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

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485248
• Other study ID #: 68923417.0.0000.5699
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2019
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 28, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Dietary Supplement:
• Beetroot Juice
140ml of Beetroot Juice containing on avarege 9 mmol of nitrate
• Placebo
140ml of Beetroot Juice (nitrate free)

Locations

Country	Name	City	State
Brazil	DST / AIDS and Viral Hepatitis Program of Macaé	Macaé	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Urinary nitrate concentrations	Analysis of nitrate in urine will be performed by using high-performance liquid chromatography system.	Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption