Healthy Body Vitamin Pack: A Randomised Controlled Trial assessing mood and behaviour in adults reporting feeling stressed in the workplace.

Terminated

• Conditions: Workplace stress; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613000295741
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-18
• Study Completion: 2014-05-31
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 38

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Workplace stress (Occupational Stress Inventory Revised)[Baseline, weeks 4, 8 and 12.]

Secondary Outcome Measures

Name	Time	Method
Other Stress: Perceived Stress Scale<br><br>[Baseline, weeks 4, 8 and 12];Mood: Profile of Moods Questionnaire; Beck Depression Inventory<br>[Baseline, weeks 4, 8 and 12];Health: General Health Questionnaire<br>[Baseline, weeks 4, 8 and 12];Cardiovascular parameters: Blood analysis[Baseline and week 12<br>]