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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
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.
Secondary ID [1] 251756 0
None
Universal Trial Number (UTN)
U1111-1114-9921
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work Stress 257388 0
Condition category
Condition code
Alternative and Complementary Medicine 257505 257505 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256466 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 258474 0
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).
Timepoint [1] 258474 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [1] 264187 0
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,
Timepoint [1] 264187 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [2] 264188 0
The Kessler-10 (K-10) measuring psychological distress
Timepoint [2] 264188 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [3] 264189 0
The production of Interleukin-1b, Interleukin-6 and Tumor necrosis factor alpha and the regulatory cytokine Interleukin-10 assessed by blood analysis.
Timepoint [3] 264189 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [4] 264191 0
The size and direction of the correlations of blood fatty acids on stress and distress measures
and cytokine production.
Timepoint [4] 264191 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [5] 264265 0
The size and direction of the correlations between the stress and distress measures and the
cytokine profiles.
Timepoint [5] 264265 0
Baseline, week 4, week 8, week 12 and week 16
Secondary outcome [6] 264266 0
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
Timepoint [6] 264266 0
Baseline, week 4, week 8, week 12 and week 16

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256959 0
Government body
Name [1] 256959 0
NHMRC
Country [1] 256959 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 256223 0
None
Name [1] 256223 0
Address [1] 256223 0
Country [1] 256223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258957 0
Southern Cross University Ethics Committee
Ethics committee address [1] 258957 0
Ethics committee country [1] 258957 0
Australia
Date submitted for ethics approval [1] 258957 0
14/08/2009
Approval date [1] 258957 0
21/08/2009
Ethics approval number [1] 258957 0
ECN-09-111

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31159 0
Address 31159 0
Country 31159 0
Phone 31159 0
Fax 31159 0
Email 31159 0
Contact person for public queries
Name 14406 0
Professor Stephen Myers
Address 14406 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
Country 14406 0
Australia
Phone 14406 0
+ 61 2 66 20 3649
Fax 14406 0
Email 14406 0
[email protected]
Contact person for scientific queries
Name 5334 0
Professor Stephen Myers
Address 5334 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480
Country 5334 0
Australia
Phone 5334 0
+ 61 2 66 20 3649
Fax 5334 0
Email 5334 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 335480-(Uploaded-21-07-2020-17-47-31)-Basic results summary.docx
Plain language summaryNo Chronic work stress doubles the risk of cardiovasc... [More Details]
Study results articleYes 2017 Bradbury, J., Myers, S. P., Meyer, B., Bro... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChronic psychological stress was not ameliorated by omega-3 eicosapentaenoic acid (EPA).2017https://dx.doi.org/10.3389/fphar.2017.00551
N.B. These documents automatically identified may not have been verified by the study sponsor.