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Trial registered on ANZCTR


Registration number
ACTRN12614000634673
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
17/06/2014
Date last updated
3/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Carbohydrate dependence during simulated half-marathon performance
Scientific title
The effect of blocking lipolysis via Nicotinic Acid on simulated half-marathon performance in well trained runners
Secondary ID [1] 284748 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endurance running performance in a healthy well-trained population 292115 0
Condition category
Condition code
Metabolic and Endocrine 292447 292447 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete four experimental trials, each consisting of a maximal self-paced half-marathon. Trials will be completed using a double blinded, Latin squared design and will be separated by a minimum of 7 days. Two trials will be commenced in a fed state and two in an unfed state (fasted state following an 8-10 h overnight fast) and in each condition participants will be administered either Nicotinic Acid or a placebo given in capsules. A standardised diet will be provided for the 24 h preceding each trial, before participants report to the ACU laboratory at 07:00 h. Upon arrival participants will have a cannula inserted into the antecubital vein in the arm to enable blood sampling (6 mL). During the “fed” trials participants will be provided with a standardised high carbohydrate breakfast (2 g/kg carbohydrate, 30 g protein and 10 g fat) 2.5 hours prior to commencing the half-marathon, followed by either Nicotonic Acid (total of 15 mg/kg body mass) or placebo capsules (no active compounds). The fasted trials will be completed under the same conditions but without the consumption of the standardised breakfast. During the fed trials participants will also be provided 60 g of carbohydrate per hour at 20 minute intervals using a commercially available sports drink. The volume of water consumed during the first trial will be recorded and repeated for all subsequent trials. There will be 7-10 days between each trial.
Intervention code [1] 289538 0
Other interventions
Comparator / control treatment
Subjects will be given a visually matched placebo (containing maltodextrin) in the same quantity and at the same time points as the Nicotinic Acid would be provided.
Control group
Placebo

Outcomes
Primary outcome [1] 292307 0
To assess substrate utilisation using online gas analysis (Metcart) when running a half-marathon at an intensity representative of a race day.
Timepoint [1] 292307 0
Average respiratory exchange ratio will be recorded during each experimental trial, it will be recorded for 5 minutes every 15 minutes throughout the approximately 90 minute duration.
Primary outcome [2] 292341 0
To assess time to completion of a simulated half-marathon.
Timepoint [2] 292341 0
The time to complete a half-marathon will be recorded on the non-motorised treadmill during the study.
Secondary outcome [1] 308692 0
Blood measures- Free fatty acids (and glycerol)
Timepoint [1] 308692 0
Blood samples will be taken every 15 minutes during each trial and analysed for plasma glucose, glycerol, free fatty acids, lactate and insulin. The first blood sample will be taken immediately upon entry into the lab, prior to breakfast or consuming any Nicotinic Acid.
Secondary outcome [2] 308812 0
Blood measures-Insulin
Timepoint [2] 308812 0
Blood samples will be taken every 15 minutes during each trial and analysed for plasma glucose, glycerol, free fatty acids, lactate and insulin. The first blood sample will be taken immediately upon entry into the lab, prior to breakfast or consuming any Nicotinic Acid and the last sample immediately post exercise.
Secondary outcome [3] 308813 0
Blood measures- Plasma glucose
Timepoint [3] 308813 0
Blood samples will be taken every 15 minutes during each trial and analysed for plasma glucose, glycerol, free fatty acids, lactate and insulin. The first blood sample will be taken immediately upon entry into the lab, prior to breakfast or consuming any Nicotinic Acid.
Secondary outcome [4] 308814 0
Blood measures- Plasma lactate
Timepoint [4] 308814 0
Blood samples will be taken every 15 minutes during each trial and analysed for plasma glucose, glycerol, free fatty acids, lactate and insulin. The first blood sample will be taken immediately upon entry into the lab, prior to breakfast or consuming any Nicotinic Acid.

