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Completed

NCT Number: NCT01425983

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiological Outpatient Practice Elke Parsi, MD

Berlin, State of Berlin, 13053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Brand name: aminoplus neurostress

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

Primary outcomes

  1. Psychological neurological questionnaire (PNF)

    Time frame: 12-week dietary intervention

    Pre-post intervention changes in total number of points PNF

Secondary outcomes

  1. Psychological neurological questionnaire (PNF)

    Time frame: 12-week dietary intervention

    Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more

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

    Time frame: 12-week dietary intervention

    Absolute difference between cortisol concentration at baseline and 12 weeks

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

    Time frame: 12-week dietary intervention

    Absolute difference between cortisol concentration at baseline and 12 weeks

  4. Serotonin concentration in blood

    Time frame: 12-week dietary intervention

    Absolute difference between serotonin concentration at baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Kyberg Vital GmbH

Industry

Registry information

Official study title

Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients

Acronym: asn01

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2011
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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