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Trial registered on ANZCTR


Registration number
ACTRN12608000117314
Ethics application status
Approved
Date submitted
11/02/2008
Date registered
4/03/2008
Date last updated
13/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Swinburne Multivitamin Study: Effects of vitamin and herbal supplementation on cognition, brain electrical activity and cardiovascular measures in older adults
Scientific title
In adults aged 50 to 70 years, do the Swisse Ultivite 50+ V Men's and Women's formulas compared with placebo improve measures of cognitive performance, brain electrical activity, cardiovascular measures and blood markers.
Secondary ID [1] 293603 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 2810 0
Cardiovascular function 2811 0
Brain function 2812 0
Blood markers of general wellbeing 2813 0
Condition category
Condition code
Mental Health 2946 2946 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 2947 2947 0 0
Normal development and function of the cardiovascular system
Neurological 2948 2948 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Swisse Women's Ulitivite 50+ V
One tablet per day for 16 weeks.
RETINYL ACETATE (equiv. to 2500 IU of vitamin A) 862.5 mcg
d-ALPHA-TOCOPHERYL ACID SUCCINATE (equiv. vitamin E 24.2 IU) 20 mg
THIAMINE HYDROCHLORIDE (vitamin B1) 30 mg
RIBOFLAVINE (vitamin B2) 30 mg
NICOTINAMIDE (vitamin B3) 20 mg
CALCIUM PANTOTHENATE (vitamin B5) (equiv. pantothenic acid 64.13mg) 70 mg
PYRIDOXINE HYDROCHLORIDE (vitamin B6) (equiv. pyridoxine 24.68mg) 30 mg
CYANOCOBALAMIN (vitamin B12) 115 mcg
CHOLECALCIFEROL (vitamin D3) (equiv. vitamin D 200 IU) 5mcg
BIOTIN (vitamin H) 150 mcg
FOLIC ACID 500 mcg
CALCIUM ASCORBATE DIHYDRATE (vitamin C)(equiv. ascorbic acid 165.3mg) 200 mg
PHYTOMENADIONE (vitamin K1) 60 mcg
CITRUS BIOFLAVONOIDS EXTRACT 20 mg
CALCIUM OROTATE (equiv. calcium 10mg) 100 mg
MAGNESIUM ASPARTATE DIHYDRATE (equiv. magnesium 6.74mg) 100 mg
SELENOMETHIONINE (equiv. selenium 26mcg) 65 mcg
MOLYBDENUM TRIOXIDE (equiv. molybdenum 45mcg) 67.5 mcg
CHROMIUM PICOLINATE (equiv. chromium 50 mcg) 402 mcg
MANGANESE AMINO ACID CHELATE (equiv. manganese 3mg) 30 mg
FERROUS FUMERATE (equiv. iron 5mg) 16.01 mg
COPPER GLUCONATE (equiv. copper 1.2mg) 8.57 mg
POTASSIUM IODIDE (equiv. iodine 149.83mcg) (equiv. potassium 46.18mcg) 196 mcg
ZINC AMINO ACID CHELATE (equiv. zinc 15mg) 75 mg
Lactobacillius rhamnosus 80 million organisms
Lactobacillus acidophilus 80 million organisms
Bifidobacterium longum 35 million organisms
VACCINIUM MACROCARPON FRUIT DRY (patented cranberry PACRAN) 800 mg
SILYBUM MARIANUM DRY FRUIT (St. Mary’s thistle) (equiv. flavanolignans calculated as silybin 17.14mg) 1500 mg
GINKGO BILOBA LEAF DRY (Maidenhair tree) (equiv. Ginkgo flavonglycosides 4.8mg and ginkgolides and bilobalide 1.2mg) 1000 mg
TUNERA DIFFUSA LEAF DRY (Damiana) 500 mg
SCUTELLARIA LATERIFLORA HERB DRY (Skullcap) 50 mg
VITIS VINIFERA DRY SEED (Grape seed) (equiv. procyanidins 7.9mg) 1000 mg
URTICA DIOICA LEAF DRY (Nettle) 100 mg
UBIDECARENONE (Co-enzyme Q10) (from patented Ultrasome CoQ10) 2 mg
CYNARA SCOLYMUS LEAF DRY (Globe artichoke) 50 mg
CIMICIFUGA RACEMOSA ROOT & RHIZOME DRY (Black cohosh) 200 mg
CURCUMA LONGA RHIZOME DRY (Tumeric) 100 mg
WITHANIA SOMNIFERA ROOT DRY (Ashwagandha) 500 mg
CRATAEGUS MONOGYNA FRUIT DRY (Hawthorn) 100 mg
SILICA COLLOIDAL ANHYDROUS (equiv. silicon 9.35mg) 20 mg
BACOPA MONNIERI WHOLE PLANT DRY (Bacopa) (equiv. bacosides calculated as bacoside A 1.125mg) 50 mg
LECITHIN POWDER – SOY PHOSPHATIDYLSERINE ENRICHED SOY (equiv. phosphatidylserine 2mg) 10 mg
SPEARMINT OIL 2 mg
VACCINIUM MYRTILLUS FRUIT DRY (Bilberry) (equiv. anthocyanosides 324mcg) 100 mg
TAGETES ERECTA FLOWER DRY (Marigold) (Lutein esters calculated as lutein (of Tagetes erecta) 1mg) 100 mg

Swisse Men's Ultivite 50+ V
Multivitamin, mineral and herbal supplementation.
One tablet per day for 16 weeks.
Swisse Men's Ultivite 50+ V

RETINYL ACETATE (equiv. to 2500 IU of vitamin A) 862.5 mcg
d-ALPHA-TOCOPHERYL ACID SUCCINATE (equiv. vitamin E 30.25 IU) 25 mg
THIAMINE HYDROCHLORIDE (vitamin B1) 35 mg
RIBOFLAVINE (vitamin B2) 35 mg
NICOTINAMIDE (vitamin B3) 25 mg
CALCIUM PANTOTHENATE (vitamin B5) (equiv. pantothenic acid 68.7mg) 75 mg
PYRIDOXINE HYDROCHLORIDE (vitamin B6) (equiv. pyridoxine 20.56mg) 25 mg
CYANOCOBALAMIN (vitamin B12) 120 mcg
CHOLECALCIFEROL (vitamin D3) (equiv. vitamin D 200 IU) 5mcg
BIOTIN (vitamin H) 200 mcg
FOLIC ACID 500 mcg
CALCIUM ASCORBATE DIHYDRATE (vitamin C) (equiv. ascorbic acid 165.3mg) 200 mg
PHYTOMENADIONE (vitamin K) 70 mcg
CITRUS BIOFLAVONOIDS EXTRACT 20 mg
CALCIUM OROTATE (equiv. calcium 10mg) 100 mg
MAGNESIUM ASPARTATE DIHYDRATE (equiv. magnesium 6.74mg) 100 mg
SELENOMETHIONINE (equiv. selenium 26mcg) 65 mcg
MOLYBDENUM TRIOXIDE (equiv. molybdenum 45mcg) 67.5 mcg
CHROMIUM PICOLINATE (equiv. chromium 50 mcg) 402 mcg
MANGANESE AMINO ACID CHELATE (equiv. manganese 4mg) 40 mg
FERROUS FUMERATE (equiv. iron 5mg) 16.01 mg
COPPER GLUCONATE (equiv. copper 1.7mg) 12.14 mg
POTASSIUM IODIDE (equiv. iodine 149.83mcg) (equiv. potassium 46.18mcg) 196 mcg
ZINC AMINO ACID CHELATE (equiv. zinc 20mg) 100 mg
Lactobacillius rhamnosus 80 million organisms
Lactobacillus acidophilus 80 million organisms
Bifidobacterium longum 35 million organisms
VACCINIUM MACROCARPON FRUIT DRY (patented cranberry PACRAN) 1000 mg
SILYBUM MARIANUM DRY FRUIT (St. Mary’s thistle) (equiv. flavanolignans calculated as silybin 19.43mg) 1700 mg
GINKGO BILOBA LEAF DRY (Maidenhair tree) (equiv. Ginkgo flavonglycosides 4.8mg and ginkgolides and bilobalide 1.2mg) 1000 mg
TRIBULUS TERRESTRIS FRUIT & ROOT DRY (Tribulus) 1000 mg
DULACIA INOPIFLORA ROOT DRY (Muirapuama) 200 mg
SCUTELLARIA LATERIFLORA HERB DRY (Skullcap) 50 mg
VITIS VINIFERA DRY SEED (Grape seed) (equiv. procyanidins 7.9mg) 1000 mg
SERENOA REPENS FRUIT DRY (Saw palmetto) (equiv. fatty acids 27mg) 300 mg
URTICA DIOICA LEAF DRY (Nettle) 50 mg
UBIDECARENONE (Co-enzyme Q10) (from patented Ultrasome CoQ10) 3 mg
CYNARA SCOLYMUS LEAF DRY (Globe artichoke) 50 mg
CRATAEGUS MONOGYNA FRUIT DRY (Hawthorn) 120 mg
LECITHIN POWDER – SOY PHOSPHATIDYLSERINE ENRICHED SOY (equiv. phosphatidylserine 2mg) 10 mg
SPEARMINT OIL 2 mg
VACCINIUM MYRTILLUS FRUIT DRY (Bilberry) (equiv. anthocyanosides 324mcg) 100 mg
TAGETES ERECTA FLOWER DRY (Marigold) (Lutein esters calculated as lutein (of Tagetes erecta) 1mg) 100 mg
Intervention code [1] 2549 0
Other interventions
Comparator / control treatment
Placebo:One tablet per day for 16 weeks.
Women's:One tablet per day for 16 weeks.
EXCIPIENTS:
CELLULOSE-MICROCRYSTALLINE
CROSPOVIDONE
CROSCARMELLOSE SODIUM
POVIDONE
MAGNESIUM STEARATE
COATING:
HYPROMELLOSE
CACROGOL 400
TITANIUM DIOXIDE
IRON OXIDE RED
IRON OXIDE YELLOW
SPEARMINT OIL
CARNAUBA WAX

Men's:One tablet per day for 16 weeks.
EXCIPIENTS:
CELLULOSE-MICROCRYSTALLINE
CROSPOVIDONE
CROSCARMELLOSE SODIUM
POVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
COATING:
CHLOROPHYLLIN COPPER COMPLEX
OPADRY II WHITE
SPEARMINT OIL
CARNAUBA WAX
Control group
Placebo

Outcomes
Primary outcome [1] 3828 0
Percentage accuracy and response time on computerised cognitive tests. Computer tasks include Response Time, Choice Response Time, Recognition Memory, Stroop Task, Spatial Working Memory, Contextual Memory, and Delayed Recognition Memory.
Timepoint [1] 3828 0
before and after 16 weeks of supplementation
Primary outcome [2] 3829 0
patterns of brain electrical activity using the steady state visual evoked potential technique
Timepoint [2] 3829 0
before and after 16 weeks of supplementation
Primary outcome [3] 3830 0
Blood pressure and augmentation index as measured by the Sphygmocor pulse wave analysis system
Timepoint [3] 3830 0
before and after 16 weeks of supplementation
Secondary outcome [1] 6458 0
Blood levels of: homocysteine; c-reactive protein; fibrinogen; lipids; vitamins B6, B12, C, E and folate; protein carbonyls; electrolytes.
Timepoint [1] 6458 0
before and after 16 weeks of supplementation

Eligibility
Key inclusion criteria
Males and females aged 50-70 years.
Minimum age
50 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking; current supplementation with multivitamins; history of psychiatric disorder, neurological disease, diabetes or food intolerance/allergy

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)
Placebo and treatment were randomised by Swisse Vitamins Pty Ltd and packaged in identical blister packs. Packets were numbered according to the randomization schedule, which is held by Swisse Vitamins. Participants are allocated the next sequential number upon enrolment to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
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
Recruitment postcode(s) [1] 574 0
3121

Funding & Sponsors
Funding source category [1] 3076 0
Commercial sector/Industry
Name [1] 3076 0
Swisse Vitamins Pty Ltd
Address [1] 3076 0
36-38 Gipps Street
Collingwood Victoria 3066
Country [1] 3076 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Pipingas
Address
Brain Sciences Institute
400 Burwood Rd
Hawthorn Victoria 3121
Country
Australia
Secondary sponsor category [1] 2770 0
Individual
Name [1] 2770 0
Elizabeth Harris
Address [1] 2770 0
Brain Sciences Institute
400 Burwood Rd
Hawthorn Victoria 3121
Country [1] 2770 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5024 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 5024 0
Swinburne University
Hawthorn Victoria 3121
Ethics committee country [1] 5024 0
Australia
Date submitted for ethics approval [1] 5024 0
Approval date [1] 5024 0
01/11/2006
Ethics approval number [1] 5024 0
06/07/073

Summary
Brief summary
This study aims to investigate the effects of multivitamin, mineral and herbal supplementation on cognitive performance in older adults.
It is hypothesized that performance on cognitive tasks will improve in the multivitamin group compared with the placebo group.
The study also aims to investigate some of the physiological correlates of cognitive performance (brain electrical activity, cardiovascular function, blood markers) in order to gain further insight to possible mechanisms of cognitive improvement through supplementation.
Trial website
Trial related presentations / publications
Harris, E., Rowsell, R., Pipingas, A., Macpherson, H.
No effect of multivitamin supplementation on central blood pressure in healthy older people: A randomized controlled trial (2016) Atherosclerosis, 246, pp. 236-242.

Harris, E., Macpherson, H., Pipingas, A.
Improved blood biomarkers but no cognitive effects from 16 weeks of multivitamin supplementation in healthy older adults (2015) Nutrients, 7 (5), pp. 3796-3812.
Public notes

Contacts
Principal investigator
Name 28363 0
A/Prof Andrew Pipingas
Address 28363 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Hawthorn, VIC, 3122
Australia
Country 28363 0
Australia
Phone 28363 0
+61392145215
Fax 28363 0
Email 28363 0
apipingas@swin.edu.au
Contact person for public queries
Name 11520 0
Dr Elizabeth Harris
Address 11520 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Hawthorn, VIC, 3122
Australia
Country 11520 0
Australia
Phone 11520 0
0392145656
Fax 11520 0
Email 11520 0
eharris@swin.edu.au
Contact person for scientific queries
Name 2448 0
Dr Elizabeth Harris
Address 2448 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Hawthorn, VIC, 3122
Australia
Country 2448 0
Australia
Phone 2448 0
0392145656
Fax 2448 0
Email 2448 0
eharris@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