Energy Drinks and Vascular Function

Not Applicable

Completed

• Conditions: Vascular Function
• Interventions: Other: energy drink; Other: caffeinated drink; Other: Energy gum; Other: Control drink; Other: placebo gum; Other: Total sleep deprivation

• Registration Number: NCT03324256
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

Detailed Description

The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2018-01-12
• Status Verified: 2019-05
• Primary Completion: 2019-05-16
• Study Completion: 2019-05-16
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

• Being Male
• 18-30 years of age
• No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
• BMI ≤ 30 kg/m^2 and blood pressure ≤ 140/90 mmHg
• Consumption of <400mg of caffeine/day
• Prior history of consumption of energy drinks

Exclusion criteria:

• Being female
• Age <18 or >30 years
• BMI> 30 kg/m^2 and blood pressure > 140/90 mmHg
• Use of medication that may affect vascular measures
• Use of tobacco products including smoking
• Vegan or vegetarian diet
• Being energy drink or caffeine naïve or consumption of >400 mg of caffeine/day
• Consumption of >1 energy drinks per month
• Being a shift worker

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control drink and energy gum	Control drink	Control drink (16oz) + 2 pieces of energy gum
Energy drink and placebo gum	energy drink	Commercially-available energy drink (16oz) + 2 pieces of placebo gum
Energy drink and placebo gum	placebo gum	Commercially-available energy drink (16oz) + 2 pieces of placebo gum
Caffeinated drink and placebo gum	caffeinated drink	Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum
Control drink and placebo gum	Control drink	Control drink (16oz) + 2 pieces of placebo gum
Energy drink and total sleep deprivation	Total sleep deprivation	Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation
Caffeinated drink and placebo gum	placebo gum	Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum
Energy drink and total sleep deprivation	placebo gum	Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation
Control drink and energy gum	Energy gum	Control drink (16oz) + 2 pieces of energy gum
Control drink and placebo gum	placebo gum	Control drink (16oz) + 2 pieces of placebo gum
Energy drink and total sleep deprivation	energy drink	Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation

Primary Outcome Measures

Name	Time	Method
Change in endothelial function	Before and 1 and 2 hrs following consumption of drink and gum	Brachial artery flow-mediated dilation

Secondary Outcome Measures

Name	Time	Method
Change in arterial stiffness	Before and 1 and 2 hrs following consumption of drink and gum	Carotid to femoral pulse wave velocity
Change in heart rhythm	Before and 1 and 2 hrs following consumption of drink and gum	Electrocardiogram
Change in wave reflection	Before and 1 and 2 hrs following consumption of drink and gum	Augmentation index
Change in peripheral and central blood pressures	Before and 1 and 2 hrs following consumption of drink and gum	Brachial and aortic blood pressures
Change in thrombosis and platelet function	Before and 1 and 2 hrs following consumption of drink and gum	Thromboelastograph and platelet aggregation tests
Change in circulating factors related to vascular function	Before and 1 and 2 hrs following consumption of drink and gum	Circulating levels of Trimethylamine N-oxide (TMAO) and markers of oxidative stress and inflammation

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States