Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000960954
Ethics application status
Approved
Date submitted
22/08/2011
Date registered
7/09/2011
Date last updated
25/08/2024
Date data sharing statement initially provided
25/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Sports Drink Taste Have Any Impact on Performance?
Scientific title
Does a pleasant taste drink enhance high - intensity exercise performance of trained cyclists compared to an unpleasant tasting sport drink?
Secondary ID [1] 262895 0
Nil
Universal Trial Number (UTN)
U1111-1123-9041
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Does a non palatable drink can alter performance? 270625 0
Condition category
Condition code
Other 270792 270792 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre Test = The participants are given Denatonium Benzoate doses of 4.28 microg , 8.55 microg, 12.84 microg, 17.12 microg, 21.4 microg twice (in 133mL sports drink samples). On the same session, the drinks are given for the first time at rest (3' between each samples), later on (after a VO2 max test) the drinks are given a second time while cycling (4' between each), all the drinks are totally swallowed. The pre test takes place at least one week prior to the first performance test.
The drink with the higher ratings regarding bitterness and the lower regarding pleasantness will be used later on as followed. The participant will test 4 drinks during the study in itself : one without any DB (control), one with the dose previously selected from the pretest, one at 2/3 of it and another one at 1/3 of it. During the test session, only one drink is given 9 times (0 minute, 9 minute, 21',33',45',53',65',77',89'), each time the volume is 133mL.
The lab test ride is made of : 5 minutes at 40% of Peak Power, 5 minutes at 50%, nine 2 minutes intervalls at 90% with 2 minutes at 50% between each, 10 minutes at 50% after the ninth, then nine 2 minutes intervalls at 80% with once again 2 minutes at 50% between each. After 90 minutes, the performance test starts : the power increases by 1 Watt every 3 seconds. The rider does not know how long he has been riding for during the performance test. He is just warned when his cadence goes below 70 RPM, after the third warning, the test ends.
Each drink is tested during a specific session, each session is spaced from the next by one week.
Intervention code [1] 269247 0
Treatment: Drugs
Intervention code [2] 269343 0
Behaviour
Comparator / control treatment
The same sport drink without Denatonium Benzoate.
Control group
Active

Outcomes
Primary outcome [1] 279486 0
Cycling performance by an incremental ramp test.
Timepoint [1] 279486 0
once a week, for 4 weeks after a 90 minutes lab test ride.
Secondary outcome [1] 287728 0
Exertion perceived by the Borg's Rating of Perceived Exertion.
Timepoint [1] 287728 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. Prior to each drink sample.
Secondary outcome [2] 287729 0
Leg fatigue with CR10 scale.
Timepoint [2] 287729 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. Prior to each drink sample.
Secondary outcome [3] 287730 0
Nausea with CR 10 scale
Timepoint [3] 287730 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. Prior to each drink sample.
Secondary outcome [4] 287731 0
Gut comfort with CR10 Scale
Timepoint [4] 287731 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. Prior to each drink sample.
Secondary outcome [5] 287732 0
Drink pleasantness with CR10 Scale
Timepoint [5] 287732 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. After each drink sample
Secondary outcome [6] 287733 0
sweetness thanks to Labelled Magnitude Scale.
Timepoint [6] 287733 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. After each drink sample
Secondary outcome [7] 287734 0
Bitterness thanks to Labelled Magnitude Scale
Timepoint [7] 287734 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. After each drink sample
Secondary outcome [8] 287936 0
Sourness thanks to Labelled Magnitude Scale
Timepoint [8] 287936 0
9 times during the 90 min lab ride (0 minute, 9', 21', 33', 45', 53', 65', 77', 89'), once a week for 4 weeks. After each drink sample

Eligibility
Key inclusion criteria
Cyclists in regular training (8 hours or more of endurance training a week) for the last 12 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No food allergies, No heart disease, No blood borne disease, No medical counter advice.

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
22/08/2011
Actual
22/08/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 3803 0
New Zealand
State/province [1] 3803 0
Wellington

Funding & Sponsors
Funding source category [1] 269719 0
University
Name [1] 269719 0
Massey University
Country [1] 269719 0
New Zealand
Primary sponsor type
University
Name
Institute of Food Nutrition and Human Health, Massey University
Address
63 Wallace Street
Block 3
mount Cook
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 268759 0
University
Name [1] 268759 0
School of Sport Science, Massey University
Address [1] 268759 0
63 Wallace Street
Block 3
mount Cook
Wellington 6140
New Zealand
Country [1] 268759 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271682 0
Massey university Human Ethics Committee
Ethics committee address [1] 271682 0
Ethics committee country [1] 271682 0
New Zealand
Date submitted for ethics approval [1] 271682 0
Approval date [1] 271682 0
04/08/2011
Ethics approval number [1] 271682 0

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

Contacts
Principal investigator
Name 33060 0
David Rowlands
Address 33060 0
Massey University Auckland
Country 33060 0
New Zealand
Phone 33060 0
+64 272099383
Fax 33060 0
Email 33060 0
[email protected]
Contact person for public queries
Name 16307 0
Theophile RACINE
Address 16307 0
School of Sport Science
Massey University
PO Box 756
Wellington 6140
New Zealand
Country 16307 0
New Zealand
Phone 16307 0
+64, 22 127 6352
Fax 16307 0
Email 16307 0
[email protected]
Contact person for scientific queries
Name 7235 0
David Rowlands
Address 7235 0
Institute of Food Nutrition and Human Health
Massey University
Pvt Box 756
Wellington 6140
New Zealand
Country 7235 0
New Zealand
Phone 7235 0
64 4 801 5799 ext 6940
Fax 7235 0
Email 7235 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.