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

Kyberg Vital GmbH80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Nervous System Disorder Imbalance of Constituents of Food Intake

Interventions

amino acid composition (asn01)DIETARY_SUPPLEMENT

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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