Energy Drinks and Vascular Function

NCT ID: NCT03324256

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2019-05-16

Brief Summary

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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

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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

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Vascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Energy drink and placebo gum

Commercially-available energy drink (16oz) + 2 pieces of placebo gum

Group Type ACTIVE_COMPARATOR

energy drink

Intervention Type OTHER

16 oz cold commercially-available energy drink

placebo gum

Intervention Type OTHER

2 pieces of commercially-available placebo gum

Caffeinated drink and placebo gum

Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum

Group Type ACTIVE_COMPARATOR

caffeinated drink

Intervention Type OTHER

16oz cold commercially-available caffeinated drink

placebo gum

Intervention Type OTHER

2 pieces of commercially-available placebo gum

Control drink and energy gum

Control drink (16oz) + 2 pieces of energy gum

Group Type ACTIVE_COMPARATOR

Energy gum

Intervention Type OTHER

2 pieces of commercially-available energy gum

Control drink

Intervention Type OTHER

16oz cold control drink

Control drink and placebo gum

Control drink (16oz) + 2 pieces of placebo gum

Group Type PLACEBO_COMPARATOR

placebo gum

Intervention Type OTHER

2 pieces of commercially-available placebo gum

Control drink

Intervention Type OTHER

16oz cold control drink

Energy drink and total sleep deprivation

Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation

Group Type ACTIVE_COMPARATOR

energy drink

Intervention Type OTHER

16 oz cold commercially-available energy drink

placebo gum

Intervention Type OTHER

2 pieces of commercially-available placebo gum

Total sleep deprivation

Intervention Type OTHER

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

Interventions

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energy drink

16 oz cold commercially-available energy drink

Intervention Type OTHER

caffeinated drink

16oz cold commercially-available caffeinated drink

Intervention Type OTHER

Energy gum

2 pieces of commercially-available energy gum

Intervention Type OTHER

placebo gum

2 pieces of commercially-available placebo gum

Intervention Type OTHER

Control drink

16oz cold control drink

Intervention Type OTHER

Total sleep deprivation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Demetra Christou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201700678

Identifier Type: -

Identifier Source: org_study_id

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