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Trial registered on ANZCTR
Registration number
ACTRN12611000094976
Ethics application status
Approved
Date submitted
20/12/2010
Date registered
27/01/2011
Date last updated
9/05/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Fish Oil and Multivitamin Study in Healthy Adults.
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Scientific title
An investigation of Omega-3 and Multivitamins on Mood, Cardiovascular health, Cognition in a healthy cohort of men and women aged 50 to 70 years of age.
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Secondary ID [1]
253103
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age-related cognitive decline in healthy individuals.
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Investigate the role of the cardiovascular system mediating cognitive performance.
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Assess mood and general wellbeing in health individuals.
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Condition category
Condition code
Mental Health
258807
258807
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0
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Studies of normal psychology, cognitive function and behaviour
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Cardiovascular
259036
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0
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Normal development and function of the cardiovascular system
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Alternative and Complementary Medicine
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The current study includes three treatment arms and one control arm. Participants were instructed to consume the supplements daily over a 4 month period. To implement the high and low dose fish oil conditions, the fish oil capsules were separated in morning and evening containers.
1) High dose fish oil and active multivitamin - Participants were instructed to consume 1 multivitamin capsule and 6 grams of fish oil daily.
2) Low dose fish oil and active multivitamin - Participants were instructed to consume 1 multivitamin and 6 grams of oil consisting of 3 grams of fish oil and 3 grams of sunola oil daily.
3) High dose fish oil and placebo multivitamin - Participants were instructed to consume 1 placebo multivitamin and 6 grams of fish oil daily.
Composition of active fish oil and multivitamin.
Active fish oil: Wild salmon Fish oil.
The high dose fish oil condition contained 6 grams of fish oil equating to 480 mg of EPA and 480 mg of DHA daily.
The low dose fish oil condition contained 3 grams of non active fish oil (sunola oil) and 3 grams of fish oil, equating to 240 mg of EPA and 240 mg of DHA daily.
Active Multivitmin formulation:
Retinyl Acetate 2500 IU
d-Alpha Tocopheryl Acid Succinate 24.2IU
Thiamine Hydrochloride 30 mg
Riboflavin 30 mg
Nicotinamide 20 mg
Pantothenic Acid 64 mg
Pyridoxine Hydrochloride 30mg
Cyanocobalamin 115mg
Cholecalciferol 200 Iu
Vitamin H 150 mcg
Folic Acid 500 mcg
Phytomenadione 60 mcg
Ascorbic acid 165 mg
Citrus Bioflavonoids Extract 20 mg
Calcium Orotate 100 mg
Magnesium Aspartate Dihydrate 100 mg
Selenomethionine 65 mcg
Molybdenum Trioxide 67.5 mcg
Chromium picolinate 50 mcg
Manganese Amino Acid Chelate 30 mg
Ferrous Fumarate 16.01 mg
Copper Gluconate 8.57 mg
Potassium Iodide 196 mcg
Zinc Amino Acid Chelate 75 mcg
Ubidecarenone 2 mg
Vaccinium Macrocarpon 800 mg
Silybum Marianum 1500 mg
Turnera diffusa Leaf
Ginkgo Biloba 1000 mg
Scutellaria Lateriflora 50 mg
Vitis Vinifera 1000 mg
Cynara Scolymus 100 mg
Urtica Dioica 100 mg
Cimicifuga Racemosa 200 mg
Tagetes Erecta 100 mg
Curcuma Longa 100 mg
Withania Somnifera 500 mg
Crataegus monogyna Fruit 100 mg
Silica Colloidal Anhydrous 20 mg
Bacopa Monnieri 50 mg
Lecithin Powder - Soy Phosphatidyl-serine Enriched Soy 10 mg
Spearmint Oil 2 mg
Vaccinium Myrtillus Fresh Fruit 100 mg
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Intervention code [1]
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Prevention
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
6grams sunola oil was used as the placebo fish oil.
Treatment four was the placebo Fish oil and placebo multivitamin - Participants were instructed to consume 1 placebo multivitamin and 6 grams of sunola oil daily.
Non active multivitamin: The placebo multivitmain contained a small amount of vitamin B to assist with blinding measures.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Cognitive performance. Reaction time and accuracy performance will be analysed across cognitive domains which include short and long term memory, working memory, attention and visual perception tasks. The Swinburne University Computerised Cognitive Battery (SUCCAB) will be implemented to assess these cognitive domains.
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Assessment method [1]
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Timepoint [1]
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Baseline, 6 weeks and 4 months
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Primary outcome [2]
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Cardiovascular health which includes arterial stiffness and cerebral blood velocity. Arterial stiffness will be assessed using the SphygmoCor. Doppler ultrasound will be used to measure blood velocity.
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Assessment method [2]
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Timepoint [2]
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Baseline, 6 weeks and 4 months
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Primary outcome [3]
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Mood and general well-being will be measured using a variety of measures which include the following:
- Beck Depression Inventory II
- Depression Anxiety Stress Scale
- General Health Questionnaire
- State and Trait anxiety stress scale
- Bond lader visual analogue scale
- Chalder fatigue scale
- Profile of Mood States.
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Assessment method [3]
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Timepoint [3]
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All mood measures will be assessed at Baseline, 6 weeks and 4 months except for the trait anxiety stress scale which will be completed only at Baseline.
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Secondary outcome [1]
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Blood profiling which includes the assessment of inflammatory markers, red blood Omega-3 states, Cholesterol and C-reactive protein.
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Assessment method [1]
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Timepoint [1]
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Baseline and 4 months
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Eligibility
Key inclusion criteria
Healthy, non-smoking individuals. Free from cardiovascular disease or diabetes. Free from neurological impediments. Not currently supplementing with any Omega-3 or multivitamins. Not currently taking any medication.
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Smoking. History of cardiovascular and neurological disease. Not currently taking Omega-3 and multivitamin supplements. Not currently taking pharmaceutical medication.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via newspaper advertisements as well as through our internal clinical trials database. Participants were randomly assigned to numbered containers which the sponsor randomly allocated to one of the four treatment conditions. The individual who screened participants and conducted testing was not involved or aware of the allocation of supplements.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation technique was implemented by using a randomization table created by Microsoft excel such that each of the 4 arms was represented once for every four sequential participant numbers.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
None
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2010
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Actual
25/01/2010
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Date of last participant enrolment
Anticipated
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Actual
15/08/2011
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Date of last data collection
Anticipated
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Actual
7/12/2011
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Sample size
Target
160
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
258234
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Commercial sector/Industry
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Name [1]
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Swisse Vitamins Pty Ltd
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Address [1]
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Street and Postal Adress:
36-38 Gipps Street,
Collingwood, Victoria, 3066, Australia.
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Swisse Vitamins Pty Ltd
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Address
Street and Postal Address:
36-38 Gipps Street,
Collingwood, Victoria, 3066 Australia.
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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Swinburne University of Technology
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Address [1]
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Street and Postal Address:
Brain and Psychological Sciences Research Instititue,
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122, Australia.
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Country [1]
251745
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Australia
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Other collaborator category [2]
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University
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Name [2]
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Southern Cross University - Professor Stephen Myers
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Address [2]
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Street Address:
School of Health & Human Sciences - Lismore,
Southern Cross University,
Military Road,
East Lismore, New South Wales, 2480, Australia.
Postal Address:
PO Box 157
Lismore NSW 2480.
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Country [2]
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Australia
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Other collaborator category [3]
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University
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Name [3]
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Deakin University - Professor Andrew Sinclair
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Address [3]
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Street and Postal Address:
School of Exercise and Nutrition Sciences,
Deakin University,
221 Burwood Highway,
Burwood, Victoria, 3125 Australia.
