Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000616077
Ethics application status
Approved
Date submitted
27/07/2010
Date registered
28/07/2010
Date last updated
28/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of fish oil supplementation on neural activity, cardiovascular functioning and cognitive performance
Scientific title
Effects of fish oil on brain efficiency in a healthy adult population and in a population of adults presenting with Attention Deficit Hyperactivity Disorder (ADHD) symptoms
Secondary ID [1] 252315 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long chain n-3 fatty acids intake and ADHD 257820 0
omega-3 fatty acids and cardiovascular functioning 257821 0
omega-3 fatty acids and neural activity/cognitive performance 257822 0
Condition category
Condition code
Mental Health 257990 257990 0 0
Other mental health disorders
Cardiovascular 257991 257991 0 0
Normal development and function of the cardiovascular system
Neurological 257992 257992 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group of 60 healthy volunteers and a population of 60 adults with ADHD will be randomly distributed into three diet groups and will be given 4 capsules a day of either an eicosapentaenoic omega-3 fatty acid (EPA)-rich diet (containing 1100 mg of EPA and 240mg of docosahexaenoic omega-3 fatty acid or DHA), or 4 capsules of a DHA-rich diet (containing 1140mg of DHA and 280mg of EPA) or a placebo treatment containing 50mg of soy oil. The supplementation period will be three or six months long (based on participants' preference).
Intervention code [1] 256882 0
Treatment: Other
Intervention code [2] 256883 0
Other interventions
Comparator / control treatment
Placebo treatment containing 50mg of soy oil
Control group
Placebo

Outcomes
Primary outcome [1] 258854 0
Cognitive performance will be measured with computerized cognitive batteries measuring attention, memory and processing speed: participants will use a hand-held button box to make responses to stimuli presented on a computer screen. Detailed instructions will be given prior to performing these tasks. Participants will also be given adequate practice. A continuous performance computer task will be used as objective measures of the participants' abilities to concentrate for a longer period of time and the ability to ignore external distractions.
Timepoint [1] 258854 0
At baseline, after 3 and after 6 months of supplementation
Primary outcome [2] 258855 0
Visual Evoked potential measurements (VEP): VEPs are similar to an electrocardiogram (ECG). The difference is that the recording discs are on the scalp to measure brain function, instead of on the chest to measure heart function. A small quantity of a water-based conductive gel will be used to make electrical contact between the scalp surface and the recording discs. This will be washed-off once data collection has been completed. The application of recording discs does not involve any breaking or piercing of the skin. A pattern on a computer monitor will change while participants concentrate on the centre of the pattern. Participants will not experience anything unpleasant, and the procedure is completely pain-free. This technique will determine the speed of conduction of electrical responses through the brain and reflects the integrity/efficiency of neural tissues in response to visual stimuli presented on a computer monitor.
Timepoint [2] 258855 0
At baseline, after 3 and after 6 months of supplementation
Primary outcome [3] 258856 0
Cardiovascular health (blood pressure, arterial stiffness, cerebral and peripheral blood flow velocity). Blood Pressure will be measured using a self-inflating cuff device with a digital display. Arterial stiffness will be calculated using a non-invasive technique where a small pressure transducer is applied on the wrist over the radial artery. Pressure waveforms associated with your heart beat will be recorded and a computer algorithm will be used to calculate arterial stiffness. The effect of fish oil supplementation on cerebral blood flow velocity will be assessed using the Compumedics Transcranial Doppler system. This non-invasive system measures blood velocity of the middle cerebral artery from a point near your ear using a handheld probe device the size of pencil. This device uses high frequency sound waves to measure blood flow velocity. This measurement will allow for the assessment of brain related changes due to fish oil status in the blood before taking fish oils and following supplementation with fish oils.
Timepoint [3] 258856 0
At baseline, after 3 and after 6 months of supplementation
Secondary outcome [1] 264979 0
Levels of omega-3 fatty acids in whole blood: a qualified nurse from the Brain Sciences Institute (BSI) or the PhD students involved in this study under supervision of the qualified nurse will collect one or two drops of your blood by puncturing your fingertip with a sterile, disposable, lancing device. Participants will be instructed to fast for at least 5 hours prior to undergoing this blood test. Blood samples will be collected in a filter paper and stored in a secure -80 degrees Celsius freezer at the BSI Building on 475 Burwood Road in Hawthorn. All blood samples will be de-identified through coding, and your name will not be associated with your blood sample from this point onwards. Only the researchers at the BSI involved in this study will have access to the information which could potentially identify your data. Blood samples will be transported through a courier (FedEx) to the Omegametrix Blood Laboratory in Martinsried (Germany) where fatty acid analyses will take place. After the essential fatty acid analyses are completed, all samples will be destroyed and disposed of by Omegametrix. At a later time these blood measures will be compared with computerized psychological tests to investigate relationships between fatty acid levels and brain function. Participants will be provided with a light breakfast or snacks prior to the commencement of cognitive testing.
Timepoint [1] 264979 0
At baseline, after 3 and after 6 months of supplementation
Secondary outcome [2] 264980 0
Severity of inattention, hyperactivity and impulsivity symptoms. We will ask participants to complete a questionnaire called the Conners' rating scale asking general questions about participants' mood, habits and behavioural traits.
Timepoint [2] 264980 0
At baseline, after 3 and after 6 months of supplementation
Secondary outcome [3] 264981 0
Dietary intake: we will ask participants to fill out questionnaires on their dietary intake and dietary habits.
Timepoint [3] 264981 0
At baseline, after 3 and after 6 months of supplementation

