A Specialized Nutraceutical for Pre-burnout (WELBI)

December 6, 2022 updated by: Jean-Michel Lecerf, Institut Pasteur de Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59019
        • NutrInvest - Institut Pasteur de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Morning and night tablets with no active ingrédients. Morning and night tablets are different.
Dietary supplement: Placebo Meta 18.06 Day and Placebo Meta 18.06 Night
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.
Dietary supplement: Meta 18.06 Day and Meta 18.06 Night
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and depression questionnaire
Time Frame: 0 day (baseline) and 120 days

A self-administered questionnaire:

  • A: Anxiety. A score over 7 describes an anxious behavior.
  • D: Depression. A score over 7 describes a depressive behavior.
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:

  • 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.
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:

  • 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
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:

  • 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.
0 day (baseline) and 120 days
SF-36 questionnaire
Time Frame: 0 day (baseline) and 120 days

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).
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:

  • 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.
0 day (baseline) and 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-A02049-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Burn Out

Clinical Trials on Placebo Meta 18.06 Day and Placebo Meta 18.06 Night

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings