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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01425983
Other study ID # Kyberg-02
Secondary ID
Status Completed
Phase Phase 3
First received August 26, 2011
Last updated September 4, 2015
Start date March 2011
Est. completion date June 2012

Study information

Verified date September 2015
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

Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic dysfunction, as well as alterations of the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia, neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms, sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT, serotonin) increases sensitivity to stress.

It is therefore the investigators hypothesis that daily oral administration of an amino acid mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease neurovegetative disorders will target these neuroendocrine and metabolic alterations in adults with psychosocial stress. The principal endpoints will be a decrease in points in the psychological-neurological questionnaire (PNF).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age: 18-65 Years

- Psychological-Neurological Questionnaire (PNF): 30 - 50 Points

Exclusion Criteria:

- Age: < 18 and > 65 Years

- Psychological neurological questionnaire (PNF): < 30 and > 50 Points

- Resting heart rate: < 70/min

- Supplementation with dietary supplements or drugs which contains amino acids, vitamins and other micronutrients

- Therapy with antipsychotic drugs such as tranquilizer, antidepressants

- acute and chronic diarrhea

- Psychological-neurological or psychiatric therapy

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:
amino acid composition (asn01)
Amino acid composition with micronutrients, once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water. Duration: 12 weeks
Other:
Placebo
Placebo; once a day (in the evening, 2 hours after dinner) 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 Cardiological Outpatient Practice Elke Parsi, MD Berlin

Sponsors (1)

Lead Sponsor Collaborator
Kyberg Vital GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Chaborski K, Bitterlich N, Alteheld B, Parsi E, Metzner C. Placebo-controlled dietary intervention of stress-induced neurovegetative disorders with a specific amino acid composition: a pilot-study. Nutr J. 2015 May 6;14:43. doi: 10.1186/s12937-015-0030-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological neurological questionnaire (PNF) Pre-post intervention changes in total number of points PNF 12-week dietary intervention No
Secondary Psychological neurological questionnaire (PNF) Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more 12-week dietary intervention No
Secondary Salivary cortisol concentration (30 minutes after waking in the morning) Absolute difference between cortisol concentration at baseline and 12 weeks 12-week dietary intervention No
Secondary Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner) Absolute difference between cortisol concentration at baseline and 12 weeks 12-week dietary intervention No
Secondary Serotonin concentration in blood Absolute difference between serotonin concentration at baseline and 12 weeks 12-week dietary intervention No
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