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Trial registered on ANZCTR


Registration number
ACTRN12612001043820
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
2/10/2012
Date last updated
10/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a multivitamin preparation on brain function.
Scientific title
Effects of 4 weeks supplementation with a multivitamin/mineral preparation on brain function in healthy volunteers assessed with Steady State Topography and fMRI during periods of mental effort: A randomized, double-blind, placebo controlled trial
Secondary ID [1] 281238 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 287430 0
Condition category
Condition code
Mental Health 287764 287764 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 287765 287765 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant will be randomly assigned to one of the following treatments:

1)Berocca Performance (registered trademark)
2)Placebo: Matched for appearance, taste and smell.

Treatments will be administered in the form of effervescent tablets.

Participants will be instructed to take one tablet daily, before lunch, dissolved in a glass of water for a duration of 28 days.

Each Berocca Performance tablet contains:


Vitamin C 500mg
Thiamine Monophosphoric acid ester chloride 18.54mg
Riboflavin (Vitamin B2) 15mg
Nicotinamide (B3/niacin) 50mg
Vitamin B5 23mg
Vitamin B6 10mg
Vitamin B12 0.01mg
Folic Acid (Vitamin B9) 0.4mg
Biotin (Vitamin B7) 0.15mg
Calcium 100mg
Magnesium 100mg
Zinc 10mg
Intervention code [1] 285704 0
Treatment: Other
Comparator / control treatment
Placebo- matched for appearance taste and smell.
Control group
Placebo

Outcomes
Primary outcome [1] 287994 0
Functional brain activity changes associated with supplementation (SST latency and amplitude, as well as fMRI BOLD response).
Timepoint [1] 287994 0
Baseline and day 28; following daily supplementation with Berocca or Placebo
Secondary outcome [1] 299222 0
Cognitive performance as assessed by the following tasks:
A-X Continuous Performance Task
Spatial Working Memory
Rapid Visual Information Processing
Inspection Time
Timepoint [1] 299222 0
Baseline and day 28; following daily supplementation with Berocca or Placebo
Secondary outcome [2] 299223 0
Mood as assessed by the following questionnaires:
Profile of Mood States (POMS)
State-Trait Anxiety Inventory
Perceived Stress Scale (PSS)
Bond-Lader Visual Analog Mood Scales
Stress, Fatigue and Energy Visual Analogue Scales (VAS)
Timepoint [2] 299223 0
Pre-SST and Post-SST at Baseline and day 28.

Eligibility
Key inclusion criteria
1.Healthy, non-smoking, males and females aged 18-40.
2.Are comfortable with computers, EEG (not photosensitive or sensitive to flashing lights) and fMRI and willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol.
3.Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
4.For participants in the fMRI condition, only right handed participants will be recruited
5.Female subjects of childbearing age using an acceptable form of contraception
6.Fluent in spoken and written English
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of or currently suffering from anxiety, depression, psychiatric disorders.
2. History of / currently suffering from heart disease, high blood pressure or diabetes
3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs within 4 weeks prior to (and duration of) study (except for routine medications to treat benign conditions, such as antibiotics to treat acne), or excessive consumption of caffeine or alcohol in this period, 4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
5. Epilepsy/Photosensitive or unable to look at flashing lights
6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder)
7. Currently pregnant or lactating
8. Left handed participants (for fMRI component only). This is for ease of analysis looking at the fMRI. There are hemispheric differences in terms of structure between right and left handed individuals that prove to be problematic when analysing the output. Given that this investigation will employ a method where participants need to press buttons as a response (in turn involving the motor cortex), it is wise to use an all right handed population.
9. People with metal implants (for fMRI component only)
10. Vital signs out of the normal range (blood pressure, pulse rate, body temperature)
11. History of head trauma
12. Hypersensitivity to the investigational product or any of the active/inactive ingredients
13. Participation in another trial within 30 days prior to the start of the study.
14. Any condition which may interfere with the subject’s ability to perform assessments (e.g. claustrophobia for the fMRI arm, dyslexia, limb deformity).

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)
A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned in ascending numerical order as each subject signs their consent form. Subjects who meet all inclusion and exclusion criteria will be randomised according to the randomisation schedule.

A disinterested third party will generate the randomisation sequence using a computerised sequence generator

Randomisation numbers will be assigned in ascending numerical order according to appearance at the study site on the day subjects are randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using computer software and will also be stratified for subjects performing the fMRI: The two strata will be : i) Subjects undergoing fMRI ii) Subjects NOT undergoing fMRI. A randomisation schedule will be prepared for each strata
The study was extended to include an additional 16 participants who completed just the fMRI competent of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study will follow a randomised, double blind, placebo-controlled, parallel groups design. Forty participants will complete the SST component of the study. Of these, 16 participants will also complete an fMRI component.
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)

Funding & Sponsors
Funding source category [1] 286017 0
Commercial sector/Industry
Name [1] 286017 0
Bayer Consumer Care AG
Address [1] 286017 0
Peter Merian-Strasse 84
P.O. Box, 4002 Basel
Switzerland
Country [1] 286017 0
Switzerland
Primary sponsor type
University
Name
Swinburne University
Address
PO Box 218
Hawthorn,
VIC, 3122
Country
Australia
Secondary sponsor category [1] 284833 0
None
Name [1] 284833 0
Address [1] 284833 0
Country [1] 284833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288067 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 288067 0
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [1] 288067 0
Australia
Date submitted for ethics approval [1] 288067 0
Approval date [1] 288067 0
14/09/2012
Ethics approval number [1] 288067 0
2012/164

Summary
Brief summary
The objective of this pilot, exploratory study is to investigate the effects of 4 weeks supplementation with a multivitamin/mineral preparation on brain activity and nutritional status assessed via established functional imaging techniques and blood biomarkers of health in healthy volunteers.

Participants will attend two testing sessions, one baseline and one after 4-weeks supplementation. During testing sessions participants will complete a series of common assessments including nutritional status and mood assessment. They will all undergo SST and a sub sample will go on to complete fMRI.

Following baseline participants will be randomly assigned to one of two treatments:

1) Berocca Performance
2)Placebo (matched for appearance, taste and smell)

Following 4-week daily supplementation with allocated treatment participants will return for their second testing day.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34716 0
Prof Andrew Scholey
Address 34716 0
Mail H24, PO Box 218
Swinburne University of Technology
Hawthorn VIC 3122
Country 34716 0
Australia
Phone 34716 0
+61392148932
Fax 34716 0
Email 34716 0
ascholey@swin.edu.au
Contact person for public queries
Name 17963 0
Ms Tinette Goh
Address 17963 0
Swinburne University
H24, Po Box 218
Hawthorn, Vic, 3122
Country 17963 0
Australia
Phone 17963 0
+613 9214 5094
Fax 17963 0
Email 17963 0
agoh@swin.edu.au
Contact person for scientific queries
Name 8891 0
Prof Professor Andrew Scholey
Address 8891 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 8891 0
Australia
Phone 8891 0
+613 9214 8932
Fax 8891 0
Email 8891 0
ascholey@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