- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575895
Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
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
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Rio de Janeiro, Brazil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Rio de Janeiro, Brazil, 22240006
- Eduardo Tibiriçá
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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