Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000157370
Ethics application status
Approved
Date submitted
31/03/2008
Date registered
2/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of carbohydrates on the exercise-induced responses of stress hormones
Scientific title
A crossover study of the effect of carbohydrate supplementation on the exercise-induced rise in stress hormone concentrations in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone responses to resistance exercise 2979 0
Condition category
Condition code
Metabolic and Endocrine 3125 3125 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume a liquid carbohydrate drink (40 grams in 600 milliliters) or liquid placebo immediately before and during completion of a one hour session of resistance exercise. Salivary hormones and plasma markers will be monitored at several time points including before and after exercise, later the same day, and for the two following days. A washout period of seven days will be used between treatments.
Intervention code [1] 2718 0
Other interventions
Comparator / control treatment
A carbohydrate-free liquid drink
Control group
Placebo

Outcomes
Primary outcome [1] 4011 0
Salivary cortisol responses to exercise following beverage consumption
Timepoint [1] 4011 0
Every 15 minutes before, during, and after exercise for 4 1/2 hours
Secondary outcome [1] 6749 0
Plasma cytokine and protein responses to exercise following beverage consumption
Timepoint [1] 6749 0
Immediately before and after exercise, 90 minutes after exercise completion, and 24 and 48 hours later

Eligibility
Key inclusion criteria
Healthy males with at least one year of resistance exercise training experience
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker, unable to exercise, history of anabolic steroid use, currently taking any supplements

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 by using a software-generated randomisation table
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
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 852 0
New Zealand
State/province [1] 852 0

Funding & Sponsors
Funding source category [1] 3243 0
Commercial sector/Industry
Name [1] 3243 0
Nestec Ltd.
Country [1] 3243 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Address
Private Bag 92169
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 2899 0
None
Name [1] 2899 0
Address [1] 2899 0
Country [1] 2899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5225 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5225 0
Ministry of Health
Private Bag 92522
Auckland 1141
Ethics committee country [1] 5225 0
New Zealand
Date submitted for ethics approval [1] 5225 0
25/02/2008
Approval date [1] 5225 0
20/03/2008
Ethics approval number [1] 5225 0
NTX/08/02/009

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

Contacts
Principal investigator
Name 28479 0
Address 28479 0
Country 28479 0
Phone 28479 0
Fax 28479 0
Email 28479 0
Contact person for public queries
Name 11636 0
Dr John Ingram
Address 11636 0
Plant & Food Research
Private Bag 92169
Auckland 1142
Country 11636 0
New Zealand
Phone 11636 0
+64 9 9257119
Fax 11636 0
+64 9 9257001
Email 11636 0
john.ingram@plantandfood.co.nz
Contact person for scientific queries
Name 2564 0
Dr John Ingram
Address 2564 0
Plant & Food Research
Private Bag 92169
Auckland 1142
Country 2564 0
New Zealand
Phone 2564 0
+64 9 9257119
Fax 2564 0
+64 9 9257001
Email 2564 0
john.ingram@plantandfood.co.nz

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.