Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000212055
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
16/03/2010
Date last updated
4/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of omega-3 fatty acid (docosahexaenoic acid) supplementation on cognitive performance in healthy adults.
Scientific title
Effects of a high docosahexaenoic acid (DHA) fatty acid supplement on cognitive performance in healthy adults
Secondary ID [1] 1487 0
None
Universal Trial Number (UTN)
U1111-1114-4016
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 256956 0
Condition category
Condition code
Mental Health 257099 257099 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 capsules per day for 6 months to be consumed orally of docosahexaenoic fatty acid supplement (providing 1.124 mg of docosahexaenoic acid/day)
Intervention code [1] 256133 0
Prevention
Comparator / control treatment
3 capsules per day for 6 months to be consumed orally of high oleic acid sunflower oil (2.25g/day)
Control group
Active

Outcomes
Primary outcome [1] 257991 0
Cognitive performance using a battery of computer based tests including: working memory (N-Back, Corsi Blocks, Letter-number sequencing task); Long-term memory (Immediate and delayed work recall, Immediate and delayed word recognition, Immediate and delayed picture recognition); Processing spead / reaction time (Finding A's, Simple reaction time, Choice reaction time); Attention (Stroop test); Sustained attention task (Digit vigilance)
Timepoint [1] 257991 0
Baseline, 6 months
Secondary outcome [1] 263547 0
Interaction of apo E genotype assessed by extracting deoxyribonucleic acid (DNA) from a blood sample and using standard laboraotry based tests.
Timepoint [1] 263547 0
6 months

Eligibility
Key inclusion criteria
Healthy men and women 18-45 years
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High habitual intake of fatty fish (>1 serving/month)
Consuming fish oil supplements
Smokers
Allergies to seafood
Pregnant or lactating

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)
The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subjects will be allocated.
Allocation will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible subjects will be randomly assigned to the docosahexaenoic acid (DHA) supplement or placebo using computer generated random numbers tables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2010
Actual
30/03/2010
Date of last participant enrolment
Anticipated
Actual
4/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2537 0
New Zealand
State/province [1] 2537 0

Funding & Sponsors
Funding source category [1] 256636 0
University
Name [1] 256636 0
Massey University Research Fund (MURF)
Country [1] 256636 0
New Zealand
Funding source category [2] 288661 0
Charities/Societies/Foundations
Name [2] 288661 0
Neurological Foundation of New Zealand
Country [2] 288661 0
New Zealand
Funding source category [3] 288662 0
Charities/Societies/Foundations
Name [3] 288662 0
Oakley Mental Health Research
Country [3] 288662 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Administrator University Research Committee
Massey University
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 255923 0
Commercial sector/Industry
Name [1] 255923 0
Efamol Ltd
Address [1] 255923 0
14 Mole Business Park
Leatherhead
Surrey
KT22 7BA
Country [1] 255923 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258667 0
Massey University Human Ethics Committee (MUHEC): Southern A
Ethics committee address [1] 258667 0
Ethics committee country [1] 258667 0
New Zealand
Date submitted for ethics approval [1] 258667 0
Approval date [1] 258667 0
10/03/2010
Ethics approval number [1] 258667 0
MUHEC: Southern A application 10/07

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

Contacts
Principal investigator
Name 30922 0
Dr Welma Stonehouse
Address 30922 0
CSIRO Animal, Food and Health Sciences, PO Box 10041 Adelaide BC, South Australia, Australia, 5000
Country 30922 0
Australia
Phone 30922 0
+61 8 8303 8919
Fax 30922 0
+61 8 8303 8899
Email 30922 0
welma.stonehouse@csiro.au
Contact person for public queries
Name 14169 0
Cath Conlon
Address 14169 0
Institute of Food Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
0745
Auckland
Country 14169 0
New Zealand
Phone 14169 0
+64 9 443 9748
Fax 14169 0
+64 9 414 9640
Email 14169 0
c.conlon@massey.ac.nz
Contact person for scientific queries
Name 5097 0
Welma Stonehouse
Address 5097 0
CSIRO Animal, Food and Health Sciences, PO Box 10041 Adelaide BC, South Australia, Australia, 5000
Country 5097 0
Australia
Phone 5097 0
+61 8 8303 8919
Fax 5097 0
+61 8 8303 8899
Email 5097 0
welma.stonehouse@csiro.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.