People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Beetroot Juice
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring HIV/AIDS, Arterial stiffness, Flow mediated-dilatation, Muscle oxygenation parameters, Microcirculation, Dietary Nitrate
Eligibility Criteria
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
Sites / Locations
- DST / AIDS and Viral Hepatitis Program of Macaé
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Beetroot juice
Placebo beet juice (Nitrate depleted)
Arm Description
Beetroot Juice cotaining on average 9mmol of nitrate per dose
Beetroot juice nitrate depleted
Outcomes
Primary Outcome Measures
Skeletal Muscle Oxygenation
Changes in skeletal muscle oxygenation in response to exercise will be evaluated by using a near-infrared spectroscopy device.
Brachial artery flow-mediated dilatation
The brachial artery flow-mediated dilation will be evaluated by using an ultrasound device.
Secondary Outcome Measures
Urinary nitrate concentrations
Analysis of nitrate in urine will be performed by using high-performance liquid chromatography system.
Full Information
NCT ID
NCT03485248
First Posted
March 13, 2018
Last Updated
April 25, 2019
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT03485248
Brief Title
People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Arterial stiffness, Flow mediated-dilatation, Muscle oxygenation parameters, Microcirculation, Dietary Nitrate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double- Blind
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beetroot juice
Arm Type
Active Comparator
Arm Description
Beetroot Juice cotaining on average 9mmol of nitrate per dose
Arm Title
Placebo beet juice (Nitrate depleted)
Arm Type
Placebo Comparator
Arm Description
Beetroot juice nitrate depleted
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice
Intervention Description
140ml of Beetroot Juice containing on avarege 9 mmol of nitrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
140ml of Beetroot Juice (nitrate free)
Primary Outcome Measure Information:
Title
Skeletal Muscle Oxygenation
Description
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
Title
Brachial artery flow-mediated dilatation
Description
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 Outcome Measure Information:
Title
Urinary nitrate concentrations
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
DST / AIDS and Viral Hepatitis Program of Macaé
City
Macaé
State/Province
Rio De Janeiro
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
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