<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997137</url>
  </required_header>
  <id_info>
    <org_study_id>Kyberg-03</org_study_id>
    <nct_id>NCT02997137</nct_id>
  </id_info>
  <brief_title>Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions</brief_title>
  <acronym>BOT-01</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Doris Meister</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyberg Vital GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.&#xD;
      These conditions are associated with a deficiency of specific amino acids and micronutrients&#xD;
      that cause endocrine-cardiometabolic abnormalities. These people have specific&#xD;
      medically-determined nutrient requirements.&#xD;
&#xD;
      Aim of this study is to demonstrate, that the daily oral administration of a specific amino&#xD;
      acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,&#xD;
      magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly&#xD;
      decrease the perceived chronic distress and associated chronic exhaustion conditions of women&#xD;
      and men after 8 and 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.&#xD;
      This clinical condition is characterized by reduced satisfaction in performance, exhaustion&#xD;
      and depersonalization. Individuals under prolonged exposure to chronic work-life stress and&#xD;
      insufficient recovery are at high risk for developing burnout symptoms. Social services,&#xD;
      caregiving and teaching professions with a perceived imbalance of effort and reward are often&#xD;
      affected. Until now, a general accepted definition of burnout syndrome and its binding&#xD;
      diagnostic criteria have not been established. Moreover, there is a strong association&#xD;
      between chronic psychological distress and somatoform symptoms, like sleeping disturbances,&#xD;
      headaches and abdominal pain that cannot be fully explained by medical or neurological&#xD;
      condition. Physiologically the hypothalamus pituitary adrenal axis (HPA-axis) is the central&#xD;
      system for the long term adaptation of an organism to stress. During stress exposure, the&#xD;
      HPA-axis is activated and the adrenal cortex produces high levels of cortisol with a stress&#xD;
      inhibitory function at the same time. However, exposure to long-term chronic stress is&#xD;
      associated with biological dysregulation and can result in hypofunctioning of the HPA-axis&#xD;
      and a state of hypocortisolism. In addition, the serotonergic system, the immune system and&#xD;
      the amino acid metabolism get adversely affected.&#xD;
&#xD;
      Stress-related eating behaviours frequently results in an imbalance of amino acids and&#xD;
      deficiency of micronutrients (i. e. B-vitamins and magnesium) that cause&#xD;
      endocrine-cardiometabolic abnormalities. Intake of specific amino acids can affect the brain&#xD;
      functioning and mental health. Some amino acids are precursors of the neurotransmitters in&#xD;
      the brain. Moreover, l-ornithine and taurine are suggested to have an antifatigue effect.&#xD;
      Dietary intake of B-vitamins and magnesium, the important stress-mineral, had positive&#xD;
      effects on mood and perceived stress.&#xD;
&#xD;
      Aim of this study is to demonstrate, that the daily oral administration of a specific amino&#xD;
      acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,&#xD;
      magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly&#xD;
      decrease the perceived chronic distress and associated chronic exhaustion conditions of women&#xD;
      and men after 8 and 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress Questionnaire (PSQ30)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Intervention changes in the total PSQ30 score at baseline and after 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Questionnaire (PSQ30)</measure>
    <time_frame>8-week dietary intervention</time_frame>
    <description>Intervention changes in the total PSQ30 score at baseline and after 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <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)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Intervention changes in difference between salivary cortisol concentrations (evening - morning) at baseline and after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Visual Analog Scale (VAS)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Intervention changes in mean VAS score at baseline and after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Visual Analog Scale (VAS)</measure>
    <time_frame>8-week dietary intervention</time_frame>
    <description>Intervention changes in mean VAS score at baseline and after 8 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Psychological Neurological Questionnaire (PNF)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Pre-post intervention changes in total number of points from the PNF and the psycho-neurovegetative stability (PN), a category of the PNF.</description>
  </other_outcome>
  <other_outcome>
    <measure>Morning salivary cortisol concentration (30 minutes after waking)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>3-day food records</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Pre-post intervention changes in dietary intake at baseline and after 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Endocrine-cardiometabolic parameters (i. e. serotonin, amino acids in the blood)</measure>
