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

Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients

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).

Study Overview

• Status: Completed
• Conditions: Nervous System Disorder; Imbalance of Constituents of Food Intake
• Intervention / Treatment: Dietary supplement: amino acid composition (asn01); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13053
    • Cardiological Outpatient Practice Elke Parsi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: amino acid composition (asn01); Dietary supplement: specific amino acid composition with micronutrients	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 Names: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological neurological questionnaire (PNF)	Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more	12-week dietary intervention
Salivary cortisol concentration (30 minutes after waking in the morning)	Absolute difference between cortisol concentration at baseline and 12 weeks	12-week dietary intervention
Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)	Absolute difference between cortisol concentration at baseline and 12 weeks	12-week dietary intervention
Serotonin concentration in blood	Absolute difference between serotonin concentration at baseline and 12 weeks	12-week dietary intervention

Collaborators and Investigators

• Sponsor: Kyberg Vital GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (ESTIMATE): August 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: stress; dietary supplement; lability and irritative disturbances; amino acid composition; psychological neurological questionnaire (PNF)
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: Kyberg-02