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Trial registered on ANZCTR
Registration number
ACTRN12610000404022
Ethics application status
Approved
Date submitted
13/05/2010
Date registered
19/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Fish Oil in Work Stress Study
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Scientific title
The efficacy of eicosapentaenoic acid (EPA) rich fish oil in the amelioration of chronic work stress. An understanding of the causal relationship between dietary fatty acids and psychological stress.
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Secondary ID [1]
251756
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None
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Universal Trial Number (UTN)
U1111-1114-9921
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Trial acronym
none
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Work Stress
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Condition category
Condition code
Alternative and Complementary Medicine
257505
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and from fish oil constitute the active intervention. Each capsule will contain 1000mg fish oil, comprising 600mg marine triglycerides as EPA 550mg and DHA 110mg. Four capsules per day will deliver 2.2g EPA, and 0.44g DHA. The particpants will take the medication for 16 weeks.
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Intervention code [1]
256466
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Treatment: Other
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Comparator / control treatment
The placebo capsules, containing 1000mg low-phenolic olive oil, consisting of predominantly monounsaturated fatty acids, will be identical to the EPA capsules in every way, including size, shape, colour and smell. participants will take 4 capsules daily for 16 weeks.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome measure is the difference between the fish oil group and placebo group in
mean changes over time on the Perceived Stress Scale (PSS).
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Assessment method [1]
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Timepoint [1]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [1]
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The difference between the fish oil group and placebo group in mean changes over time on the Occupational Stress Inventory Revised(OSI-R) Strain Subscales,
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Assessment method [1]
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Timepoint [1]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [2]
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The Kessler-10 (K-10) measuring psychological distress
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Assessment method [2]
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Timepoint [2]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [3]
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The production of Interleukin-1b, Interleukin-6 and Tumor necrosis factor alpha and the regulatory cytokine Interleukin-10 assessed by blood analysis.
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Assessment method [3]
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Timepoint [3]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [4]
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The size and direction of the correlations of blood fatty acids on stress and distress measures
and cytokine production.
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Assessment method [4]
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Timepoint [4]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [5]
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The size and direction of the correlations between the stress and distress measures and the
cytokine profiles.
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Assessment method [5]
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Timepoint [5]
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Baseline, week 4, week 8, week 12 and week 16
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Secondary outcome [6]
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The size and direction of the correlation of dietary fatty acids as measured by the Food Frequency Questionnaire on
stress and distress measures, and cytokines
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Assessment method [6]
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Timepoint [6]
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Baseline, week 4, week 8, week 12 and week 16
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Eligibility
Key inclusion criteria
Inclusions criteria
Participants with scores below or equal to 17 on the PSS asking about stress levels over the past three months at baseline
Participants have not taken a course of fish oil in the past three months, and consumes less than two non-fried fish meals per week on average
Participants will be instructed to maintain their usual diets which will be monitored by the electronic Food Frequency Questionnaire at t=0, t=4, t= 8, t=12 and t=16 weeks
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria
The following criteria will used to exclude individuals from entering the study:
Participants with a know seafood allergy
Participants taking immunosuppressive medications
Participants with an inflammatory disorder
Participants with an infection
Participants that have suffered a significant trauma, such as surgery, within the last 6 months
Participants with unexplained weight loss
Participants with any kind of malignancy
Participants with any significant disease or disorder or any condition that, in the opinion of the investigators, might interfere with the study objectives.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will stratified according to age and a computer program will be used to
generate the randomisation schedule. The coding will kept in sealed envelopes in a locked filing
cabinet until the completion of the trial. An independent staff member of the Department of Natural
and Complementary Medicine not associated with the current study or funding bodies, will conduct
the randomisation and coding of the supplement bottles. The success of the blinding procedure will
be checked by asking each of the subjects to identify the agent they believed they were taking.
Blinding will also be correlated with blood cell membranes of fatty acids as a further cross check.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer programme
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
NHMRC
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Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
256223
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Country [1]
256223
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Cross University Ethics Committee
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Ethics committee address [1]
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Southern Cross University
Military Road
Lismore
NSW 2480
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/08/2009
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Approval date [1]
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21/08/2009
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Ethics approval number [1]
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ECN-09-111
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Summary
Brief summary
The primary aim of this study is to determine the efficacy of EPA-rich fish oil in the amelioration of
chronic work stress. A secondary aim is to contribute to the understanding of the causal relationship
between dietary fatty acids and psychological stress. The primary hypothesis is that that EPA-rich
fish oil will significantly reduce chronic work stress in comparison to a placebo over a 16 week
period.
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Trial website
None
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Professor Stephen Myers
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Address
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NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
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Country
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Australia
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Phone
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+ 61 2 66 20 3649
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Stephen Myers
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Address
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NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
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Country
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Australia
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Phone
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+ 61 2 66 20 3649
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Fax
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Email
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[email protected]
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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
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3787
Basic results
No
335480-(Uploaded-21-07-2020-17-47-31)-Basic results summary.docx
3916
Plain language summary
No
Chronic work stress doubles the risk of cardiovasc...
[
More Details
]
4286
Study results article
Yes
2017 Bradbury, J., Myers, S. P., Meyer, B., Bro...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Chronic psychological stress was not ameliorated by omega-3 eicosapentaenoic acid (EPA).
2017
https://dx.doi.org/10.3389/fphar.2017.00551
N.B. These documents automatically identified may not have been verified by the study sponsor.
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