Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)

Imbalance of Constituents of Food Intake Clinical Trial

— asn01  

Official title:

Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425983
• Other study ID #: Kyberg-02
• 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

• Imbalance of Constituents of Food Intake
• Nervous System Diseases
• Nervous System Disorder

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