Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
NCT ID: NCT03353441
Last Updated: 2018-07-26
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-11-15
2018-06-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Glycine (MSG)
Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST
Microencapsulated Sublingual Glycine (MSG)
Glycine (MSG) tablet
Placebo
Lactose: 1 tablet prior to TSST; 1 tablet after the TSST
Placebo
Lactose tablet manufactured to mimic Glycine (MSG) tablet
No treatment
No interventions assigned to this group
Interventions
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Microencapsulated Sublingual Glycine (MSG)
Glycine (MSG) tablet
Placebo
Lactose tablet manufactured to mimic Glycine (MSG) tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* normally stressed subjects as verified by the TICS questionnaire with scores \>3 and \<37
Exclusion Criteria
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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OOO MNPK BIOTIKI
UNKNOWN
Daacro
NETWORK
Responsible Party
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Juliane Hellhammer
PhD
Locations
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daacro GmbH & Co. KG
Trier, Rhineland-Palatinate, Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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daacro homepage
Other Identifiers
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BI02-2017
Identifier Type: -
Identifier Source: org_study_id
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