Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001150730
Ethics application status
Approved
Date submitted
22/03/2022
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin B Multivitamin Supplement on Neural Connectivity and Oxidative Metabolism
Scientific title
Effect of High-Dose-Vitamin-B Multivitamin Supplement on Neural Connectivity and Oxidative Metabolism in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled, Phase I Clinical Trial
Secondary ID [1] 306179 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive decline 324887 0
Oxidative Stress 326541 0
Condition category
Condition code
Alternative and Complementary Medicine 322323 322323 0 0
Other alternative and complementary medicine
Neurological 322324 322324 0 0
Other neurological disorders
Inflammatory and Immune System 324507 324507 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Executive B Stress, Blackmores, Australia containing Passiflora Incarnata herbal extract; Two oral tablets per day. Each tablet contains 56.6 mg Vitamin B1, 10 mg Vitamin B2, 100 mg Vitamin B3, 25.53 mg Vitamin B6, 250 mg Vitamin C, 30 IU Vitamin E, 75 mg Vitamin B5, 254.11 mg Magnesium phosphate pentahydrate, 30 mcg Vitamin B12, 50 mcg Biotin, 200 mcg Folic acid, 25 mg Choline bitartrate, 25 mg Inositol, 18.67 mg Zinc oxide, 75 mg Potassium sulphate, 100 mg dried Passiflora incarnata herbal extract.

Group 2: Executive B Stress, Blackmores, Australia without Passiflora Incarnata herbal extract; Two oral tablets per day. Each tablet contains 56.6 mg Vitamin B1, 10 mg Vitamin B2, 100 mg Vitamin B3, 25.53 mg Vitamin B6, 250 mg Vitamin C, 30 IU Vitamin E, 75 mg Vitamin B5, 254.11 mg Magnesium phosphate pentahydrate, 30 mcg Vitamin B12, 50 mcg Biotin, 200 mcg Folic acid, 25 mg Choline bitartrate, 25 mg Inositol, 18.67 mg Zinc oxide, 75 mg Potassium sulphate.
Intervention code [1] 322587 0
Prevention
Comparator / control treatment
Placebo that contains glucose and trace quantities of Riboflavin (B2) to match the colour and taste of the active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 330090 0
Composite Primary Outcome:
The effect of high-dose-B-vitamin multivitamin supplement with and without Passiflora Incarnata herbal extract on the connectivity of the default mode network will be assessed by resting-state functional magnetic resonance imaging (rs-fMRI) and diffusion tensor imaging (DTI) on specific brain regions.
Timepoint [1] 330090 0
Baseline (Week 0, pre-intervention commencement), Weeks 6, 12, and 24 (primary endpoint) post-intervention commencement
Primary outcome [2] 331575 0
The safety end-point will be assessed through the vital signs measurements. Heart rate and blood pressure will be measured using a digital sphygmomanometer, red and white blood cells and liver function will be assessed using a blood sample.
Timepoint [2] 331575 0
Baseline (Week 0, pre-intervention commencement), Weeks 6, 12, and 24 (primary endpoint) post-intervention commencement
Secondary outcome [1] 404852 0
The effect of high-dose-vitamin-B multivitamin supplement with and without Passiflora Incarnata herbal extract on neural metabolites for oxidative stress will be assessed by 1H-MRS (Proton magnetic resonance spectroscopy).
Timepoint [1] 404852 0
Baseline (Week 0, pre-intervention commencement), Weeks 6, 12, and 24 post-intervention commencement.
Secondary outcome [2] 410334 0
The effect of high-dose-vitamin-B multivitamin supplement with and without Passiflora Incarnata herbal extract on plasma biomarkers for oxidative stress will be assessed by blood plasma analysis for oxidative stress biomarkers (i.e. folate, B6, B16 and homocysteine)
Timepoint [2] 410334 0
Baseline (Week 0, pre-intervention commencement), Weeks 6, 12, and 24 post-intervention commencement

Eligibility
Key inclusion criteria
• Healthy non-smoking males and females aged between 30 and 55 years
• Not heavy consumers of alcohol (i.e., females consumed < 14 standard drinks per week, males consumed < 28 standard drinks per week)
• No history of psychiatric disorders including clinical depression, anxiety or epilepsy
• No history of / do not currently suffer from heart disease or high blood pressure or diabetes
• Free from cognitive and memory impairment and does not suffer from any neurological disorders
• Not taking any form of vitamin, mineral, herbal supplement, medications or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) the study such as multivitamins, B vitamins, Ginkgo biloba, antioxidants or other supplements
• Not 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
• No clinically relevant abnormalities in their medical history that would render them ineligible for MRI
• Not pregnant or possibility of being pregnant
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Gluten intolerance
• Having claustrophobia (fear of constrained space)
• History of head injury/stroke
• Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years
• Clinically relevant abnormalities in their medical history that would render them ineligible for MRI
• Currently taking Warfarin
• Having metallic implants and other abnormalities in their medical history that would render them ineligible for MRI

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)
Randomisation of the products will be performed independently of the investigators using sealed opaque and identical envelopes containing identity of either A, B or C group.

The investigational products will be delivered to the investigators in trial product containers that are identical in function and appearance, marked as A, B or C. Once enrolled in the trial, participants will be randomly allocated to either A group (n = 30), B group (n = 30) or C group (n = 30). The participant is randomized into either the group A, B or C by choosing a closed envelope. Investigators will be blinded to the randomisation and therefore blinded to which subjects are allocated to the active and treatment arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary and secondary outcome endpoints at baseline, week 6, week ,12, and week 24will be analysed using a two way repeated measures ANOVA for treatment and time. The primary and secondary outcome endpoints will also be assessed for statistical difference within-groups (change from baseline) and between groups by t-tests. The correlations will be calculated using the Pearson Correlation Co-efficient. Effect sizes are reported as Eta squared.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/03/2021
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
17/04/2023
Actual
Sample size
Target
90
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 24491 0
Malaysia
State/province [1] 24491 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 310522 0
Commercial sector/Industry
Name [1] 310522 0
Blackmores Institute, Australia
Country [1] 310522 0
Australia
Primary sponsor type
University
Name
Taylor's University
Address
Taylor's University, No. 1, Jalan Taylors, 47500 Subang Jaya, Selangor
Country
Malaysia
Secondary sponsor category [1] 311693 0
University
Name [1] 311693 0
University of Malaya
Address [1] 311693 0
University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country [1] 311693 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310146 0
Medical Research and Ethics Committee (MREC), Malaysia
Ethics committee address [1] 310146 0
Ethics committee country [1] 310146 0
Malaysia
Date submitted for ethics approval [1] 310146 0
15/03/2019
Approval date [1] 310146 0
30/09/2019
Ethics approval number [1] 310146 0
NMRR-19-379-46101
Ethics committee name [2] 310615 0
University of Malaya Medical Centre
Ethics committee address [2] 310615 0
Ethics committee country [2] 310615 0
Malaysia
Date submitted for ethics approval [2] 310615 0
10/06/2019
Approval date [2] 310615 0
21/11/2019
Ethics approval number [2] 310615 0
2019610-7501

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

Contacts
Principal investigator
Name 116642 0
Prof Yeong Chai Hong
Address 116642 0
School of Medicine, Faculty of Health and Medical Sciences, Taylor's Univerisity.
No. 1, Jalan Taylors, 47500 Subang Jaya, Selangor
Country 116642 0
Malaysia
Phone 116642 0
+60167016875
Fax 116642 0
Email 116642 0
[email protected]
Contact person for public queries
Name 116643 0
Yeong Chai Hong
Address 116643 0
School of Medicine, Faculty of Health and Medical Sciences, Taylor's Univerisity.
No. 1, Jalan Taylors, 47500 Subang Jaya, Selangor
Country 116643 0
Malaysia
Phone 116643 0
+60167016875
Fax 116643 0
Email 116643 0
[email protected]
Contact person for scientific queries
Name 116644 0
Yeong Chai Hong
Address 116644 0
School of Medicine, Faculty of Health and Medical Sciences, Taylor's Univerisity.
No. 1, Jalan Taylors, 47500 Subang Jaya, Selangor
Country 116644 0
Malaysia
Phone 116644 0
+60167016875
Fax 116644 0
Email 116644 0
[email protected]

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?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.