Efficacy and Tolerance of B-Back® on the Burnout Syndrome
Conditions
Keywords
Burnout syndrome, Depression work-related, Food supplement
Brief summary
The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and Extramel®, on the burnout syndrome.
Detailed description
The burnout syndrome currently concern all the professional categories. In 2010 the WHO estimated that the three countries with the most important work-related depression are Unites States, Ukraine and France. The direct and indirect costs of work-related stress for the insurance program were not insignificant. The purpose of this study is to determine the efficacy of the food supplement B-Back® proposed in order to improved the symptoms of the burnout syndrome : stress, fatigue, emotional imbalance, anxiety, sleep, etc. The main objective is to determine the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Burnout Measure Short version (BMS-10). The others objectives were to evaluate the tolerance of the product, to evaluate the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Maslach Burnout Inventory, depression, and the global quality of professional and family life, sleep,and fatigue (energy).
Interventions
DIETARY_SUPPLEMENTDietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)
2 tablets/day after breakfast during 12 weeks
DIETARY_SUPPLEMENTB-Back® placebo (without active compounds)
2 tablets/day after breakfast during 12 weeks
Sponsors
Nanox International Laboratory (Belgique)
Université Victor Segalen Bordeaux 2
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* males and females outpatients aged 30-65 years old * practicing professionals in contact with patients, students,... * symptoms suggestive of burnout syndrome * minimum score to the BMS-10 = 4 * able to understand the sdudy documents * agreeing to go to dates of controls * able to give informed consent * affiliated to a French national insurance program
Exclusion criteria
* current anxiolytic or antidepressant treatment * allergy known about one of the components of the food complement in the study * intolerance in the lactose and in the proteins of milk * pregnancy or feeding * progressive pathology involving life-threatening during study * professional on sick leave * cancer not stabilized for at least five years or considered as not recovered * subjects deprived of liberty court decision * subjects in the psychic incapacity to understand the constraints of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks | baseline and after 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Maslach Burnout Inventory score at 6 weeks | baseline and after 6 weeks |
| Change from baseline in Maslach Burnout Inventory score at 12 weeks | baseline and after 12 weeks |
| Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks | baseline and after 6 weeks |
| Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks | baseline and after 12 weeks |
| Change from baseline in BMS-10 score at 6 weeks | baseline and after 6 weeks |
| Change from baseline in Beck Depression Inventory score at 12 weeks | baseline and after 12 weeks |
| Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep, fatigue at 6 weeks | baseline and after 6 weeks |
| Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep,fatigue at 12 weeks | baseline and after 12 weeks |
| Change from baseline in Beck Depression Inventory score at 6 weeks | baseline and after 6 weeks |
Countries
France
Outcome results
None listed