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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.
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.
Secondary ID [1] 253103 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related cognitive decline in healthy individuals. 258661 0
Investigate the role of the cardiovascular system mediating cognitive performance. 260896 0
Assess mood and general wellbeing in health individuals. 260897 0
Condition category
Condition code
Mental Health 258807 258807 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 259036 259036 0 0
Normal development and function of the cardiovascular system
Alternative and Complementary Medicine 259037 259037 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 257623 0
Prevention
Intervention code [2] 257772 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 259669 0
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.
Timepoint [1] 259669 0
Baseline, 6 weeks and 4 months
Primary outcome [2] 259670 0
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.
Timepoint [2] 259670 0
Baseline, 6 weeks and 4 months
Primary outcome [3] 259671 0
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.
Timepoint [3] 259671 0
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.
Secondary outcome [1] 266367 0
Blood profiling which includes the assessment of inflammatory markers, red blood Omega-3 states, Cholesterol and C-reactive protein.
Timepoint [1] 266367 0
Baseline and 4 months

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.
Minimum age
50 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking. History of cardiovascular and neurological disease. Not currently taking Omega-3 and multivitamin supplements. Not currently taking pharmaceutical medication.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 258234 0
Commercial sector/Industry
Name [1] 258234 0
Swisse Vitamins Pty Ltd
Address [1] 258234 0
Street and Postal Adress:
36-38 Gipps Street,
Collingwood, Victoria, 3066, Australia.
Country [1] 258234 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Vitamins Pty Ltd
Address
Street and Postal Address:
36-38 Gipps Street,
Collingwood, Victoria, 3066 Australia.
Country
Australia
Secondary sponsor category [1] 257401 0
None
Name [1] 257401 0
Address [1] 257401 0
Country [1] 257401 0
Other collaborator category [1] 251745 0
University
Name [1] 251745 0
Swinburne University of Technology
Address [1] 251745 0
Street and Postal Address:
Brain and Psychological Sciences Research Instititue,
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122, Australia.
Country [1] 251745 0
Australia
Other collaborator category [2] 251746 0
University
Name [2] 251746 0
Southern Cross University - Professor Stephen Myers
Address [2] 251746 0
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.
Country [2] 251746 0
Australia
Other collaborator category [3] 251747 0
University
Name [3] 251747 0
Deakin University - Professor Andrew Sinclair
Address [3] 251747 0
Street and Postal Address:
School of Exercise and Nutrition Sciences,
Deakin University,
221 Burwood Highway,
Burwood, Victoria, 3125 Australia.
Country [3] 251747 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260213 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 260213 0
Research ethics officer
Swinburne research (H68)
Swinburne University of Technology
PO Boz 218
Hawthorn Vic, 3122
Ethics committee country [1] 260213 0
Australia
Date submitted for ethics approval [1] 260213 0
13/03/2009
Approval date [1] 260213 0
30/06/2009
Ethics approval number [1] 260213 0
2009/051 Effect of Omega-3 and Multivitamin Supplementation on Cognition, Mood and Cardiovascular Function in a Group of Older Males and Females.

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 Alzeimer’s 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.
Trial website
N/A
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.
Public notes

Contacts
Principal investigator
Name 31920 0
A/Prof Andrew Pipingas
Address 31920 0
PO Box 218. Swinburne University of Technology. Hawthorn, Victoria, Australia. 3122
Country 31920 0
Australia
Phone 31920 0
+61 3 9214 5215
Fax 31920 0
Email 31920 0
apipingas@swin.edu.au
Contact person for public queries
Name 15167 0
A/Prof Andrew Pipingas
Address 15167 0
PO Box 218. Swinburne University of Technology. Hawthorn, Victoria, Australia. 3122
Country 15167 0
Australia
Phone 15167 0
+61 3 9214 5215
Fax 15167 0
+61 3 9214 5525
Email 15167 0
apipingas@swin.edu.au
Contact person for scientific queries
Name 6095 0
A/Prof Dr. Andrew Pipingas
Address 6095 0
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.
Country 6095 0
Australia
Phone 6095 0
+61 3 9214 5215
Fax 6095 0
+61 3 9214 5525
Email 6095 0
apipingas@groupwise.swin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary