Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000295842
Ethics application status
Approved
Date submitted
14/03/2012
Date registered
15/03/2012
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Alcohol and Energy Drink on Cognitive Performance and Mood
Scientific title
An investigation of Red Bull and Vodka on Mood and Cognition in a healthy cohort of men and women aged 18-50 years of age.
Secondary ID [1] 280124 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related cognitive impairment 286048 0
Energy drink cognitive improvement 286049 0
Interaction of stimulant and depressant 286050 0
Condition category
Condition code
Mental Health 286239 286239 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design of the current study is a randomised, double-blind, placebo-controlled and crossover trial administering 0.6g/kg alcohol (Absolut Vodka, 40% alcohol) and 250ml Energy Drink plus water to form 500 ml. Participants will be randomly allocated to an alcohol, Energy Drink, alcohol and Energy Drink combination, and placebo sequence with a washout period of seven days between each condition.

The alcohol treatment of 0.6g/kg was selected based on previous research to attain a BAC reading of 0.05 and the 250ml Red Bull was selected based on the 250 ml cans available for purchase and contains:

Energy 480 kj
Protein 0g
Fat total
-Saturated 0g
0g
Carbohydrates
-Sugars 27g
27g
Sodium 100mg
Taurine 1000mg
Caffeine 80mg
Glucuronolactone 60mg
Inositol 50mg
Niacinamide 20mg
Pantothenic Acid 5mg
Vitamin B6 5mg
Vitamin B12 5mcg

Participants will be randomly assigned to a treatment sequence and will consume one treatment on each of the four testing sessions. Treatment randomisation and mixing will be completed by a third party to ensure double blinding. Participants will be given 10 minutes to consume the drink.
Intervention code [1] 284458 0
Other interventions
Comparator / control treatment
The placebo treatment will be 250 ml energy drink minus the active ingredients (excluding glucose and sucrose). The placebo will be identical in appearance and as close as possible to identical in flavour and smell. In each alcohol free condition, alcohol will be wiped around the rim of the glass to ensure that participants remain blind to the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 286713 0
Four-Choice Reaction Time

A 2 x 2 stimulus array of circles corresponded to a response array of four squares. The circles will light up one at a time and the participant has to tap the corresponding square. The task will be scored for reaction time and number of errors.
Timepoint [1] 286713 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [1] 296514 0
Number Pairs

A series of five-digit arrays will be presented on the screen. For each array the participant is to decide whether the second and fourth digits are the same. Yes/No responses will be recorded and the task will be scored for reaction time and number of errors.
Timepoint [1] 296514 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [2] 296515 0
Serial Sevens

Participants will be presented with a three-digit number between 800 and 999 from which they will subtract seven, then subtract seven again and so on for the duration of two minutes. The number of responses and errors will be recorded. The task is a measure of concentration and working memory.
Timepoint [2] 296515 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [3] 296516 0
Visuospatial Working Memory

A series of two arrays of four pictures will be presented on the screen. Each array will be displayed for five seconds with a delay of two seconds between each array. Two of the four pictures in the first array will be the same. The second array will contain four pictures, two of which will be the same as the first and one will be in the same position while the second will be in a difference position. A third array will appear on the screen containing eight pictures and the direction "Tap on the picture that was shown in both displays IN DIFFERENT POSITIONS". The task will be scored for accuracy.
Timepoint [3] 296516 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [4] 296517 0
Memory Scanning (Sternberg, 1975)

Participants will be asked to remember a set of three, four and then five digits. After each set of digits, they will be presented with a series of digits one at a time and have to indicate whether or not each was in the original set. Reaction times and number of errors will be recorded.
Timepoint [4] 296517 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [5] 296518 0
Rectangular Maze

A light-coloured maze against a dark background will be presented on the screen. A stylus will be placed against a star in one corner and a ring will signal the participant to begin tracing around the maze to a target flag placed in the opposite corner to the star as quickly as possible while trying to remain within the boundaries of the maze. The task will be scored for completion time and errors.
Timepoint [5] 296518 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [6] 296519 0
Digit-Symbol Matching

A key will be presented on the screen displaying the digits one through to nine with a unique symbol below each. Below this will be a series of digit-symbol pairs appearing sequentially and the participant is to indicate whether it matches the key by selecting "yes" or "no". Fifty stimuli will be presented and reactions times and errors will be recorded.
Timepoint [6] 296519 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [7] 296520 0
Bond Lader VAS (Bond & Lader, 1974)

