Cardiological Outpatient Practice Elke Parsi, MD
Berlin, State of Berlin, 13053, Germany
NCT Number: NCT01425983
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Berlin, State of Berlin, 13053, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Brand name: aminoplus neurostress
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
Time frame: 12-week dietary intervention
Pre-post intervention changes in total number of points PNF
Time frame: 12-week dietary intervention
Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more
Time frame: 12-week dietary intervention
Absolute difference between cortisol concentration at baseline and 12 weeks
Time frame: 12-week dietary intervention
Absolute difference between cortisol concentration at baseline and 12 weeks
Time frame: 12-week dietary intervention
Absolute difference between serotonin concentration at baseline and 12 weeks
Kyberg Vital GmbH
Industry
Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
Acronym: asn01
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