Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of a Specific Amino Acid Composition With Micronutrients on Wellbeing and Endocrine-cardiometabolic Situation of Patients With Chronic Exhaustion Conditions, Such as Burnout

Conditions
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Psychological Distress

Intervention / Treatment
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* Dietary Supplement: BOT-01
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years Perceived Stress Questionnaire 30 (PSQ30): total score > 0.50 Exclusion Criteria: Age: < 18 and > 65 Years Perceived Stress Questionnaire (PSQ30): total score ≤ 0.50 Supplementation or therapy with dietary supplements or drugs which contains amino acids (e. g. l-tryptophan), vitamins and other micronutrients (have to discontinue 4 weeks prior to the start of the study) Therapy with antidepressant drugs such as monoamine oxidase inhibitors Hypertension (untreated > 150/90 mmHg, treated > 140/85 mmHg) Organic fatigue Phenylketonuria Acute and chronic diarrhea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BOT-01<br>Dietary supplement: specific amino acid composition with micronutrients | Dietary Supplement: BOT-01<br>* Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water. Duration: 12 weeks<br>* Other names: Brand name: aminoplus burnout;|
| Placebo Comparator: Placebo<br>Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Questionnaire (PSQ30) | Intervention changes in the total PSQ30 score at baseline and after 12 weeks | 12-week dietary intervention | 
| Perceived Stress Questionnaire (PSQ30) | Intervention changes in the total PSQ30 score at baseline and after 8 weeks | 8-week dietary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol concentration in the evening (between 10 and 11 pm, at least 30 minutes after dinner) and in the morning (30 minutes after waking in the morning) | Intervention changes in difference between salivary cortisol concentrations (evening - morning) at baseline and after 12 weeks | 12-week dietary intervention | 
| The Visual Analog Scale (VAS) | Intervention changes in mean VAS score at baseline and after 12 weeks | 12-week dietary intervention | 
| The Visual Analog Scale (VAS) | Intervention changes in mean VAS score at baseline and after 8 weeks | 8-week dietary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic psychological distress, Chronic exhaustion conditions, Perceived Stress Questionnaire 30 (PSQ30), Stress management, Dietary supplement