Burn OutWELBINCT04532892
A Specialized Nutraceutical for Pre-burnout
A study testing Meta 18.06 Day and Meta 18.06 Night in people with Burn Out and Psychological Disturbance, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Out, Psychological Disturbance
- What is being tested?
- Meta 18.06 Day and Meta 18.06 Night
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2020to 25 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male aged between 30 and 65 years (limits included),
- Presenting symptoms of stress, work or emotional overload based on :
- COHEN questionnaire (score ≥ 21 allowed the inclusion),
- CUNGI questionnaire (part 1: score ≥ 18 allowed the inclusion; part 2: score ≥ 30 allowed the inclusion).
Who cannot join
- Suffering from depression based on the Hospital anxiety and depression scale (depression score over 14),
- Considered in burn-out, based on MBI questionnaire:
- Burnout > 30
- Depersonalization > 12
- Personnal achievement < 33 2 conditions should be fulfilling to exclude participant.
- Under nutritional supplement or drugs (psychotropics, betablockers) acting on mental health according to the investigator or stopped less than 3 months before the study.
- Diagnose of burn-out for less than 2y.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance of a Specialized Nutraceutical for Pre-burnout - a Randomized, Double Blind Placebo Controlled Study
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress.
Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction.
Read more
Recently, adaptogen plants have shown promising effects (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) by increasing the body's ability to resist stress and exert a balancing effect on various systems of the body.
This study is focused on the effect of a specialized nutraceutical, containing adaptogen plants (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).
Read the detailed description
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout is an outcome of chronic depletion of the individual's coping resources resulting from prolonged exposure to stress, particularly work-related stress. In Germany, 8% of the working population believe they suffer from burnout syndrome. Among 7400 Czech Physicians, 34% feel they show symptoms and 83% perceive themselves at risk for having a burnout. Currently, the prevention of burnout has been discussed worldwide as absenteeism and other negative consequences related to job satisfaction, work performance and patient care lead to an economic burden.
Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress. The 3 major dimensions of Burnout are emotional exhaustion, depersonalizations (cynicism) and a decreased sense of personal accomplishment or inefficacy. It is characterized by fatigue, mood disorder, sleep problems and cognitive impairment but is difficult to differentiate from depression as both illnesses are often related. The main difference with depression is at physiological level, mainly in Cortisol and dehydroepiandrosterone-sulphate (DHEA) levels.
Increased psychological stress affects the hypothalamus-pituitary-adrenal (HPA) axis regulation. During acute stress, plasma cortisol levels rise but during chronic stress, cortisol levels decline leading to a state of depletion. This depletion leads to a smaller increase of cortisol shortly after waking up, also known as the cortisol awakening response, leading to a disruption of the circadian rhythm, fatigue and a decreased mental performance. Next to cortisol, also DHEA levels are lower, especially in young Burnout patients. DHEA is an active hormone with effects on its own and a precursor of androgens and estrogens. It has a regenerative and protective role important for maintenance and restoration of health, thus very important in Burnout.
Next to hormones, also nutritional deficiencies related to HPA axis dysfunction could play a role in the development of Burnout. Vitamin C for example is needed for steroid biosynthesis, Niacin derivates are cofactors and Pantothenic acid and folic acid are vital to maintain steroid secretion from the adrenal cortex. Adrenocortical insufficiency has also been noted during biotin deficiency.
Diagnosis of Burnout often occurs via psychological scales (e.g. Maslach Burnout Inventory) with high scores for exhaustion and cynicism and low scores for professional efficacy.
Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction. Additionally, antidepressants lower also the cortisol levels putting Burnout patients even at higher risk of spiraling into Burnout.
Recently, adaptogens have also shown promising effects e.g. a clinical trial with Rhodiola rosea in 60 patients provided evidence of an antifatigue effect and an improvement in burnout symptoms. These botanicals (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) are defined as substances that increase the body's ability to resist stress and exert a balancing effect on various systems of the body. These have shown to have an additive and beneficial effect in relieving HPA axis dysfunction in combination with vitamins and minerals and could thus have a beneficial effect in the treatment of Burnout.
This study is focused on the effect of a specialized nutraceutical, containing adaptogens (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).
- Conditions
- Burn Out, Psychological Disturbance
- Being tested
- Meta 18.06 Day and Meta 18.06 Night, Placebo Meta 18.06 Day and Placebo Meta 18.06 Night
- Keywords
- Burnout, Dietary Supplement, Anxiety, Stress, Plants
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta 18.06 Day and Meta 18.06 NightDietary supplement
5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3)
Placebo Meta 18.06 Day and Placebo Meta 18.06 NightDietary supplement
5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Morning and night tablets with no active ingrédients. Morning and night tablets are different. Receives: Dietary Supplement: Placebo Meta 18.06 Day and Placebo Meta 18.06 Night |
| Dietary supplément | Experimental | Morning and night tablets with active ingrédients. Morning and night tablets are different. Receives: Dietary Supplement: Meta 18.06 Day and Meta 18.06 Night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)
A self-administered questionnaire. Score from 0 to 10 (from very bad Quality of Life to very good Quality of Life).
