Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000629639
Ethics application status
Approved
Date submitted
5/06/2014
Date registered
13/06/2014
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carbohydrate dependence during endurance exercise (The effect of Nicotinic acid on endurance performance in trained cyclists)
Scientific title
The effect of Nicotinic acid on endurance performance in trained cyclists
Secondary ID [1] 284746 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endurance exercise performance in healthy trained athletes 292112 0
Condition category
Condition code
Metabolic and Endocrine 292445 292445 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a repeated measures design, we will test our hypothesis in 10 well-trained cyclists who will each perform six maximal, all-out cycling time-trials (over 60, 90 and 120 min duration), three under conditions where lipolysis and fat oxidation are ‘blocked’ and three under normal conditions (control). Lipolysis will be blocked via orally administered nicotinic acid.

1a) The dose administered for the the 60 min trial will be 20 mg/kg BM
The dose administered for the 90 min trial will be 25 mg/kg BM
The dose for the 120 min trial will be 30 mg/kg BM
b)Doses 1x10 mg/kg BM dose 30 mins before trial, 1x5 mg/kg dose 15 min before trial, and 5 mg/kg BM after completion of every 30 min of trial.
2)TT's will be conducted on a stationary bike.
3) wash out period will be at least 72 hr between trials
Intervention code [1] 289531 0
Other interventions
Comparator / control treatment
Control conditions will be the same conditions as the experimental group but instead of taking the nicotinic acid participants will be orally administered small doses of glucose powder (placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 292304 0
Time to complete time trial
Timepoint [1] 292304 0
compare time trial times under nicotinic acid conditions to control/placebo conditions
Secondary outcome [1] 308682 0
Respiratory Exchange Ratio values. assessed using a Parvomedics metabolic cart.
Timepoint [1] 308682 0
compare values attained during nicotinic acid conditions with values attained during control/placebo conditions. These outcome will be assessed at the completion of all trials from all subjects

Eligibility
Key inclusion criteria
Inclusion criteria:
Aged 18-35 years
Participants must be engaged in cycling training > 200km/week.
Participants must have at least 2 years of competitive cycling experience.
VO2max of greater than 60 mL/ (kg BM/min).
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Current or prior use of anabolic steroids or other prohibited substances.
Contraindications to strenuous physical activity as indicated by cardiovascular risk factor questionnaire.

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)
Initially telephone interviews, e-mail or a face to face meeting will assess suitability and if subjects comply with inclusion/exclusion criteria. Subsequently, participants will attend a physiological testing session to assess suitability for the study. The selected participants will then be informed about all the details of the study and the risks and benefits involved. A signed Informed consent document approved by the Human Ethics Committee at the Australian Catholic University will be obtained prior to any experimental trials.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
trial conditions will assigned a number (1, 2, 3, 4, 5 or 6) with each number only being used once. These 6 numbers will then be entered into a random code generator of which 10 combinations will be selected for the 10 participants. each participant will then be allocated a code and that is the order that they will complete the trials.

the method of allocation concealment we will use is numbered containers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
Actual
4/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289360 0
Government body
Name [1] 289360 0
Australian Institute of Sport
Country [1] 289360 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 288045 0
Government body
Name [1] 288045 0
Australian Institute of Sport
Address [1] 288045 0
Leverrier Crescent, Bruce ACT 2617
Country [1] 288045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294944 0
Australian Catholic University Human Ethics Committee
Ethics committee address [1] 294944 0
Ethics committee country [1] 294944 0
Australia
Date submitted for ethics approval [1] 294944 0
20/02/2014
Approval date [1] 294944 0
01/04/2014
Ethics approval number [1] 294944 0
2014 51V

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

Contacts
Principal investigator
Name 49002 0
Prof John Hawley
Address 49002 0
Australian Catholic University
Daniel Mannix Building
Level One
office 1.32
115 Victoria Parade Fitzroy Victoria 3065
Country 49002 0
Australia
Phone 49002 0
+61 2 9953 5552
Fax 49002 0
Email 49002 0
John.Hawley@acu.edu.au
Contact person for public queries
Name 49003 0
John Hawley
Address 49003 0
Australian Catholic University
Daniel Mannix Building
Level One
office 1.32
115 Victoria Parade Fitzroy Victoria 3065
Country 49003 0
Australia
Phone 49003 0
+61 2 9953 5552
Fax 49003 0
Email 49003 0
John.Hawley@acu.edu.au
Contact person for scientific queries
Name 49004 0
John Hawley
Address 49004 0
Australian Catholic University
Daniel Mannix Building
Level One
office 1.32
115 Victoria Parade Fitzroy Victoria 3065
Country 49004 0
Australia
Phone 49004 0
+61 2 9953 5552
Fax 49004 0
Email 49004 0
John.Hawley@acu.edu.au

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.