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Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)

NCT01425983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-09-07

No results posted yet for this study

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).

Conditions

  • Nervous System Disorder
  • Imbalance of Constituents of Food Intake

Interventions

DIETARY_SUPPLEMENT

amino 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

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

Sponsors & Collaborators

  • Kyberg Vital GmbH

    lead INDUSTRY

Principal Investigators

  • Christine Metzner, Professor MD · Bonn Education Association for Dietetics r.A., Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425983 on ClinicalTrials.gov