Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02997137
Other study ID # Kyberg-03
Secondary ID
Status Completed
Phase Phase 3
First received December 15, 2016
Last updated December 15, 2016
Start date October 2014
Est. completion date February 2016

Study information

Verified date December 2016
Source Kyberg Vital GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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:
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

Locations

Country Name City State
Germany Department of Urology, University of Bonn Bonn Sigmund-Freud Str. 25

Sponsors (1)

Lead Sponsor Collaborator
Doris Meister

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 No
Other 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 No
Other 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 No
Other 3-day food records Pre-post intervention changes in dietary intake at baseline and after 12 weeks 12-week dietary intervention No
Other 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 No
Primary Perceived Stress Questionnaire (PSQ30) Intervention changes in the total PSQ30 score at baseline and after 12 weeks 12-week dietary intervention No
Primary Perceived Stress Questionnaire (PSQ30) Intervention changes in the total PSQ30 score at baseline and after 8 weeks 8-week dietary intervention No
Secondary 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 No
Secondary The Visual Analog Scale (VAS) Intervention changes in mean VAS score at baseline and after 12 weeks 12-week dietary intervention No
Secondary The Visual Analog Scale (VAS) Intervention changes in mean VAS score at baseline and after 8 weeks 8-week dietary intervention No
See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT05526235 - A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities N/A
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03720600 - Forms of Racial Discrimination Study N/A
Not yet recruiting NCT05400096 - Psychological Wellbeing in Clients in Tier 3 Weight Management Service N/A
Completed NCT02212236 - Psychological Intervention for Distress During HSCT Phase 2
Active, not recruiting NCT00892138 - Mindfulness Training for Stress Management N/A
Recruiting NCT04815278 - NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations N/A
Recruiting NCT04936828 - Ecological Momentary Intervention for Stroke Caregivers' Psychological Support N/A
Withdrawn NCT03341364 - Acceptance and Commitment Based Group Therapy for Cancer Patients N/A
Recruiting NCT05137925 - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum N/A
Completed NCT04376723 - Mental Health Apps for Mild Psychological Distress Amongst Adolescents N/A
Active, not recruiting NCT04020497 - Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients N/A
Not yet recruiting NCT03652168 - Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees Phase 3
Terminated NCT03587896 - Implementation of Self Help Plus in Adult Syrian Refugees in Turkey (RE-DEFINE) N/A
Completed NCT03721770 - Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation
Recruiting NCT05849454 - Messy Memories: Mobile Application Therapy Following Critical Illness N/A
Recruiting NCT05525299 - Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors N/A
Recruiting NCT06052904 - Music Breathing for Caregivers of Children Newly Diagnosed With Cancer N/A