ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Workplace stress

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Mental Health

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]

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]

Workplace stress as measured by the Occupational Stress Inventory - Revised

Timepoint [1]

Baseline, and then week 4, 8, 12, 16, 20 & 24.

Secondary outcome [1]

Cognition as measured by Swinburne University Computerised Cognitive Ability Battery.

Timepoint [1]

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]

Commercial sector/Industry

Name [1]

Blackmores

Address [1]

20 Jubilee Avenue
Warriewood NSW 2102, Australia

Country [1]

Australia

Primary sponsor type

University

Name

Swinburne University of Technology

Address

John Street, Hawthorn, Victoria, 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee

Ethics committee address [1]

John Street, Hawthorn, Victoria, 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/02/2013

Ethics approval number [1]

2012/293

Summary

Brief summary

The general aim of this study is to investigate the effect of Executive B Stress Formula supplementation on mood and workplace stress in a healthy workplace sample. More specifically, a six month supplementation is expected to improve participants' experience of workplace stress, workplace variables, and mood in conjunction with biological measures.

The participant group will be 165 full time employees, who report feeling stressed in the workplace. These participants will be aged between 30-55 years, who are able to commit to two visits to Swinburne University to provide blood samples and complete computerised cognitive assessments. They will also be asked to complete online questionnaires on a monthly basis. Participants will be randomly assigned to take either Exectutive B tablets or placebo daily for 24 weeks.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Con Stough

Address

PO Box 218
Mail H24
Hawthorn, VIC, 3122

Country

Australia

Phone

+613 9214 8167

Fax

cstough@swin.edu.au

Contact person for public queries

Name

Antionette Goh

Address

PO Box 218
Mail H24
Hawthorn, VIC, 3122

Country

Australia

Phone

+613 9214 5094

Fax

agoh@swin.edu.au

Contact person for scientific queries

Name

Con Stough

Address

PO Box 218
Mail H24
Hawthorn, VIC, 3122

Country

Australia

Phone

+613 9214 8167

Fax

cstough@swin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Reducing occupational stress with a B-vitamin focussed intervention: A randomized clinical trial: Study protocol.	2014	https://dx.doi.org/10.1186/1475-2891-13-122
Embase	The 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.	2018	https://dx.doi.org/10.3390/nu10121860
Embase	Trait and state anxiety is marked by increased working memory-related parietal BOLD signal.	2018	https://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.

Trial Review

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Documents added manually

Documents added automatically