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

NCT05575895 | Completed

• 1 other identifier: CAAE 13135219.0.0000.5272
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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).

Conditions

Endothelial Function

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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®)

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

Interventions

Ingestion of the energy drink (Red Bull®) DIETARY_SUPPLEMENT

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

Energy Drink

Ingestion of mineral water DIETARY_SUPPLEMENT

Ingestion of 250 ml of mineral water (Minalba®)

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy male volunteers with no relevant findings in the medical history

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (2)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: January 10, 2020
• Primary Completion: June 10, 2022
• Study Completion: June 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

BR (2)