Eligibility
Key inclusion criteria
Aged 18-35 yr
Able to run a half-marathon within 90 minutes
VO2max greater than 60 mL/kg/min
No pre-existing medical conditions or chronic injuries
Not currently using any prohibited substance on the World-Anti Doping Agency List.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone with pre-existing medical conditions or chronic injuries
Anyone using any prohibited substance on the World Anti-Doping Agency List.
Anyone with a discrepancy in the cardiovascular risk assessment 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)
Subjects will volunteer for the study and be provided with an information sheet explaining all 4 experimental trials. If the volunteer wishes to take part in the study they will complete a consent form. They will complete an initial health screening prior to any experimental trials. The subject will be blinded to which trial they are completing each time as the capsules of placebo and Nicotinic acid will be visually identical.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each trial will be coded with a number by an individual that is not directly part of the testing procedures. A random on-line number generator will then be used to assign subjects to certain trials. This will ensure complete randomisation of the trials.
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
Type of endpoint/s
Statistical methods / analysis
A Latin-squared design was chosen as it is a robust statistical design. The 12 subjects will be randomly allocated one of the 4 orders in which to complete the trials, 12 subjects is enough participants to ensure the study is robust as research shows less subjects are required for a within subjects design. Data will be analysed using the Statistical Package for Social Sciences (SPSS). A two-way ANOVA for repeated measures will be used to compare time points and trials. Significance will be set at p< 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2014
Actual
13/10/2014
Date of last participant enrolment
Anticipated
14/07/2014
Actual
23/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8286 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 289361 0
Commercial sector/Industry
Name [1] 289361 0
SiS (Science in Sport) Limited
Country [1] 289361 0
United Kingdom
Primary sponsor type
Individual
Name
Prof John Hawley
Address
Exercise & Nutrition Research Group
School of Exercise Sciences
8-18 Brunswick St
Australian Catholic University (ACU)
Locked Bag 4115
Fitzroy
Victoria 3165
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 288098 0
Commercial sector/Industry
Name [1] 288098 0
SiS (Science in Sport) Ltd
Address [1] 288098 0
4th Floor, 16-18 Hatton Garden
Farringdon, London
EC1N 8AT
Country [1] 288098 0
United Kingdom
Other collaborator category [1] 277994 0
Individual
Name [1] 277994 0
Dr James Morton
Address [1] 277994 0
Senior Lecturer in Exercise Metabolism and Nutrition
Liverpool John Moores University
Tom Reilly Building
Byrom St Campus
L3 3AF
Country [1] 277994 0
United Kingdom
Other collaborator category [2] 277995 0
Individual
Name [2] 277995 0
Jill Leckey
Address [2] 277995 0
Exercise & Nutrition Research Group
School of Exercise Sciences
8-18 Brunswick St
Australian Catholic University (ACU)
Locked Bag 4115
Fitzroy
Victoria 3165
AUSTRALIA
Country [2] 277995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291144 0
Australian Catholic University Ethics Comittee
Ethics committee address [1] 291144 0
Ethics committee country [1] 291144 0
Australia
Date submitted for ethics approval [1] 291144 0
20/02/2014
Approval date [1] 291144 0
01/04/2014
Ethics approval number [1] 291144 0
2014 152V

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

Contacts
Principal investigator
Name 49014 0
Prof John Hawley
Address 49014 0
Professor and Head
Exercise & Nutrition Research Group
School of Exercise Sciences
8-18 Brunswick St
Australian Catholic University (ACU)
Locked Bag 4115
Fitzroy
Victoria 3165
AUSTRALIA
Country 49014 0
Australia
Phone 49014 0
+61-3-9953 3552
Fax 49014 0
Email 49014 0
John.Hawley@acu.edu.au
Contact person for public queries
Name 49015 0
John Hawley
Address 49015 0
Professor and Head
Exercise & Nutrition Research Group
School of Exercise Sciences
8-18 Brunswick St
Australian Catholic University (ACU)
Locked Bag 4115
Fitzroy
Victoria 3165
AUSTRALIA
Country 49015 0
Australia
Phone 49015 0
+61-3-9953 3552
Fax 49015 0
Email 49015 0
John.Hawley@acu.edu.au
Contact person for scientific queries
Name 49016 0
John Hawley
Address 49016 0
Professor and Head

8-18 Brunswick St
Australian Catholic University (ACU)
Locked Bag 4115
Fitzroy
Victoria 3165
AUSTRALIA
Country 49016 0
Australia
Phone 49016 0
+61-3-9953 3552
Fax 49016 0
Email 49016 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
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Documents added automatically
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