Efficacy and Tolerance of B-Back® on the Burnout SyndromeNCT01599169
Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome
A study testing Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel) in people with Efficacy and Tolerance of B-Back® on the Burnout Syndrome, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Efficacy and Tolerance of B-Back® on the Burnout Syndrome
- What is being tested?
- Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2
Bordeaux
About this study
Official title: 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.
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).
- Being tested
- Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel), B-Back® placebo (without active compounds)
- Keywords
- Burnout syndrome, Depression work-related, Food supplement
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)Dietary supplement
2 tablets/day after breakfast during 12 weeks
B-Back® placebo (without active compounds)Dietary supplement
2 tablets/day after breakfast during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| B-Back® verum | Experimental | Not described Receives: Dietary Supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel) |
| B-Back® placebo | Placebo comparator | Not described Receives: Dietary Supplement: B-Back® placebo (without active compounds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks
Measured: baseline and after 12 weeks
Secondary outcomes (9)
Change from baseline in BMS-10 score at 6 weeks
Measured: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 6 weeks
Measured: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 12 weeks
Measured: baseline and after 12 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks
Measured: baseline and after 6 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks
Measured: baseline and after 12 weeks
Change from baseline in Beck Depression Inventory score at 6 weeks
Measured: baseline and after 6 weeks
Change from baseline in Beck Depression Inventory score at 12 weeks
Measured: 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
Measured: 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
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Efficacy and Tolerance of B-Back® on the Burnout SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Collaborators
- Nanox International Laboratory (Belgique)
- Responsible party
- Principal investigator, Alain Jacquet, Université Victor Segalen Bordeaux 2
- Investigators
- Nicholas Moore, MD, PhD, Study director, Université Victor Segalen Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599169
- Sponsor's protocol ID
- ID-RCB : 2012 - A00096 - 37
- Other IDs
- e530
- Status last verified
- Apr 2013
- First submitted
- 6 May 2012
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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 17136040Milesi 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 19754931Kong 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 16540157Facchinetti 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01599169
- Acronym / sponsor ID
- ID-RCB : 2012 - A00096 - 37
- Keywords
- Burnout syndrome, Depression work-related, Food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Collaborators
- Nanox International Laboratory (Belgique)
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)2 tablets/day after breakfast during 12 weeks | Dietary supplement | B-Back® verum |
| B-Back® placebo (without active compounds)2 tablets/day after breakfast during 12 weeks | Dietary supplement | B-Back® placebo |
Primary outcome
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks
Time frame: baseline and after 12 weeks
9 secondary outcomes
Change from baseline in BMS-10 score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in Beck Depression Inventory score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Beck Depression Inventory score at 12 weeks
Time frame: 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
Time frame: 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
Time frame: baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- BackgroundMalach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88
- BackgroundBenezech 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: PubMed 17136040Kim 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.
- Background: PubMed 19754931Milesi 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.
- Background: PubMed 16540157Kong 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.
- BackgroundFacchinetti 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: PubMed 14971626Hartz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Moore, MD, PhD study director
Université Victor Segalen Bordeaux 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel) in people with Efficacy and Tolerance of B-Back® on the Burnout Syndrome, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks (time frame: baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599169, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.