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Completed

NCT Number: NCT02997137

Impact of an Amino Acid Composition With Micronutrients on Wellbeing of Patients With Chronic Exhaustion Conditions

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Urology, University of Bonn

Bonn, Sigmund-Freud Str. 25, 53105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOT-01

Dietary Supplement

Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.

Duration: 12 weeks

Other names: Brand name: aminoplus burnout

Placebo

Other

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

Primary outcomes

  1. Perceived Stress Questionnaire (PSQ30)

    Time frame: 12-week dietary intervention

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

  2. Perceived Stress Questionnaire (PSQ30)

    Time frame: 8-week dietary intervention

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

Secondary outcomes

  1. 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

    Intervention changes in difference between salivary cortisol concentrations (evening - morning) at baseline and after 12 weeks

  2. The Visual Analog Scale (VAS)

    Time frame: 12-week dietary intervention

    Intervention changes in mean VAS score at baseline and after 12 weeks

  3. The Visual Analog Scale (VAS)

    Time frame: 8-week dietary intervention

    Intervention changes in mean VAS score at baseline and after 8 weeks

Other outcomes

  1. Psychological Neurological Questionnaire (PNF)

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in total number of points from the PNF and the psycho-neurovegetative stability (PN), a category of the PNF.

  2. Morning salivary cortisol concentration (30 minutes after waking)

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks

  3. Evening salivary cortisol concentration (between 10 and 11 pm, at least 30 minutes after dinner)

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in salivary cortisol concentration at baseline and after 12 weeks

  4. 3-day food records

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in dietary intake at baseline and after 12 weeks

  5. Endocrine-cardiometabolic parameters (i. e. serotonin, amino acids in the blood)

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in blood parameters at baseline and after 12 weeks

Sponsors and collaborators

Lead sponsor

Doris Meister

Industry

Registry information

Official study 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

Acronym: BOT-01

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2016
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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