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

NCT ID: NCT05575895

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-10

Study Completion Date

2022-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Endothelial Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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 the energy drink (Red Bull®)

Intervention Type DIETARY_SUPPLEMENT

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 mineral water

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 250 ml of mineral water (Minalba®)

Interventions

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Ingestion of the energy drink (Red Bull®)

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

Intervention Type DIETARY_SUPPLEMENT

Ingestion of mineral water

Ingestion of 250 ml of mineral water (Minalba®)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eduardo Tibirica, MD, PhD

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, , Brazil

Site Status

Eduardo Tibiriçá

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE 13135219.0.0000.5272

Identifier Type: -

Identifier Source: org_study_id

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