ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Platelet aggregation

Condition category

Condition code

Blood

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]

Prevention

Comparator / control treatment

Placebo Group: 2 x 1g sunola oil capsules

Control group

Placebo

Outcomes

Primary outcome [1]

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]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

University Drive, Callaghan Campus, New South Wales, 2308

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive, Callaghan Campus, New South Wales, 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Office, The Chancellory, The University of Newcastle, Unversity Drive, Callaghan, New South Wales, 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Melinda Phang

Address

Nutraceuticals Research Group
School of Biomedical Sciences & Pharmacy
305 Medical Sciences Building
The University of Newcastle,
Uinversity Drive, Callaghan
New South Wales 2308

Country

Australia

Phone

+61 2 49215636

Fax

[email protected]

Contact person for scientific queries

Name

Manohar Garg

Address

Nutraceuticals Research Group
School of Biomedical Sciences & Pharmacy
305 Medical Sciences Building
The University of Newcastle,
University Drive, Callaghan
New South Wales 2308

Country

Australia

Phone

+61 2 49215647

Fax

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Eicosapentaenoic and Docosahexaenoic Acid Supplementations Reduce Platelet Aggregation and Hemostatic Markers Differentially in Men and Women	2013	https://doi.org/10.3945/jn.112.171249
Embase	Reduction of prothrombin and Factor V levels following supplementation with omega-3 fatty acids is sex dependent: A randomised controlled study.	2014	https://dx.doi.org/10.1016/j.jnutbio.2014.05.001
Embase	Circulating CD36+ microparticles are not altered by docosahexaenoic or eicosapentaenoic acid supplementation.	2016	https://dx.doi.org/10.1016/j.numecd.2015.12.003

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically