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

NCT ID: NCT03485248

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2018-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double- Blind

Study Groups

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Beetroot juice

Beetroot Juice cotaining on average 9mmol of nitrate per dose

Group Type ACTIVE_COMPARATOR

Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

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

Placebo beet juice (Nitrate depleted)

Beetroot juice nitrate depleted

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

140ml of Beetroot Juice (nitrate free)

Interventions

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Beetroot Juice

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

140ml of Beetroot Juice (nitrate free)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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DST / AIDS and Viral Hepatitis Program of MacaƩ

MacaƩ, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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68923417.0.0000.5699

Identifier Type: -

Identifier Source: org_study_id

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