Skip to main content
Clinical Trials/NCT02997137
NCT02997137CompletedPhase 3

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

Doris Meister1 site in 1 country74 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
Perceived Stress Questionnaire (PSQ30)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

BOT-01

Active Comparator

Dietary supplement: specific amino acid composition with micronutrients

Intervention: BOT-01 (Dietary Supplement)

Placebo

Placebo Comparator

Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Perceived Stress Questionnaire (PSQ30)

Time Frame: 8-week dietary intervention

Intervention changes in the total PSQ30 score at baseline and after 8 weeks

Perceived Stress Questionnaire (PSQ30)

Time Frame: 12-week dietary intervention

Intervention changes in the total PSQ30 score at baseline and after 12 weeks

Secondary Outcomes

  • 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)(12-week dietary intervention)
  • The Visual Analog Scale (VAS)(8-week dietary intervention)
  • The Visual Analog Scale (VAS)(12-week dietary intervention)

Investigators

Sponsor
Doris Meister
Sponsor Class
Industry
Responsible Party
Sponsor Investigator
Principal Investigator

Doris Meister

Doris Meister, Sponsor-Investigator

Kyberg Vital GmbH

Study Sites (1)

Loading locations...

Similar Trials

Impact of an Amino Acid Composition With... | Clinical Trial