Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000326392
Ethics application status
Approved
Date submitted
4/07/2008
Date registered
14/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of salivary cortisol phase on the stress hormone response to an acute anaerobic exercise challenge
Scientific title
A crossover study of the effect of rising or falling salivary cortisol levels on the response of stress hormones to an acute anaerobic exercise challenge in healthy participants
Secondary ID [1] 619 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone responses to anaerobic exercise 3368 0
Condition category
Condition code
Metabolic and Endocrine 3520 3520 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will provide saliva samples every 15 minutes from awakening for approximately 8 hours. Endogenous cortisol levels will begin to be measured in the samples in real-time using a biosensor beginning approximately 4 hours after awakening. The salivary cortisol phase (successively rising or falling concentrations of cortisol) will be identified. Participants will be randomised into groups where either a rising or a falling cortisol phase is sought, and the alternate phase will be sought from the same subject on a second crossover study day as described below.

During the identified cortisol phase, the subject will complete two back-to-back 30 second Wingate anaerobic exercise challenges on a braked cycle ergometer using a brake weight of 10% of the subject's body weight. Saliva sampling will continue for the remaining 4 hours. Plasma samples will be collected via lancet immediately before, immediately after, 30 minutes after, and 60 minutes after the Wingate challenge.

A washout period of at least seven days will be used before repetition of the study protocol using the alternate salivary cortisol phase. Including this washout period, the total study time is approximately eight days.
Intervention code [1] 3098 0
Other interventions
Comparator / control treatment
Subjects act as their own controls. One study day will examine rising levels of salivary cortisol, and the other will examine falling levels of salivary cortisol.
Control group
Active

Outcomes
Primary outcome [1] 4420 0
salivary cortisol responses to a Wingate anaerobic exercise challenge
Timepoint [1] 4420 0
every 15 minutes from awakening for approximately 8 hours
Secondary outcome [1] 7459 0
plasma hormone responses to a Wingate anaerobic exercise challenge
Timepoint [1] 7459 0
immediately before, immediately after, 30 minutes after, and 60 minutes after the Wingate anaerobic exercise challenge

Eligibility
Key inclusion criteria
Healthy individuals
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any health conditions likely to affect their ability to perform intense exercise, including hypertension, heart and/or breathing problems, hernia, or other injuries, as well as sleep disorders which may affect endogenous stress hormone levels.

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 determined by staff who are not involved in any other aspects of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin tosses
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
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1015 0
New Zealand
State/province [1] 1015 0
Auckland

Funding & Sponsors
Funding source category [1] 3553 0
Commercial sector/Industry
Name [1] 3553 0
The New Zealand Institute of Plant and Food Research Ltd. (Plant & Food Research)
Country [1] 3553 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute of Plant and Food Research Ltd. (Plant & Food Research)
Address
Private Bag 92169
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3192 0
None
Name [1] 3192 0
Address [1] 3192 0
Country [1] 3192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5595 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5595 0
Ethics committee country [1] 5595 0
New Zealand
Date submitted for ethics approval [1] 5595 0
Approval date [1] 5595 0
28/03/2007
Ethics approval number [1] 5595 0
NTY/07/02/017

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

Contacts
Principal investigator
Name 28727 0
Address 28727 0
Country 28727 0
Phone 28727 0
Fax 28727 0
Email 28727 0
Contact person for public queries
Name 11884 0
Dr John Ingram
Address 11884 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 92169
Auckland 1142
Country 11884 0
New Zealand
Phone 11884 0
+64 9 9257119
Fax 11884 0
+64 9 9257001
Email 11884 0
[email protected]
Contact person for scientific queries
Name 2812 0
Dr John Ingram
Address 2812 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 92169
Auckland 1142
Country 2812 0
New Zealand
Phone 2812 0
+64 9 9257119
Fax 2812 0
+64 9 9257001
Email 2812 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.