Energy Drinks and Vascular Function

Vascular Function Clinical Trial

Official title:

Acute Effect of Energy Drinks on Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324256
• Other study ID #: IRB201700678
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: May 16, 2019

Study information

• Verified date: May 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Function

Intervention

Other:
• energy drink
16 oz cold commercially-available energy drink
• caffeinated drink
16oz cold commercially-available caffeinated drink
• Energy gum
2 pieces of commercially-available energy gum
• placebo gum
2 pieces of commercially-available placebo gum
• Control drink
16oz cold control drink
• Total sleep deprivation
24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelial function	Brachial artery flow-mediated dilation	Before and 1 and 2 hrs following consumption of drink and gum
Secondary	Change in arterial stiffness	Carotid to femoral pulse wave velocity	Before and 1 and 2 hrs following consumption of drink and gum
Secondary	Change in wave reflection	Augmentation index	Before and 1 and 2 hrs following consumption of drink and gum
Secondary	Change in peripheral and central blood pressures	Brachial and aortic blood pressures	Before and 1 and 2 hrs following consumption of drink and gum
Secondary	Change in thrombosis and platelet function	Thromboelastograph and platelet aggregation tests	Before and 1 and 2 hrs following consumption of drink and gum
Secondary	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
Secondary	Change in heart rhythm	Electrocardiogram	Before and 1 and 2 hrs following consumption of drink and gum