Arterial HypertensionNCT05384340
NO3-rich Beet Juice and Exercise on Postmenopausal Women Cardiovascular Health
A study testing Beetroot juice rich in nitrate in people with Arterial Hypertension and Postmenopausal; Menorrhagia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
In the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (NO3) (>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Arterial Hypertension, Postmenopausal; Menorrhagia, Cardiovascular Diseases
- What is being tested?
- Beetroot juice rich in nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 31 May 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with 50 to 65 old years;
- Physically inactive;
- Postmenopausal diagnosis (amenorrhea for 12 months or more);
- Arterial hypertension diagnosis (previously);
- Systolic blood pressure values >120mmHg up to 159mmHg and diastolic blood pressure values >80mmHg up to 99mmHg.
Who cannot join
- Previous history of acute myocardial infarction and/or stroke;
- Allergy or intolerance to nitrate, gluten, or milk;
- Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, São Paulo
Cicero Jonas R. Benjamim, PhD Student, 87988621194, benjamim.nutricao@gmail.com
About this study
Official title: Nitrate-rich Beet Juice Intake and Aerobic Exercise on Cardiovascular Health of Postmenopausal Women With Arterial Hypertension
In the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (NO3) (>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. We will investigate the effects of beetroot juice rich in NO3 acutely (first day: 140mL/800mg) and during a week with daily doses (second to the seventh day: 70mL/400mg) on blood pressure, heart rate (HR), cardiac autonomic control, EF, inflammatory, hormonal, and stress biomarkers oxidative stress and enzymes involved in nitric oxide synthesis and mitochondrial regulation, under resting conditions, as well as mediated by submaximal aerobic exercise sessions. Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 20 physically inactive hypertensive women will undergo an acute and 7-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval. On collection days, exercise will be performed on a treadmill for 40 minutes at a speed corresponding to 65-70% of VO2peak. The collection of variables (cardiovascular, autonomic, and blood samples for molecular analyses) of the study will take place at rest (120 minutes after ingestion of the intervention), during exercise (40 minutes), and in the effort recovery stage (during 65 minutes) based on previously validated protocols. The collections were arranged so that the measurement of one variable does not interfere with the other and that they have adequate intervals between them.
- Being tested
- Beetroot juice rich in nitrate
- Medical subject headings
- Hypertension, Menorrhagia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juice rich in nitrateDietary supplement
On the first day, an acute test will be carried out with beet juice rich in nitrate, in which two units of juice will be provided, totaling 140 ml (800 mg of nitrate) for each protocol. That is, each participant will receive 2 units of juice bottles. From the second to the seventh day, participants will receive 6 units of vials of the juice corresponding to the first intervention on the first visit to the laboratory and will drink one vial a day for a week. Of the 8 units (100%), six bottles (75%) will be provided for the participants to take home. On the seventh day of the intervention, the participants will return to the laboratory for the consumption of the seventh and last bottle of juice. Between one protocol and another, a 7-day washout interval will be given for the purification of the compounds provided by the protocols.
| Study group | Role | What they receive |
|---|---|---|
| Beet protocol | Experimental | Acute intervention: 1st day [140 ml - Beet It Juice, 800mg nitrate/day] Continued intervention: 2nd to 7th day [70 ml - Beet It Juice, 400mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days Receives: Dietary Supplement: Beetroot juice rich in nitrate |
| Placebo protocol | Placebo comparator | Acute intervention (1st day): [140 ml - Beet It Juice, 0mg nitrate/day] Continued intervention (2nd to 7th day): [70 ml - Beet It Juice, 0mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days Receives: Dietary Supplement: Beetroot juice rich in nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of systolic and diastolic blood pressure (mmHg)
Measured: up to 2 years
Secondary outcomes (8)
Values of heart rate variability (ms)
Measured: up to 2 years
Values of heart rate (beats per minute)
Measured: up to 2 years
Macrovascular function (Flow mediated dilatation%)
Measured: up to 2 years
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Measured: up to 2 years
Blood concentration of Adiponectin (ug/mL)
Measured: up to 2 years
Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)
Measured: up to 2 years
Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)
Measured: up to 2 years
Blood concentrations of Epinephrine and Norepinephrine (pg/mL)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start31 May 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas R Benjamim, University of Sao Paulo
- Investigators
- Carlos Bueno Júnior, PhD, Principal investigator, EEFERP/USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384340
- Sponsor's protocol ID
- BeetMPH5070
- Status last verified
- Jan 2023
- First submitted
- 17 Apr 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamim CJR, da Silva LSL, Sousa YBA, Rodrigues GDS, Pontes YMM, Rebelo MA, Goncalves LDS, Tavares SS, Guimaraes CS, da Silva Sobrinho AC, Tanus-Santos JE, Gualano B, Bueno Junior CR. Acute and short-term beetroot juice nitrate-rich ingestion enhances cardiovascular responses following aerobic exercise in postmenopausal women with arterial hypertension: A triple-blinded randomized controlled trial. Free Radic Biol Med. 2024 Feb 1;211:12-23. doi: 10.1016/j.freeradbiomed.2023.11.039. Epub 2023 Dec 11.
PubMed 38092272Benjamim CJR, Sousa YBA, Porto AA, de Moraes Pontes YM, Tavares SS, da Silva Rodrigues G, da Silva LSL, da Silva Goncalves L, Guimaraes CS, Rebelo MA, da Silva Sobrinho AC, Tanus-Santos JE, Valenti VE, Gualano B, Bueno Junior CR. Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial. Trials. 2023 Feb 7;24(1):94. doi: 10.1186/s13063-023-07117-2.
