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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amino acid composition (asn01) | Active Comparator | Dietary supplement: specific amino acid composition with micronutrients |
|
| Sugar powder | Placebo Comparator | Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological neurological questionnaire (PNF) | Pre-post intervention changes in total number of points PNF | 12-week dietary intervention |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Metzner, Professor MD | Bonn Education Association for Dietetics r.A., Cologne, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiological Outpatient Practice Elke Parsi, MD | Berlin | State of Berlin | 13053 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25943490 | Result | 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. |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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|
| Placebo | Other | 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 |
|
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 |