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Country [3]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Swinburne University Human Research Ethics Committee (SUHREC)
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Ethics committee address [1]
260213
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Research ethics officer
Swinburne research (H68)
Swinburne University of Technology
PO Boz 218
Hawthorn Vic, 3122
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Ethics committee country [1]
260213
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Australia
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Date submitted for ethics approval [1]
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13/03/2009
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Approval date [1]
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30/06/2009
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Ethics approval number [1]
260213
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2009/051 Effect of Omega-3 and Multivitamin Supplementation on Cognition, Mood and Cardiovascular Function in a Group of Older Males and Females.
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Summary
Brief summary
In Australia, the population is ageing due to lower birth rates and increased life expectancy. The implication of this changing demographic means that the age group with the greatest needs will be the elderly. Research in this area includes studies assessing the efficacy of fish oils and multivitamins to improve memory and cognitive function in the elderly. Research is also focussing on the potential neuroprotective effects of these supplements to protect the elderly from more insidious cognitive decline, such as Alzeimerās disease. The primary aim of the current study is to investigate whether supplementing diets with fish oils and multivitmains improve cognitive function in a healthy cohort of women and men aged 50 to 70 years of age. This research could potentially have significant bearing on the cognitive health of the elderly as well as the predicted economic burden in decades to come. Based on previous research, it is hypothesised that diets supplemented with a high dose of fish oil will improve cogntive performance namely spatial working memory performance and attentional processes. It is also anticipated that a high dose of fish oil compliemented with a multivitamin will provide additional benefits to cognitive performance as the multivitamins will limit oxidation of the Omega-3's once they have been ingested.
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Trial website
N/A
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Trial related presentations / publications
Pipingas, A., Cockerell, R., Grima, N., Sinclair, A., Stough, C., Scholey A., Myers, A., Croft, K., Sali, A., & Pase, M.P. (2014). Randomized controlled trial examining the effects of fish oil and multivitamin supplementation on the incorporation of n-3 and n-6 fatty acids into red blood cells. Nutrients, 6 (5); 1956-1970.
Pase, M.P., Grima, A., Cockerell, R., Stough, C., Scholey, A., Sali, A., & Pipingas, A. (2015). The effects of Omega-3 fish oils and multivitamins on cognitive and cardiovascular function: A randomized, controlled clinical trial. Journal of the American College of Nutrition.
Pipingas, A., Sinclair, A., Croft, K.D., Januszewski, A.S., Jenkins, A.J., Mori, T.A., Cockerell, R., Grima, N.A., Stough, C., Scholey, A., Myers, S.P., Sali, A., Pase, M.P. (2014). Fish oil and multivitamin supplementation reduces oxidative stress but not inflammation in healthy older adults: A randomised controlled trial. Journal of Functional Foods, 19, 949-957.
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Andrew Pipingas
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Address
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PO Box 218. Swinburne University of Technology. Hawthorn, Victoria, Australia. 3122
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Country
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Australia
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Phone
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+61 3 9214 5215
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Andrew Pipingas
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Address
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PO Box 218. Swinburne University of Technology. Hawthorn, Victoria, Australia. 3122
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Country
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Australia
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Phone
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+61 3 9214 5215
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Fax
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+61 3 9214 5525
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Dr. Andrew Pipingas
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Address
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Street and Postal Address:
Att: Dr. Andrew Pipingas
Brain and Psychological Sciences Research Instititue,
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122, Australia.
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Country
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Australia
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Phone
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+61 3 9214 5215
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Fax
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+61 3 9214 5525
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The Effects of Long-Chain Omega-3 Fish Oils and Multivitamins on Cognitive and Cardiovascular Function: A Randomized, Controlled Clinical Trial.
2015
https://dx.doi.org/10.1080/07315724.2014.880660
Dimensions AI
Randomized Controlled Trial Examining the Effects of Fish Oil and Multivitamin Supplementation on the Incorporation of n-3 and n-6 Fatty Acids into Red Blood Cells
2014
https://doi.org/10.3390/nu6051956
N.B. These documents automatically identified may not have been verified by the study sponsor.
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