Energy Drinks & Driving Ability

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness.

Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving.

Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old.

Intervention: Each subject performs 3 test days:

1. 4 hours continued driving
2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving
3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.

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Detailed Description

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Conditions

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Driver Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No break

Group Type NO_INTERVENTION

Red Bull Energy drink

Intervention Type OTHER

During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.

Placebo Energy Drink

During a 15 minute break, subjects consume a placebo energy drink

Group Type PLACEBO_COMPARATOR

Red Bull Energy drink

Intervention Type OTHER

During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.

Red Bull Energy Drink

during a 15 minute break, subjects consume Red Bull Energy Drink

Group Type EXPERIMENTAL

Red Bull Energy drink

Intervention Type OTHER

During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.

Interventions

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Red Bull Energy drink

During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* He/she is aged between 21 and 35 years old
* BMI between 21 and 30,
* 55-85 kg body weight
* Non smoker
* Written informed consent
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Possession of a valid driver's license for at least 3 years
* Regular driver (\> 5000 km / year)
* Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria

* Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test
* Use of psychoactive medication
* Pregnancy
* Positive alcohol breath test
* Prior enrolment in the same study
* Physical or mental illness
* Excessive alcohol use (\>21 alcoholic drinks per week)
* Intake of caffeine-containing beverages under 2 or over 4 glasses per day
* Regular consumption of Energy Drinks (\>1 per month)
* Shift worker (or no regular sleep pattern)
* Epworth Sleepiness Score (ESS) \> 10

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes