Clinical trial NCT01425983: Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)
Official title: Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nervous System Disorder
Imbalance of Constituents of Food Intake
Keywords: stress
lability and irritative disturbances
dietary supplement
amino acid composition
psychological neurological questionnaire (PNF)
Lead sponsor: Kyberg Vital GmbH
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Psychological neurological questionnaire (PNF)
timeFrame: 12-week dietary intervention
Secondary outcomes:
measure: Psychological neurological questionnaire (PNF)
timeFrame: 12-week dietary intervention
measure: Salivary cortisol concentration (30 minutes after waking in the morning)
timeFrame: 12-week dietary intervention
measure: Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)
timeFrame: 12-week dietary intervention
measure: Serotonin concentration in blood
timeFrame: 12-week dietary intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Cardiological Outpatient Practice Elke Parsi, MD
Study officials:
affiliation: Bonn Education Association for Dietetics r.A., Cologne, Germany
name: Christine Metzner, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.