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

NCT03353441 | Completed

• 1 other identifier: BI02-2017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy; Stress, Psychological; Cognitive Impairment

Keywords

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

Outcome Measures

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

  20 minutes after second product intake

Secondary Outcomes (15)

• Delayed memory performance before and during the TSST

  15 minutes before and 42 minutes after first product intake

• Immediate memory performance before and after the TSST

  44 minutes before, 13 and 48 minutes after first product intake

• VAS stress

  20 minutes, 37 minutes and 46 minutes after first product intake

• VAS anxiety

  20 minutes, 37 minutes and 46 minutes after first product intake

• VAS insecurity

  20 minutes, 37 minutes and 46 minutes after first product intake

Other Outcomes (5)

• TICS

  Baseline

• STAI-trait

  Baseline

• Mental arithmetic performance during the TSST

  37.5 minutes after first product intake

Study Arms (3)

Glycine (MSG)

ACTIVE COMPARATOR

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

Dietary Supplement: Microencapsulated Sublingual Glycine (MSG)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

No treatment

NO INTERVENTION

Interventions

Microencapsulated Sublingual Glycine (MSG) DIETARY_SUPPLEMENT

Glycine (MSG) tablet

Also known as: Bidicin

Glycine (MSG)

Placebo DIETARY_SUPPLEMENT

Lactose tablet manufactured to mimic Glycine (MSG) tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daacro: lead
• OOO MNPK BIOTIKI: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, Rhineland-Palatinate, 54296, Germany

Location

Related Publications (10)

• 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.

  PMID: 23290054 BACKGROUND

• 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.

  PMID: 28368148 BACKGROUND

• 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.

  PMID: 27371161 BACKGROUND

• 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.

  PMID: 10443770 BACKGROUND

• 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.

  PMID: 24395182 BACKGROUND

• 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.

  PMID: 18359168 BACKGROUND

• 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.

  PMID: 27230831 BACKGROUND

• 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.

  PMID: 16095452 BACKGROUND

• 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.

  PMID: 10587285 BACKGROUND

• 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.

  PMID: 1653913 BACKGROUND

Related Links

• daacro homepage

MeSH Terms

Conditions

Stress, Psychological; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Partly double-blind (Glycine (MSG), Placebo, control without treatment)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 27, 2017
• Study Start: November 15, 2017
• Primary Completion: March 15, 2018
• Study Completion: June 15, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)