People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
Effect of Ingestion of Beet Juice on Endothelial Function, Arterial Stiffness and Muscle Oxygenation Parameters in People Living With HIV / AIDS Using Antiretroviral Therapy
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2017
CompletedFirst Submitted
Initial submission to the registry
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2018
CompletedApril 29, 2019
April 1, 2019
10 months
March 13, 2018
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Skeletal Muscle Oxygenation
Changes in skeletal muscle oxygenation in response to exercise will be evaluated by using a near-infrared spectroscopy device.
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.
Baseline and approximately after 150 minutes of beetroot juice consumption
Secondary Outcomes (1)
Urinary nitrate concentrations
Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption
Study Arms (2)
Beetroot juice
ACTIVE COMPARATORBeetroot Juice cotaining on average 9mmol of nitrate per dose
Placebo beet juice (Nitrate depleted)
PLACEBO COMPARATORBeetroot juice nitrate depleted
Interventions
140ml of Beetroot Juice containing on avarege 9 mmol of nitrate
140ml of Beetroot Juice (nitrate free)
Eligibility Criteria
You may qualify if:
- HIV infection for a period of 1 year or greater
- Regular use of high-potency antiretroviral therapy for at least one year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DST / AIDS and Viral Hepatitis Program of Macaé
Macaé, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double- Blind
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 13, 2018
First Posted
April 2, 2018
Study Start
October 18, 2017
Primary Completion
August 15, 2018
Study Completion
November 28, 2018
Last Updated
April 29, 2019
Record last verified: 2019-04