HIV/AIDSNCT03485248
People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
A study testing Beetroot Juice in people with HIV/AIDS, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Oct 2017to 28 Nov 2018
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV infection for a period of 1 year or greater
- Regular use of high-potency antiretroviral therapy for at least one year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
DST / AIDS and Viral Hepatitis Program of Macaé
Macaé, Rio de Janeiro
About this study
Official title: Effect of Ingestion of Beet Juice on Endothelial Function, Arterial Stiffness and Muscle Oxygenation Parameters in People Living With HIV / AIDS Using Antiretroviral Therapy
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.
- Conditions
- HIV/AIDS
- Being tested
- Beetroot Juice, Placebo
- Keywords
- HIV/AIDS, Arterial stiffness, Flow mediated-dilatation, Muscle oxygenation parameters, Microcirculation, Dietary Nitrate
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
140ml of Beetroot Juice containing on avarege 9 mmol of nitrate
PlaceboDietary supplement
140ml of Beetroot Juice (nitrate free)
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Active comparator | Beetroot Juice cotaining on average 9mmol of nitrate per dose Receives: Dietary Supplement: Beetroot Juice |
| Placebo beet juice (Nitrate depleted) | Placebo comparator | Beetroot juice nitrate depleted Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Oxygenation
Changes in skeletal muscle oxygenation in response to exercise will be evaluated by using a near-infrared spectroscopy device.
Measured: Baseline and approximately after 150 minutes of beetroot juice consumption
Brachial artery flow-mediated dilatation
The brachial artery flow-mediated dilation will be evaluated by using an ultrasound device.
Measured: 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.
Measured: Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start18 Oct 2017
- Primary completion15 Aug 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485248
- Sponsor's protocol ID
- 68923417.0.0000.5699
- Status last verified
- Apr 2019
- First submitted
- 13 Mar 2018
- Last updated
- 29 Apr 2019
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ingestion of Beet Juice on Endothelial Function, Arterial Stiffness and Muscle Oxygenation Parameters in People Living With HIV / AIDS Using Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT03485248
- Acronym / sponsor ID
- 68923417.0.0000.5699
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Arterial stiffness, Flow mediated-dilatation, Muscle oxygenation parameters, Microcirculation, Dietary Nitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 2 Apr 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Active comparator | Dietary Supplement: Beetroot JuiceBeetroot Juice cotaining on average 9mmol of nitrate per dose |
| Placebo beet juice (Nitrate depleted) | Placebo comparator | Dietary Supplement: PlaceboBeetroot juice nitrate depleted |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HIV infection for a period of 1 year or greater
- Regular use of high-potency antiretroviral therapy for at least one year
Key exclusion criteria (4 listed)
- 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
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 Juice140ml of Beetroot Juice containing on avarege 9 mmol of nitrate | Dietary supplement | Beetroot juice |
| Placebo140ml of Beetroot Juice (nitrate free) | Dietary supplement | Placebo beet juice (Nitrate depleted) |
Primary outcome
Skeletal Muscle Oxygenation
Time frame: Baseline and approximately after 150 minutes of beetroot juice consumption
Changes in skeletal muscle oxygenation in response to exercise will be evaluated by using a near-infrared spectroscopy device.
Brachial artery flow-mediated dilatation
Time frame: Baseline and approximately after 150 minutes of beetroot juice consumption
The brachial artery flow-mediated dilation will be evaluated by using an ultrasound device.
1 secondary outcome
Urinary nitrate concentrations
Time frame: Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption
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 29 Apr 2019.
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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.
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 study testing Beetroot Juice in people with HIV/AIDS, run by Universidade Federal do Rio de Janeiro 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 2 inclusion and 4 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 29 Apr 2019. 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?
Skeletal Muscle Oxygenation (time frame: Baseline and approximately after 150 minutes of beetroot juice consumption). The study lists 2 primary outcomes in all. 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 29 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.