HealthyNCT03353441
Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
A study testing Microencapsulated Sublingual Glycine (MSG) in people with Healthy and Stress, Psychological, run by Daacro at 1 site in Germany.
Trial summary
The aim of this study is to assess whether intake of Glycine (MSG) leads to an increase of cognitive performance after an acute stressor compared to placebo. One group will receive verum, one group placebo and one group will not receive any intervention. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Stress, Psychological, Cognitive Impairment
- What is being tested?
- Microencapsulated Sublingual Glycine (MSG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2017to 15 Jun 2018
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- subject signs the informed consent to participate in the study
- normally stressed subjects as verified by the TICS questionnaire with scores >3 and <37
Who cannot join
- smoker
- any known allergies to the test substances
- lactose intolerance
- any known addiction to drugs and/or alcohol
- hyper- or hypotension (except for those whose blood pressure is stable using medication for more than 3 months)
- known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
Show all 18Show fewer
- any known current/acute or chronic physical or psychological diseases besides minor medical conditions (e.g. seasonal allergies)
- intake of any medication which may affect the cognitive performance (e.g. psychotropics, sedating or stimulating medication)
- any color vision impairment (e.g. red-green deficiency)
- intake of dietary supplements or homoeopathic remedies during 2 weeks before V1 or during the study conduction
- consumption of alcohol during 2 days before V1 or during the study conduction
- excessive caffeine consumption (>400 mg caffeine/day or >= 4 cups of caffeinated coffee)
- on a strict diet or practicing sport, extensively
- attending an exam one week before and after the study participation
- subjects having previously participated in the TSST
- employee of the sponsor or Contract Research Organisation (CRO)
- Investigator doubts truthfulness of self-reported health information
- not suitable because of limited verbal and cognitive abilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor - a Randomized, Partly Double-blind Placebo-controlled Clinical Trial
The aim of this study is to assess whether intake of Glycine (MSG) leads to an increase of cognitive performance after an acute stressor compared to placebo. One group will receive verum, one group placebo and one group will not receive any intervention. Cognitive testing will be performed in connection with the Trier Social Stress Test (TSST).
Read the detailed description
Stress can enhance or impair memory performances depending on the timing of the stressor and the timing of the memory processes in relation to the stressor. If stress occurs directly before or during the retrieval of information, the performance is impaired. Decreased performances using an acute stressor were also observed for other domains of cognitive functioning like working memory, interference control, cognitive flexibility and attention tasks.
Glycine, the simplest of the amino acids, is an essential component of important biological molecules, a key substance in many metabolic reactions, the major inhibitory neurotransmitter in the spinal cord and brain stem, and an anti-inflammatory, cytoprotective, and immune modulating substance. Studies have found positive effects of Glycine on episodic memory retrieval and in a word retrieval task.
To assess the effect of Glycine (MSG) on cognitive performance after an acute stressor, subjects perform baseline cognitive testing before intake of investigational products (Glycine (MSG), placebo or nothing) and participation in a stress test (Trier Social Stress Test - TSST). After the TSST stress-induced changes in cognitive performance are assessed. A second treatment intake takes place between the first and the remaining cognitive tests.
- Conditions
- Healthy, Stress, Psychological, Cognitive Impairment
- Being tested
- Microencapsulated Sublingual Glycine (MSG), Placebo
- Keywords
- Verbal Learning and Memory Test (VLMT), Stroop Test, Attention, Working Memory, Learning and recognition, CogTrack
- Medical subject headings
- Stress, Psychological, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microencapsulated Sublingual Glycine (MSG)Dietary supplement
Also called Bidicin
Glycine (MSG) tablet
PlaceboDietary supplement
Lactose tablet manufactured to mimic Glycine (MSG) tablet
| Study group | Role | What they receive |
|---|---|---|
| Glycine (MSG) | Active comparator | Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST Receives: Dietary Supplement: Microencapsulated Sublingual Glycine (MSG) |
| Placebo | Placebo comparator | Lactose: 1 tablet prior to TSST; 1 tablet after the TSST Receives: Dietary Supplement: Placebo |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed memory performance after the TSST (correct words)
Efficacy of the intake of Glycine (MSG) on performance in the Verbal Learning and Memory Test (VLMT) delayed recall task (number of correct words) compared to placebo and control group
Measured: 20 minutes after second product intake
Secondary outcomes (15)
Delayed memory performance before and during the TSST
Efficacy of the intake of Glycine (MSG) on performance in the Verbal Learning and Memory Test (VLMT) delayed recall task (number of correct words, number of perseverations and wrong words) compared to placebo and control group
Measured: 15 minutes before and 42 minutes after first product intake
Immediate memory performance before and after the TSST
Efficacy of the intake of Glycine (MSG) on Performance in the Verbal Learning and Memory Test (VLMT) immediate recall task (number of correct words, decreased number of perseverations and wrong words) compared to placebo and control group
Measured: 44 minutes before, 13 and 48 minutes after first product intake
VAS stress
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute stress compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS anxiety
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute anxiety compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS insecurity
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute insecurity compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS sleepiness
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute sleepiness compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS tension
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute tension compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS lack of energy
Efficacy of the intake of Glycine (MSG) on subjective evaluation of acute lack of energy compared to placebo and control group measured on a Visual Analogue Scale (VAS). The VAS is a 10cm bipolar visual scale ranging from "not at all" to "highly". VAS scores are obtained by using a ruler and measuring the position of the participant's mark with millimeter precision. To control for possible variations due to printing, the total length of the line is also measured and percentage scores for each subject are computed. Percentage scores range from 0-100.
