Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
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
Trial website
Trial related presentations / publications
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
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
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.