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CompletedNCT04020796Updated Jul 28, 2020

Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients

An interventional study of Beetroot juice in Hypertension, sponsored by Hospital Universitario Pedro Ernesto. Completed at 1 site in Brazil. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Hospital Universitario Pedro Ernesto · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital Universitario Pedro Ernesto is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of both sexes
  • Age between 40 and 70 years
  • Previous diagnosis of primary systemic arterial hypertension
  • Signed the Term.

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Beetroot juice

    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.

    Dietary Supplement: Beetroot juice

  • Placebo comparator
    Mineral water

    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.

    Dietary Supplement: Beetroot juice

Interventions

  • Dietary supplementBeetroot juice

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 150 minutes

07

Study locations

1 site
  • Samanta de Souza Mattos
    Rio de Janeiro, RJ 20551-030, Brazil
08

References and documents

Individual participant data

Plan to share: No — No plans to share IPD with other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2019 to primary completion in Jul 2019, 1 month.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 1 month is below that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2019
First posted
Jul 16, 2019
StartActual
Jun 20, 2019
Primary completionActual
Jul 30, 2019
CompletionActual
Aug 15, 2019
Last update
Jul 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04020796
Lead sponsor
Hospital Universitario Pedro Ernesto
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Samanta De Souza Mattos (Nutritionist, Hospital Universitario Pedro Ernesto) — Principal investigator
First posted
Jul 16, 2019
Start date
Jun 20, 2019
Primary completion
Jul 30, 2019
Completion
Aug 15, 2019
Last update
Jul 28, 2020

Study contacts

Samanta S Mattos
principal investigator · State University of Rio de Janeiro
Mario F Neves, MD, PhD
study director · State University of Rio de Janeiro

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Beet juice

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