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

NCT02997137 | Completed Phase 3

• 1 other identifier: Kyberg-03
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Questionnaire (PSQ30)

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

  12-week dietary intervention

• Perceived Stress Questionnaire (PSQ30)

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

  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)

  12-week dietary intervention

• The Visual Analog Scale (VAS)

  12-week dietary intervention

• The Visual Analog Scale (VAS)

  8-week dietary intervention

Other Outcomes (5)

• Psychological Neurological Questionnaire (PNF)

  12-week dietary intervention

• Morning salivary cortisol concentration (30 minutes after waking)

  12-week dietary intervention

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

  12-week dietary intervention

Study Arms (2)

BOT-01

ACTIVE COMPARATOR

Dietary supplement: specific amino acid composition with micronutrients

Dietary Supplement: BOT-01

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Also known as: Brand name: aminoplus burnout

BOT-01

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• Perceived Stress Questionnaire 30 (PSQ30): total score \> 0.50

You may not qualify if:

• 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

Sponsors & Collaborators

• Doris Meister: lead

Study Sites (1)

Department of Urology, University of Bonn

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

Location

Study Officials

• Christine Metzner, Professor MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doris Meister, Sponsor-Investigator

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)