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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Nervous System Disorder Imbalance of Constituents of Food Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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amino acid composition (asn01)

Dietary supplement: specific amino acid composition with micronutrients

Group Type ACTIVE_COMPARATOR

amino acid composition (asn01)

Intervention Type 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

Sugar powder

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Other Intervention Names

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Brand name: aminoplus neurostress

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No