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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Delayed memory performance after the TSST (correct words)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Partly double-blind (Glycine (MSG), Placebo, control without treatment)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •subject signs the informed consent to participate in the study
- •normally stressed subjects as verified by the TICS questionnaire with scores >3 and <37
排除标准
- •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
研究组 & 干预措施
No treatment
Glycine (MSG)
Microencapsulated Sublingual Glycine (MSG): 1 tablet prior to TSST; 1 tablet after the TSST
干预措施: Microencapsulated Sublingual Glycine (MSG) (Dietary Supplement)
Placebo
Lactose: 1 tablet prior to TSST; 1 tablet after the TSST
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Delayed memory performance after the TSST (correct words)
时间窗: 20 minutes after second product intake
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
次要结局
- 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 sleepiness(20 minutes, 37 minutes and 46 minutes after first product intake)
- VAS insecurity(20 minutes, 37 minutes and 46 minutes after first product intake)
- VAS tension(20 minutes, 37 minutes and 46 minutes after first product intake)
- VAS anxiety(20 minutes, 37 minutes and 46 minutes after first product intake)
- Cognitive performance before and after the TSST (Stroop)(10 minutes before first product intake and 23 minutes after second product intake)
- Delayed memory performance before and during the TSST(15 minutes before and 42 minutes after first product intake)
- Delayed memory performance after the TSST (perseverations, wrong words)(20 minutes after second product intake)
- Heart rate(Continous measurement starting 10 minutes after first product intake and ending 10 minutes after second product intake)
- VAS lack of energy(20 minutes, 37 minutes and 46 minutes after first product intake)
- STAI-state(20 minutes and 46 minutes after first product intake)
- Cognitive performance before and after the TSST (CogTrack)(40 minutes before first product intake, immediately after second product intake)
- Salivary Cortisol(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)
- Systolic and diastolic blood pressure(25 minutes and 46 minutes after first product intake)
研究者
Juliane Hellhammer
PhD
Daacro