Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Memory function
研究概览
简要总结
To examine the cognitive and metabolic effects of a probiotic supplement that is readily and already available for purchase in public drug stores. This study is a double-blinded randomized cross-over placebo-controlled intervention study. Participants will be randomized to receive either the probiotic supplement or the placebo during the first intervention period which will last 2 weeks. This will be followed by a washout period, after which they will proceed to the second intervention period, also lasting 2 weeks and also followed by a washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-28y
- •Healthy (self-reported) and not on medication
- •Non-smoking
- •Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)
- •Regular meal patterns with daily breakfast
排除标准
- •Major illness
- •Taking any serious medications
- •Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
- •Any dietary issues with the food items provided
- •Current or history of endocrine, neurological or psychiatric disorders
- •Shift work in the preceding three months or for a long duration
- •Time travel over a significant number of time zones in the preceding two months
- •Too much weight gain or weight loss in the preceding three months
- •Excessive intake of fermented dairy products
- •Intake of probiotics
- •Recent antibiotic treatment (last 6 months)
- •Recent intake of certain dietary supplements
- •Excessive caffeine (>5 cups daily) or alcohol intake (>2 alcohol units daily)
结局指标
主要结局
Memory function
时间窗: Change in memory function assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory)
次要结局
- Glycometabolic regulation(Change in glycometabolic regulation assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
- Inhibitory task(Change in inhibitory task performance assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
- Sleep patterns(Change in sleep patterns as assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
- Food preferences(Change in food preferences assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
- Food consumption task(Change in food consumption task assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
- Microbiome changes(Microbiome assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12))
研究者
Jonathan Cedernaes
Medical doctor, PhD
Uppsala University