Clinical trial NCT03353441: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Stress, Psychological
Cognitive Impairment
Keywords: Verbal Learning and Memory Test (VLMT)
Stroop Test
Attention
Working Memory
Learning and recognition
CogTrack
Lead sponsor: Daacro
Sponsor class: NETWORK
Collaborators: name: OOO MNPK BIOTIKI
First posted: 2017-11-27
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delayed memory performance after the TSST (correct words)
timeFrame: 20 minutes after second product intake
Secondary outcomes:
measure: Delayed memory performance before and during the TSST
timeFrame: 15 minutes before and 42 minutes after first product intake
measure: Immediate memory performance before and after the TSST
timeFrame: 44 minutes before, 13 and 48 minutes after first product intake
measure: VAS stress
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: VAS anxiety
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: VAS insecurity
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: VAS sleepiness
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: VAS tension
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: VAS lack of energy
timeFrame: 20 minutes, 37 minutes and 46 minutes after first product intake
measure: STAI-state
timeFrame: 20 minutes and 46 minutes after first product intake
measure: Systolic and diastolic blood pressure
timeFrame: 25 minutes and 46 minutes after first product intake
measure: Delayed memory performance after the TSST (perseverations, wrong words)
timeFrame: 20 minutes after second product intake
measure: Cognitive performance before and after the TSST (Stroop)
timeFrame: 10 minutes before first product intake and 23 minutes after second product intake
measure: Cognitive performance before and after the TSST (CogTrack)
timeFrame: 40 minutes before first product intake, immediately after second product intake
measure: Heart rate
timeFrame: Continous measurement starting 10 minutes after first product intake and ending 10 minutes after second product intake
measure: Salivary Cortisol
timeFrame: 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:
measure: TICS
timeFrame: Baseline
measure: STAI-trait
timeFrame: Baseline
measure: Mental arithmetic performance during the TSST
timeFrame: 37.5 minutes after first product intake
measure: eCB levels
timeFrame: 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
measure: Blood Glucose levels
timeFrame: 75 minutes before first product intake, 25 and 46 minutes after first product intake
Locations:
city: Trier
country: Germany
facility: daacro GmbH & Co. KG
state: Rhineland-Palatinate
Study officials:
References:
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