PubMed 36750904
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrate-rich Beet Juice Intake and Aerobic Exercise on Cardiovascular Health of Postmenopausal Women With Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05384340
- Acronym / sponsor ID
- BeetMPH5070
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 20 May 2022 (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.
In the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (NO3) (>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. We will investigate the effects of beetroot juice rich in NO3 acutely (first day: 140mL/800mg) and during a week with daily doses (second to the seventh day: 70mL/400mg) on blood pressure, heart rate (HR), cardiac autonomic control, EF, inflammatory, hormonal, and stress biomarkers oxidative stress and enzymes involved in nitric oxide synthesis and mitochondrial regulation, under resting conditions, as well as mediated by submaximal aerobic exercise sessions. Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 20 physically inactive hypertensive women will undergo an acute and 7-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval. On collection days, exercise will be performed on a treadmill for 40 minutes at a speed corresponding to 65-70% of VO2peak. The collection of variables (cardiovascular, autonomic, and blood samples for molecular analyses) of the study will take place at rest (120 minutes after ingestion of the intervention), during exercise (40 minutes), and in the effort recovery stage (during 65 minutes) based on previously validated protocols. The collections were arranged so that the measurement of one variable does not interfere with the other and that they have adequate intervals between them.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beet protocol | Experimental | Dietary Supplement: Beetroot juice rich in nitrateAcute intervention: 1st day [140 ml - Beet It Juice, 800mg nitrate/day] Continued intervention: 2nd to 7th day [70 ml - Beet It Juice, 400mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days |
| Placebo protocol | Placebo comparator | Dietary Supplement: Beetroot juice rich in nitrateAcute intervention (1st day): [140 ml - Beet It Juice, 0mg nitrate/day] Continued intervention (2nd to 7th day): [70 ml - Beet It Juice, 0mg nitrate/day] Exercise intervention [Treadmill - 40 minutes duration, 65% - 70% VO2 Peak]: Acute [Just on day] / Continued [First and latest day] Washout: 7 days |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with 50 to 65 old years;
- Physically inactive;
- Postmenopausal diagnosis (amenorrhea for 12 months or more);
- Arterial hypertension diagnosis (previously);
- Systolic blood pressure values >120mmHg up to 159mmHg and diastolic blood pressure values >80mmHg up to 99mmHg.
Key exclusion criteria (3 listed)
- Previous history of acute myocardial infarction and/or stroke;
- Allergy or intolerance to nitrate, gluten, or milk;
- Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
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 juice rich in nitrateOn the first day, an acute test will be carried out with beet juice rich in nitrate, in which two units of juice will be provided, totaling 140 ml (800 mg of nitrate) for each protocol. That is, each participant will receive 2 units of juice bottles. From the second to the seventh day, participants will receive 6 units of vials of the juice corresponding to the first intervention on the first visit to the laboratory and will drink one vial a day for a week. Of the 8 units (100%), six bottles (75%) will be provided for the participants to take home. On the seventh day of the intervention, the participants will return to the laboratory for the consumption of the seventh and last bottle of juice. Between one protocol and another, a 7-day washout interval will be given for the purification of the compounds provided by the protocols. | Dietary supplement | Beet protocol, Placebo protocol |
Primary outcome
Values of systolic and diastolic blood pressure (mmHg)
Time frame: up to 2 years
8 secondary outcomes
Values of heart rate variability (ms)
Time frame: up to 2 years
Values of heart rate (beats per minute)
Time frame: up to 2 years
Macrovascular function (Flow mediated dilatation%)
Time frame: up to 2 years
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Time frame: up to 2 years
Blood concentration of Adiponectin (ug/mL)
Time frame: up to 2 years
Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)
Time frame: up to 2 years
Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)
Time frame: up to 2 years
Blood concentrations of Epinephrine and Norepinephrine (pg/mL)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38092272Benjamim CJR, da Silva LSL, Sousa YBA, Rodrigues GDS, Pontes YMM, Rebelo MA, Goncalves LDS, Tavares SS, Guimaraes CS, da Silva Sobrinho AC, Tanus-Santos JE, Gualano B, Bueno Junior CR. Acute and short-term beetroot juice nitrate-rich ingestion enhances cardiovascular responses following aerobic exercise in postmenopausal women with arterial hypertension: A triple-blinded randomized controlled trial. Free Radic Biol Med. 2024 Feb 1;211:12-23. doi: 10.1016/j.freeradbiomed.2023.11.039. Epub 2023 Dec 11.
- Derived from this study: PubMed 36750904Benjamim CJR, Sousa YBA, Porto AA, de Moraes Pontes YM, Tavares SS, da Silva Rodrigues G, da Silva LSL, da Silva Goncalves L, Guimaraes CS, Rebelo MA, da Silva Sobrinho AC, Tanus-Santos JE, Valenti VE, Gualano B, Bueno Junior CR. Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial. Trials. 2023 Feb 7;24(1):94. doi: 10.1186/s13063-023-07117-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carlos Bueno Júnior, PhD principal investigator
EEFERP/USP
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 juice rich in nitrate in people with Arterial Hypertension and Postmenopausal; Menorrhagia, run by University of Sao Paulo 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 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cicero JR Benjamim, PhD Student (+5587988621194, benjamim.nutricao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of systolic and diastolic blood pressure (mmHg) (time frame: up to 2 years). 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 NCT05384340, which also lists 2 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 12 Jan 2023.