- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532892
A Specialized Nutraceutical for Pre-burnout (WELBI)
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.
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nord
-
Lille, Nord, France, 59019
- NutrInvest - Institut Pasteur de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Morning and night tablets with no active ingrédients.
Morning and night tablets are different.
|
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)
|
Experimental: Dietary supplément
Morning and night tablets with active ingrédients.
Morning and night tablets are different.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0 day (baseline), 60 days, 120 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and depression questionnaire
Time Frame: 0 day (baseline) and 120 days
|
A self-administered questionnaire:
|
0 day (baseline) and 120 days
|
Cungi questionnaire
Time Frame: 0 day (baseline) and 120 days
|
This self-administered questionnaire is divided in two parts:
|
0 day (baseline) and 120 days
|
Cohen questionnaire
Time Frame: 0 day (baseline) and 120 days
|
This self-administered questionnaire contains 10 items.
A score ≥ 27 corresponds to a high stress level.
|
0 day (baseline) and 120 days
|
MBI questionnaire (Maslach Burn Out Inventory Questionnaire)
Time Frame: 0 day (baseline) and 120 days
|
This self-administered questionnaire will be filled by the subject at V0 and V4 visits. The questionnaire is subdivided in 3 categories:
Each category will be analyzed as follow: Section A: Burnout
Section B: Depersonalization
Section C: Personal Achievement
|
0 day (baseline) and 120 days
|
PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX)
Time Frame: 0 day (baseline) and 120 days
|
The PSQI measured sleep quality and disturbances over a one-month interval across one global score and 7 component scores:
|
0 day (baseline) and 120 days
|
SF-36 questionnaire
Time Frame: 0 day (baseline) and 120 days
|
The SF36 measures health across 8 domains:
Two component summary measures can be calculated:
|
0 day (baseline) and 120 days
|
Saliva Cortisol
Time Frame: 0 day (baseline) and 120 days
|
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:
|
0 day (baseline) and 120 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A02049-48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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