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

NCT01599169 | Completed

• 2 other identifiers: ID-RCB : 2012 - A00096 - 37e530
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Burnout syndrome; Depression work-related; Food supplement

Outcome Measures

Primary Outcomes (1)

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

  baseline and after 12 weeks

Secondary Outcomes (9)

• 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

Study Arms (2)

B-Back® verum

EXPERIMENTAL

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

B-Back® placebo

PLACEBO COMPARATOR

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

Interventions

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

2 tablets/day after breakfast during 12 weeks

B-Back® verum

B-Back® placebo (without active compounds) DIETARY_SUPPLEMENT

2 tablets/day after breakfast during 12 weeks

B-Back® placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Victor Segalen Bordeaux 2: lead
• Nanox International Laboratory (Belgique): collaborator

Study Sites (1)

Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2

Bordeaux, France

Location

Related Publications (7)

• Malach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17136040 BACKGROUND

• 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.

  PMID: 19754931 BACKGROUND

• 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.

  PMID: 16540157 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14971626 BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Taurine; Siberian ginseng root; Extramel

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Nicholas Moore, MD, PhD

  Université Victor Segalen Bordeaux 2

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

FR (1)