Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions (BOT-01)

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

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.

Study Overview

• Status: Completed
• Conditions: Psychological Distress
• Intervention / Treatment: Dietary supplement: BOT-01; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Sigmund-Freud Str. 25
    • Bonn, Sigmund-Freud Str. 25, Germany, 53105
      • Department of Urology, University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BOT-01; Dietary supplement: specific amino acid composition with micronutrients	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 Names: Brand name: aminoplus burnout
Placebo Comparator: Placebo; Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
3-day food records	Pre-post intervention changes in dietary intake at baseline and after 12 weeks	12-week dietary intervention
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

Collaborators and Investigators

• Sponsor: Doris Meister

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Dietary supplement; Stress management; Chronic psychological distress; Chronic exhaustion conditions; Perceived Stress Questionnaire 30 (PSQ30)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: Kyberg-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO