ClinicalTrials.gg
CompletedNCT03485248Updated Apr 29, 2019

People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation

An interventional study of Beetroot Juice and Placebo in HIV/AIDS, sponsored by Universidade Federal do Rio de Janeiro. Completed at 1 site in Brazil. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by Universidade Federal do Rio de Janeiro · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2017, registered Mar 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil — 7 open to participants now, 10 under way, 4 of them phase 3. Acquired Immunodeficiency Syndrome · Brazil.

Enrollment
41st of 42
12 · median 132
Started
2017
with 3 others
No phase
11 of 57
none open now
Registered
40th of 57
by date

Among the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil, this one is the 41st largest by enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2017, is one of 11 with no phase, and was the 40th registered.

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

7 of the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

This study: 18 Years to 59 Years · all sexes · healthy volunteers too.

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02

Study summary

Administration of antiretroviral therapy has brought benefits for infective human immunodeficiency virus-1 (HIV-1)-patients, reducing the number of AIDS-related morbidity and mortality. However, it is responsible for intensifying complications triggered by the chronic inflammatory state associated with virus infection, such as cardiovascular diseases. The current study evaluated effects of single dose (140mL) of Beetroot Juice (BJ) on macro and microvascular endothelial function in HIV-1-patients undergoing antiretroviral terapy, once BJ was shown to be effective in improving these physiological parameters in uninfected individuals.

03

Conditions studied

  • HIV/AIDS

Keywords

  • HIV/AIDS
  • Arterial stiffness
  • Flow mediated-dilatation
  • Muscle oxygenation parameters
  • Microcirculation
  • Dietary Nitrate
04

Who can participate

Ages eligible
18 Years to 59 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

  • infection for a period of 1 year or greater
  • Regular use of high-potency antiretroviral therapy for at least one year

Exclusion criteria

Exclusion Criteria:

  • Individuals who are physically active
  • Individuals who are allergic to some component of beet
  • Individuals who use nutritional and / or pharmacological ergogenics
  • Individuals receiving antibiotics or who have osteomioarticular problems
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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Beetroot juice

    Beetroot Juice cotaining on average 9mmol of nitrate per dose

    Dietary Supplement: Beetroot Juice

  • Placebo comparator
    Placebo beet juice (Nitrate depleted)

    Beetroot juice nitrate depleted

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementBeetroot Juice

    140ml of Beetroot Juice containing on avarege 9 mmol of nitrate

  • Dietary supplementPlacebo

    140ml of Beetroot Juice (nitrate free)

06

What researchers measure

Primary outcomes

  1. Skeletal Muscle Oxygenation

    Changes in skeletal muscle oxygenation in response to exercise will be evaluated by using a near-infrared spectroscopy device.

    Time frame: Baseline and approximately after 150 minutes of beetroot juice consumption

  2. Brachial artery flow-mediated dilatation

    The brachial artery flow-mediated dilation will be evaluated by using an ultrasound device.

    Time frame: Baseline and approximately after 150 minutes of beetroot juice consumption

Secondary outcomes

  1. Urinary nitrate concentrations

    Analysis of nitrate in urine will be performed by using high-performance liquid chromatography system.

    Time frame: Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption

07

Study locations

1 site
  • DST / AIDS and Viral Hepatitis Program of Macaé
    Macaé, Rio De Janeiro, Brazil
08

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 Oct 2017 to primary completion in Aug 2018, 9 months.

Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 9 months is below that.

Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.

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

Registered
Mar 13, 2018
First posted
Apr 2, 2018
StartActual
Oct 18, 2017
Primary completionActual
Aug 15, 2018
CompletionActual
Nov 28, 2018
Last update
Apr 29, 2019
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 Apr 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03485248
Responsible party
Thiago Alvares (PhD, Universidade Federal do Rio de Janeiro) — Principal investigator
First posted
Apr 2, 2018
Start date
Oct 18, 2017
Primary completion
Aug 15, 2018
Completion
Nov 28, 2018
Last update
Apr 29, 2019

Oversight

Data monitoring committee
No
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 Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Beet juice

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