Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000164291
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
3/04/2009
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gender specific responses in platelet function following long chain omega-3 fatty acid supplementation
Scientific title
Supplementation with long chain omega-3 polyunsaturated fatty acids to reduce platelet aggregation differentially by gender in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platelet aggregation 4314 0
Condition category
Condition code
Blood 4546 4546 0 0
Normal development and function of platelets and erythrocytes
Cardiovascular 4846 4846 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants of equal gender are randomised to receive an oral administration of a single dose of either omega-3 fish oil capsules or placebo containing:
(i) 2 x 1g dose 500mg Docosahexaenoic Acid (DHA) [1:5 EPA/DHA]
(ii) 2 x 1g dose 500mg Eicosapentaenoic Acid [5:1 EPA/DHA]
(iii) 2 x 1g dose Placebo (olive oil)
Participants are assessed at baseline and at post 2, 5 and 24 hours following consumption of the capsules.
Intervention code [1] 4319 0
Prevention
Comparator / control treatment
Oral administration of a single dose of 2 x 1g olive oil capsules
Control group
Placebo

Outcomes
Primary outcome [1] 5426 0
The primary outcome of this trial is to determine the gender-specific responses in platelet function (aggregation) following omega-3 fatty acid supplementation.
Timepoint [1] 5426 0
Blood samples from participants will be collected at the commencement of the study (prior to suppplementation) and again at 2, 5 and 24 hours following supplementation. 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] 9121 0
The secondary outcome is to compare the efficacy of each individual long chain omega-3 fatty acid (Eicosapentaenoic Acid, Docosahexaenoic Acid) to inhibit platelet aggregation at each timepoint by analysis of blood samples.
Timepoint [1] 9121 0
All these outcomes will be measured at baseline, 2, 5 and 24 hours post intervention.

Eligibility
Key inclusion criteria
Healthy participants aged 25 years or above.
Minimum age
25 Years
Maximum age
65 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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
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] 4744 0
Self funded/Unfunded
Name [1] 4744 0
Professor Manohar Garg
Country [1] 4744 0
Australia
Funding source category [2] 4745 0
Self funded/Unfunded
Name [2] 4745 0
Professor Manohar Garg
Country [2] 4745 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan Campus, New South Wales, 2308
Country
Australia
Secondary sponsor category [1] 4284 0
University
Name [1] 4284 0
The University of Newcastle
Address [1] 4284 0
University Drive, Callaghan Campus, New South Wales, 2308
Country [1] 4284 0
Australia
Secondary sponsor category [2] 4285 0
University
Name [2] 4285 0
The University of Newcastle
Address [2] 4285 0
University Drive, Callaghan Campus, New South Wales, 2308
Country [2] 4285 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6784 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 6784 0
Research Office, The Chancellory, The University of Newcastle, Unversity Drive, Callaghan, New South Wales, 2308
Ethics committee country [1] 6784 0
Australia
Date submitted for ethics approval [1] 6784 0
05/05/2008
Approval date [1] 6784 0
20/06/2008
Ethics approval number [1] 6784 0
H-2008-0149

Summary
Brief summary
The primary purpose of this study is to determine the gender specific responses in platelet reactivity following supplementation with long chain omega-3 polyunsaturated fatty acids (LCn-3 PUFA). It is anticipated that there will be significant gender related differences in response to different concentration ratios of long chain n-3 PUFA supplementation.
This research study is designed to assess the effectiveness of Eicosapentaenoic Acid and Docoshexaenoic Acid to inhibit platelet aggregation in healthy males versus females. These studies will be randomised controlled trials where platelet function of healthy subjects will be monitored over the intervention period following dietary supplementation of the fish oil concentrates or placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29274 0
Address 29274 0
Country 29274 0
Phone 29274 0
Fax 29274 0
Email 29274 0
Contact person for public queries
Name 12521 0
Melinda Phang
Address 12521 0
Nutraceuticals Research Group
School of Biomedical Sciences
305 Medical Sciences Building
The University of Newcastle, Callaghan
New South Wales 2308
Country 12521 0
Australia
Phone 12521 0
+61 2 49215636
Fax 12521 0
Email 12521 0
melinda.phang@studentmail.newcastle.edu.au
Contact person for scientific queries
Name 3449 0
Manohar Garg
Address 3449 0
Nutraceuticals Research Group
School of Biomedical Sciences
305C Medical Sciences Building
The University of Newcastle, Callaghan
New South Wales 2308
Country 3449 0
Australia
Phone 3449 0
+61 2 49215647
Fax 3449 0
Email 3449 0
manohar.garg@newcastle.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
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