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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

Page last updated: August 23, 2015

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