CompletedNCT03324256Updated May 20, 2019

Energy Drinks and Vascular Function

An interventional study of energy drink and caffeinated drink in Vascular Function, sponsored by University of Florida. Completed at 1 site in United States. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 19
Allocation: Randomized
Ages: 18 Years to 30 Years
Sex: Male

Study 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.

Read the 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.

Conditions studied

Vascular Function

Keywords

Energy drink consumption

Who can participate

Ages eligible: 18 Years to 30 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 19 participants (actual)

Study arms

Active comparator
Energy drink and placebo gum
Commercially-available energy drink (16oz) + 2 pieces of placebo gum
Other: energy drink · Other: placebo gum
Active comparator
Caffeinated drink and placebo gum
Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum
Other: caffeinated drink · Other: placebo gum
Active comparator
Control drink and energy gum
Control drink (16oz) + 2 pieces of energy gum
Other: Energy gum · Other: Control drink
Placebo comparator
Control drink and placebo gum
Control drink (16oz) + 2 pieces of placebo gum
Other: placebo gum · Other: 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 · Other: placebo gum · Other: Total sleep deprivation

Interventions

Otherenergy drink
16 oz cold commercially-available energy drink
Othercaffeinated drink
16oz cold commercially-available caffeinated drink
OtherEnergy gum
2 pieces of commercially-available energy gum
Otherplacebo gum
2 pieces of commercially-available placebo gum
OtherControl drink
16oz cold control drink
OtherTotal sleep deprivation
24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in arterial stiffness
Carotid to femoral pulse wave velocity
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in wave reflection
Augmentation index
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in peripheral and central blood pressures
Brachial and aortic blood pressures
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in thrombosis and platelet function
Thromboelastograph and platelet aggregation tests
Time frame: 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
Time frame: Before and 1 and 2 hrs following consumption of drink and gum
Change in heart rhythm
Electrocardiogram
Time frame: Before and 1 and 2 hrs following consumption of drink and gum

Study locations

1 site

University of Florida
Gainesville, Florida 32611, United States

Registry details

Key details

Study ID: NCT03324256
Lead sponsor: University of Florida
Responsible party: Sponsor
First posted: Oct 27, 2017
Start date: Jan 12, 2018
Primary completion: May 16, 2019
Completion: May 16, 2019
Last update: May 20, 2019

Study contacts

Demetra Christou, PhD

principal investigator · University of Florida

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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