Clinical trial NCT04532892: A Specialized Nutraceutical for Pre-burnout
Official title: Efficacy and Tolerance of a Specialized Nutraceutical for Pre-burnout - a Randomized, Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Out
Psychological Disturbance
Keywords: Burnout
Dietary Supplement
Anxiety
Stress
Plants
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, double-blind, randomized, placebo-controlled, 2-parallel arm study on outpatients
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Mean score of the validated MQLI questionnaire (Multicultural Quality of Life Index)
timeFrame: 0 day (baseline), 60 days, 120 days
Secondary outcomes:
measure: Hospital Anxiety and depression questionnaire
timeFrame: 0 day (baseline) and 120 days
measure: Cungi questionnaire
timeFrame: 0 day (baseline) and 120 days
measure: Cohen questionnaire
timeFrame: 0 day (baseline) and 120 days
measure: MBI questionnaire (Maslach Burn Out Inventory Questionnaire)
timeFrame: 0 day (baseline) and 120 days
measure: PSQI Questionnaire (PITTSBURG SLEEP QUALITY INDEX)
timeFrame: 0 day (baseline) and 120 days
measure: SF-36 questionnaire
timeFrame: 0 day (baseline) and 120 days
measure: Saliva Cortisol
timeFrame: 0 day (baseline) and 120 days
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
References: