Status:
COMPLETED
Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
Lead Sponsor:
Daacro
Collaborating Sponsors:
OOO MNPK BIOTIKI
Conditions:
Healthy
Stress, Psychological
Eligibility:
MALE
18-40 years
Phase:
NA
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 pl...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03353441
Start Date
November 15 2017
End Date
June 15 2018
Last Update
July 26 2018
Active Locations (1)
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1
daacro GmbH & Co. KG
Trier, Rhineland-Palatinate, Germany, 54296