None listed
Conditions
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.
Interventions
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
Vit
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
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed