ClinicalTrials.gg
CompletedNCT03353441Updated Jul 26, 2018

Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor

An interventional study of Microencapsulated Sublingual Glycine (MSG) and Placebo in Healthy, Stress, Psychological and Cognitive Impairment, sponsored by Daacro. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Daacro · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 27 studies in Stress, Psychological with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Stress, Psychological · Germany.

Enrollment
10th of 19
90 · median 90
Started
2017
with 1 other
No phase
19 of 27
2 open now
Registered
5th of 27
by date
Lead sponsor
2 of 27
Daacro

Among the 27 studies in Stress, Psychological with a site in Germany, this one is the 10th largest by enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2017, is one of 19 with no phase, and was the 5th registered.

Stress, Psychological

848 studies on the registry are indexed under Stress, Psychological; 139 are open to participants now.

Browse Stress, Psychological studies →

Open to participants now

6 of the 27 studies in Stress, Psychological with a site in Germany are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 75 Stress, Psychological studies recruiting now, 34 (45%) set no upper age limit and 37 (49%) stop at 75 or younger; 14 take children under 18; 49 take healthy volunteers.

This study: 18 Years to 40 Years · male · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Healthy
  • Stress, Psychological
  • Cognitive Impairment

Keywords

  • Verbal Learning and Memory Test (VLMT)
  • Stroop Test
  • Attention
  • Working Memory
  • Learning and recognition
  • CogTrack
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subject signs the to participate in the study
  • normally stressed subjects as verified by the TICS questionnaire with scores >3 and \<37

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Glycine (MSG)

    Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST

    Dietary Supplement: Microencapsulated Sublingual Glycine (MSG)

  • Placebo comparator
    Placebo

    Lactose: 1 tablet prior to TSST; 1 tablet after the TSST

    Dietary Supplement: Placebo

  • No intervention
    No treatment

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 20 minutes after second product intake

Secondary outcomes

  1. 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

    Time frame: 15 minutes before and 42 minutes after first product intake

  2. 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

    Time frame: 44 minutes before, 13 and 48 minutes after first product intake

  3. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  4. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  5. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  6. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  7. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  8. 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.

    Time frame: 20 minutes, 37 minutes and 46 minutes after first product intake

  9. 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.

    Time frame: 20 minutes and 46 minutes after first product intake

  10. 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

    Time frame: 25 minutes and 46 minutes after first product intake

  11. 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

    Time frame: 20 minutes after second product intake

  12. 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

    Time frame: 10 minutes before first product intake and 23 minutes after second product intake

  13. 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

    Time frame: 40 minutes before first product intake, immediately after second product intake

  14. Heart rate

    Efficacy of the intake of Glycine (MSG) on heart rate in response to the TSST compared to placebo and control group

    Time frame: Continous measurement starting 10 minutes after first product intake and ending 10 minutes after second product intake

  15. 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

    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

Other outcomes

  1. TICS

    Do Trier Inventory for Chronic Stress (TICS) scores differ between groups? The TICS includes 57 items. Stress chronicity is measured by the frequency of stressful events perceived retrospectively within the last 3 months. Answers are given on a five-point rating scale, where 0 resembles "never" and 4 "very often". For analysis the questionnaire items are assigned to 10 scales: Work overload (range 0-32), Social overload (0-24), Pressure to succeed (0-36), Work dissatisfaction (0-32), excessive demands at work (0-24), Lack of social recognition (0-16), Social stress (0-24), Social isolation (0-24) and Chronic worrying (0-16); the last scale presents a Screening scale for chronic stress (0-48). Scores are obtained by summing up the values of the scale specific questionnaire items.

    Time frame: Baseline

  2. STAI-trait

    Do State Trait Anxiety Inventory (STAI) trait scores differ between groups? The STAI-trait measures anxiety as a personality trait and comprises 20 items. Answers are given on a four-point rating scale ranging from 1 = "almost never" to 4 = "almost always". 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 trait anxiety. The score range is 20-80; higher scores indicate more anxiety.

    Time frame: Baseline

  3. Mental arithmetic performance during the TSST

    Efficacy of the intake of Glycine (MSG) on arithmetic performance compared to placebo and control group. One part of the Trier Social Stress Test (TSST) is a mental arithmetic task. The subject is asked to stepwise subtract 17 from 2023 as quickly and correctly as possible. Performance will be measured by counting how many numbers the subject enumerates and how many times the subject has to restart. Furthermore, the lowest correct number and the shortest run will be recorded.

    Time frame: 37.5 minutes after first product intake

  4. eCB levels

    Exploration of endocannabinoid levels (eCB)

    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

  5. Blood Glucose levels

    Exploration of blood glucose levels

    Time frame: 75 minutes before first product intake, 25 and 46 minutes after first product intake

07

Study locations

1 site
  • daacro GmbH & Co. KG
    Trier, Rhineland-Palatinate 54296, Germany
08

References and documents

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 23290054 ↗
  • Shields 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 28368148 ↗
  • Shields 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 27371161 ↗
  • Lupien 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 10443770 ↗
  • Olver 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 24395182 ↗
  • Schoofs 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 18359168 ↗
  • Shields 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 27230831 ↗
  • Gundersen 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 16095452 ↗
  • File 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 10587285 ↗
  • Schwartz 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 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Mar 2018, 4 months.

Of 459 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 4 months is below that.

Counting every sponsor, half of 472 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2017
First posted
Nov 27, 2017
StartActual
Nov 15, 2017
Primary completionActual
Mar 15, 2018
CompletionActual
Jun 15, 2018
Last update
Jul 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353441
Lead sponsor
Daacro
Collaborators
OOO MNPK BIOTIKI
Responsible party
Juliane Hellhammer (PhD, Daacro) — Principal investigator
First posted
Nov 27, 2017
Start date
Nov 15, 2017
Primary completion
Mar 15, 2018
Completion
Jun 15, 2018
Last update
Jul 26, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Sodium Glutamate

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