Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000740099
Ethics application status
Approved
Date submitted
3/09/2010
Date registered
6/09/2010
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of supplementing fish oil and aspirin on blood levels of factors involved in the resolution of inflammation in healthy men and women
Scientific title
Measurement of anti-inflammatory resolvins and protectins in healthy individuals taking omega-3 fatty acids in combination with aspirin or placebo.
Secondary ID [1] 252627 0
Nil
Universal Trial Number (UTN)
Trial acronym
OARS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low level inflammation 258125 0
Condition category
Condition code
Cardiovascular 258299 258299 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 healthy men and women will be recruited from the general population by newspaper advertisements. They will be matched for age and gender. They will be asked to take 4 x 1g fish oil capsules daily (Omega Daily, Blackmores Ltd, Australia) supplying 2.4g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), for 7 days. On the sixth day they will be randomly allocated to take either 3 x 100mg tablets per day of aspirin (Bayer, Australia) or the same number of placebo (microcellulose) tablets. Volunteers will be asked to take aspirin or placebo tablets on both the sixth and seventh days, in addition to the fish oil. Fish oil capsules and aspirin or placebo tablets will be taken orally. Blood samples will be collected at baseline (day 0), and at days 5 and 7.
Intervention code [1] 257140 0
Prevention
Comparator / control treatment
The study will be placebo controlled for aspirin intake. Placebo tablets will contain microcellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 259148 0
Plasma anti-inflammatory resolvins and protectins
Timepoint [1] 259148 0
Blood samples will be taken at days 0, 5 and 7
Secondary outcome [1] 265475 0
Fasting plasma fatty acids
Timepoint [1] 265475 0
Blood samples will be taken at days 0, 5 and 7

Eligibility
Key inclusion criteria
Men aged 20-70 years, and post-menopausal women aged less than 70 years will be recruited from the general population by newspaper advertisements. Volunteers will be included if they do not meet any of the criteria for the metabolic syndrome as defined by the National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATPIII).
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers, history of cardiovascular or peripheral vascular disease, diabetes, renal disease, liver disease or taking anti-hypertensive agents, lipid lowering drugs, hormone replacement therapy (women only), > 2 standard alcoholic drinks for women and >3 standard alcoholic drinks for men per day, aspirin or non-steroidal anti-inflammatory drugs, omega-3 fatty acids or >2 fish meals per week.

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)
For the aspirin / placebo: central allocation by a statistician not involved with the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
7/06/2010
Date of last participant enrolment
Anticipated
15/04/2011
Actual
7/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257590 0
Charities/Societies/Foundations
Name [1] 257590 0
Royal Perth Hospital Medical Research Foundation
Country [1] 257590 0
Australia
Primary sponsor type
Individual
Name
Professor Trevor Mori
Address
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 256817 0
Individual
Name [1] 256817 0
Dr Anne Barden
Address [1] 256817 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country [1] 256817 0
Australia
Other collaborator category [1] 251473 0
Individual
Name [1] 251473 0
Dr Emilie Mas
Address [1] 251473 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country [1] 251473 0
Australia
Other collaborator category [2] 251474 0
Individual
Name [2] 251474 0
Professor Kevin Croft
Address [2] 251474 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country [2] 251474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259614 0
University of Western Australia
Ethics committee address [1] 259614 0
35 Stirling Highway
Crawley 6009
Western Australia
Ethics committee country [1] 259614 0
Australia
Date submitted for ethics approval [1] 259614 0
Approval date [1] 259614 0
22/02/2010
Ethics approval number [1] 259614 0
RA/4/1/4014

Summary
Brief summary
The hypothesis is that in healthy humans dietary omega-3 fatty acids and aspirin enhance the formation of the potent antiinflammatory metabolites resolvins and protectins. Specifically, we aim to determine blood resolvin and protectin levels in a randomised controlled trial of aspirin or
placebo in healthy men and women taking omega-3 fatty acids.
Trial website
Trial related presentations / publications
Details of published manuscript
Short-term n-3 fatty acid supplementation but not aspirin increases plasma proresolving mediators of inflammation.
Anne Barden, Emilie Mas, Kevin D. Croft, Michael Phillips, Trevor A. Mori
Journal of Lipid Research 2014; 55: 2401–2407.
Public notes

Contacts
Principal investigator
Name 31602 0
Prof Trevor Mori
Address 31602 0
School of Medicine and Pharmacology,
Medical Research Foundation Building
GPO Box X2213 Perth WA 6848
Country 31602 0
Australia
Phone 31602 0
61-8-92240273
Fax 31602 0
Email 31602 0
[email protected]
Contact person for public queries
Name 14849 0
Prof Professor Trevor Mori
Address 14849 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 14849 0
Australia
Phone 14849 0
61-8-9224 0273
Fax 14849 0
61-8-9224 0246
Email 14849 0
[email protected]
Contact person for scientific queries
Name 5777 0
Prof Professor Trevor Mori
Address 5777 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 5777 0
Australia
Phone 5777 0
61-8-9224 0273
Fax 5777 0
61-8-9224 0246
Email 5777 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
EmbaseTherapeutic Potential of Lipoxin A4in Chronic Inflammation: Focus on Cardiometabolic Disease.2020https://dx.doi.org/10.1021/acsptsci.9b00097
N.B. These documents automatically identified may not have been verified by the study sponsor.