Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000520437
Ethics application status
Approved
Date submitted
6/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Taurine Supplementation on 20-km Self-Paced Cycling Performance in the Heat
Scientific title
Effect of Taurine Supplementation on 20-km Self-Paced Cycling Performance of Trained Cyclists in the Heat
Secondary ID [1] 314377 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thermoregulation 337377 0
Condition category
Condition code
Metabolic and Endocrine 333756 333756 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will complete by 14 trained male and female cyclists, age between 18-55 who are not currently accustomed to hot environments. Participants will complete three visits, including VO2max and familiarization, and two experimental trials. Experimental trials will be conducted in a double-blind, randomized, placebo-controlled, crossover fashion and involved 4-days of oral supplementation of either 50 mg per Kg of body weight (mg/kg/bw) of taurine or a placebo (50 mg/kg/bm of maltodextrin) prior to the performance trial. Supplementation will occur each day over the 4-days. Participants will consume the taurine and placebo in powder form (mixed with water, juice or other drink). The supplement will be consumed at home by the participants. Participants will be asked to return unused supplement which will be weighed to assess compliance. To prevent carry-over effects between the two supplementation conditions, a 7 -day washout period will be implemented. The performance trial will involve a self-paced 20km time trial in heat (36°C with 40% relative humidity). Core body temperature, sweat rate, heart rate and perceptual responses will be assessed prior to and during the experimental trials.
Intervention code [1] 330990 0
Treatment: Other
Comparator / control treatment
Experimental trials will be conducted in a double-blind, randomized, placebo-controlled, crossover fashion. Participants will act as their own control. During the placebo condition, participants will consume 50 mg/kg/bm of maltodextrin each day of the 4-days prior to the performance trial.
Control group
Placebo

Outcomes
Primary outcome [1] 341340 0
Self-paced exercise performance during a 20km cycling time trial
Timepoint [1] 341340 0
Immediately following 4 days of supplementation with Taurine and immediately following four days of placebo supplementation. At least a 7-day washout will occur between conditions.
Secondary outcome [1] 447171 0
Skin body temperature during a self-paced 20km time trial
Timepoint [1] 447171 0
Skin body temperature will be assessed during a simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least a 7-day washout will occur between conditions.
Secondary outcome [2] 447172 0
Heart rate
Timepoint [2] 447172 0
Heart rate will be assessed during a simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least a 7-day washout will occur between conditions.
Secondary outcome [3] 447173 0
Sweat rate
Timepoint [3] 447173 0
Sweat rate will be assessed during the simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least 7-days washout will occur between conditions.
Secondary outcome [4] 447698 0
Core body temperature during a self-paced 20km time trialSkin body temperature during a self-paced 20km time trial
Timepoint [4] 447698 0
Core body temperature will be assessed during a simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least a 7-day washout will occur between conditions.
Secondary outcome [5] 447699 0
Rating of Perceived Exertion
Timepoint [5] 447699 0
Rating of perceived exertion will be assessed during a simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least a 7-day washout will occur between conditions.
Secondary outcome [6] 447700 0
Thermal Sensation
Timepoint [6] 447700 0
Thermal sensation will be assessed during a simulated 20km time trial performed following 4 days of supplementation with Taurine and following 4 days of placebo supplementation. At least a 7-day washout will occur between conditions.

Eligibility
Key inclusion criteria
Fourteen trained cyclists aged 18 to 55 years, who have not been accustomed to heat exposure in the past 14 days will be recruited for this study. These individuals will be physically active, indicated by a maximal oxygen uptake of at least 50 mL /kg/min for men and 40 mL/kg/min for women. Participants will complete an adult pre-exercise screening questionnaire prior to the study. Individuals with contraindications to exercise (as per the screening tool and guide) will be asked to seek medical approval from a health professional prior to their participation. Participants will also provide details on their physical activity levels, and lack of significant recent heat exposure. Those with significant recent exposure to heat will be excluded.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with recent structured heat acclimatisation will be excluded
.
Individuals that do not meet the fitness criteria as per the inclusion criteria will be excluded.

Individuals with contraindications to exercise (as per the screening tool and guide) will be asked to seek medical approval from a health professional prior to their participation.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created in excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
27/10/2025
Actual
Date of last data collection
Anticipated
10/11/2025
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318896 0
University
Name [1] 318896 0
Edith Cowan University
Country [1] 318896 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 321359 0
None
Name [1] 321359 0
Address [1] 321359 0
Country [1] 321359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317511 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317511 0
Ethics committee country [1] 317511 0
Australia
Date submitted for ethics approval [1] 317511 0
17/12/2024
Approval date [1] 317511 0
02/05/2025
Ethics approval number [1] 317511 0

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

Contacts
Principal investigator
Name 141278 0
Prof Chris Abbiss
Address 141278 0
Edith Cowan University, 260 Joondalup Drive, Joondalup, 6016, Western Australia
Country 141278 0
Australia
Phone 141278 0
+61 8 63045740
Fax 141278 0
Email 141278 0
[email protected]
Contact person for public queries
Name 141279 0
Chris Abbiss
Address 141279 0
Edith Cowan University, 260 Joondalup Drive, Joondalup, 6016, Western Australia
Country 141279 0
Australia
Phone 141279 0
+61 8 63045740
Fax 141279 0
Email 141279 0
[email protected]
Contact person for scientific queries
Name 141280 0
Chris Abbiss
Address 141280 0
Edith Cowan University, 260 Joondalup Drive, Joondalup, 6016, Western Australia
Country 141280 0
Australia
Phone 141280 0
+61 8 63045740
Fax 141280 0
Email 141280 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.