    <time_frame>12-week dietary intervention</time_frame>
    <description>Pre-post intervention changes in blood parameters at baseline and after 12 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>BOT-01</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary supplement: specific amino acid composition with micronutrients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BOT-01</intervention_name>
    <description>Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.&#xD;
Duration: 12 weeks</description>
    <arm_group_label>BOT-01</arm_group_label>
    <other_name>Brand name: aminoplus burnout</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, once a day (in the morning) content of a sachet mixed with 200 ml water.&#xD;
Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties.&#xD;
Duration: 12 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Perceived Stress Questionnaire 30 (PSQ30): total score &gt; 0.50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: &lt; 18 and &gt; 65 Years&#xD;
&#xD;
          -  Perceived Stress Questionnaire (PSQ30): total score ≤ 0.50&#xD;
&#xD;
          -  Supplementation or therapy with dietary supplements or drugs which contains amino&#xD;
             acids (e. g. l-tryptophan), vitamins and other micronutrients (have to discontinue 4&#xD;
             weeks prior to the start of the study)&#xD;
&#xD;
          -  Therapy with antidepressant drugs such as monoamine oxidase inhibitors&#xD;
&#xD;
          -  Hypertension (untreated &gt; 150/90 mmHg, treated &gt; 140/85 mmHg)&#xD;
&#xD;
          -  Organic fatigue&#xD;
&#xD;
          -  Phenylketonuria&#xD;
&#xD;
          -  Acute and chronic diarrhea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Metzner, Professor MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bonn Education Association for Dietetics r.A., Cologne, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology, University of Bonn</name>
      <address>
        <city>Bonn</city>
        <state>Sigmund-Freud Str. 25</state>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kyberg Vital GmbH</investigator_affiliation>
    <investigator_full_name>Doris Meister</investigator_full_name>
    <investigator_title>Doris Meister, Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic psychological distress</keyword>
  <keyword>Chronic exhaustion conditions</keyword>
  <keyword>Perceived Stress Questionnaire 30 (PSQ30)</keyword>
  <keyword>Stress management</keyword>
  <keyword>Dietary supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997137
org study id: Kyberg-03
nct id: NCT02997137
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Perceived Stress Questionnaire (PSQ30)
time frame: 12-week dietary intervention
description: Intervention changes in the total PSQ30 score at baseline and after 12 weeks
measure: Perceived Stress Questionnaire (PSQ30)
time frame: 8-week dietary intervention
description: Intervention changes in the total PSQ30 score at baseline and after 8 weeks
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)
time frame: 12-week dietary intervention
description: Intervention changes in difference between salivary cortisol concentrations (evening - morning) at baseline and after 12 weeks
measure: The Visual Analog Scale (VAS)
time frame: 12-week dietary intervention
description: Intervention changes in mean VAS score at baseline and after 12 weeks
measure: The Visual Analog Scale (VAS)
time frame: 8-week dietary intervention
description: Intervention changes in mean VAS score at baseline and after 8 weeks
measure: Psychological Neurological Questionnaire (PNF)
time frame: 12-week dietary intervention
description: Pre-post intervention changes in total number of points from the PNF and the psycho-neurovegetative stability (PN), a category of the PNF.
measure: Morning salivary cortisol concentration (30 minutes after waking)
time frame: 12-week dietary intervention
description: Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks
measure: Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)
time frame: 12-week dietary intervention
description: Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks
measure: 3-day food records
time frame: 12-week dietary intervention
description: Pre-post intervention changes in dietary intake at baseline and after 12 weeks
measure: Endocrine-cardiometabolic parameters (i. e. serotonin, amino acids in the blood)
time frame: 12-week dietary intervention
description: Pre-post intervention changes in blood parameters at baseline and after 12 weeks
arm group label: BOT-01
arm group type: Active Comparator
description: Dietary supplement: specific amino acid composition with micronutrients
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties
intervention type: Dietary Supplement
intervention name: BOT-01
description: Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.
Duration: 12 weeks
arm group label: BOT-01
other name: Brand name: aminoplus burnout
intervention type: Other
intervention name: Placebo
description: 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
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Christine Metzner, Professor MD
role: Principal Investigator
affiliation: Bonn Education Association for Dietetics r.A., Cologne, Germany
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Kyberg Vital GmbH
investigator full name: Doris Meister
investigator title: Doris Meister, Sponsor-Investigator
mesh term: Disease
sharing ipd: No