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OpenTrials
Completed

NCT Number: NCT03485248

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DST / AIDS and Viral Hepatitis Program of Macaé

Macaé, Rio de Janeiro, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot juice

Dietary Supplement

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

Placebo

Dietary Supplement

140ml of Beetroot Juice (nitrate free)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Urinary nitrate concentrations

    Time frame: Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption

    Analysis of nitrate in urine will be performed by using high-performance liquid chromatography system.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2018
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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