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

Overview

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).

Full Title of Study: “Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

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

Arms, Groups and Cohorts

  • Active Comparator: amino acid composition (asn01)
    • Dietary supplement: specific amino acid composition with micronutrients
  • Placebo Comparator: Sugar powder
    • Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties.

Clinical Trial Outcome Measures

Primary Measures

  • Psychological neurological questionnaire (PNF)
    • Time Frame: 12-week dietary intervention
    • Pre-post intervention changes in total number of points PNF

Secondary Measures

  • Psychological neurological questionnaire (PNF)
    • Time Frame: 12-week dietary intervention
    • 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
    • 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
    • Absolute difference between cortisol concentration at baseline and 12 weeks
  • Serotonin concentration in blood
    • Time Frame: 12-week dietary intervention
    • Absolute difference between serotonin concentration at baseline and 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyberg Vital GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Doris Meister, Doris Meister, Sponsor-Investigator – Kyberg Vital GmbH
  • Overall Official(s)
    • Christine Metzner, Professor MD, Principal Investigator, Bonn Education Association for Dietetics r.A., Cologne, Germany

Citations Reporting on Results

Chaborski K, Bitterlich N, Alteheld B, Parsi E, Metzner C. Placebo-controlled dietary intervention of stress-induced neurovegetative disorders with a specific amino acid composition: a pilot-study. Nutr J. 2015 May 6;14:43. doi: 10.1186/s12937-015-0030-3.

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