Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000294752
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
18/03/2013
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Executive B and Stress: Randomised Clinical Trial
Scientific title
The effects of an Executive B supplementation, relative to placebo, on mood and stress in adults reporting feeling stressed in the workplace.
Secondary ID [1] 282084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace stress 288584 0
Condition category
Condition code
Alternative and Complementary Medicine 288912 288912 0 0
Herbal remedies
Mental Health 288913 288913 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly allocated to receive one of two treatments to be taken twice daily for 24 weeks:

A. Blackmores Executive B Stress Formula (1 tablet with breakfast, 1 tablet with lunch)

OR

B. Placebo (1 tablet with breakfast, 1 tablet with lunch)

Please note each Executive B Stress Formula tablet contains the following:

Vitamin B1 (Thiamine hydrochloride) 75 mg
Vitamin B2 (Riboflavin) 10 mg
Nicotinamide 100 mg
Vitamin B5(Pantothenic acid from calcium pantothenate 75mg) 68.7 mg
Vitamin B6 (Pyridoxine hydrochloride) 25 mg
Vitamin B12 (Cyanocobalamin) 30 microgram
Vitamin H (Biotin) 20 microgram
Calcium ascorbate 145 mg
Ascorbic acid (Total Vitamin C 250mg) 130 mg
Vitamin E (d-alpha-Tocopheryl acid succinate 41.3 mg)50 IU
Magnesium phosphate 140 mg
Calcium phosphate 100 mg
Potassium phosphate monobasic 117.3 mg
Folic acid 150 microgram
Avena sativa (Oats) extract equiv. to dry seed 100 mg
Passiflora incarnata (Passion flower) extract equiv. to dry herb 250 mg
Lecithin 50 mg
Choline bitartrate 25 mg
Inositol 25 mg
Intervention code [1] 286687 0
Treatment: Other
Comparator / control treatment
Placebo capsules identical in appearance and taste to the active treatment, but not containing any significant amount of active ingredient. Contains trace quantities of Riboflavin (B2) so as to be matched for colour and taste.
Control group
Placebo

Outcomes
Primary outcome [1] 289040 0
Workplace stress as measured by the Occupational Stress Inventory - Revised
Timepoint [1] 289040 0
Baseline, and then week 4, 8, 12, 16, 20 & 24.
Secondary outcome [1] 301630 0
Cognition as measured by Swinburne University Computerised Cognitive Ability Battery.
Timepoint [1] 301630 0
Baseline and week 24

Eligibility
Key inclusion criteria
Participants who meet the following eligibility criteria will be recruited in the trial:
1. Healthy, non-smoking males and females aged between 30 and 65 years.

2. Currently in full-time employment.

3. Fluent in English.

4. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonable be expected to interfere with cognition or mood for 4 weeks prior to admission to (and duration of) the study (such as multivitamins, B vitamins, ginkgo biloba, antioxidants or other supplements.

5. 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.

6. Willing and able to participate in all study requirements, treatment plan, have facilities to access to complete online measures, and other trial procudures according to the protocol.

7. Willing to provide 2 blood samples on the two proscribed visits in the testing phase.

8. Provide all personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Heavy drinker of alcohol (defined as greater than 14 standard drinks per week for women and 28 standard drinks for men).

2. History of anxiety, depression, psychiatric disorders or epilepsy.

3. History of heart-disease, high blood pressure or diabetes

4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diesase.

5. Preganant or breast feeding.

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)
Participants will be recruited through advertising in local newspapers and community bulletin boards. Participants will contact researchers where they will be screened for eligibility over the phone to ensure they are eligible to participate in the study. Participants will be randomly allocated to treatment A or B once allocated a trial participants number.

Randomisation of participants to treatment groups will be determined by random allocation. All participants will be assigned to treatment group A or B using a computer generated random number generator by a disinterested third party. Eligible, recruited participants will be assigned a participant number. The treatment number that has been placed next to the participant’s number will be the allocated treatment for that individual. Randomisation codes will be kept in a password protected computer file.

Blinding will be achieved by enlisting a person outside of the project to code the treatments, conceal them in sealed opaque containers for dispensing and maintain the key to this code until data collection is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using computerised random number generator software.
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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2013
Actual
26/09/2013
Date of last participant enrolment
Anticipated
Actual
13/07/2016
Date of last data collection
Anticipated
Actual
21/12/2016
Sample size
Target
165
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286872 0
Commercial sector/Industry
Name [1] 286872 0
Blackmores
Country [1] 286872 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 285664 0
None
Name [1] 285664 0
Address [1] 285664 0
Country [1] 285664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288934 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 288934 0
Ethics committee country [1] 288934 0
Australia
Date submitted for ethics approval [1] 288934 0
Approval date [1] 288934 0
19/02/2013
Ethics approval number [1] 288934 0
2012/293

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

Contacts
Principal investigator
Name 38350 0
Prof Con Stough
Address 38350 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38350 0
Australia
Phone 38350 0
+613 9214 8167
Fax 38350 0
Email 38350 0
[email protected]
Contact person for public queries
Name 38351 0
Antionette Goh
Address 38351 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38351 0
Australia
Phone 38351 0
+613 9214 5094
Fax 38351 0
Email 38351 0
[email protected]
Contact person for scientific queries
Name 38352 0
Con Stough
Address 38352 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38352 0
Australia
Phone 38352 0
+613 9214 8167
Fax 38352 0
Email 38352 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
The data collected during the trial are jointly owned by Swinburne University and Blackmores Ltd. Due to the potential use of the data for commercial purposes the data will not be made publicly available unless a publishing journal requests that they are added to an appropriate repository.


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
EmbaseReducing occupational stress with a B-vitamin focussed intervention: A randomized clinical trial: Study protocol.2014https://dx.doi.org/10.1186/1475-2891-13-122
EmbaseThe effect of a high-dose vitamin b multivitamin supplement on the relationship between brain metabolism and blood biomarkers of oxidative stress: A randomized control trial.2018https://dx.doi.org/10.3390/nu10121860
EmbaseTrait and state anxiety is marked by increased working memory-related parietal BOLD signal.2018https://dx.doi.org/10.1016/j.pscychresns.2018.05.009
N.B. These documents automatically identified may not have been verified by the study sponsor.