Department of Urology, University of Bonn
Bonn, Sigmund-Freud Str. 25, 53105, Germany
NCT Number: NCT02997137
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Bonn, Sigmund-Freud Str. 25, 53105, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.
Duration: 12 weeks
Other names: Brand name: aminoplus burnout
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
Time frame: 12-week dietary intervention
Intervention changes in the total PSQ30 score at baseline and after 12 weeks
Time frame: 8-week dietary intervention
Intervention changes in the total PSQ30 score at baseline and after 8 weeks
Time frame: 12-week dietary intervention
Intervention changes in difference between salivary cortisol concentrations (evening - morning) at baseline and after 12 weeks
Time frame: 12-week dietary intervention
Intervention changes in mean VAS score at baseline and after 12 weeks
Time frame: 8-week dietary intervention
Intervention changes in mean VAS score at baseline and after 8 weeks
Time frame: 12-week dietary intervention
Pre-post intervention changes in total number of points from the PNF and the psycho-neurovegetative stability (PN), a category of the PNF.
Time frame: 12-week dietary intervention
Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks
Time frame: 12-week dietary intervention
Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks
Time frame: 12-week dietary intervention
Pre-post intervention changes in dietary intake at baseline and after 12 weeks
Time frame: 12-week dietary intervention
Pre-post intervention changes in blood parameters at baseline and after 12 weeks
Doris Meister
Industry
Impact of a Specific Amino Acid Composition With Micronutrients on Wellbeing and Endocrine-cardiometabolic Situation of Patients With Chronic Exhaustion Conditions, Such as Burnout
Acronym: BOT-01
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