Imbalance of Constituents of Food Intake, Nervous System Disorder
Conditions
Keywords
stress, lability and irritative disturbances, dietary supplement, amino acid composition, psychological neurological questionnaire (PNF)
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).
Interventions
DIETARY_SUPPLEMENTamino acid composition (asn01)
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
OTHERPlacebo
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
Sponsors
Kyberg Vital GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological neurological questionnaire (PNF) | 12-week dietary intervention | Pre-post intervention changes in total number of points PNF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed