Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000295741
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
18/03/2013
Date last updated
7/08/2020
Date data sharing statement initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Body Vitamin Pack: A Randomised Controlled Trial assessing mood and behaviour in adults reporting feeling stressed in the workplace.
Scientific title
The effects of Healthy Body Pack supplementation, relative to placebo, on mood and behaviour in adults reporting feeling stressed in the workplace.
Secondary ID [1] 282108 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace stress
 288603 0
Condition category
Condition code
Mental Health 288935 288935 0 0
Other mental health disorders
Alternative and Complementary Medicine 288963 288963 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly allocated to receive one of two treatments to be consumed once daily with a meal for a period of 12 weeks:

A. Healthy Body Vitamin Pack (containing 2 x 600mg fish oil softgels and 1 x Basic One Iron free multivitamin and mineral oral tablet)

OR

B. Placebo tablets (2 x softgels and 1 x oral tablet) matched for appearance and flavor.

Please note:

The daily dosage of 1 Basic One Iron free multivitamin and mineral oral tablet contains:
Vitamin A (as natural beta carotene) 2,000IU
Vitamin C (ascorbic acid) 150mg
Vitamin D (cholecalciferol) 2,000IU
Vitamin E (as d-alpha tocopherol succinate) 200IU
Thiamine (Vitamin B1 as HCI) 1.5mg
Riboflavin (Vitamin B2) 2mg
Niacinamide (niacinamide/Vitamin B3) 20mg
Vitamin B6 (pyridoxine hydrochloride) 10mg
Folic Acid (Folate/Vitamin B9) 400mcg
Vitamin B12 (Cyanocobalamin) 400mcg
Pantothenic Acid (as calcium pantothenate) 10mg
Magnesium (as magnesium oxide) 200mg
Zinc (zinc oxide) 15mg
Selenium (as selenium chelate) 100mcg
Chromium (as chromium amino acid chelate) 100mcg
Lycopene 5mg
Intervention code [1] 286710 0
Treatment: Other
Comparator / control treatment
Placebo tablets matched for appearance and taste, but does not contain any active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 289062 0
Workplace stress (Occupational Stress Inventory Revised)
Timepoint [1] 289062 0
Baseline, weeks 4, 8 and 12.
Secondary outcome [1] 301662 0
Other Stress: Perceived Stress Scale
Timepoint [1] 301662 0
Baseline, weeks 4, 8 and 12
Secondary outcome [2] 301702 0
Mood: Profile of Moods Questionnaire; Beck Depression Inventory
Timepoint [2] 301702 0
Baseline, weeks 4, 8 and 12
Secondary outcome [3] 301703 0
Health: General Health Questionnaire
Timepoint [3] 301703 0
Baseline, weeks 4, 8 and 12
Secondary outcome [4] 301704 0
Cardiovascular parameters: Blood analysis
Timepoint [4] 301704 0
Baseline and week 12

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 55 years.
2. Currently in full-time employment.
3. Are not heavy drinkers of alcohol (defined as greater than 14 standard drinks per week for women and 28
standard drinks per week for men).
4. No history of anxiety, depression, psychiatric disorders or epilepsy
5. No history of / do not currently suffer from heart disease or high blood pressure or diabetes.
6. 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 (such as
multivitamins, B vitamins, ginkgo biloba, antioxidants or other supplements).
7. 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
8. No 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)
9. Not pregnant or breast feeding
10. Not allergic to gluten/wheat
11. Are willing and able to participate in all study requirements, treatment plan, have access to
completeonline measures, and other trial procedures according to the protocol.
12. Are willing to provide blood samples on the two prescribed visits in the testing phase.
13. Provide a personally signed and dated informed consent indicating that the participant has been
informed of all pertinent aspects of the trial.
14. Fluent in written and spoken English
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants presenting with any of the following will not be included in the trial:
1. Cigarette smoker
2. Current heavy regular use of alcohol exceeding 14 standard drinks per week for women and 28 standard
drinks per week for men).
3. Diagnosis of Type 1 or Type 2 diabetes.
4. History of anxiety, depression, psychiatric disorders or epilepsy
5. History of / currently suffers from heart disease or high blood pressure.
6. 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
7. Use of any over-the-counter herbal extracts, vitamin supplements and/or other dietary supplements which
might influence cognition or mood for four weeks prior to the practice day (such as multivitamins, B vitamins,
ginkgo biloba, antioxidants or other supplements).
8. Currently taking any illicit drugs and/or a history of substance abuse.
9. Health conditions that would affect food metabolism including the following: food allergies, kidney disease,
liver disease and/or gastrointestinal diseases (e.g. have Irritable bowel syndrome, coeliac disease, peptic
ulcers)
10. Pregnant or breast feeding
11. Not fluent in written or spoken English
12. Allergy to gluten/wheat
13. Are not willing to provide blood samples throughout the testing phases
14. Current participation in any other trials involving investigational or marketed products within 30 days prior
to the practice day.
15. History of head injury/stroke
16. Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of
laboratory tests.
17. Currently taking Warfarin
18. Are unable to participate in the treatment plan and other trial procedures according to the protocol

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 achieved through the use of 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The Project was discontinued due to the funder’s decision not to not continue providing insurance for trial participants and their request to discontinue the trial due to financial reasons
Date of first participant enrolment
Anticipated
1/05/2013
Actual
11/10/2013
Date of last participant enrolment
Anticipated
Actual
1/05/2014
Date of last data collection
Anticipated
Actual
31/05/2014
Sample size
Target
90
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286876 0
Commercial sector/Industry
Name [1] 286876 0
Cooper Concepts
Country [1] 286876 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 285667 0
None
Name [1] 285667 0
Address [1] 285667 0
Country [1] 285667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288939 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 288939 0
Ethics committee country [1] 288939 0
Australia
Date submitted for ethics approval [1] 288939 0
22/02/2013
Approval date [1] 288939 0
09/08/2013
Ethics approval number [1] 288939 0

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

Contacts
Principal investigator
Name 38414 0
Prof Con Stough
Address 38414 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38414 0
Australia
Phone 38414 0
+613 9214 8167
Fax 38414 0
Email 38414 0
[email protected]
Contact person for public queries
Name 38415 0
Antionette Goh
Address 38415 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38415 0
Australia
Phone 38415 0
+613 9214 5094
Fax 38415 0
Email 38415 0
[email protected]
Contact person for scientific queries
Name 38416 0
Luke Downey
Address 38416 0
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 38416 0
Australia
Phone 38416 0
+613 9214 5781
Fax 38416 0
Email 38416 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?

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
No additional documents have been identified.