Measured: 0 day (baseline), 60 days, 120 days
Secondary outcomes (7)
Hospital Anxiety and depression questionnaire
A self-administered questionnaire:
- A: Anxiety. A score over 7 describes an anxious behavior.
- D: Depression. A score over 7 describes a depressive behavior.
Measured: 0 day (baseline) and 120 days
Cungi questionnaire
This self-administered questionnaire is divided in two parts:
- Part 1: stress factor scale. A score ≥ 18 is related to a high perception of environmental stress (many potential sources of stress).
- Part 2: evaluation stress scale. Scores range from 11 to 66. A score ≥ 30 is related to an intermediate stress score.
Measured: 0 day (baseline) and 120 days
Cohen questionnaire
This self-administered questionnaire contains 10 items. A score ≥ 27 corresponds to a high stress level.
Measured: 0 day (baseline) and 120 days
MBI questionnaire (Maslach Burn Out Inventory Questionnaire)
This self-administered questionnaire will be filled by the subject at V0 and V4 visits.
The questionnaire is subdivided in 3 categories:
- Professional exhaustion,
- Depersonalization,
- Personal achievement.
Each category will be analyzed as follow:
Section A: Burnout
- Total 17 or less: Low-level burnout
- Total between 18 and 29 inclusive: Moderate burnout
- Total over 30: High-level burnout
Section B: Depersonalization
- Total 5 or less: Low-level burnout
- Total between 6 and 11 inclusive: Moderate burnout
- Total of 12 and greater: High-level burnout
Section C: Personal Achievement
- Total 33 or less: High-level burnout
- Total between 34 and 39 inclusive: Moderate burnout
- Total greater than 40: Low-level burnout
Measured: 0 day (baseline) and 120 days
PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX)
The PSQI measured sleep quality and disturbances over a one-month interval across one global score and 7 component scores:
- Duration of sleep (DURAT)
- Sleep Disturbance (DISTB)
- Sleep Latency (LATEN)
- Day Dysfunction due to sleepiness (DAYDIS)
- Sleep Efficiency (HSE)
- Overall Sleep Quality (SLPQUAL)
- Need Meds to Sleep (MEDS) The global score is calculated by the sum of the 7 subscores: DURAT + DISTB + LATEN + DAYDYS + HSE + SLPQUAL + MEDS.
Measured: 0 day (baseline) and 120 days
SF-36 questionnaire
The SF36 measures health across 8 domains:
- Physical function (PF);
- Role physical (RP);
- Bodily pain (BP);
- General Health (GH);
- Vitality (VT);
- Social function (SF);
- Role Emotional (RE);
- Mental Health (MH).
Two component summary measures can be calculated:
- Physical Composite Score (PCS);
- Mental Composite Score (MCS). One item considers the general health status (health transition, HT).
Measured: 0 day (baseline) and 120 days
Saliva Cortisol
Saliva will be collected at the following time points at baseline (V0) and after 4 months of product consumption (V4) to analyze the salivary cortisol:
- When the subject wakes up
- 30 minutes after waking up
- At 20 hours in the evening RIA method was used to analyze cortisol from saliva.
Measured: 0 day (baseline) and 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start3 Mar 2020
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn OutStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, double-blind, randomized, placebo-controlled, 2-parallel arm study on outpatients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532892
- Sponsor's protocol ID
- 2019-A02049-48
- Acronym
- WELBI
- Status last verified
- Dec 2022
- First submitted
- 9 Jul 2020
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of a Specialized Nutraceutical for Pre-burnout - a Randomized, Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04532892
- Acronym / sponsor ID
- WELBI / 2019-A02049-48
- Conditions
- Burn Out, Psychological Disturbance
- Keywords
- Burnout, Dietary Supplement, Anxiety, Stress, Plants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- 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.
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress.
Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction.
Recently, adaptogen plants have shown promising effects (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) by increasing the body's ability to resist stress and exert a balancing effect on various systems of the body.
This study is focused on the effect of a specialized nutraceutical, containing adaptogen plants (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).
Detailed description
High demands, professional overload and emotional stress are well known negative influences on mental health. Chronic stress-related occupational diseases, especially Burnout, are becoming an important issue. Burnout is an outcome of chronic depletion of the individual's coping resources resulting from prolonged exposure to stress, particularly work-related stress. In Germany, 8% of the working population believe they suffer from burnout syndrome. Among 7400 Czech Physicians, 34% feel they show symptoms and 83% perceive themselves at risk for having a burnout. Currently, the prevention of burnout has been discussed worldwide as absenteeism and other negative consequences related to job satisfaction, work performance and patient care lead to an economic burden.
