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

Endothelial Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575895
• Other study ID #: CAAE 13135219.0.0000.5272
• Status: Completed
• Start date: January 10, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Function

Intervention

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

Locations

Country	Name	City	State
Brazil	Eduardo Tibiriçá	Rio de Janeiro
Brazil	National Institute of Cardiology, Ministry of Health, Brazil	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependent skin microvascular reactivity	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.