Nervous System DisorderPhase 3asn01NCT01425983
Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)
A Phase 3 study testing amino acid composition (asn01) in people with Nervous System Disorder and Imbalance of Constituents of Food Intake, run by Kyberg Vital GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nervous System Disorder, Imbalance of Constituents of Food Intake
- What is being tested?
- amino acid composition (asn01)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 Years
- Psychological-Neurological Questionnaire (PNF): 30 - 50 Points
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Cardiological Outpatient Practice Elke Parsi, MD
Berlin, State of Berlin, 13053
About this study
Official title: Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
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).
- Being tested
- amino acid composition (asn01), Placebo
- Keywords
- stress, lability and irritative disturbances, dietary supplement, amino acid composition, psychological neurological questionnaire (PNF)
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid composition (asn01)Dietary supplement
Also called Brand name: aminoplus neurostress
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| amino acid composition (asn01) | Active comparator | Dietary supplement: specific amino acid composition with micronutrients Receives: Dietary Supplement: amino acid composition (asn01) |
| Sugar powder | Placebo comparator | Placebo contains no amino acids and no micronutrients and is identical in appearance and solution properties. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological neurological questionnaire (PNF)
Pre-post intervention changes in total number of points PNF
Measured: 12-week dietary intervention
Secondary outcomes (4)
Psychological neurological questionnaire (PNF)
Pre-post improvement in total number of points from the psychological-neurological questionnaire (PNF) about 10 Points or more
Measured: 12-week dietary intervention
Salivary cortisol concentration (30 minutes after waking in the morning)
Absolute difference between cortisol concentration at baseline and 12 weeks
Measured: 12-week dietary intervention
Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)
Absolute difference between cortisol concentration at baseline and 12 weeks
Measured: 12-week dietary intervention
Serotonin concentration in blood
Absolute difference between serotonin concentration at baseline and 12 weeks
Measured: 12-week dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nervous System DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyberg Vital GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Doris Meister, Kyberg Vital GmbH
- Investigators
- Christine Metzner, Professor MD, Principal investigator, Bonn Education Association for Dietetics r.A., Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425983
- Sponsor's protocol ID
- Kyberg-02
- Acronym
- asn01
- Status last verified
- Sep 2015
- First submitted
- 26 Aug 2011
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chaborski K, Bitterlich N, Alteheld B, Parsi E, Metzner C. Placebo-controlled dietary intervention of stress-induced neurovegetative disorders with a specific amino acid composition: a pilot-study. Nutr J. 2015 May 6;14:43. doi: 10.1186/s12937-015-0030-3.
PubMed 25943490
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients
- ClinicalTrials.gov ID
- NCT01425983
- Acronym / sponsor ID
- asn01 / Kyberg-02
- Keywords
- stress, lability and irritative disturbances, dietary supplement, amino acid composition, psychological neurological questionnaire (PNF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyberg Vital GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amino acid composition (asn01) | Active comparator | Dietary Supplement: amino acid composition (asn01)Dietary supplement: specific amino acid composition with micronutrients |
| Sugar powder | Placebo comparator | Other: PlaceboPlacebo contains no amino acids and no micronutrients and is identical in appearance and solution properties. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-65 Years
- Psychological-Neurological Questionnaire (PNF): 30 - 50 Points
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amino acid composition (asn01)Also: Brand name: aminoplus neurostressAmino 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 | Dietary supplement | amino acid composition (asn01) |
| PlaceboPlacebo; 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 | Other | Sugar powder |
Primary outcome
Psychological neurological questionnaire (PNF)
Time frame: 12-week dietary intervention
Pre-post intervention changes in total number of points PNF
4 secondary outcomes
Psychological neurological questionnaire (PNF)
Time frame: 12-week dietary intervention
Salivary cortisol concentration (30 minutes after waking in the morning)
Time frame: 12-week dietary intervention
Salivary cortisol concentration (in the evening between 8 and 10 pm, 2 hours after dinner)
Time frame: 12-week dietary intervention
Serotonin concentration in blood
Time frame: 12-week dietary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Results publication: PubMed 25943490Chaborski K, Bitterlich N, Alteheld B, Parsi E, Metzner C. Placebo-controlled dietary intervention of stress-induced neurovegetative disorders with a specific amino acid composition: a pilot-study. Nutr J. 2015 May 6;14:43. doi: 10.1186/s12937-015-0030-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Metzner, Professor MD principal investigator
Bonn Education Association for Dietetics r.A., Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amino acid composition (asn01) in people with Nervous System Disorder and Imbalance of Constituents of Food Intake, run by Kyberg Vital GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological neurological questionnaire (PNF) (time frame: 12-week dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.