The scale comprises a total of 16 100-mm lines anchored at either end by antonyms. Participants mark their current subjective state between the antonyms on the line. Each line is scored as millimeters to the mark from the negative antonym. From the resultant scores, three measures derived by factor analysis can be isolated. These have been described by Bond and Lader as representing the following: "alertness", "calmness" and "contentedness". Scores for each factor represent the unweighted average number of millimeters (maximum 100 mm) from the negative antonym for the individual scales contributing to the factor. The antonyms drunk-sober will be added to the end of the scale.
Timepoint [7] 296520 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.
Secondary outcome [8] 296521 0
Profile of Mood States (McNair, Lorr & Droppleman, 1971)

Participants indicate on a 5-point scale from 0 (not at all) to 4 (extremely) the degree to which they have identified with each of 65 mood-related adjectives within the past week. Items are summed into six factors; Tension-Anxiety, Confusion-Bewilderment, Vigor-Activity, Anger-Hostility, Depression-Dejection and Fatigue-Inertia. A Total Mood Disturbance (TMD) score is computed as the sum of the first 5 factors minus Vigor-Activity. High scores indicate greater mood disturbance on all scales except Vigor-Activity.
Timepoint [8] 296521 0
Baseline, 45 minutes, 90 minutes and 180 minutes post administration.

Eligibility
Key inclusion criteria
-Males and females aged 18-50 years of age
-Currently a regular caffeine consumer
-Fluent in English
-Participant must have signed the consent form
-Willing and able to participate in all scheduled visits
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Smoker
-Diagnosis of any psychiatric disorder
-Diagnosis of any intellectual/mental impairment
-Current or past alcohol abuse
-Individuals with chronic health problems
-Pregnant or lactating
-Taking any prescription medication (other than the contraceptive pill)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertising and word of mouth. After successfully completing the phone screen and practice session, participants will be randomly allocated to a treatment schedule by a disinterested third person. This will be completed by a randomised computer number sequence generator. Randomization codes will be kept in a sealed opaque envelope in a secure safe and will only be opened in case of emergency.

Over the course of the investigation, participants will complete testing under each of the four conditions plus placebo with treatment order counterbalanced across participants. A disinterested third party will be responsible for the blinding procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation technique will be implemented by using a randomization table created by Microsoft excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2012
Actual
2/05/2012
Date of last participant enrolment
Anticipated
Actual
27/07/2012
Date of last data collection
Anticipated
Actual
24/08/2012
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284885 0
Commercial sector/Industry
Name [1] 284885 0
Red Bull GmBH
Country [1] 284885 0
Austria
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 283764 0
None
Name [1] 283764 0
Address [1] 283764 0
Country [1] 283764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286882 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 286882 0
Ethics committee country [1] 286882 0
Australia
Date submitted for ethics approval [1] 286882 0
Approval date [1] 286882 0
07/11/2011
Ethics approval number [1] 286882 0
SUHREC Project 2011/139

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33911 0
Prof Andrew Scholey
Address 33911 0
Centre for Human Psychopharmacology, Swinburne University of Technology, 427-451 Burwood Road, Hawthorn, VIC, 3122
Country 33911 0
Australia
Phone 33911 0
+61392148932
Fax 33911 0
Email 33911 0
[email protected]
Contact person for public queries
Name 17158 0
Sarah Benson
Address 17158 0
Centre for Human Psychopharmacology, Swinburne University of Technology, 427-451 Burwood Road, Hawthorn, VIC, 3122
Country 17158 0
Australia
Phone 17158 0
+61 3 9214 5212
Fax 17158 0
Email 17158 0
[email protected]
Contact person for scientific queries
Name 8086 0
Prof Andrew Scholey
Address 8086 0
Centre for Human Psychopharmacology, Swinburne University of Technology, 427-451 Burwood Road, Hawthorn, VIC, 3122
Country 8086 0
Australia
Phone 8086 0
+ 61 3 9214 8932
Fax 8086 0
Email 8086 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAttentional and working memory performance following alcohol and energy drink: A randomised, double-blind, placebo-controlled, factorial design laboratory study.2019https://dx.doi.org/10.1371/journal.pone.0209239
N.B. These documents automatically identified may not have been verified by the study sponsor.