Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001116819
Ethics application status
Approved
Date submitted
16/10/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of multi-vitamin/mineral preparations on brain imaging during periods of mental effort
Scientific title
Acute effects of multi-vitamin/mineral preparations on brain imaging assessed with steady state tomography and fMRI during periods of mental effort in healthy adults aged 18-40 years
Secondary ID [1] 281403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 287648 0
Condition category
Condition code
Mental Health 287978 287978 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 287979 287979 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a treatment (drink) pre-prepared by the investigator. Each treatment will consist of one effervescent tablet mixed with water as per the manufacturer’s recommended dosage. Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products).

The 3 treatments are:
- Berocca Performance (Registered Trademark)
- Berocca Boost (Registered Trademark)
- Placebo (matched for taste and appearance)

Each Berocca Performance tablet (effervescent) 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

Each Berocca Boost tablet (effervescent) contains:
Vitamin B1 1.40mg
Vitamin B2 1.60mg
Nicotinamide 18mg
Pantothenic Acid 6mg
Vitamin B6 2mg
Folic Acid 200ug
Vitamin B12 1ug
Biotin 150ug
Vitamin C 60mg
Calcium 100mg
Magnesium 100mg
Zinc 9.50mg
Guarana (containing 40mg of caffeine) 222.2mg

All participants will be randomized to one cell of a Latin Square representing one of the following treatment orders:
1. PLACEBO => BEROCCA PERFORMANCE => BEROCCA BOOST
2. PLACEBO => BEROCCA BOOST => BEROCCA PERFORMANCE
3. BEROCCA PERFORMANCE => BEROCCA BOOST => PLACEBO
4. BEROCCA PERFORMANCE => PLACEBO => BEROCCA BOOST
5. BEROCCA BOOST => PLACEBO=> BEROCCA PERFORMANCE
6. BEROCCA BOOST =>BEROCCA PERFORMANCE => PLACEBO
Intervention code [1] 285890 0
Treatment: Other
Comparator / control treatment
Placebo- matched for appearance taste and smell
Control group
Placebo

Outcomes
Primary outcome [1] 288190 0
Cognitive performance on Spatial Working Memory, Continuous performance, and Cognitive Demand Battery
Timepoint [1] 288190 0
Baseline and 30 mins post dose
Secondary outcome [1] 299582 0
Steady State Topography latency and amplitude
Timepoint [1] 299582 0
30 mins post dose
Secondary outcome [2] 299583 0
Mood (alert, calm, content, stress, fatigue, tiredness) using Profile of Mood States (POMS), State-Trait Anxiety Inventory, Bond Lader and Stress and Fatigue Visual Analogue Mood Scales (VAMS)
Timepoint [2] 299583 0
Baseline and 30 mins post dose
Secondary outcome [3] 299592 0
fMRI brain imaging (and performance on RVIP and Inspection Time tasks)
Timepoint [3] 299592 0
30 mins post dose

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. Must be right-handed
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of anxiety, depression, psychiatric disorders.
2. Currently suffering from/ or have history of heart disease or high blood pressure or diabetes
3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
4. Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
5. 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)
6. Epilepsy/Photosensitive or unable to look at flashing lights
7. Left handed participants. 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.
8. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder),
9. Currently pregnant or lactating
10. People with metal implants (for MRI component)

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)
Randomization of participants to a treatment sequence will be determined by a latin square. Eligible, recruited participants will be assigned a participant number. The randomisation order that has been placed next to the participant’s number will be the allocated treatment for that individual. Participants will be randomly allocated to the fMRI assessment (5 participants) or the CDB/SST assessment (15 participants)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
placebo-controlled, double-blind, randomized, crossover trial
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286161 0
Commercial sector/Industry
Name [1] 286161 0
Bayer
Country [1] 286161 0
Germany
Primary sponsor type
University
Name
Swinburne University of Technology
Address
427-451 Burwood Road, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 284971 0
None
Name [1] 284971 0
Address [1] 284971 0
Country [1] 284971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288216 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 288216 0
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [1] 288216 0
Australia
Date submitted for ethics approval [1] 288216 0
Approval date [1] 288216 0
25/05/2011
Ethics approval number [1] 288216 0
2010/300

Summary
Brief summary
This study will follow a randomized, double blind, placebo-controlled, cross over design. 20 participants will complete the study, of which 15 will take part in the SST/CDB part and 5 participants will take part in the fMRI component with the RVIP and inspection time tasks. For the 15 participant group, they will attend 3 testing days and will first do baseline testing of the CDB, followed by treatment administration and post dose testing of all tasks at 30min post dose (post dose testing will consist of CDB and SST. For the fMRI group, participants will consume their allocated treatment and undergo the cognitive tasks in the fMRI scanner 30mins post dose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34840 0
Address 34840 0
Country 34840 0
Phone 34840 0
Fax 34840 0
Email 34840 0
Contact person for public queries
Name 18087 0
Antionette Goh
Address 18087 0
Mail H24, PO Box 218,
Swinburne University
Hawthorn VIC 3122
Country 18087 0
Australia
Phone 18087 0
+61 3 9214 5094
Fax 18087 0
Email 18087 0
[email protected]
Contact person for scientific queries
Name 9015 0
Prof Andrew Scholey
Address 9015 0
Mail H24, PO Box 218,
Swinburne University
Hawthorn VIC 3122
Country 9015 0
Australia
Phone 9015 0
+61 3 9214 8932
Fax 9015 0
Email 9015 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of a single dose of multivitamin and mineral combinations with and without guarana on functional brain activity during a continuous performance task.2017https://dx.doi.org/10.1179/1476830514Y.0000000157
N.B. These documents automatically identified may not have been verified by the study sponsor.