Psychological DistressPhase 3BOT-01NCT02997137
Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions
A Phase 3 study testing BOT-01 in people with Psychological Distress, run by Doris Meister at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- BOT-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Perceived Stress Questionnaire 30 (PSQ30): total score > 0.50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology, University of Bonn
Bonn, Sigmund-Freud Str. 25, 53105
About this study
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
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- BOT-01, Placebo
- Keywords
- Chronic psychological distress, Chronic exhaustion conditions, Perceived Stress Questionnaire 30 (PSQ30), Stress management, Dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOT-01Dietary supplement
Also called Brand name: aminoplus burnout
Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.
Duration: 12 weeks
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| BOT-01 | Active comparator | Dietary supplement: specific amino acid composition with micronutrients Receives: Dietary Supplement: BOT-01 |
| Placebo | Placebo comparator | Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Questionnaire (PSQ30)
Intervention changes in the total PSQ30 score at baseline and after 12 weeks
Measured: 12-week dietary intervention
Perceived Stress Questionnaire (PSQ30)
Intervention changes in the total PSQ30 score at baseline and after 8 weeks
Measured: 8-week dietary intervention
Secondary outcomes (3)
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
Measured: 12-week dietary intervention
The Visual Analog Scale (VAS)
Intervention changes in mean VAS score at baseline and after 12 weeks
Measured: 12-week dietary intervention
The Visual Analog Scale (VAS)
Intervention changes in mean VAS score at baseline and after 8 weeks
Measured: 8-week dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doris Meister
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Doris Meister, Kyberg Vital GmbH
- Investigators
- Christine Metzner, Professor MD, Principal investigator, Bonn Education Association for Dietetics r.A., Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997137
- Sponsor's protocol ID
- Kyberg-03
- Acronym
- BOT-01
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02997137
- Acronym / sponsor ID
- BOT-01 / Kyberg-03
- Conditions
- Psychological Distress
- Keywords
- Chronic psychological distress, Chronic exhaustion conditions, Perceived Stress Questionnaire 30 (PSQ30), Stress management, Dietary supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Doris MeisterIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOT-01 | Active comparator | Dietary Supplement: BOT-01Dietary supplement: specific amino acid composition with micronutrients |
| Placebo | Placebo comparator | Other: PlaceboPlacebo contains no amino acids and no micronutrients and is identical in appearance and solution properties |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-65 years
- Perceived Stress Questionnaire 30 (PSQ30): total score > 0.50
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOT-01Also: Brand name: aminoplus burnoutAmino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water. Duration: 12 weeks | Dietary supplement | BOT-01 |
| PlaceboPlacebo, 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 | Other | Placebo |
Primary outcome
Perceived Stress Questionnaire (PSQ30)
Time frame: 12-week dietary intervention
Intervention changes in the total PSQ30 score at baseline and after 12 weeks
Perceived Stress Questionnaire (PSQ30)
Time frame: 8-week dietary intervention
Intervention changes in the total PSQ30 score at baseline and after 8 weeks
3 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)
Time frame: 12-week dietary intervention
The Visual Analog Scale (VAS)
Time frame: 12-week dietary intervention
The Visual Analog Scale (VAS)
Time frame: 8-week dietary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Metzner, Professor MD principal investigator
Bonn Education Association for Dietetics r.A., Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BOT-01 in people with Psychological Distress, run by Doris Meister at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Questionnaire (PSQ30) (time frame: 12-week dietary intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.