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

NCT ID: NCT02997137

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-02-29

Brief 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.

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

Keywords

Chronic psychological distress; Chronic exhaustion conditions; Perceived Stress Questionnaire 30 (PSQ30); Stress management; Dietary supplement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BOT-01

Dietary supplement: specific amino acid composition with micronutrients

Group Type: ACTIVE_COMPARATOR

BOT-01

Intervention Type: 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

Placebo

Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Other Intervention Names

Brand name: aminoplus burnout

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Doris Meister

INDUSTRY

Sponsor Role: lead

Responsible Party

Doris Meister

Doris Meister, Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christine Metzner, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Bonn Education Association for Dietetics r.A., Cologne, Germany

Locations

Department of Urology, University of Bonn

Bonn, Sigmund-Freud Str. 25, Germany

Countries

Germany

Other Identifiers

Kyberg-03

Identifier Type: -

Identifier Source: org_study_id