Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000708055
Ethics application status
Approved
Date submitted
24/08/2010
Date registered
25/08/2010
Date last updated
21/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of blood levels of factors involved in resolving inflammation in individuals with features of the metabolic syndrome versus matched healthy controls
Scientific title
Measurement of anti-inflammatory resolvins and protectins in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin
Secondary ID [1] 252565 0
Nil
Universal Trial Number (UTN)
Trial acronym
OARS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight men and women 258046 0
Condition category
Condition code
Cardiovascular 258209 258209 0 0
Other cardiovascular diseases
Diet and Nutrition 258215 258215 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 men and women with features of the metabolic syndrome and 20 age and gender matched healthy controls will enter a 4 week trial of parallel design. All participants will be asked to take 4 x 1g fish oil capsules daily (Omega Daily, Blackmores Ltd, Australia) supplying approximately 2.4g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), for 4 weeks. They will be asked to take 300mg aspirin/day in addition to the fish oil, during the last (4th) week. fish oil capsules and aspirin tablets will be taken orally. Blood samples will be taken at week 0 and at weeks 3 and 4.
Intervention code [1] 257081 0
Other interventions
Comparator / control treatment
The study will compare individuals with features of the metabolic syndrome with healthy controls undergoing the same intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259071 0
Plasma and serum anti-inflammatory resolvins and protectins
Timepoint [1] 259071 0
Blood samples will be taken at week 0 and at weeks 3 and 4.
Secondary outcome [1] 265352 0
Other anti-inflammatory metabolites are Interleukin-6 (IL-6) and C-Reactive Protein (CRP)
Timepoint [1] 265352 0
Blood samples will be taken at week 0 and at weeks 3 and 4.

Eligibility
Key inclusion criteria
Men and post-menopausal women not taking hormone replacement therapy, aged 20-70 years, will be recruited from the general population by newspaper advertisements. Subjects will recruited on the basis of being untreated but having features of the metabolic syndrome using the criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATP III). They will be invited to participate if they have a waist circumference >102cm for males and >88cm for females and systolic blood pressure (SBP) >130 mmHg,
Age and gender matched healthy control subjects will be recruited from the general population. Subjects will be included if in the age range 20 to 70 years with a waist circumference <102cm for males and <88cm for females and no other defining criteria for the metabolic syndrome.
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, aspirin or non-steroidal anti-inflammatory drugs, omega-3 fatty acids or >2 fish meals /week.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2010
Actual
11/10/2010
Date of last participant enrolment
Anticipated
Actual
26/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257529 0
Charities/Societies/Foundations
Name [1] 257529 0
National Heart Foundation of Australia
Country [1] 257529 0
Australia
Primary sponsor type
Individual
Name
Professor Trevor Mori
Address
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth 6847
Western Australia
Country
Australia
Secondary sponsor category [1] 256757 0
Individual
Name [1] 256757 0
Dr Anne Barden
Address [1] 256757 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth 6847
Western Australia
Country [1] 256757 0
Australia
Other collaborator category [1] 251452 0
Individual
Name [1] 251452 0
Professor Kevin Croft
Address [1] 251452 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth 6847
Western Australia
Country [1] 251452 0
Australia
Other collaborator category [2] 251475 0
Individual
Name [2] 251475 0
Professor Lawrence Beilin
Address [2] 251475 0
School of Medicine and Pharmacology University of Western Australia GPO Box X2213 Perth 6847 Western Australia
Country [2] 251475 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259558 0
University of Western Australia
Ethics committee address [1] 259558 0
35 Stirling Highway
Crawley 6009
Western Australia
Ethics committee country [1] 259558 0
Australia
Date submitted for ethics approval [1] 259558 0
Approval date [1] 259558 0
18/12/2009
Ethics approval number [1] 259558 0
RA/4/1/2610

Summary
Brief summary
The hypothesis is that in humans dietary omega-3 fatty acids and aspirin augment the formation of the potent anti-inflammatory metabolites resolvins and protectins. We aim to measure resolvin and protectin levels in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin;
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31566 0
Prof Trevor Mori
Address 31566 0
School of Medicine and Pharmacology
Medical Research Foundation Building
GPO Box X2213
Perth WA 6847
Country 31566 0
Australia
Phone 31566 0
61-8-92240273
Fax 31566 0
Email 31566 0
[email protected]
Contact person for public queries
Name 14813 0
Prof Professor Trevor Mori
Address 14813 0
School of Medicine and Pharmacology
University of Western Australia
PO Box X2213
Perth 6847
Western Australia
Country 14813 0
Australia
Phone 14813 0
61-8-9224 0273
Fax 14813 0
61-8-9224 0246
Email 14813 0
[email protected]
Contact person for scientific queries
Name 5741 0
Prof Professor Trevor Mori
Address 5741 0
School of Medicine and Pharmacology
University of Western Australia
PO Box X2213
Perth 6847
Western Australia
Country 5741 0
Australia
Phone 5741 0
61-8-9224 0273
Fax 5741 0
61-8-9224 0246
Email 5741 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
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