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Energy Drinks & Driving Ability

Primary Purpose

Driver Sleepiness

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Red Bull Energy drink
Sponsored by
Utrecht Institute for Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Driver Sleepiness focused on measuring sleepiness, driving

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Utrecht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

No break

Placebo Energy Drink

Red Bull Energy Drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane

Secondary Outcome Measures

Number of collisions

Full Information

First Posted
October 13, 2009
Last Updated
April 8, 2011
Sponsor
Utrecht Institute for Pharmaceutical Sciences
Collaborators
Red Bull GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01007877
Brief Title
Energy Drinks & Driving Ability
Official Title
'Study to Investigate the Effects of an Energy Drink During a 15-minute Break Versus Continued Driving on Driving Performance in the STISIM Driving Simulator'
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Utrecht Institute for Pharmaceutical Sciences
Collaborators
Red Bull GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 4 hours continued driving 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Driver Sleepiness
Keywords
sleepiness, driving

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No break
Arm Type
No Intervention
Arm Title
Placebo Energy Drink
Arm Type
Placebo Comparator
Arm Description
During a 15 minute break, subjects consume a placebo energy drink
Arm Title
Red Bull Energy Drink
Arm Type
Experimental
Arm Description
during a 15 minute break, subjects consume Red Bull Energy Drink
Intervention Type
Other
Intervention Name(s)
Red Bull Energy drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
Time Frame
the 2 hours of driving following the intervention
Secondary Outcome Measure Information:
Title
Number of collisions
Time Frame
the 2 hours of driving following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joris Verster, PhD
Organizational Affiliation
Utrecht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utrecht University
City
Utrecht
ZIP/Postal Code
3508TB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21063868
Citation
Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull(R) Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-2078-2. Epub 2010 Nov 10.
Results Reference
result

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Energy Drinks & Driving Ability

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