Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Nervous System Disorder Imbalance of Constituents of Food Intake |
Dietary Supplement: asn01 Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients |
- Psychological neurological questionnaire (PNF) [ Time Frame: 12-week dietary intervention ] [ Designated as safety issue: No ]Pre-post intervention changes in total number of points PNF
- Psychological neurological questionnaire (PNF) [ Time Frame: 12-week dietary intervention ] [ Designated as safety issue: No ]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) [ Time Frame: 12-week dietary intervention ] [ Designated as safety issue: No ]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) [ Time Frame: 12-week dietary intervention ] [ Designated as safety issue: No ]Absolute difference between cortisol concentration at baseline and 12 weeks
- Serotonin concentration in blood [ Time Frame: 12-week dietary intervention ] [ Designated as safety issue: No ]Absolute difference between serotonin concentration at baseline and 12 weeks
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: amino acid composition |
Dietary Supplement: 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 Other Name: Brand name: aminoplus neurostress
|
|
Placebo Comparator: Sugar powder
Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties.
|
Other: Placebo
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Christine Metzner, Professor MD | 0049 (0)221 4849436 | info-bfd@t-online.de |
| Germany | |
| Cardiological Outpatient Practice Elke Parsi, MD | Recruiting |
| Berlin, Germany, 13053 | |
| Contact: Elke Parsi, MD 0049 (0)30 9864639 | |
| Principal Investigator: | Christine Metzner, Professor MD | Bonn Education Association for Dietetics r.A., Cologne, Germany |
More Information
No publications provided
| Responsible Party: | Doris Meister, Doris Meister, Sponsor-Investigator, Kyberg Vital GmbH |
| ClinicalTrials.gov Identifier: | NCT01425983 History of Changes |
| Other Study ID Numbers: | Kyberg-02 |
| Study First Received: | August 26, 2011 |
| Last Updated: | August 29, 2011 |
| Health Authority: | Germany: Federal Ministry of Food, Agriculture and Consumer Protection |
Keywords provided by Kyberg Vital GmbH:
|
stress lability and irritative disturbances dietary supplement amino acid composition psychological neurological questionnaire (PNF) |
Additional relevant MeSH terms:
|
Nervous System Diseases Micronutrients Trace Elements |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013