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

Study Overview
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Brief Summary
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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).

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

Conditions
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Nervous System Disorder, Imbalance of Constituents of Food Intake

Intervention / Treatment
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* Dietary Supplement: amino acid composition (asn01)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amino acid composition (asn01)<br>Dietary supplement: specific amino acid composition with micronutrients | Dietary Supplement: amino acid composition (asn01)<br>* 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<br>* Other names: Brand name: aminoplus neurostress;|
| Placebo Comparator: Sugar powder<br>Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties. | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological neurological questionnaire (PNF) | Pre-post intervention changes in total number of points PNF | 12-week dietary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Salivary cortisol concentration (30 minutes after waking in the morning) | Absolute difference between cortisol concentration at baseline and 12 weeks | 12-week dietary intervention | 
| 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 | 
| Serotonin concentration in blood | Absolute difference between serotonin concentration at baseline and 12 weeks | 12-week dietary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, lability and irritative disturbances, dietary supplement, amino acid composition, psychological neurological questionnaire (PNF)