ANZCTR - Registration

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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]

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

Condition category

Condition code

Alternative and Complementary Medicine

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]

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]

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]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [1]

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]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [2]

The Kessler-10 (K-10) measuring psychological distress

Timepoint [2]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [3]

The production of Interleukin-1b, Interleukin-6 and Tumor necrosis factor alpha and the regulatory cytokine Interleukin-10 assessed by blood analysis.

Timepoint [3]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [4]

The size and direction of the correlations of blood fatty acids on stress and distress measures
and cytokine production.

Timepoint [4]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [5]

The size and direction of the correlations between the stress and distress measures and the
cytokine profiles.

Timepoint [5]

Baseline, week 4, week 8, week 12 and week 16

Secondary outcome [6]

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]

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]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Cross University Ethics Committee

Ethics committee address [1]

Southern Cross University
Military Road
Lismore
NSW 2480

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/08/2009

Approval date [1]

21/08/2009

Ethics approval number [1]

ECN-09-111

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.

Trial website

None

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Professor Stephen Myers

Address

NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480

Country

Australia

Phone

+ 61 2 66 20 3649

Fax

Email

stephen.myers@scu.edu.au

Contact person for scientific queries

Name

Professor Stephen Myers

Address

NatMed-Research
Southern Cross University
Military Road
Lismore NSW 2480

Country

Australia

Phone

+ 61 2 66 20 3649

Fax

Email

stephen.myers@scu.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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			335480-(Uploaded-21-07-2020-17-47-31)-Basic results summary.docx
Plain language summary	No		Chronic work stress doubles the risk of cardiovasc... [More Details]
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.