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

Sponsor

Kyberg Vital GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01425983

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Nervous System Disorder Imbalance of Constituents of Food Intake	Dietary Supplement: amino acid composition (asn01) Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Psychological neurological questionnaire (PNF) [12-week dietary intervention]
Pre-post intervention changes in total number of points PNF

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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