Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000804280
Ethics application status
Not yet submitted
Date submitted
7/09/2009
Date registered
16/09/2009
Date last updated
16/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of N-acetylcysteine supplementation on cycling performance and adaptation to exercise in well-trained athletes
Scientific title
The effect of N-acetylcysteine on cycling performance and adaptation to exercise in well-trained athletes: a double blind randomised placebo controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise adaptation 243680 0
Condition category
Condition code
Other 239950 239950 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
This study has two 9-day intervention periods with a 3-week washout period between each intervention. The trial involves taking 1200 mg oral tablet of n-acetyl cysteine per day in addition to the participant's usual physical training.
Intervention code [1] 241227 0
Treatment: Other
Comparator / control treatment
placebo (lactose) - 1200 mg oral tablet
Control group
Placebo

Outcomes
Primary outcome [1] 240755 0
Cycle ergometer performance time trial.
Timepoint [1] 240755 0
pre (day 1) and post (day 9) of each experimental period
Primary outcome [2] 240756 0
Venous blood testing to determine changes total antioxidant status (TAS), glutathione/reduced glutathione ratio (GSSG:GSH), thiobarbituric acid-reactive substances (TBARS), interlukin-6 (IL-6), nuclear factor-kB and creatine kinase.
Timepoint [2] 240756 0
pre, immediately post, 2 h post and 24 h post each Cycle ergometer test
Secondary outcome [1] 257426 0
Training diaries and the Daily Analysis of Life Demands for Athletes
Timepoint [1] 257426 0
Completed on a daily basis during the experimental period

Eligibility
Key inclusion criteria
High level of physical fitness
Completed 10-15 h/wk physical training for at least 2 y in either cycling or triathlon
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular antioxidant supplementation for previous 4 wks
Illness or injury which may be exacerbated through participation in the study

Study design
Purpose of the study
Treatment
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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243608 0
Government body
Name [1] 243608 0
Australian Sports Commission
Country [1] 243608 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
Kuringai Campus
Eton Rd
Lindfield
NSW
2070
Country
Australia
Secondary sponsor category [1] 237057 0
Government body
Name [1] 237057 0
NSW Institute of Sport
Address [1] 237057 0
Sydney Markets
PO Box 476
NSW
2129
Country [1] 237057 0
Australia
Other collaborator category [1] 841 0
Individual
Name [1] 841 0
Katie Slattery
Address [1] 841 0
Kuringai Campus
Eton Rd
Lindfield
NSW
2070
Country [1] 841 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243734 0
University of Technology, Sydney, Human Research Ethics Committee
Ethics committee address [1] 243734 0
PO Box 123
Broadway NSW 2007
Ethics committee country [1] 243734 0
Australia
Date submitted for ethics approval [1] 243734 0
25/06/2009
Approval date [1] 243734 0
Ethics approval number [1] 243734 0

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

Contacts
Principal investigator
Name 30156 0
Address 30156 0
Country 30156 0
Phone 30156 0
Fax 30156 0
Email 30156 0
Contact person for public queries
Name 13403 0
Dr Aaron Coutts
Address 13403 0
University of Technology, Sydney
Kuringai Campus
Eton Rd,
Lindfield
NSW
2070
Country 13403 0
Australia
Phone 13403 0
+61 2 9514 5188
Fax 13403 0
+61 2 9514 5195
Email 13403 0
[email protected]
Contact person for scientific queries
Name 4331 0
Dr Aaron Coutts
Address 4331 0
University of Technology, Sydney
Kuringai Campus
Eton Rd,
Lindfield
NSW
2070
Country 4331 0
Australia
Phone 4331 0
+61 2 9514 5188
Fax 4331 0
+61 2 9514 5195
Email 4331 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.