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

NCT01425983 | Completed Phase 3

• 1 other identifier: Kyberg-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stress; lability and irritative disturbances; dietary supplement; amino acid composition; psychological neurological questionnaire (PNF)

Outcome Measures

Primary Outcomes (1)

• Psychological neurological questionnaire (PNF)

  Pre-post intervention changes in total number of points PNF

  12-week dietary intervention

Secondary Outcomes (4)

• Psychological neurological questionnaire (PNF)

  12-week dietary intervention

• Salivary cortisol concentration (30 minutes after waking in the morning)

  12-week dietary intervention

• Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)

  12-week dietary intervention

• Serotonin concentration in blood

  12-week dietary intervention

Study Arms (2)

amino acid composition (asn01)

ACTIVE COMPARATOR

Dietary supplement: specific amino acid composition with micronutrients

Dietary Supplement: amino acid composition (asn01)

Sugar powder

PLACEBO COMPARATOR

Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties.

Other: Placebo

Interventions

amino acid composition (asn01) DIETARY_SUPPLEMENT

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

Also known as: Brand name: aminoplus neurostress

amino acid composition (asn01)

Placebo OTHER

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

Sugar powder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 Years
• Psychological-Neurological Questionnaire (PNF): 30 - 50 Points

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyberg Vital GmbH: lead

Study Sites (1)

Cardiological Outpatient Practice Elke Parsi, MD

Berlin, State of Berlin, 13053, Germany

Location

Related Publications (1)

• 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.

  PMID: 25943490 RESULT

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Christine Metzner, Professor MD

  Bonn Education Association for Dietetics r.A., Cologne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doris Meister, Sponsor-Investigator

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

DE (1)