Energy Drinks and Vascular Function

Study Overview
=================
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.

Official Title
-----------------
Acute Effect of Energy Drinks on Vascular Function

Conditions
-----------------
Vascular Function

Intervention / Treatment
-----------------
* Other: energy drink
* Other: caffeinated drink
* Other: Energy gum
* Other: placebo gum
* Other: Control drink
* Other: Total sleep deprivation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy drink consumption