Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions
Condition: Psychological Distress
MeSH terms: Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.
      These conditions are associated with a deficiency of specific amino acids and micronutrients
      that cause endocrine-cardiometabolic abnormalities. These people have specific
      medically-determined nutrient requirements.

      Aim of this study is to demonstrate, that the daily oral administration of a specific amino
      acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,
      magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly
      decrease the perceived chronic distress and associated chronic exhaustion conditions of women
      and men after 8 and 12 weeks.
    

Detailed description: 
      Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.
      This clinical condition is characterized by reduced satisfaction in performance, exhaustion
      and depersonalization. Individuals under prolonged exposure to chronic work-life stress and
      insufficient recovery are at high risk for developing burnout symptoms. Social services,
      caregiving and teaching professions with a perceived imbalance of effort and reward are often
      affected. Until now, a general accepted definition of burnout syndrome and its binding
      diagnostic criteria have not been established. Moreover, there is a strong association
      between chronic psychological distress and somatoform symptoms, like sleeping disturbances,
      headaches and abdominal pain that cannot be fully explained by medical or neurological
      condition. Physiologically the hypothalamus pituitary adrenal axis (HPA-axis) is the central
      system for the long term adaptation of an organism to stress. During stress exposure, the
      HPA-axis is activated and the adrenal cortex produces high levels of cortisol with a stress
      inhibitory function at the same time. However, exposure to long-term chronic stress is
      associated with biological dysregulation and can result in hypofunctioning of the HPA-axis
      and a state of hypocortisolism. In addition, the serotonergic system, the immune system and
      the amino acid metabolism get adversely affected.

      Stress-related eating behaviours frequently results in an imbalance of amino acids and
      deficiency of micronutrients (i. e. B-vitamins and magnesium) that cause
      endocrine-cardiometabolic abnormalities. Intake of specific amino acids can affect the brain
      functioning and mental health. Some amino acids are precursors of the neurotransmitters in
      the brain. Moreover, l-ornithine and taurine are suggested to have an antifatigue effect.
      Dietary intake of B-vitamins and magnesium, the important stress-mineral, had positive
      effects on mood and perceived stress.

      Aim of this study is to demonstrate, that the daily oral administration of a specific amino
      acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,
      magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly
      decrease the perceived chronic distress and associated chronic exhaustion conditions of women
      and men after 8 and 12 weeks.
    

Intervention name(s): BOT-01; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.
Duration: 12 weeks; Placebo, once a day (in the morning) content of a sachet mixed with 200 ml water.
Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties.
Duration: 12 weeks
Other intervention name(s): Brand name: aminoplus burnout
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic psychological distress; Chronic exhaustion conditions; Perceived Stress Questionnaire 30 (PSQ30); Stress management; Dietary supplement