Eligibility
Key inclusion criteria
For Healthy controls
1)No history of epilepsy
2)No history of psychiatric disorders prior to the current study
3)No history of neurological disorders
4)No cardiovascular disease
5)No intake of medication for cardiovascular or blood disorders
6)No fish oil supplementation, herbal supplements or cognitive enhancers within the last month

for the clinical group:
1) Participants fulfilling the Diagnostic and Statistical manual of mental disorders-Text Revision 4th Edition (or DSM-IV-TR) criteria of ADHD
2)No history of epilepsy
3)No history of neurological disorders
4)No cardiovascular disease
5)No intake of medication for cardiovascular or blood disorders
6)No fish oil supplementation, herbal supplements or cognitive enhancers within the last month
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For all the participants
1) history of epilepsy
3) history of neurological disorders
4) cardiovascular disease
5) intake of medication for cardiovascular or blood disorders
6) fish oil supplementation, herbal supplements or cognitive enhancers within the last month

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)
The research students involved in this study will determine if prospective participants are eligible for the healthy controls or ADHD groups but they are blinded in respect to which supplementation group the subject will be allocated to. The study sponsor Novasel (who is off-site) has coded the containers containing the fish oil supplementations and the research students are unaware of which supplementation group each subject belongs to. The study sponsor has sent the identifying codes in a sealed letter to the chief investigator. This information will be stored in a locked location until the end of the study (that is till data collection is completed and data has been analysed). Participants will be randomly allocated to the three supplementation groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subject codes will be randomly associated
with treatment or placebo using a randomizing computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257347 0
Commercial sector/Industry
Name [1] 257347 0
Novasel
Country [1] 257347 0
Australia
Primary sponsor type
Government body
Name
Australian Research Council
Address
1st Floor, 8 Brindabella Circuit
Brindabella Business Park
GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 256587 0
University
Name [1] 256587 0
Swinburne University of Technology
Address [1] 256587 0
Swinburne University
PO Box 218
HAWTHORN VIC 3122
Country [1] 256587 0
Australia
Other collaborator category [1] 251406 0
University
Name [1] 251406 0
La Trobe University
Address [1] 251406 0
La Trobe University
Bundoora Victoria 3086
Australia
Country [1] 251406 0
Australia
Other collaborator category [2] 251407 0
University
Name [2] 251407 0
Deakin University
Address [2] 251407 0
221 Burwood Highway
Burwood Victoria 3125
Australia
Country [2] 251407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259369 0
Swinburne University of Technology
Ethics committee address [1] 259369 0
Swinburne University
PO Box 218
HAWTHORN VIC 3122
Ethics committee country [1] 259369 0
Australia
Date submitted for ethics approval [1] 259369 0
Approval date [1] 259369 0
03/12/2009
Ethics approval number [1] 259369 0
2009/186

Summary
Brief summary
Fish oil supplementation containing DHA and EPA omega-3 fatty acids has been shown to play an important role in the human nervous and
vascular system. Omega-3 fatty acids have been associated with improved cognitive performance such as enhanced attentional skills and decreased reaction times. Recent studies suggest that there is improved cognitive performance in a population with ADHD, Alzheimer’s disease and metabolic disorders after omega-3 supplementation. Results are however controversial and seem to depend on the EPA/DHA ratio contained in the supplementation, the length of the supplementation period, the study
design and the type of cognitive tasks utilized. In this double-blinded, placebo-controlled, parallel study, a group of 60 healthy volunteers and a population of 60 adults with ADHD will be randomly distributed into three diet groups and will be given either an EPA-rich diet (EPA/DHA ratio 4.5:1), a DHA-rich diet (EPA/DHA ratio 1:4) or a placebo treatment. The supplementation period will be three or six months long. Cognitive performance, brain activity and vascular parameters will be assessed using modern techniques, such as computer-generated and computer-measured tasks, fMRI, Visual Evoked Potentials (VEP) and Pulse Wave Velocity System (SphygmoCor).
VEP will determine the speed of conduction of electrical responses through the brain and reflects the integrity/efficiency of neural tissues in response to visual stimuli. In every diet group a smaller group of participants (11-12 participants) will be randomly selected to perform part of their tasks while their brains are being scanned with an MRI scanner using functional magnetic resonance imaging (fMRI) and diffusion weighting imaging (DWI) techniques.
Trial website
Trial related presentations / publications
Human Brain Mapping conference (San Francisco-June 2009) - Abstract presentation: Omega-3
dietary supplementation changes BOLD activation in an attentional task.
Public notes

Contacts
Principal investigator
Name 31439 0
Address 31439 0
Country 31439 0
Phone 31439 0
Fax 31439 0
Email 31439 0
Contact person for public queries
Name 14686 0
Isabelle Bauer/Laura Sellick
Address 14686 0
Brain Sciences Institute
400 Burwood Road
3122 Hawthorn VIC
Country 14686 0
Australia
Phone 14686 0
+613 9214 4542
Fax 14686 0
Email 14686 0
[email protected]/[email protected]
Contact person for scientific queries
Name 5614 0
David Crewther
Address 5614 0
Brain Sciences Institute
400 Burwood Road
PO BOX 218
3122 Hawthorn VIC
Country 5614 0
Australia
Phone 5614 0
+61 3 9214 5877
Fax 5614 0
Email 5614 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.