Energy Drinks and Vascular Function

Acute Effect of Energy Drinks on Vascular Function

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.

Study Overview

• Status: Completed
• Conditions: Vascular Function
• Intervention / Treatment: Other: energy drink; Other: placebo gum; Other: caffeinated drink; Other: Energy gum; Other: Control drink; Other: Total sleep deprivation

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Energy drink and placebo gum; Commercially-available energy drink (16oz) + 2 pieces of placebo gum	Other: energy drink; 16 oz cold commercially-available energy drink; Other: placebo gum; 2 pieces of commercially-available placebo gum
Active Comparator: Caffeinated drink and placebo gum; Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum	Other: placebo gum; 2 pieces of commercially-available placebo gum; Other: caffeinated drink; 16oz cold commercially-available caffeinated drink
Active Comparator: Control drink and energy gum; Control drink (16oz) + 2 pieces of energy gum	Other: Energy gum; 2 pieces of commercially-available energy gum; Other: Control drink; 16oz cold control drink
Placebo Comparator: Control drink and placebo gum; Control drink (16oz) + 2 pieces of placebo gum	Other: placebo gum; 2 pieces of commercially-available placebo gum; Other: Control drink; 16oz cold control drink
Active Comparator: Energy drink and total sleep deprivation; Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation	Other: energy drink; 16 oz cold commercially-available energy drink; Other: placebo gum; 2 pieces of commercially-available placebo gum; Other: Total sleep deprivation; 24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in endothelial function	Brachial artery flow-mediated dilation	Before and 1 and 2 hrs following consumption of drink and gum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Energy drink consumption
• Other Study ID Numbers: IRB201700678

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No