Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000670673
Ethics application status
Approved
Date submitted
5/06/2014
Date registered
25/06/2014
Date last updated
3/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of beetroot juice and sodium bicarbonate supplementation on 4 km cycling time trial time to completion in well-trained male cyclists
Scientific title
Effect of beetroot juice and sodium bicarbonate supplementation on 4 km cycling time trial time to completion in well-trained male cyclists
Secondary ID [1] 284744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cycling performance in healthy trained athletes
 292110 0
Condition category
Condition code
Other 292442 292442 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 interventions for this research project that aims to examine the isolated and combined effects of the treatments:

Arm 1: Sodium bicarbonate + placebo beetroot juice. 0.3 g/kg body mass sodium bicarbonate consumed in capsule form orally with water, 80 g (20 g per day) of nitrate-free beetroot powder consumed orally with water for 4 days.

Arm 2: Placebo sodium bicarbonate + beetroot juice. 0.3 g/kg body mass maltodextrin consumed in capsule form orally with water, 80 g (20 g per day) of beetroot juice crystals consumed orally for 4 days with water.

Arm 3: Sodium bicarbonate + beetroot juice. 0.3 g/kg body mass sodium bicarbonate consumed in capsule form orally with water, 80 g (20 g per day) of beetroot juice crystals consumed orally for 4 days with water.

Sodium bicarbonate is administered 2.5 hours prior to the commencement of each 4 km time trial.

Beetroot juice crystals/placebo is administered once nightly in the 3 days prior to a 4 km trial and again 1 hour prior to the commencement of each 4 km time trial.

The wash-out period is 3 days between each arm of the study.
Intervention code [1] 289529 0
Other interventions
Comparator / control treatment
Placebo sodium bicarbonate + placebo beetroot juice. 0.3 g/kg body mass maltodextrin consumed in capsule form orally with water, 80 g (20 g per day) of nitrate-free beetroot powder consumed orally with water for 4 days.

Control group
Placebo

Outcomes
Primary outcome [1] 292302 0
Time to completion of each 4 km cycling time trial (performance)
Timepoint [1] 292302 0
Immediately upon completion
Secondary outcome [1] 308679 0
Plasma nitrate / nitrite concentrations
Timepoint [1] 308679 0
Baseline, 1 h, and immediately pre 4 km time trial

Immediately after and 75 min post 4 km time trial
Secondary outcome [2] 308680 0
Plasma bicarbonate concentrations
Timepoint [2] 308680 0
Baseline, 1 h, and immediately pre 4 km time trial

Immediately after and 75 min post 4 km time trial

Eligibility
Key inclusion criteria
VO2 max > 65 ml.kg.min, > 2 years competitive cycling experience
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
VO2 max < 65 ml.kg.min, any physical contraindications to high intensity exercise

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2014
Actual
19/06/2014
Date of last participant enrolment
Anticipated
15/08/2014
Actual
25/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289358 0
University
Name [1] 289358 0
Australian Catholic University
Country [1] 289358 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy, 3065, VIC
Country
Australia
Secondary sponsor category [1] 288043 0
None
Name [1] 288043 0
Address [1] 288043 0
Country [1] 288043 0
Other collaborator category [1] 277991 0
Government body
Name [1] 277991 0
Australian Institute of Sport
Address [1] 277991 0
Leverrier Street, Bruce, 2617, Australian Capital Territory
Country [1] 277991 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291126 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 291126 0
115 Victoria Parade, Melbourne, 3065, VIC
Ethics committee country [1] 291126 0
Australia
Date submitted for ethics approval [1] 291126 0
Approval date [1] 291126 0
23/05/2014
Ethics approval number [1] 291126 0
2014 50V

Summary
Brief summary
The primary purpose is to determine if there is an additive effect of beetroot juice and sodium bicarbonate on 4 km cycling time trial performance.

Sodium bicarbonate and beetroot juice act via different mechanisms once ingested and therefore we hypothesise that combined supplementation will improve 4 km time trial performance (time to completion) more than beetroot juice or sodium bicarbonate alone or placebo.
Trial website
Trial related presentations / publications
Presentation at Sports Dietitians Australia, Melbourne October 2015: Callahan, M.C., Parr, E.B., Burke, L.M., Hawley, J.A., (2015). Effect of beetroot juice and sodium bicarbonate supplementation on 4 km cycling time trial time to completion in well-trained male cyclists.
Public notes

Contacts
Principal investigator
Name 48994 0
Prof John Hawley
Address 48994 0
Australian Catholic University
The Daniel Mannix Building
Level 1
Office 1.32
115 Victoria Parade, Fitzroy, 3065, VIC
Country 48994 0
Australia
Phone 48994 0
+ 61 03 9953 3552
Fax 48994 0
Email 48994 0
[email protected]
Contact person for public queries
Name 48995 0
Prof John Hawley
Address 48995 0
Australian Catholic University
The Daniel Mannix Building
Level 1
Office 1.32
115 Victoria Parade, Fitzroy, 3065, VIC
Country 48995 0
Australia
Phone 48995 0
+ 61 03 9953 3552
Fax 48995 0
Email 48995 0
[email protected]
Contact person for scientific queries
Name 48996 0
Prof John Hawley
Address 48996 0
Australian Catholic University
The Daniel Mannix Building
Level 1
Office 1.32
115 Victoria Parade, Fitzroy, 3065, VIC
Country 48996 0
Australia
Phone 48996 0
+ 61 03 9953 3552
Fax 48996 0
Email 48996 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.