Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000124235
Ethics application status
Approved
Date submitted
17/07/2008
Date registered
20/02/2009
Date last updated
19/02/2021
Date data sharing statement initially provided
19/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary Oils in Stress Pilot Study
Scientific title
A Pilot Randomised Controlled Double Blind Intervention Study of the Effects of docosahexaenoic acid-(DHA)-Rich Fish Oil Compared with Olive Oil in Psychological Stress.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Stress 3424 0
Condition category
Condition code
Diet and Nutrition 3578 3578 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DHA-rich Fish Oil Supplements, 4 capsules per day for 12 weeks. Each capsule contains 1000mg fish oil, containing (DHA) 500mg, and eicosapentaenoic acid (EPA) 100 mg
Intervention code [1] 3154 0
Prevention
Comparator / control treatment
Olive Oil (low phenolic) supplements. 4 capsules per day for 12 weeks, each containing 1000 mg low phenolic olive oil.
Control group
Placebo

Outcomes
Primary outcome [1] 4481 0
The difference between groups on the Perceived Stress Scale
Timepoint [1] 4481 0
Baseline and 12 weeks
Secondary outcome [1] 7578 0
The difference between groups on the Kessler-10 Scale of Psychological Distress
Timepoint [1] 7578 0
Baseline and at 12 weeks
Secondary outcome [2] 7579 0
The difference between groups in the ex vivo production of proinflammatory cytokines (IL-1-beta, IL-6, TNF-alpha) in serum (blood analysis)
Timepoint [2] 7579 0
Baseline and at 12 weeks
Secondary outcome [3] 7580 0
The difference between groups on the Auditory Verbal Learning Task
Timepoint [3] 7580 0
Baseline and at 12 weeks
Secondary outcome [4] 7581 0
The difference between groups in red blood cell membrane DHA levels (blood analysis)
Timepoint [4] 7581 0
Baseline and at 12 weeks

Eligibility
Key inclusion criteria
Fulltime students, aged between 18-45, has normal eating habits, has not radically changed diet in past 3m, consumes less than 2 fish meals per week on average, describes self as someone that experiences a lot of stress under pressure, willing to refrain from other medications during trial
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
allergy to seafood, aversion to taking fish oil, has taken a course of fish oil in past 3m, has a systemic chronic disease such as diabetes or heart disease, has a history of haemophilia or any type of clotting disorder, has a history of psychiatric illness, history of taking antipsychotics or antidepressants, current infectious, allergic or inflammatory response, any medications in past 2 weeks, non-sterioidal antiinflammatory medications in past 30 days, corticosteroids in past 3m, females with menstrual irregularities, females that are pregnant or lactating, poor venous access, any other condition which in the opinion of the investigators may impact on study outcomes.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/07/2008
Actual
13/08/2008
Date of last participant enrolment
Anticipated
Actual
20/08/2008
Date of last data collection
Anticipated
Actual
30/11/2008
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3609 0
Commercial sector/Industry
Name [1] 3609 0
Blackmores Ltd
Country [1] 3609 0
Australia
Funding source category [2] 3610 0
University
Name [2] 3610 0
Southern Cross University
Country [2] 3610 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores Ltd
Address
23 Rosberry Street
Bolgowlah NSW 2093
Country
Australia
Secondary sponsor category [1] 3244 0
University
Name [1] 3244 0
NatMed-Research Unit,
Southern Cross University
Address [1] 3244 0
PO Box 157
Lismore, NSW, 2482
Country [1] 3244 0
Australia
Other collaborator category [1] 336 0
University
Name [1] 336 0
Brain Sciences Institute,
Swinbourne University of Technology
Address [1] 336 0
PO Box 218
HAWTHORN VIC 3122
Country [1] 336 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5657 0
Human Research Ethics Committee
Ethics committee address [1] 5657 0
Ethics committee country [1] 5657 0
Australia
Date submitted for ethics approval [1] 5657 0
Approval date [1] 5657 0
03/07/2007
Ethics approval number [1] 5657 0
ECN-07-90
Ethics committee name [2] 5658 0
Medical Research Ethics Committee
Ethics committee address [2] 5658 0
Ethics committee country [2] 5658 0
Australia
Date submitted for ethics approval [2] 5658 0
Approval date [2] 5658 0
03/07/2007
Ethics approval number [2] 5658 0
2007001082

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

Contacts
Principal investigator
Name 28763 0
Address 28763 0
Country 28763 0
Phone 28763 0
Fax 28763 0
Email 28763 0
Contact person for public queries
Name 11920 0
Joanne Bradbury
Address 11920 0
NatMed-Research
Southern Cross University
PO Box 157
Lismore NSW 2482
Country 11920 0
Australia
Phone 11920 0
+61 2 6626 9453
Fax 11920 0
Email 11920 0
[email protected]
Contact person for scientific queries
Name 2848 0
Joanne Bradbury
Address 2848 0
NatMed-Research
Southern Cross University
PO Box 157
Lismore NSW 2482
Country 2848 0
Australia
Phone 2848 0
+61 2 6626 9453
Fax 2848 0
Email 2848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.