Trial Review

Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Tuesday 19th August for website maintenance.
Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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
ACTRN12614000136606
Ethics application status
Approved
Date submitted
28/01/2014
Date registered
5/02/2014
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of branched-chain amino acid (BCAA) supplementation in delaying fatigue during prolonged exercise.
Scientific title
In healthy males, does branched-chain amino acid (BCAA) supplementation delay fatigue during prolonged exercise?
Secondary ID [1] 283901 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue during prolonged exercise 290897 0
Condition category
Condition code
Diet and Nutrition 291249 291249 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 291250 291250 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BCAA supplements will be a mix of 7g of BCAA powder and non sugar cordial in 1 liter of water. The amount consumed will be 2ml/kg of body weight for every 15 minutes during prolonged cycling exercise. Participants will have to cycle twice with at least 3 days gap as wash out period and during each session participants will have to cycle as quick as possible to reach pre-determined total energy expenditure which will endure for about 60 - 90 minutes
Intervention code [1] 288583 0
Treatment: Other
Comparator / control treatment
non-sugar cordial mixed with water will be used as placebo
Control group
Placebo

Outcomes
Primary outcome [1] 291248 0
Metabolites associated with serotonin metabolism in blood sample.
Timepoint [1] 291248 0
Before, during, immediately after cycling and post-exercise.
Secondary outcome [1] 306342 0
Cycling performance (i.e. time trial to complete the given task)
Timepoint [1] 306342 0
The duration required to complete the amount of work.

Eligibility
Key inclusion criteria
Healthy males
sedentary to recreationally active
Minimum age
18 Years
Maximum age
44 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with hypertension, asthma, diabetes, bronchitis, anaemia, any injury, heart problems, kidney or liver diseases and or any other major diseases will be excluded.

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)
Allocation will be concealed by using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Eighteen healthy men between the ages of 18 – 44 years old will be recruited for this study from the community by the local advertisement. The minimum sample size for this study was calculated based on power analysis (a = 0.05, power = 0.80, calculated sample size = 6) using differences in (plasma concentrations of free tryptophan), pre and post of a 60 min bout of steady-paced treadmill running (75% VO2max) in subjects who were fed with combined carbohydrate, protein & fat meal 3 hours before running (Zanker et al., 1997).

A mixed model analysis will be used to examine the effects of BCAA supplementation across time and the interaction between the two. LSD will be used as Confidence Interval Adjustment. Significance level is set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
1/07/2014
Date of last participant enrolment
Anticipated
8/08/2014
Actual
31/12/2014
Date of last data collection
Anticipated
31/12/2014
Actual
11/01/2015
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288547 0
Charities/Societies/Foundations
Name [1] 288547 0
McCusker Grant
Country [1] 288547 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch 6150, Western Australia
Country
Australia
Secondary sponsor category [1] 287259 0
None
Name [1] 287259 0
Address [1] 287259 0
Country [1] 287259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290411 0
Murdoch University Ethics Committee
Ethics committee address [1] 290411 0
Ethics committee country [1] 290411 0
Australia
Date submitted for ethics approval [1] 290411 0
17/01/2014
Approval date [1] 290411 0
12/12/2013
Ethics approval number [1] 290411 0

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

Contacts
Principal investigator
Name 45530 0
Mr FAIZAL ABDUL MANAF
Address 45530 0
REF 3.001, Social Science Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 45530 0
Australia
Phone 45530 0
+61 415846644
Fax 45530 0
Email 45530 0
[email protected]
Contact person for public queries
Name 45531 0
FAIZAL ABDUL MANAF
Address 45531 0
REF 3.001, Social Science Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 45531 0
Australia
Phone 45531 0
+61 415846644
Fax 45531 0
Email 45531 0
[email protected]
Contact person for scientific queries
Name 45532 0
FAIZAL ABDUL MANAF
Address 45532 0
REF 3.001, Social Science Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 45532 0
Australia
Phone 45532 0
+61 415846644
Fax 45532 0
Email 45532 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.