Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers

October 11, 2022 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.

Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).

Study Overview

Detailed Description

Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rio de Janeiro, Brazil, 22240-006
        • National Institute of Cardiology, Ministry of Health, Brazil
      • Rio de Janeiro, Brazil, 22240006
        • Eduardo Tibiriçá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

healthy male volunteers with no relevant findings in the medical history

Description

Inclusion Criteria:

  • healthy male volunteers with no relevant findings in the medical history

Exclusion Criteria:

  • being a competitive athlete;
  • being on regular medication;
  • using illicit drugs;
  • being allergic to coffee, taurine or any of the components of the selected energy drink; - -
  • having a body mass index ≥ 30 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Energy Drink

Ingestion of 250 ml of the energy drink (Red Bull®)

- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

Ingestion of 250 ml of the energy drink (Red Bull®)
Control

Ingestion of 250 ml of mineral water (Minalba®)

- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

Ingestion of 250 ml of mineral water (Minalba®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelium-dependent skin microvascular reactivity
Time Frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Cutaneous microvascular flow measured with laser speckle contrast imaging
Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

June 10, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CAAE 13135219.0.0000.5272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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