Clinical trial NCT02997137: Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions
Official title: Impact of a Specific Amino Acid Composition With Micronutrients on Wellbeing and Endocrine-cardiometabolic Situation of Patients With Chronic Exhaustion Conditions, Such as Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychological Distress
Keywords: Chronic psychological distress
Chronic exhaustion conditions
Perceived Stress Questionnaire 30 (PSQ30)
Stress management
Dietary supplement
Lead sponsor: Kyberg Vital GmbH
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Questionnaire (PSQ30)
timeFrame: 12-week dietary intervention
measure: Perceived Stress Questionnaire (PSQ30)
timeFrame: 8-week dietary intervention
Secondary outcomes:
measure: 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)
timeFrame: 12-week dietary intervention
measure: The Visual Analog Scale (VAS)
timeFrame: 12-week dietary intervention
measure: The Visual Analog Scale (VAS)
timeFrame: 8-week dietary intervention
Other outcomes:
measure: Psychological Neurological Questionnaire (PNF)
timeFrame: 12-week dietary intervention
measure: Morning salivary cortisol concentration (30 minutes after waking)
timeFrame: 12-week dietary intervention
measure: Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)
timeFrame: 12-week dietary intervention
measure: 3-day food records
timeFrame: 12-week dietary intervention
measure: Endocrine-cardiometabolic parameters (i. e. serotonin, amino acids in the blood)
timeFrame: 12-week dietary intervention
Locations:
city: Bonn
country: Germany
facility: Department of Urology, University of Bonn
state: Sigmund-Freud Str. 25
Study officials:
affiliation: Bonn Education Association for Dietetics r.A., Cologne, Germany
name: Christine Metzner, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: