Resistant Arterial HypertensionEarly Phase 1NCT07058922
Acute Effects of Powdered Beetroot Extract Supplementation on the Microcirculation of Resistant Hypertensive Individuals
A Early Phase 1 study testing evaluation of systemic microvascular reactivity, ABPM and beetroot supplement in people with Resistant Arterial Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
Arterial hypertension is a major public health issue and is considered to be a new epidemic due to its high mortality and morbidity rates. Elevated blood pressure levels increase the risk of coronary artery disease, heart failure, stroke, chronic kidney disease and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Arterial Hypertension
- What is being tested?
- evaluation of systemic microvascular reactivity, ABPM and beetroot supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2024to Dec 2026
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant hypertensive patients, with a diagnosis documented in medical records, without any change in medication or increase in dosage in the past 30 days.
Who cannot join
- Patients will be excluded from the study if they have: neoplasms, heart failure, are using medications containing nitrate in their formulation, or have undergone renal denervation.
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
National Institute of Cardiology
Rio de Janeiro, Rio de Janeiro, 20397-230
About this study
Arterial hypertension is a major public health issue and is considered to be a new epidemic due to its high mortality and morbidity rates. Elevated blood pressure levels increase the risk of coronary artery disease, heart failure, stroke, chronic kidney disease and death. Dietary nitrate supplementation in the form of beetroot powder extract may offer a more accessible way to increase systemic nitric oxide availability and consequently promote vasodilation in these patients. However, studies are needed to assess its benefits in patients with hypertension.
Read the detailed description
Methods and Analyses: This is a double-blind, placebo-controlled clinical trial in which patients with hypertension will be randomly assigned to two groups to receive either nitrate powder supplementation or placebo for a duration of 60 days. The primary outcome will be the reduction in blood pressure levels. Secondary outcomes will include systemic microvascular reactivity and quality of life.
- Conditions
- Resistant Arterial Hypertension
- Being tested
- evaluation of systemic microvascular reactivity, ABPM, beetroot supplement
- Keywords
- arterial hypertension, systemic microcirculation, beetroot extract
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of systemic microvascular reactivityDiagnostic test
Evaluation of systemic microvascular reactivity using laser speckle contrast imaging.
ABPMDiagnostic test
Ambulatory blood pressure measuring: systolic, diastolic and mean arterial pressures
beetroot supplementDietary supplement
A powdered beetroot extract supplement containing 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g.
| Study group | Role | What they receive |
|---|---|---|
| beetroot powder extract supplement | Experimental | A powdered beetroot extract supplement containing 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g. Receives: Diagnostic Test: evaluation of systemic microvascular reactivity; Diagnostic Test: ABPM; Dietary Supplement: beetroot supplement |
| placebo control | Placebo comparator | An isocaloric, colored, and flavored supplement composed of maltodextrin will be orally administered. Receives: Diagnostic Test: evaluation of systemic microvascular reactivity; Diagnostic Test: ABPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
ABPM - measurement of systolic, diastolic and mean arterial pressure.
Measured: 60 days of tratment
Secondary outcomes (1)
Systemic microvascular reactivity
Measured: 60 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant Arterial 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nutritional supplement containing a powdered beetroot extract - 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058922
- Sponsor's protocol ID
- CAAE70847523.9.0000.5272
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Powdered Beetroot Extract Supplementation on the Microcirculation of Resistant Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT07058922
- Acronym / sponsor ID
- CAAE70847523.9.0000.5272
- Conditions
- Resistant Arterial Hypertension
- Keywords
- arterial hypertension, systemic microcirculation, beetroot extract
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
Arterial hypertension is a major public health issue and is considered to be a new epidemic due to its high mortality and morbidity rates. Elevated blood pressure levels increase the risk of coronary artery disease, heart failure, stroke, chronic kidney disease and death. Dietary nitrate supplementation in the form of beetroot powder extract may offer a more accessible way to increase systemic nitric oxide availability and consequently promote vasodilation in these patients. However, studies are needed to assess its benefits in patients with hypertension.
Detailed description
Methods and Analyses: This is a double-blind, placebo-controlled clinical trial in which patients with hypertension will be randomly assigned to two groups to receive either nitrate powder supplementation or placebo for a duration of 60 days. The primary outcome will be the reduction in blood pressure levels. Secondary outcomes will include systemic microvascular reactivity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Nutritional supplement containing a powdered beetroot extract - 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g.
| Arm | Type | Receives |
|---|---|---|
| beetroot powder extract supplement | Experimental | Diagnostic Test: evaluation of systemic microvascular reactivity, Diagnostic Test: ABPM, Dietary Supplement: beetroot supplementA powdered beetroot extract supplement containing 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g. |
| placebo control | Placebo comparator | Diagnostic Test: evaluation of systemic microvascular reactivity, Diagnostic Test: ABPMAn isocaloric, colored, and flavored supplement composed of maltodextrin will be orally administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resistant hypertensive patients, with a diagnosis documented in medical records, without any change in medication or increase in dosage in the past 30 days.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they have: neoplasms, heart failure, are using medications containing nitrate in their formulation, or have undergone renal denervation.
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 |
|---|---|---|
| evaluation of systemic microvascular reactivityEvaluation of systemic microvascular reactivity using laser speckle contrast imaging. | Diagnostic test | beetroot powder extract supplement, placebo control |
| ABPMAmbulatory blood pressure measuring: systolic, diastolic and mean arterial pressures | Diagnostic test | beetroot powder extract supplement, placebo control |
| beetroot supplementA powdered beetroot extract supplement containing 400 mg of nitrate per dose will be used in the supplement group, administered orally at a daily amount of 10 g. | Dietary supplement | beetroot powder extract supplement |
Primary outcome
Blood pressure
Time frame: 60 days of tratment
ABPM - measurement of systolic, diastolic and mean arterial pressure.
1 secondary outcome
Systemic microvascular reactivity
Time frame: 60 days treatment
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 23 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing evaluation of systemic microvascular reactivity, ABPM and beetroot supplement in people with Resistant Arterial Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 23 Jul 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Blood pressure (time frame: 60 days of tratment). 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 23 Jul 2025.