Measured: 20 minutes, 37 minutes and 46 minutes after first product intake
STAI-state
Efficacy of the intake of Glycine (MSG) on state anxiety as measured by the State Trait Anxiety Inventory (STAI) compared to placebo and control group. The STAI-state measures anxiety as a temporary emotional state and comprises 20 items. Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". Some STAI questions relate to the absence of anxiety, and are reversely scored. For analysis of the STAI-scale, items are combined in one scale, which then informs about state anxiety. The score range is 20-80; higher scores indicate more anxiety.
Measured: 20 minutes and 46 minutes after first product intake
Systolic and diastolic blood pressure
Efficacy of the intake of Glycine (MSG) on blood pressure in response to the TSST compared to placebo and control group
Measured: 25 minutes and 46 minutes after first product intake
Delayed memory performance after the TSST (perseverations, wrong words)
Efficacy of the intake of Glycine (MSG) on performance in the Verbal Learning and Memory Test (VLMT) delayed recall task (decreased number of perseverations and wrong words) compared to placebo and control group
Measured: 20 minutes after second product intake
Cognitive performance before and after the TSST (Stroop)
Efficacy of the intake of Glycine (MSG) on performance in the Stroop test (speed and accuracy) compared to placebo and control group
Measured: 10 minutes before first product intake and 23 minutes after second product intake
Cognitive performance before and after the TSST (CogTrack)
Efficacy of the intake of Glycine (MSG) on performance in attention, working memory, learning and recognition tasks of CogTrack compared to placebo and control group
Measured: 40 minutes before first product intake, immediately after second product intake
Heart rate
Efficacy of the intake of Glycine (MSG) on heart rate in response to the TSST compared to placebo and control group
Measured: Continous measurement starting 10 minutes after first product intake and ending 10 minutes after second product intake
Salivary Cortisol
Efficacy of the intake of Glycine (MSG) on salivary cortisol raw values in response to the TSST compared to placebo and control group
Measured: 45, 10 minutes before first product intake, 28, 46, 55 minutes after first product intake, 10, 20, 35 and 50 minutes after second product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start15 Nov 2017
- Primary completion15 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daacro
- Sponsor type
- Research network
- Collaborators
- OOO MNPK BIOTIKI
- Responsible party
- Principal investigator, Juliane Hellhammer, Daacro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353441
- Sponsor's protocol ID
- BI02-2017
- Status last verified
- Jul 2018
- First submitted
- 10 Nov 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwabe L, Wolf OT. Stress and multiple memory systems: from 'thinking' to 'doing'. Trends Cogn Sci. 2013 Feb;17(2):60-8. doi: 10.1016/j.tics.2012.12.001. Epub 2013 Jan 2.
PubMed 23290054Shields GS, Sazma MA, McCullough AM, Yonelinas AP. The effects of acute stress on episodic memory: A meta-analysis and integrative review. Psychol Bull. 2017 Jun;143(6):636-675. doi: 10.1037/bul0000100. Epub 2017 Apr 3.
PubMed 28368148Shields GS, Sazma MA, Yonelinas AP. The effects of acute stress on core executive functions: A meta-analysis and comparison with cortisol. Neurosci Biobehav Rev. 2016 Sep;68:651-668. doi: 10.1016/j.neubiorev.2016.06.038. Epub 2016 Jun 28.
PubMed 27371161Lupien SJ, Gillin CJ, Hauger RL. Working memory is more sensitive than declarative memory to the acute effects of corticosteroids: a dose-response study in humans. Behav Neurosci. 1999 Jun;113(3):420-30. doi: 10.1037//0735-7044.113.3.420.
PubMed 10443770Olver JS, Pinney M, Maruff P, Norman TR. Impairments of spatial working memory and attention following acute psychosocial stress. Stress Health. 2015 Apr;31(2):115-23. doi: 10.1002/smi.2533. Epub 2014 Jan 3.
PubMed 24395182Schoofs D, Preuss D, Wolf OT. Psychosocial stress induces working memory impairments in an n-back paradigm. Psychoneuroendocrinology. 2008 Jun;33(5):643-53. doi: 10.1016/j.psyneuen.2008.02.004. Epub 2008 Mar 21.
PubMed 18359168Shields GS, Trainor BC, Lam JC, Yonelinas AP. Acute stress impairs cognitive flexibility in men, not women. Stress. 2016 Sep;19(5):542-6. doi: 10.1080/10253890.2016.1192603. Epub 2016 Jun 20.
PubMed 27230831Gundersen RY, Vaagenes P, Breivik T, Fonnum F, Opstad PK. Glycine--an important neurotransmitter and cytoprotective agent. Acta Anaesthesiol Scand. 2005 Sep;49(8):1108-16. doi: 10.1111/j.1399-6576.2005.00786.x.
PubMed 16095452File SE, Fluck E, Fernandes C. Beneficial effects of glycine (bioglycin) on memory and attention in young and middle-aged adults. J Clin Psychopharmacol. 1999 Dec;19(6):506-12. doi: 10.1097/00004714-199912000-00004.
PubMed 10587285Schwartz BL, Hashtroudi S, Herting RL, Handerson H, Deutsch SI. Glycine prodrug facilitates memory retrieval in humans. Neurology. 1991 Sep;41(9):1341-3. doi: 10.1212/wnl.41.9.1341.
PubMed 1653913
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor - a Randomized, Partly Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03353441
- Acronym / sponsor ID
- BI02-2017
- Conditions
- Healthy, Stress, Psychological, Cognitive Impairment
- Keywords
- Verbal Learning and Memory Test (VLMT), Stroop Test, Attention, Working Memory, Learning and recognition, CogTrack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- DaacroResearch network
- Collaborators
- OOO MNPK BIOTIKI
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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.
The aim of this study is to assess whether intake of Glycine (MSG) leads to an increase of cognitive performance after an acute stressor compared to placebo. One group will receive verum, one group placebo and one group will not receive any intervention. Cognitive testing will be performed in connection with the Trier Social Stress Test (TSST).
Detailed description
Stress can enhance or impair memory performances depending on the timing of the stressor and the timing of the memory processes in relation to the stressor. If stress occurs directly before or during the retrieval of information, the performance is impaired. Decreased performances using an acute stressor were also observed for other domains of cognitive functioning like working memory, interference control, cognitive flexibility and attention tasks.
Glycine, the simplest of the amino acids, is an essential component of important biological molecules, a key substance in many metabolic reactions, the major inhibitory neurotransmitter in the spinal cord and brain stem, and an anti-inflammatory, cytoprotective, and immune modulating substance. Studies have found positive effects of Glycine on episodic memory retrieval and in a word retrieval task.
To assess the effect of Glycine (MSG) on cognitive performance after an acute stressor, subjects perform baseline cognitive testing before intake of investigational products (Glycine (MSG), placebo or nothing) and participation in a stress test (Trier Social Stress Test - TSST). After the TSST stress-induced changes in cognitive performance are assessed. A second treatment intake takes place between the first and the remaining cognitive tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glycine (MSG) | Active comparator | Dietary Supplement: Microencapsulated Sublingual Glycine (MSG)Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboLactose: 1 tablet prior to TSST; 1 tablet after the TSST |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- subject signs the informed consent to participate in the study
- normally stressed subjects as verified by the TICS questionnaire with scores >3 and <37
Key exclusion criteria (18 listed)
- smoker
- any known allergies to the test substances
- lactose intolerance
- any known addiction to drugs and/or alcohol
- hyper- or hypotension (except for those whose blood pressure is stable using medication for more than 3 months)
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 |
|---|---|---|
| Microencapsulated Sublingual Glycine (MSG)Also: BidicinGlycine (MSG) tablet | Dietary supplement | Glycine (MSG) |
| PlaceboLactose tablet manufactured to mimic Glycine (MSG) tablet | Dietary supplement | Placebo |
Primary outcome
Delayed memory performance after the TSST (correct words)
Time frame: 20 minutes after second product intake
Efficacy of the intake of Glycine (MSG) on performance in the Verbal Learning and Memory Test (VLMT) delayed recall task (number of correct words) compared to placebo and control group
15 secondary outcomes
Delayed memory performance before and during the TSST
Time frame: 15 minutes before and 42 minutes after first product intake
Immediate memory performance before and after the TSST
Time frame: 44 minutes before, 13 and 48 minutes after first product intake
VAS stress
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS anxiety
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS insecurity
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS sleepiness
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS tension
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
VAS lack of energy
Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake
STAI-state
Time frame: 20 minutes and 46 minutes after first product intake
Systolic and diastolic blood pressure
Time frame: 25 minutes and 46 minutes after first product intake
Delayed memory performance after the TSST (perseverations, wrong words)
Time frame: 20 minutes after second product intake
Cognitive performance before and after the TSST (Stroop)
Time frame: 10 minutes before first product intake and 23 minutes after second product intake
Cognitive performance before and after the TSST (CogTrack)
Time frame: 40 minutes before first product intake, immediately after second product intake
Heart rate
Time frame: Continous measurement starting 10 minutes after first product intake and ending 10 minutes after second product intake
Salivary Cortisol
Time frame: 45, 10 minutes before first product intake, 28, 46, 55 minutes after first product intake, 10, 20, 35 and 50 minutes after second product intake
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 26 Jul 2018.
- Background: PubMed 23290054Schwabe L, Wolf OT. Stress and multiple memory systems: from 'thinking' to 'doing'. Trends Cogn Sci. 2013 Feb;17(2):60-8. doi: 10.1016/j.tics.2012.12.001. Epub 2013 Jan 2.
- Background: PubMed 28368148Shields GS, Sazma MA, McCullough AM, Yonelinas AP. The effects of acute stress on episodic memory: A meta-analysis and integrative review. Psychol Bull. 2017 Jun;143(6):636-675. doi: 10.1037/bul0000100. Epub 2017 Apr 3.
- Background: PubMed 27371161Shields GS, Sazma MA, Yonelinas AP. The effects of acute stress on core executive functions: A meta-analysis and comparison with cortisol. Neurosci Biobehav Rev. 2016 Sep;68:651-668. doi: 10.1016/j.neubiorev.2016.06.038. Epub 2016 Jun 28.
- Background: PubMed 10443770Lupien SJ, Gillin CJ, Hauger RL. Working memory is more sensitive than declarative memory to the acute effects of corticosteroids: a dose-response study in humans. Behav Neurosci. 1999 Jun;113(3):420-30. doi: 10.1037//0735-7044.113.3.420.
- Background: PubMed 24395182Olver JS, Pinney M, Maruff P, Norman TR. Impairments of spatial working memory and attention following acute psychosocial stress. Stress Health. 2015 Apr;31(2):115-23. doi: 10.1002/smi.2533. Epub 2014 Jan 3.
- Background: PubMed 18359168Schoofs D, Preuss D, Wolf OT. Psychosocial stress induces working memory impairments in an n-back paradigm. Psychoneuroendocrinology. 2008 Jun;33(5):643-53. doi: 10.1016/j.psyneuen.2008.02.004. Epub 2008 Mar 21.
- Background: PubMed 27230831Shields GS, Trainor BC, Lam JC, Yonelinas AP. Acute stress impairs cognitive flexibility in men, not women. Stress. 2016 Sep;19(5):542-6. doi: 10.1080/10253890.2016.1192603. Epub 2016 Jun 20.
- Background: PubMed 16095452Gundersen RY, Vaagenes P, Breivik T, Fonnum F, Opstad PK. Glycine--an important neurotransmitter and cytoprotective agent. Acta Anaesthesiol Scand. 2005 Sep;49(8):1108-16. doi: 10.1111/j.1399-6576.2005.00786.x.
- Background: PubMed 10587285File SE, Fluck E, Fernandes C. Beneficial effects of glycine (bioglycin) on memory and attention in young and middle-aged adults. J Clin Psychopharmacol. 1999 Dec;19(6):506-12. doi: 10.1097/00004714-199912000-00004.
- Background: PubMed 1653913Schwartz BL, Hashtroudi S, Herting RL, Handerson H, Deutsch SI. Glycine prodrug facilitates memory retrieval in humans. Neurology. 1991 Sep;41(9):1341-3. doi: 10.1212/wnl.41.9.1341.
- daacro homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microencapsulated Sublingual Glycine (MSG) in people with Healthy and Stress, Psychological, run by Daacro 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 18 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 26 Jul 2018. 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.
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?
Delayed memory performance after the TSST (correct words) (time frame: 20 minutes after second product intake). 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 NCT03353441, which also lists 10 linked publications.
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 26 Jul 2018.