Effect of Supplementation With Saccharomyces Boulardii and Lactobacillus Rhamnosus on Examination-related Stress in Healthy Medical Students: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Performance under examination-related stress
研究概览
简要总结
Probiotics are live microorganisms exhibiting multiple properties beneficial to health. An increasing body of evidence indicates that probiotics may support healthy brain function and may relieve stress. Recent research in this area has examined lactic acid bacteria in detail, but little is known about the stress-relieving effects of Saccharomyces, a yeast with probiotic properties.
Psychological stress is a factor that allows people to successfully cope with various daily life situations. On the other hand, excessive stress may lead to bodily harm and decrease performance, e.g. academic achievements. Probiotics may help manage stress, but little is known whether probiotics improve performance under stress.
The aim of this trial is to examine whether the healthy medical students may demonstrate better performance in academic examinations when supplementing their diet with a yeast probiotic strain Saccharomyces boulardii (CNCM I-1079) or bacterial probiotic strain Lactobacillus rhamnosus GG (ATCC 53103). The secondary aim of the trial is to evaluate the potential effects of this supplementation on state anxiety as well as on biochemical and physiological stress markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a third year medical student of the Faculty of Medicine or Faculty of Military Medicine, Medical University of Lodz
排除标准
- •formal inability to sit the first attempt of the final examination of Basic Medical Pharmacology
- •chronic diseases: neurological, psychiatric, cardiological, gastroenterological, immunological, endocrine or infectious
- •state of immunosuppression
- •history of hospitalization (< 3 months before entrance to the study)
- •presence of central venous catheter
- •parenteral nutrition
- •current pregnancy or intention to become pregnant within 3 months from the entrance to the study
- •current lactation
- •allergic reaction (< 3 months before entrance to the study)
- •hypersensitivity to yeast, maltodextrins, potato starch, magnesium stearate, hypromellose, gelatin, glycerol or titanium dioxide
- •body mass index over 30
- •chronic medication use (current or < 3 months before entrance to the study)
- •systemic antibacterial or antifungal medication use (current or < 3 months before entrance to the study)
- •overuse of alcohol or psychoactive substances (current or < 3 months before entrance to the study)
- •tobacco smoking - more than 5 cigarettes (or equivalents) a day (currently or < 3 months before entrance to the study)
- •pro- or prebiotic preparations intake (< 3 months before entrance to the study)
- •vegan or other atypical diet
- •doing professional or extreme sports
结局指标
主要结局
Performance under examination-related stress
时间窗: The examination is held on the 30th day of the trial.
Number of correctly-answered questions in the final examination in Basic Medical Pharmacology
次要结局
- Cortisol(Measured a day before the final examination in Basic Medical Pharmacology)
- State anxiety under examination-related stress(30 minutes before the final examination in Basic Medical Pharmacology)
- Pulse rate(30 minutes before the final examination in Basic Medical Pharmacology)
- Metanephrine(Measured a day before the final examination in Basic Medical Pharmacology)
研究者
Michal Karbownik
Research assistant
Medical University of Lodz