Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
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.