Burnout can be defined as a negative affective state consisting of emotional exhaustion, cognitive weariness and physical fatigue, which is caused by chronic psychosocial stress. The 3 major dimensions of Burnout are emotional exhaustion, depersonalizations (cynicism) and a decreased sense of personal accomplishment or inefficacy. It is characterized by fatigue, mood disorder, sleep problems and cognitive impairment but is difficult to differentiate from depression as both illnesses are often related. The main difference with depression is at physiological level, mainly in Cortisol and dehydroepiandrosterone-sulphate (DHEA) levels.
Increased psychological stress affects the hypothalamus-pituitary-adrenal (HPA) axis regulation. During acute stress, plasma cortisol levels rise but during chronic stress, cortisol levels decline leading to a state of depletion. This depletion leads to a smaller increase of cortisol shortly after waking up, also known as the cortisol awakening response, leading to a disruption of the circadian rhythm, fatigue and a decreased mental performance. Next to cortisol, also DHEA levels are lower, especially in young Burnout patients. DHEA is an active hormone with effects on its own and a precursor of androgens and estrogens. It has a regenerative and protective role important for maintenance and restoration of health, thus very important in Burnout.
Next to hormones, also nutritional deficiencies related to HPA axis dysfunction could play a role in the development of Burnout. Vitamin C for example is needed for steroid biosynthesis, Niacin derivates are cofactors and Pantothenic acid and folic acid are vital to maintain steroid secretion from the adrenal cortex. Adrenocortical insufficiency has also been noted during biotin deficiency.
Diagnosis of Burnout often occurs via psychological scales (e.g. Maslach Burnout Inventory) with high scores for exhaustion and cynicism and low scores for professional efficacy.
Currently, there is no standard treatment for Burnout but different forms of psychological interventions are usually attempted. Also the administration of anxiolytics, antidepressants and sedatives only targets symptoms with a risk of addiction. Additionally, antidepressants lower also the cortisol levels putting Burnout patients even at higher risk of spiraling into Burnout.
Recently, adaptogens have also shown promising effects e.g. a clinical trial with Rhodiola rosea in 60 patients provided evidence of an antifatigue effect and an improvement in burnout symptoms. These botanicals (e.g. Siberian Ginseng, Panax Ginseng, Rhodiola rosea and Ashwagandha) are defined as substances that increase the body's ability to resist stress and exert a balancing effect on various systems of the body. These have shown to have an additive and beneficial effect in relieving HPA axis dysfunction in combination with vitamins and minerals and could thus have a beneficial effect in the treatment of Burnout.
This study is focused on the effect of a specialized nutraceutical, containing adaptogens (Ashwagandha, Rhodiole rosea, Ginseng) as well as Vitamins and minerals (e.g. Vitamin C) needed for a normal hypothalamus-pituitary-adrenal (HPA) axis regulation in subjects suffering of early Burnout symptoms (pré-Burnout).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, double-blind, randomized, placebo-controlled, 2-parallel arm study on outpatients
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Meta 18.06 Day and Placebo Meta 18.06 NightMorning and night tablets with no active ingrédients. Morning and night tablets are different. |
| Dietary supplément | Experimental | Dietary Supplement: Meta 18.06 Day and Meta 18.06 NightMorning and night tablets with active ingrédients. Morning and night tablets are different. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male aged between 30 and 65 years (limits included),
- Presenting symptoms of stress, work or emotional overload based on :
Key exclusion criteria (7 listed)
- Suffering from depression based on the Hospital anxiety and depression scale (depression score over 14),
- Considered in burn-out, based on MBI questionnaire:
- Under nutritional supplement or drugs (psychotropics, betablockers) acting on mental health according to the investigator or stopped less than 3 months before the study.
- Diagnose of burn-out for less than 2y.
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 |
|---|---|---|
| Meta 18.06 Day and Meta 18.06 Night5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3) | Dietary supplement | Dietary supplément |
| Placebo Meta 18.06 Day and Placebo Meta 18.06 Night5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 \& V4) and calls for antistress advices and adverse events, concomitant medication reporting \& compliance (V1 \& V3) | Dietary supplement | Placebo |
Primary outcome
Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)
Time frame: 0 day (baseline), 60 days, 120 days
A self-administered questionnaire. Score from 0 to 10 (from very bad Quality of Life to very good Quality of Life).
7 secondary outcomes
Hospital Anxiety and depression questionnaire
Time frame: 0 day (baseline) and 120 days
Cungi questionnaire
Time frame: 0 day (baseline) and 120 days
Cohen questionnaire
Time frame: 0 day (baseline) and 120 days
MBI questionnaire (Maslach Burn Out Inventory Questionnaire)
Time frame: 0 day (baseline) and 120 days
PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX)
Time frame: 0 day (baseline) and 120 days
SF-36 questionnaire
Time frame: 0 day (baseline) and 120 days
Saliva Cortisol
Time frame: 0 day (baseline) and 120 days
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 8 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta 18.06 Day and Meta 18.06 Night in people with Burn Out and Psychological Disturbance, run by Institut Pasteur de Lille 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 4 inclusion and 7 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 8 Dec 2022. 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?
Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index) (time frame: 0 day (baseline), 60 days, 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2022.