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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Kyberg Vital GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Doris Meister, Kyberg Vital GmbH
ClinicalTrials.gov Identifier:
NCT01425983
First received: August 26, 2011
Last updated: August 29, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Kyberg Vital GmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425983

Contacts
Contact: Christine Metzner, Professor MD 0049 (0)221 4849436 info-bfd@t-online.de

Locations
Germany
Cardiological Outpatient Practice Elke Parsi, MD Recruiting
Berlin, Germany, 13053
Contact: Elke Parsi, MD    0049 (0)30 9864639      
Sponsors and Collaborators
Kyberg Vital GmbH
Investigators
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:
Disease
Nervous System Diseases
Pathologic Processes
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014