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
Sponsor study identifier
interventional
74
1 country
1
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 2016
Actual (reported)February 2016
Actual (reported)December 15, 2016
Actual (reported)December 19, 2016
Actual (reported)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
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)
12-week dietary intervention
The Visual Analog Scale (VAS)
8-week dietary intervention
Psychological Neurological Questionnaire (PNF)
12-week dietary intervention
Morning salivary cortisol concentration (30 minutes after waking)
12-week dietary intervention
Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)
12-week dietary intervention
Dietary supplement: specific amino acid composition with micronutrients
Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties
Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water. Duration: 12 weeks
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
Department of Urology, University of Bonn
Bonn, Sigmund-Freud Str. 25, 53105, Germany
Christine Metzner, Professor MD
Bonn Education Association for Dietetics r.A., Cologne, Germany
74 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2016
First Posted
December 19, 2016
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
December 19, 2016
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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