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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03482063




Registration number
NCT03482063
Ethics application status
Date submitted
14/03/2018
Date registered
29/03/2018

Titles & IDs
Public title
The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood
Scientific title
The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood: The Memory + Focus Clinical Trial (MAST - Memory and Attention Supplement Trial)
Secondary ID [1] 0 0
MAST
Universal Trial Number (UTN)
Trial acronym
MAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive Function 0 0
Mood 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Swisse Ultiboost Memory + Focus
Other interventions - Placebo

Experimental: Swisse Ultiboost Memory + Focus - two tablets daily, one tablet during or immediately after breakfast, and one tablet during or immediately after lunch, for the duration of the trial period

Placebo comparator: Placebo - two tablets daily, one tablet during or immediately after breakfast, and one tablet during or immediately after lunch, for the duration of the trial period


Treatment: Other: Swisse Ultiboost Memory + Focus
B vitamins help energy release, help with metabolism of food into energy, assist energy production and vitality.

Vitamin B5 helps support normal mental performance. Brahmi, Ginkgo, Vitamin B12 and B3 help support brain function. Ginkgo helps maintain healthy circulation and delivery of oxygenated blood to the brain.

Brahmi supports memory function and recall. Vitamin B5, B6 are important for adrenal function, assist adrenal glands during stress periods.

Vitamin B2, B3, B5, B6, B12 help relieve tiredness and fatigue.

Other interventions: Placebo
riboflavin (2.2mg)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in short term memory, as measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery.
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Changes in focus, as measured by the incongruent version of the stroop colour-word task from the Swinburne University Computerised Cognitive Assessment Battery
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Simple reaction time component of the Swinburne University Computerised Cognitive Aging Battery (SUCCAB)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Choice reaction time component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Immediate/Delayed Recognition component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Stroop Colour-Word component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Contextual memory component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Serial Threes Subtraction component of the Cognitive Demand Battery
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Serial Sevens Subtraction component of the Cognitive Demand Battery
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Rapid Visual Information Processing component of the Cognitive Demand Battery
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Perceived Stress Scale (PSS)
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Profile of Mood States (PROMS)
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
The Depression, Anxiety and Stress Scale (DASS)
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
State-Trait Anxiety Inventory - State Subscale (STAI-S)
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Bond-Lader Visual Analogue Scales (VAS)
Timepoint [13] 0 0
12 weeks
Secondary outcome [14] 0 0
Stress, Anxiety, Mental Fatigue, Concentration and Mental Stamina Visual Analogue Mood Scales (VAMS)
Timepoint [14] 0 0
12 weeks
Secondary outcome [15] 0 0
Prospective and Retrospective Memory Questionnaire (PRMQ)
Timepoint [15] 0 0
12 weeks
Secondary outcome [16] 0 0
Chalder Fatigue Scale (CFS)
Timepoint [16] 0 0
12 weeks
Secondary outcome [17] 0 0
Subjective Experience Survey
Timepoint [17] 0 0
12 weeks
Secondary outcome [18] 0 0
Biomedical measures
Timepoint [18] 0 0
12 weeks
Secondary outcome [19] 0 0
Neuroimaging
Timepoint [19] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Healthy males and females aged between 40 and 65 years
2. Non-smokers
3. English speaking
4. Not currently being treated for anxiety, depression or psychiatric disorders (if treatment was >2 years ago, can include)
5. Not suffering from cognitive impairment
6. No history of or currently suffering from neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
7. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) study, as defined by the exclusion list (Appendix 9)
8. No health conditions that would affect absorption of food, including the following: food allergies, impaired kidney function , liver disease (Hepatitis C, cirrhosis) and/or gastrointestinal diseases (e.g. Inflammatory bowel disease (Ulcerative Colitis, Crohn's Disease), coeliac disease, peptic ulcers)
9. Right handed (MRI component only)
10. Not hypertensive (systolic < 160 mm Hg and/or diastolic < 100 mm Hg at rest)
11. Not misusing substances
12. Have internet access in the home
13. Normal or corrected vision and normal colour vision
14. Not currently participating, or has not participated in another study investigating a nutraceutical supplement within the past 4 weeks
15. Not currently pregnant or lactating (for female participants of child bearing potential, the use of effective contraceptive method(s) for birth control for the duration of the study)
16. Willing and able to provide written informed consent.
17. Understands and is willing and able to comply with all study procedures.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Chronic health condition
2. Smoker
3. Non-English speaking
4. Treatment for anxiety, depression (Becks Depression Inventory score =20 to be confirmed at screening visit) or other psychiatric conditions within the past 2 years
5. Suffering from cognitive impairment, dementia, Alzheimer's disease and/or a score of <24 on the Mini-Mental State Examination (to be confirmed at screening visit)
6. Neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
7. Use of concomitant medications and/or vitamin supplements that could have cognitive or mood effects in the 4 weeks preceding the baseline visit, as defined by the exclusion list (Appendix 9)
8. Health conditions that would affect absorption of food, including the following: food allergies, impaired kidney function, liver disease (Hepatitis C, cirrhosis) and/or gastrointestinal diseases (e.g. Inflammatory bowel disease (Ulcerative Colitis, Crohn's Disease), coeliac disease, peptic ulcers)
9. Left handed (MRI participants only)
10. Blood pressure consistent with uncontrolled hypertension, (systolic > 160 mm Hg and/or diastolic > 100 mm Hg at rest)
11. Alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week.
12. Hypersensitivity to the investigational product or any of the active/inactive ingredients
13. Currently taking Warfarin
14. Currently participating, or has participated in another study investigating a nutraceutical supplement within the past 4 weeks
15. People with metal implants, pacemaker or aneurism clip (MRI participants only)
16. Currently pregnant or lactating
17. Any condition which may interfere with the subject's ability to perform assessments (e.g. claustrophobia for the MRI arm, dyslexia, colour blindness)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2020
Sample size
Target
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Swisse Wellness Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Swinburne University of Technology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Pipingas
Address 0 0
Swinburne University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03482063