Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)
Information source: Kyberg Vital GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nervous System Disorder; Imbalance of Constituents of Food Intake
Intervention: asn01 (Dietary Supplement); Placebo (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Kyberg Vital GmbH Official(s) and/or principal investigator(s): Christine Metzner, Professor MD, Principal Investigator, Affiliation: Bonn Education Association for Dietetics r.A., Cologne, Germany
Overall contact: Christine Metzner, Professor MD, Phone: 0049 (0)221 4849436, Email: info-bfd@t-online.de
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).
Clinical Details
Official title: Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Psychological neurological questionnaire (PNF)
Secondary outcome: Psychological neurological questionnaire (PNF)Salivary cortisol concentration (30 minutes after waking in the morning) Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner) Serotonin concentration in blood
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Christine Metzner, Professor MD, Phone: 0049 (0)221 4849436, Email: info-bfd@t-online.de
Cardiological Outpatient Practice Elke Parsi, MD, Berlin 13053, Germany; Recruiting Elke Parsi, MD, Phone: 0049 (0)30 9864639
Additional Information
Starting date: March 2011
Last updated: August 29, 2011
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