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

Phase 3

Completed

• Conditions: Nervous System Disorder; Imbalance of Constituents of Food Intake
• Interventions: Dietary Supplement: amino acid composition (asn01); Other: Placebo

• Registration Number: NCT01425983
• Lead Sponsor: Kyberg Vital GmbH

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amino acid composition (asn01)	amino acid composition (asn01)	Dietary supplement: specific amino acid composition with micronutrients
Sugar powder	Placebo	Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties.

Primary Outcome Measures

Name	Time	Method
Psychological neurological questionnaire (PNF)	12-week dietary intervention	Pre-post intervention changes in total number of points PNF

Secondary Outcome Measures

Name	Time	Method
Psychological neurological questionnaire (PNF)	12-week dietary intervention	Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more
Salivary cortisol concentration (30 minutes after waking in the morning)	12-week dietary intervention	Absolute difference between cortisol concentration at baseline and 12 weeks
Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)	12-week dietary intervention	Absolute difference between cortisol concentration at baseline and 12 weeks
Serotonin concentration in blood	12-week dietary intervention	Absolute difference between serotonin concentration at baseline and 12 weeks

Trial Locations

Locations (1)

Cardiological Outpatient Practice Elke Parsi, MD; 🇩🇪 Berlin, Germany