Back to resultsEffects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
Primary Purpose
Healthy, Stress, Psychological, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Microencapsulated Sublingual Glycine (MSG)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Verbal Learning and Memory Test (VLMT), Stroop Test, Attention, Working Memory, Learning and recognition, CogTrack
Eligibility Criteria
Inclusion Criteria:
- subject signs the informed consent to participate in the study
- normally stressed subjects as verified by the TICS questionnaire with scores >3 and <37
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
Sites / Locations
- daacro GmbH & Co. KG
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Glycine (MSG)
Placebo
No treatment
Arm Description
Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST
Lactose: 1 tablet prior to TSST; 1 tablet after the TSST
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
Heart rate
Efficacy of the intake of Glycine (MSG) on heart rate in response to the TSST compared to placebo and control group
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
Full Information
NCT ID
NCT03353441
First Posted
November 10, 2017
Last Updated
July 24, 2018
Sponsor
Daacro
Collaborators
OOO MNPK BIOTIKI
1. Study Identification
Unique Protocol Identification Number
NCT03353441
Brief Title
Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daacro
Collaborators
OOO MNPK BIOTIKI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Stress, Psychological, Cognitive Impairment
Keywords
Verbal Learning and Memory Test (VLMT), Stroop Test, Attention, Working Memory, Learning and recognition, CogTrack
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Partly double-blind (Glycine (MSG), Placebo, control without treatment)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycine (MSG)
Arm Type
Active Comparator
Arm Description
Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lactose: 1 tablet prior to TSST; 1 tablet after the TSST
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Microencapsulated Sublingual Glycine (MSG)
Other Intervention Name(s)
Bidicin
Intervention Description
Glycine (MSG) tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Lactose tablet manufactured to mimic Glycine (MSG) tablet
Primary Outcome Measure Information:
Title
Delayed memory performance after the TSST (correct words)
Description
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 Outcome Measure Information:
Title
Delayed memory performance before and during the TSST
Description
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
Title
Immediate memory performance before and after the TSST
Description
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
Title
VAS stress
Description
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
Title
VAS anxiety
Description
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
Title
VAS insecurity
Description
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
Title
VAS sleepiness
Description
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
Title
VAS tension
Description
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
Title
VAS lack of energy
Description
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
Title
STAI-state
Description
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
Title
Systolic and diastolic blood pressure
Description
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
Title
Delayed memory performance after the TSST (perseverations, wrong words)
Description
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
Title
Cognitive performance before and after the TSST (Stroop)
Description
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
Title
Cognitive performance before and after the TSST (CogTrack)
Description
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
Title
Heart rate
Description
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
Title
Salivary Cortisol
Description
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 Pre-specified Outcome Measures:
Title
TICS
Description
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
Title
STAI-trait
Description
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
Title
Mental arithmetic performance during the TSST
Description
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
Title
eCB levels
Description
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
Title
Blood Glucose levels
Description
Exploration of blood glucose levels
Time Frame
75 minutes before first product intake, 25 and 46 minutes after first product intake
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subject signs the informed consent to participate in the study
normally stressed subjects as verified by the TICS questionnaire with scores >3 and <37
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
Facility Information:
Facility Name
daacro GmbH & Co. KG
City
Trier
State/Province
Rhineland-Palatinate
ZIP/Postal Code
54296
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://www.daacro.de
Description
daacro homepage
Learn more about this trial
Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
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