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

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT05575895

Collaborator

(none)

Enrollment

Locations

29.6

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Endothelial Function	Dietary Supplement: Ingestion of the energy drink (Red Bull®) Dietary Supplement: Ingestion of mineral water

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 Design

Study Type:

Observational

Actual Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 10, 2020

Actual Primary Completion Date :

Jun 10, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	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.	Dietary Supplement: Ingestion of the energy drink (Red Bull®) 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.	Dietary Supplement: Ingestion of mineral water Ingestion of 250 ml of mineral water (Minalba®)

Arm

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.

Dietary Supplement: Ingestion of the energy drink (Red Bull®)

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.

Dietary Supplement: Ingestion of mineral water

Ingestion of 250 ml of mineral water (Minalba®)

Outcome Measures

Primary Outcome Measures

Endothelium-dependent skin microvascular reactivity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiology, Ministry of Health, Brazil	Rio de Janeiro		Brazil	22240-006
2	Eduardo Tibiriçá	Rio de Janeiro		Brazil	22240006

Sponsors and Collaborators

National Institute of Cardiology, Laranjeiras, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eduardo Tibirica, MD, PhD, Senior researcher, National Institute of Cardiology, Laranjeiras, Brazil

ClinicalTrials.gov Identifier:

NCT05575895

Other Study ID Numbers:

CAAE 13135219.0.0000.5272

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 14, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 14, 2022