A Specialized Nutraceutical for Pre-burnout
Condition: Burn Out; Psychological Disturbance
MeSH terms: Burnout, Psychological
Study type: Interventional

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).
    

Intervention name(s): Meta 18.06 Day and Meta 18.06 Night; Placebo Meta 18.06 Day and Placebo Meta 18.06 Night
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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); 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric, double-blind, randomized, placebo-controlled, 2-parallel arm study on outpatients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Burnout; Dietary Supplement; Anxiety; Stress; Plants