Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000098932
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
28/01/2011
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of fish oil on platelet function
Scientific title
Differential effects following 4 weeks of fish oil supplementation on platelet function in healthy male and female subjects
Secondary ID [1] 252042 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platelet aggregation 257580 0
Condition category
Condition code
Blood 257754 257754 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is a double-blinded placebo controlled trial.

There are 3 groups of participants of equal gender randomised to a treatment group to receive either fish oil capsules or placebo. The 3 treatment groups in this trial are:
(i) 2 x 1g dose 500mg Docosahexaenoic Acid (DHA) [1:5 EPA/DHA]
OR
(ii) 2 x 1g dose 500mg Eicosapentaenoic Acid (EPA) [5:1 EPA/DHA]
OR
(iii) 2 x 1g dose Placebo (sunola oil)

Participants are required to consume the above dose, corresponding to the group they have been randomised to, daily for a 4 week dietary intervention period.
Participants are assessed at baseline and after the 4 week period.
Intervention code [1] 256678 0
Prevention
Comparator / control treatment
Placebo Group: 2 x 1g sunola oil capsules
Control group
Placebo

Outcomes
Primary outcome [1] 258636 0
The primary outcome of this trial is to determine the gender-specific responses in platelet function (aggregation) following omega-3 fatty acid supplementation over a 4 week period.
Timepoint [1] 258636 0
Blood samples from participants will be collected at the commencement of the study (prior to suppplementation) and again after the 4 week supplementation period. Whole blood platelet aggregation, platelet count, biomarkers of coagulation and a complete plasma lipid profile will be generated from each blood sample.
Secondary outcome [1] 264593 0
The secondary outcome is to compare the difference in the efficacy of the varying concencentrations of the omega-3 fatty acids in the treatment groups (Eicosapentaenoic Acid, Docosahexaenoic Acid) to influence platelet function.
Timepoint [1] 264593 0
All these outcomes will be measured at baseline and at 4 weeks post intervention.

Eligibility
Key inclusion criteria
Healthy participants aged 18 years or above.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants diagnosed with any hematological or cardiovascular disorders and are taking fish oil capsules or medication affecting coagulation.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257149 0
University
Name [1] 257149 0
University of Newcastle
Country [1] 257149 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan Campus, New South Wales, 2308
Country
Australia
Secondary sponsor category [1] 256409 0
None
Name [1] 256409 0
Address [1] 256409 0
Country [1] 256409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259193 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259193 0
Research Office, The Chancellory, The University of Newcastle, Unversity Drive, Callaghan, New South Wales, 2308
Ethics committee country [1] 259193 0
Australia
Date submitted for ethics approval [1] 259193 0
Approval date [1] 259193 0
Ethics approval number [1] 259193 0

Summary
Brief summary
The purpose of this research is to examine how different fish oil (omega-3 fatty acids) concentrates can influence platelet activity and improve platelet function in males and females. There is evidence in the published literature that response to fish oil supplementation is influenced by a gender-specific manner. Moreover, fish oil supplements contain different concentration ratios of the active ingredients, EPA and DHA. This research project will determine how gender influences fish oil supplementation so that males and females can receive maximum benefit against cardiovascular disease risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31300 0
Address 31300 0
Country 31300 0
Phone 31300 0
Fax 31300 0
Email 31300 0
Contact person for public queries
Name 14547 0
Melinda Phang
Address 14547 0
Nutraceuticals Research Group
School of Biomedical Sciences & Pharmacy
305 Medical Sciences Building
The University of Newcastle,
Uinversity Drive, Callaghan
New South Wales 2308
Country 14547 0
Australia
Phone 14547 0
+61 2 49215636
Fax 14547 0
Email 14547 0
[email protected]
Contact person for scientific queries
Name 5475 0
Manohar Garg
Address 5475 0
Nutraceuticals Research Group
School of Biomedical Sciences & Pharmacy
305 Medical Sciences Building
The University of Newcastle,
University Drive, Callaghan
New South Wales 2308
Country 5475 0
Australia
Phone 5475 0
+61 2 49215647
Fax 5475 0
Email 5475 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
SourceTitleYear of PublicationDOI
EmbaseCirculating CD36+ microparticles are not altered by docosahexaenoic or eicosapentaenoic acid supplementation.2016https://dx.doi.org/10.1016/j.numecd.2015.12.003
EmbaseReduction of prothrombin and Factor V levels following supplementation with omega-3 fatty acids is sex dependent: A randomised controlled study.2014https://dx.doi.org/10.1016/j.jnutbio.2014.05.001
Dimensions AIEicosapentaenoic and Docosahexaenoic Acid Supplementations Reduce Platelet Aggregation and Hemostatic Markers Differentially in Men and Women2013https://doi.org/10.3945/jn.112.171249
N.B. These documents automatically identified may not have been verified by the study sponsor.