Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome

Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome. Double-blind, Randomized, Monocentric Trial With Two Parallel Groups (B-Back® Verum Versus B-Back® Placebo)

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.

Study Overview

• Status: Completed
• Conditions: Efficacy and Tolerance of B-Back® on the Burnout Syndrome
• Intervention / Treatment: Dietary supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel); Dietary supplement: B-Back® placebo (without active compounds)

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).

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: B-Back® verum	Dietary supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel); 2 tablets/day after breakfast during 12 weeks
PLACEBO_COMPARATOR: B-Back® placebo	Dietary supplement: B-Back® placebo (without active compounds); 2 tablets/day after breakfast during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks	baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in BMS-10 score at 6 weeks	baseline and after 6 weeks
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 Beck Depression Inventory 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

Collaborators and Investigators

• Sponsor: Université Victor Segalen Bordeaux 2
• Collaborators: Nanox International Laboratory (Belgique)
• Investigators: Study Director: Nicholas Moore, MD, PhD, Université Victor Segalen Bordeaux 2

Publications and helpful links

General Publications

• Malach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88
• Benezech M, Mullens E, Lalonde R, Desor D, Messaoudi M. Un anxiolytique naturel : l'hydrolysat trypsique de caséine alpha-s1 de lait bovin. Son intérêt en médecine humaine et vétérinaire. Annales Médico-Psychologiques. 2009;167:605-10.
• Kim JH, Desor D, Kim YT, Yoon WJ, Kim KS, Jun JS, Pyun KH, Shim I. Efficacy of alphas1-casein hydrolysate on stress-related symptoms in women. Eur J Clin Nutr. 2007 Apr;61(4):536-41. doi: 10.1038/sj.ejcn.1602553. Epub 2006 Nov 29.
• Milesi MA, Lacan D, Brosse H, Desor D, Notin C. Effect of an oral supplementation with a proprietary melon juice concentrate (Extramel) on stress and fatigue in healthy people: a pilot, double-blind, placebo-controlled clinical trial. Nutr J. 2009 Sep 15;8:40. doi: 10.1186/1475-2891-8-40.
• Kong WX, Chen SW, Li YL, Zhang YJ, Wang R, Min L, Mi X. Effects of taurine on rat behaviors in three anxiety models. Pharmacol Biochem Behav. 2006 Feb;83(2):271-6. doi: 10.1016/j.pbb.2006.02.007. Epub 2006 Mar 15.
• Facchinetti F, Neri I, Tarabusi M. Eleutherococcus senticosus reduces cardi-ovascular stress response in healthy subjects: a randomized, placebo-controlled trial. Stress and Health. 2002;18:11-7.
• Hartz AJ, Bentler S, Noyes R, Hoehns J, Logemann C, Sinift S, Butani Y, Wang W, Brake K, Ernst M, Kautzman H. Randomized controlled trial of Siberian ginseng for chronic fatigue. Psychol Med. 2004 Jan;34(1):51-61. doi: 10.1017/s0033291703008791.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: May 6, 2012
• First Submitted That Met QC Criteria: May 13, 2012
• First Posted (ESTIMATE): May 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 21, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Food supplement; Burnout syndrome; Depression work-related
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease; Stress, Psychological; Syndrome; Burnout, Psychological
• Other Study ID Numbers: ID-RCB : 2012 - A00096 - 37; e530 (OTHER: Clinical Pharmacology Department of University Victor Segalen Bordeaux 2)