Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001332516p
Ethics application status
Submitted, not yet approved
Date submitted
30/11/2015
Date registered
4/12/2015
Date last updated
4/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of sodium bicarbonate and sodium phosphate supplementation on cycling performance
Scientific title
Sodium bicarbonate and sodium phosphate supplementation: effect on blood buffering capacity, 2, 3-diphosphoglycerate and cycling power output, in well-trained cyclists.
Secondary ID [1] 288026 0
None known
Universal Trial Number (UTN)
U1111-1177-0531
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cycling performance 296893 0
Condition category
Condition code
Diet and Nutrition 297123 297123 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two safe and legal supplements (sodium phosphate and sodium bicarbonate) will be administered to well-trained cyclists, prior to performing a cycling-based performance test in the laboratory.

Participants' performance will be compared to their own baseline performance, and also to the placebo condition. There will be four treatment groups:
1) Sodium phosphate supplementation - requiring participants to ingest sodium phosphate for the six days prior to the second cycling performance test, and a placebo on the day of the second performance test.
2) Sodium phosphate and sodium bicarbonate supplementation - requiring participants to ingest sodium phosphate for the six days prior to the second performance test, and sodium bicarbonate on the day of the second performance test.
3) Sodium bicarbonate supplementation - requiring participants to ingest a placebo for the six days prior to the second performance test, and sodium bicarbonate on the day of the second performance test.
4) Placebo - requiring participants to ingest a placebo for the six days prior to the second performance test, and also ingest a placebo on the day of the second performance test.

The sodium bicarbonate will be administered at a dose of 300 mg per kg of the participants' body mass, and will be ingested in capsule form, 90 min prior to the start of the second cycling performance test. The sodium bicarbonate will be ingested in the laboratory, on the day of the second cycling performance test, under the supervision of staff.

The sodium phosphate will be administered at a dose of 50 mg per kg of participants' fat free mass (as determined by a DEXA scan), and will be ingested as a solution (sodium phosphate powder mixed with sports drink powder, and then dissolved in water). The sodium phosphate dosage will be provided to participants after they perform their baseline test, and they will be instructed to ingest the sodium phosphate daily for the six days prior to the second cycling performance test. Participants will be asked to verbally confirm that they have ingested the sodium phosphate as instructed.

There will be one week between the baseline and post-intervention cycling tests. The cycling test comprises six sets of repeated sprints and time trials, and is 43 min in total duration. The performance test has previously been used in a previous study (Brewer et al., 2015). This reference has now been attached to the application. To summarise the performance test, the first set comprises 6 x 15 second sprints, with 45 seconds active recovery between each sprint. The second set comprises 6 x 15 second sprints, with 15 seconds of active recovery between each sprint. The third set comprises a continuous, 5 min time trial. The fourth set again comprises 6 x 15 second sprints with 45 seconds active recovery, the fifth set is 6 x 15 second sprints with 15 seconds active recovery, and the sixth set is a continuous, 5 min time trial. A 3 minute active recovery at a minimum power output of 100 watts is performed after the first 5 sets, and the test concludes at the end of the sixth set.

Performance will be measured in comparison to baseline performance on the same cycling performance test.
Intervention code [1] 293351 0
Treatment: Other
Comparator / control treatment
The placebo used for the sodium bicarbonate supplement comprises gluten free cornflour encased in opaque gelatine capsules, while the placebo used for the sodium phosphate supplement will be a mixture of glucose and salt, to be dissolved in water.
Control group
Placebo

Outcomes
Primary outcome [1] 296742 0
Cycling performance, measured in power.
Timepoint [1] 296742 0
Throughout the cycling performance test, peak power, mean power and total work will be measured. Specifically, these measures will be recorded throughout each of the six sets in the performance test.
Secondary outcome [1] 319234 0
Blood buffering capacity will be measured, via the analysis of capillary blood samples to determine blood pH and blood bicarbonate concentration.
Timepoint [1] 319234 0
Blood buffering capacity will be determined via the change between baseline and experimental trials.

