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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy, Stress, Psychological, Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: Microencapsulated Sublingual Glycine (MSG)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glycine (MSG)<br>Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST | Dietary Supplement: Microencapsulated Sublingual Glycine (MSG)<br>* Glycine (MSG) tablet<br>* Other names: Bidicin;|
| Placebo Comparator: Placebo<br>Lactose: 1 tablet prior to TSST; 1 tablet after the TSST | Dietary Supplement: Placebo<br>* Lactose tablet manufactured to mimic Glycine (MSG) tablet<br>|
| No Intervention: No treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Verbal Learning and Memory Test (VLMT), Stroop Test, Attention, Working Memory, Learning and recognition, CogTrack