Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Psychological neurological questionnaire (PNF)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Psychological neurological questionnaire (PNF)
Time Frame: 12-week dietary intervention
Pre-post intervention changes in total number of points PNF
Secondary Outcomes
- 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)
Investigators
Doris Meister
Doris Meister, Sponsor-Investigator
Kyberg Vital GmbH