Capillary blood samples will be taken during participants' second and third visits to the laboratory (baseline and experimental testing sessions). A capillary blood sample will be taken upon participants' arrival at the laboratory, as well as approximately 1 minute prior to the start of the performance test. Further capillary blood samples will also be taken immediately after completion of the six sets included in the cycling performance test.
Secondary outcome [2] 319293 0
Blood 2,3-diphosphoglycerate and phosphate content will be determined via the analysis of venous blood samples.
Timepoint [2] 319293 0
Venous blood samples will be taken upon participants' arrival in the laboratory (for their second and third laboratory visits), and 1 minute after the completion of the cycling performance test.

Eligibility
Key inclusion criteria
Male and female, well trained cyclists. Cyclists will need to demonstrate evidence of participation in a recent Criterium (short road race).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children under 18 years of age, as well as pregnant women.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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)
For this trial, each participant will complete two cycling performance tests. The first test for each participant will be their baseline trial, and the second test for each participant will be their experimental trial.

The allocation of participants to one of the four experimental groups will not be randomised; rather four equal groups will be selected by the researchers, on the basis of participants’ gender, age, current training and competition status (as reported in the questionnaire answered by participants), and VO2max (measured in participants' first visit to the laboratory).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A one-way ANOVA will be used to assess the differences between the four protocols, for the key variables.

The total number of participants to be recruited will be 120.

A sample size estimate was performed, based on the results of a similar, previous study (Brewer et al., 2015), where the standard deviation for total work (for cycling performance, in the experimental trial - placebo condition) was 78kJ, and the smallest worthwhile change was deemed to be 17kJ. The smallest worthwhile change was calculated as 0.2 of the between-subject standard deviation at baseline, in the placebo condition (0.2 x 75kJ).

The calculation indicated that a sample size of 81 participants would be required (approximately 2o participants in each of the four groups). In the present study, 30 participants will be recruited for each group, to allow adequate statistical power in the even of participant drop out throughout the course of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12295 0
3125 - Burwood
Recruitment postcode(s) [2] 12296 0
3207 - Port Melbourne
Recruitment postcode(s) [3] 12297 0
3182 - St Kilda
Recruitment postcode(s) [4] 12298 0
3206 - Albert Park
Recruitment postcode(s) [5] 12300 0
3187 - Brighton East
Recruitment postcode(s) [6] 12301 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 292477 0
University
Name [1] 292477 0
School of Exercise and Nutrition Sciences, Deakin University
Country [1] 292477 0
Australia
Primary sponsor type
Individual
Name
Dr Amelia Carr
Address
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood Vic 3025
Country
Australia
Secondary sponsor category [1] 291175 0
Other
Name [1] 291175 0
Australian Institute of Sport
Address [1] 291175 0
Leverrier St
Bruce ACT
2617
Country [1] 291175 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293941 0
Deakin Unviersity Human Reseach Ethics Committee
Ethics committee address [1] 293941 0
Ethics committee country [1] 293941 0
Australia
Date submitted for ethics approval [1] 293941 0
09/09/2015
Approval date [1] 293941 0
Ethics approval number [1] 293941 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 655 655 0 0
/AnzctrAttachments/369701-Brewer et al., 2015.pdf

Contacts
Principal investigator
Name 61862 0
Dr Amelia Carr
Address 61862 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood Vic 3025
Country 61862 0
Australia
Phone 61862 0
+61 3 9251 7309
Fax 61862 0
Email 61862 0
[email protected]
Contact person for public queries
Name 61863 0
Amelia Carr
Address 61863 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood Vic 3025
Country 61863 0
Australia
Phone 61863 0
+61 3 9251 7309
Fax 61863 0
Email 61863 0
[email protected]
Contact person for scientific queries
Name 61864 0
Amelia Carr
Address 61864 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood Vic 3125
Country 61864 0
Australia
Phone 61864 0
+61 3 9251 7309
Fax 61864 0
Email 61864 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
No additional documents have been identified.