (Nitrate-rich); Dietary Supplement: Placebo; Behavioral: Exercise; Other: Rest (Control Condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure
Assessed using a validated automatic or semi-automatic device. Results measured in millimeters of mercury (mmHg).
Measured: 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
Assessed via Near-Infrared Spectroscopy (NIRS) placed on the vastus lateralis muscle. Measured in percentage (%).
Measured: 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).
Measured: Baseline (Pre-intervention) and immediately post-intervention (after exercise or rest).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start8 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Kowalewski Carvalho, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444138
- Sponsor's protocol ID
- 7.865.400
- Other IDs
- 88887.174291/2025-00, 7.865.400
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32772466van 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.
PubMed 34284348Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Tanaka 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.
PubMed 11153730Caldwell 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.
PubMed 30531488Benjamim 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.
PubMed 38403254
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07444138
- Acronym / sponsor ID
- 7.865.400
- Conditions
- Hypertension, Hypertension (HTN)
- Keywords
- Dietary Nitrate, Beetroot Extract, Aerobic Exercise, Nitric Oxide, Older Adults, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (All Participants) | Experimental | Dietary Supplement: Beetroot Extract (Nitrate-rich), Dietary Supplement: Placebo, Behavioral: Exercise, Other: Rest (Control Condition)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Experimental Group (All Participants) |
| PlaceboCapsules 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. | Dietary supplement | Experimental Group (All Participants) |
| ExerciseParticipants 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). | Behavioural | Experimental Group (All Participants) |
| 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. | Other | Experimental Group (All Participants) |
Primary outcome
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).
2 secondary outcomes
Muscle Oxygen Saturation
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 32772466Guimaraes 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.
- Background: PubMed 34284348van 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.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 11153730Tanaka 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.
- Background: PubMed 30531488Caldwell 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.
- Background: PubMed 38403254Benjamim 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Extract (Nitrate-rich) and Exercise in people with Hypertension and Hypertension (HTN), run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anderson S Zago, Professor (+55 14 98199-9293, anderson.zago@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444138, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.