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

Psychological Distress Clinical Trial

— BOT-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997137
• Other study ID #: Kyberg-03
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2016
• Last updated: December 15, 2016
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: Kyberg Vital GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Dietary Supplement:
• BOT-01
Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water. Duration: 12 weeks

Other:
• Placebo
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

Locations

Country	Name	City	State
Germany	Department of Urology, University of Bonn	Bonn	Sigmund-Freud Str. 25

Sponsors (1)

Lead Sponsor	Collaborator
Doris Meister

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological Neurological Questionnaire (PNF)	Pre-post intervention changes in total number of points from the PNF and the psycho-neurovegetative stability (PN), a category of the PNF.	12-week dietary intervention	No
Other	Morning salivary cortisol concentration (30 minutes after waking)	Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks	12-week dietary intervention	No
Other	Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)	Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks	12-week dietary intervention	No
Other	3-day food records	Pre-post intervention changes in dietary intake at baseline and after 12 weeks	12-week dietary intervention	No
Other	Endocrine-cardiometabolic parameters (i. e. serotonin, amino acids in the blood)	Pre-post intervention changes in blood parameters at baseline and after 12 weeks	12-week dietary intervention	No
Primary	Perceived Stress Questionnaire (PSQ30)	Intervention changes in the total PSQ30 score at baseline and after 12 weeks	12-week dietary intervention	No
Primary	Perceived Stress Questionnaire (PSQ30)	Intervention changes in the total PSQ30 score at baseline and after 8 weeks	8-week dietary intervention	No
Secondary	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	No
Secondary	The Visual Analog Scale (VAS)	Intervention changes in mean VAS score at baseline and after 12 weeks	12-week dietary intervention	No
Secondary	The Visual Analog Scale (VAS)	Intervention changes in mean VAS score at baseline and after 8 weeks	8-week dietary intervention	No