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CompletedNCT01599169Updated Apr 23, 2013

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

An interventional study of Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel) and B-Back® placebo (without active compounds) in Efficacy and Tolerance of B-Back® on the Burnout Syndrome, sponsored by Université Victor Segalen Bordeaux 2. Completed at 1 site in France. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-23.

Sponsored by Université Victor Segalen Bordeaux 2 · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Keywords

  • Burnout syndrome
  • Depression work-related
  • Food supplement
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 87 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Université Victor Segalen Bordeaux 2 is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    B-Back® verum

    Dietary Supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)

  • Placebo comparator
    B-Back® placebo

    Dietary Supplement: B-Back® placebo (without active compounds)

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks

    Time frame: baseline and after 12 weeks

Secondary outcomes

  1. Change from baseline in BMS-10 score at 6 weeks

    Time frame: baseline and after 6 weeks

  2. Change from baseline in Maslach Burnout Inventory score at 6 weeks

    Time frame: baseline and after 6 weeks

  3. Change from baseline in Maslach Burnout Inventory score at 12 weeks

    Time frame: baseline and after 12 weeks

  4. Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks

    Time frame: baseline and after 6 weeks

  5. Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks

    Time frame: baseline and after 12 weeks

  6. Change from baseline in Beck Depression Inventory score at 6 weeks

    Time frame: baseline and after 6 weeks

  7. Change from baseline in Beck Depression Inventory score at 12 weeks

    Time frame: baseline and after 12 weeks

  8. Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep, fatigue at 6 weeks

    Time frame: baseline and after 6 weeks

  9. Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep,fatigue at 12 weeks

    Time frame: baseline and after 12 weeks

07

Study locations

1 site
  • Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2
    Bordeaux, France
08

References and documents

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. PubMed 17136040 ↗
  • 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. PubMed 19754931 ↗
  • 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. PubMed 16540157 ↗
  • 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. PubMed 14971626 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01599169
Lead sponsor
Université Victor Segalen Bordeaux 2
Collaborators
Nanox International Laboratory (Belgique)
Responsible party
Alain Jacquet (MD, Université Victor Segalen Bordeaux 2) — Principal investigator
First posted
May 15, 2012
Start date
May 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Apr 23, 2013

Study contacts

Nicholas Moore, MD, PhD
study director · Université Victor Segalen Bordeaux 2

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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