Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000710527
Ethics application status
Approved
Date submitted
22/06/2015
Date registered
9/07/2015
Date last updated
23/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of 4 week of arachidonic acid supplementation muscle protein synthesis following resistance exercise in resistance trained young men
Scientific title
The effects of 4 week of arachidonic acid supplementation on Muscle protein synthesis following resistance exercise in resistance trained young men
Secondary ID [1] 286952 0
Nil
Universal Trial Number (UTN)
U111111616511
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal response to resistance exercise 295404 0
Condition category
Condition code
Musculoskeletal 295661 295661 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 weeks of daily supplementation with 1.5 g of arachidonic acid via oral capsule. Supplement is consumed twice daily: 0.75 g (two capsules) in the morning and 0.75 g (two capsules) prior to exercise or in the evening if no exercise is preformed. Subjects will continue their normal exercise routine during the supplementation period.

Supervised acute exercise will take place in the morning following the 28th day (4th week) of supplementation. The supplement will not be consumed the morning of the acute exercise session.
The acute exercise intervention will consist of 8 sets of both leg press and leg extension at 80% 1RM. With 2 min rest between sets.
Intervention code [1] 292155 0
Treatment: Other
Comparator / control treatment
4 weeks of daily supplementation with 1.5 g of a corn/soy oil blend. Supplement is consumed twice daily: 0.75 g in the morning and 0.75 g prior to exercise or in the evening if no exercise is preformed.
Control group
Placebo

Outcomes
Primary outcome [1] 295367 0
Muscle protein synthesis (fractional synthetic rate) in response to acute resistance exercise. Fractional synthetic rate will be calculated based on the difference in vastus lateralis myofibrillar enrichments using an isotope ratio mass spectrometer. A Primed constant infusion of ring 13C6 phenylalanine will be used to ensure a constant precursor pool enrichments.
Timepoint [1] 295367 0
0-1.5 h post exercise and 1.5-4 hours post exercise
Secondary outcome [1] 315437 0
Muscle satellite cell content (NCAM+ cells), measured using immunohistochemistry on muscle biopsy sections

Timepoint [1] 315437 0
1.5 h post exercise, 4 h post exercise, 48 h post exercise
Secondary outcome [2] 315540 0
Muscle lipid mediator profile, measured using a liquid chromatography separation module coupled to triple quadrupole mass spectrometer
Timepoint [2] 315540 0
1.5 h post exercise, 4 h post exercise, 48 h post exercise
Secondary outcome [3] 315541 0
Knee extension torque, measured isometrically using a Biodex dynamometer.
Timepoint [3] 315541 0
1.5 h post exercise, 4 h post exercise, 48 h post exercise

Eligibility
Key inclusion criteria
A history of resistance training for greater than one year. Including training the lower body at least once per week.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions or medication use
anabolic steroid use
omega 3 or 6 supplement in the previous month

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once subjects are enrolled they are entered into a spreadsheet which only reveal the allocation post enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated with www.random.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two way ANVOA (condition, time)

A sample size of 10 per condition was calculated with 80% power based on the difference in muscle fractional synthetic rate seen between nutritional treatments after exercise in http://www.ncbi.nlm.nih.gov/pubmed/22451437
mean difference of 0.038 %/h and SD of 0.03 h/%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2015
Actual
18/05/2015
Date of last participant enrolment
Anticipated
Actual
8/06/2016
Date of last data collection
Anticipated
Actual
21/07/2016
Sample size
Target
20
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 6992 0
New Zealand
State/province [1] 6992 0
Auckland

Funding & Sponsors
Funding source category [1] 291511 0
University
Name [1] 291511 0
University of Auckland
Faculty research and development grant
Country [1] 291511 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Liggins Institute The University of Auckland
Private Bag 92019
1142
Country
New Zealand
Secondary sponsor category [1] 290192 0
None
Name [1] 290192 0
Address [1] 290192 0
Country [1] 290192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293051 0
Northern A Health and Disability Ethics Committee (New Zealand)
Ethics committee address [1] 293051 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
6011
WELLINGTON
Ethics committee country [1] 293051 0
New Zealand
Date submitted for ethics approval [1] 293051 0
18/09/2014
Approval date [1] 293051 0
01/10/2014
Ethics approval number [1] 293051 0
14/NTA/147/AM01

Summary
Brief summary
Resistance trained men will undergo 4 week of supplementation with 1.5 g per day of arachidonic acid or a placebo. They will then complete an acute bout of resistance exercise. Muscle biopsies will be collated at 1.5, 4 and 48 hours after the exercise. It is hypothesized that arachidonic acid supplementation will increase the rate of muscle protein synthesis and the muscle satellite cell to a greater extent than placebo following the acute exercise bout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58258 0
Prof David Cameron-Smith
Address 58258 0
Liggins Institute, University of Auckland

85 Park Road, Grafton
1142
Country 58258 0
New Zealand
Phone 58258 0
64 9 923 1336
Fax 58258 0
Email 58258 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 58259 0
Cameron MItchell
Address 58259 0
Liggins Institute, University of Auckland
85 Park Road, Grafton
1142
Country 58259 0
New Zealand
Phone 58259 0
+64211717948
Fax 58259 0
Email 58259 0
cameron.mitchell@auckland.ac.nz
Contact person for scientific queries
Name 58260 0
Cameron MItchell
Address 58260 0
Liggins Institute, University of Auckland
85 Park Road, Grafton
1142
Country 58260 0
New Zealand
Phone 58260 0
+64211717948
Fax 58260 0
Email 58260 0
cameron.mitchell@auckland.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseArachidonic acid supplementation modulates blood and skeletal muscle lipid profile with no effect on basal inflammation in resistance exercise trained men.2018https://dx.doi.org/10.1016/j.plefa.2017.12.003
N.B. These documents automatically identified may not have been verified by the study sponsor.