Trial Review

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
ACTRN12608000485336
Ethics application status
Approved
Date submitted
20/08/2008
Date registered
30/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of moderate exercise on breath levels of pentane
Scientific title
In healthy participants, can moderate exercise reliably increase breath pentane levels compared with other markers of oxidative stress?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress responses to moderate exercise 3586 0
Condition category
Condition code
Metabolic and Endocrine 3746 3746 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will perform four sessions of moderate exercise on a rowing ergometer, with one week between each session. In the first session, blood will be sampled from the earlobe during exercise to determine the exercise intensity corresponding to the lactate threshold. This session will last long enough to determine the lactate threshold, no longer than 30 minutes in total.
In sessions two through four, participants will exercise for 30 minutes, with breath and blood samples collected pre-exercise, immediately post-exercise, and at 0.5, 1, 2, and 6 hours post-exercise.
Intervention code [1] 3302 0
Not applicable
Comparator / control treatment
Each participant's breath and blood samples will be compared between their pre-exercise and post-exercise time points.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4645 0
Changes in breath levels of pentane in response to exercise as measured by gas chromatography-mass spectrometry (GC-MS)
Timepoint [1] 4645 0
Immediately before and after exercise, and 0.5, 1, 2, and 6 hours later
Secondary outcome [1] 7854 0
Changes in blood levels of malondialdehyde and protein carbonyls (markers of oxidative stress) in response to exercise
Timepoint [1] 7854 0
Immediately before and after exercise, and 0.5, 1, 2, and 6 hours later

Eligibility
Key inclusion criteria
Healthy participants who do not perform regular aerobic exercise
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any conditions likely to affect the participant's ability to perform moderate exercise

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2008
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] 1171 0
New Zealand
State/province [1] 1171 0
Hamilton

Funding & Sponsors
Funding source category [1] 3762 0
Government body
Name [1] 3762 0
Foundation for Research, Science and Technology (FRST)
Country [1] 3762 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Horticulture and Food Research Institute of New Zealand Ltd. (HortResearch)
Address
Private Bag 92169
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3375 0
None
Name [1] 3375 0
Address [1] 3375 0
Country [1] 3375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5822 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5822 0
Ministry of Health
PO Box 1031
Hamilton
Ethics committee country [1] 5822 0
New Zealand
Date submitted for ethics approval [1] 5822 0
Approval date [1] 5822 0
06/08/2008
Ethics approval number [1] 5822 0
NTY/08/04/028

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

Contacts
Principal investigator
Name 28865 0
Address 28865 0
Country 28865 0
Phone 28865 0
Fax 28865 0
Email 28865 0
Contact person for public queries
Name 12022 0
Dr Peter Schaare
Address 12022 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 3123
Hamilton 3240
Country 12022 0
New Zealand
Phone 12022 0
+64 7 959 4493
Fax 12022 0
+64 7 9594431
Email 12022 0
[email protected]
Contact person for scientific queries
Name 2950 0
Dr Peter Schaare
Address 2950 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 3123
Hamilton 3240
Country 2950 0
New Zealand
Phone 2950 0
+64 7 959 4493
Fax 2950 0
+64 7 9594431
Email 2950 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.