Energy Drinks & Driving Ability

Not Applicable

Completed

• Conditions: Driver Sleepiness
• Interventions: Other: Red Bull Energy drink

• Registration Number: NCT01007877
• Lead Sponsor: Utrecht Institute for Pharmaceutical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No break	Red Bull Energy drink	-
Placebo Energy Drink	Red Bull Energy drink	During a 15 minute break, subjects consume a placebo energy drink
Red Bull Energy Drink	Red Bull Energy drink	during a 15 minute break, subjects consume Red Bull Energy Drink

Primary Outcome Measures

Name	Time	Method
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane	the 2 hours of driving following the intervention

Secondary Outcome Measures

Name	Time	Method
Number of collisions	the 2 hours of driving following the intervention

Trial Locations

Locations (1)

Utrecht University; 🇳🇱 Utrecht, Netherlands