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Completed

NCT Number: NCT03324256

Energy Drinks and 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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy drink

Other

16 oz cold commercially-available energy drink

caffeinated drink

Other

16oz cold commercially-available caffeinated drink

Energy gum

Other

2 pieces of commercially-available energy gum

Placebo gum

Other

2 pieces of commercially-available placebo gum

Control drink

Other

16oz cold control drink

Total sleep deprivation

Other

24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

Primary outcomes

  1. Change in endothelial function

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Brachial artery flow-mediated dilation

Secondary outcomes

  1. Change in arterial stiffness

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Carotid to femoral pulse wave velocity

  2. Change in wave reflection

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Augmentation index

  3. Change in peripheral and central blood pressures

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Brachial and aortic blood pressures

  4. Change in thrombosis and platelet function

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Thromboelastograph and platelet aggregation tests

  5. Change in circulating factors related to vascular function

    Time frame: 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

  6. Change in heart rhythm

    Time frame: Before and 1 and 2 hrs following consumption of drink and gum

    Electrocardiogram

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Acute Effect of Energy Drinks on Vascular Function

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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