HypertensionNCT04020796
Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients
A study testing Beetroot juice in people with Hypertension, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2019to 15 Aug 2019
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both sexes
- Age between 40 and 70 years
- Previous diagnosis of primary systemic arterial hypertension
- Signed the Informed Consent Term.
Who cannot join
- Secondary hypertension
- Systolic blood pressure greater than or equal to 180 mmHg or diastolic BP greater than or equal to 110 mmHg
- In use of beta-blockers
- Diabetes mellitus
- History of cancer
- Use of any dietary supplement
- Any serious life-threatening illness
- Cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients
To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.
Read the detailed description
Systemic arterial hypertension is an established risk factor for cardiovascular disease (CVD). Among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against CVD due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in vascular health. Associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. The objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.
- Conditions
- Hypertension
- Being tested
- Beetroot juice
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Active comparator | Randomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of beetroot juice in a single moment. Receives: Dietary Supplement: Beetroot juice |
| Mineral water | Placebo comparator | Randomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of mineral water in a single moment. Receives: Dietary Supplement: Beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular reactivity
A laser speckle contrast imaging system with a laser wavelength of 785 nm system will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.
Measured: 150 minutes
Secondary outcomes (1)
Central blood pressure
Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure before and after intervention and their potential effects on changes in subendocardial viability ratio and ejection duration after intervention with beetroot juice and water.
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start20 Jun 2019
- Primary completion30 Jul 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, crossover, placebo-controlled
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Samanta De Souza Mattos, Hospital Universitario Pedro Ernesto
- Investigators
- Samanta S Mattos, Principal investigator, State University of Rio de JaneiroMario F Neves, MD, PhD, Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020796
- Sponsor's protocol ID
- BRJ-700
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04020796
- Acronym / sponsor ID
- BRJ-700
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 16 Jul 2019 (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.
To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.
Detailed description
Systemic arterial hypertension is an established risk factor for cardiovascular disease (CVD). Among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against CVD due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in vascular health. Associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. The objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, crossover, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Active comparator | Dietary Supplement: Beetroot juiceRandomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of beetroot juice in a single moment. |
| Mineral water | Placebo comparator | Dietary Supplement: Beetroot juiceRandomized cross-over trial. Thirty-seven hypertension, age 40-70 years were randomized to receive a 500ml volume of mineral water in a single moment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes
- Age between 40 and 70 years
- Previous diagnosis of primary systemic arterial hypertension
- Signed the Informed Consent Term.
Key exclusion criteria (8 listed)
- Secondary hypertension
- Systolic blood pressure greater than or equal to 180 mmHg or diastolic BP greater than or equal to 110 mmHg
- In use of beta-blockers
- Diabetes mellitus
- History of cancer
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 juiceThirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment. | Dietary supplement | Beetroot juice, Mineral water |
Primary outcome
Microvascular reactivity
Time frame: 150 minutes
A laser speckle contrast imaging system with a laser wavelength of 785 nm system will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.
1 secondary outcome
Central blood pressure
Time frame: 150 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No. No plans to share IPD with other researchers
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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.
Samanta S Mattos principal investigator
State University of Rio de Janeiro
Mario F Neves, MD, PhD study director
State University of Rio de Janeiro
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 in people with Hypertension, run by Hospital Universitario Pedro Ernesto 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular reactivity (time frame: 150 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.