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

Kyberg Vital

Status and phase: Completed; Phase 3

Conditions: Nervous System Disorder; Imbalance of Constituents of Food Intake

Treatments: Dietary Supplement: amino acid composition (asn01); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425983

Kyberg-02

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

amino acid composition (asn01)

Active Comparator group

Description:

Dietary supplement: specific amino acid composition with micronutrients

Treatment:

Dietary Supplement: amino acid composition (asn01)

Sugar powder

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo