The Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Corsi Block Tapping Test performance
研究概览
简要总结
This study aims to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy adults.
详细描述
This study will employ a double-blind, randomised, placebo-controlled crossover design to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy older adults. A total of 30 participants will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day Ecologic Barrier©) or a matched placebo in the first arm, before having a 4 week washout period and continuing with 8 weeks of the second treatment not consumed within the first arm. Outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. These will include cognitive measures of affective processing, immediate and delayed verbal memory, visuospatial working memory and executive functions, and mood measures of depressive symptoms, cognitive reactivity, anxiety, stress and general mood. In addition, faecal samples will be collected at all timepoints in order to explore faecal microbiota profiles before and after probiotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 65 - 80
- •Agree not to not consume probiotic or prebiotic supplements or live yoghurt throughout the course of study.
- •Proficient in the English language
排除标准
- •Already a habitual user of probiotics
- •Antibiotic treatment within last 3 months
- •Current diagnosis of and not currently receiving treatment for mental health disorder
- •Gastrointestinal disorder
- •Allergic to any ingredient of the active or placebo treatment
- •Regular smoker
- •Diabetes mellitus
结局指标
主要结局
Change in Corsi Block Tapping Test performance
时间窗: Baseline, 24 hours and 8 weeks
A standardised assessment of visuospatial working memory. The task comprises nine identical squares fixed in a random arrangement on a screen. Participants observe sequences of between two and nine blocks, which they then reproduce as accurately as possible. The dependent variable is the number of blocks pointed out in the correct order. Four versions of each sequence length are presented during the task. A novel sequence will be presented on each occasion, the order of which will be counterbalanced across participants.
Change in Immediate Word Recall from the Rey Auditory Verbal Learning Task
时间窗: Baseline, 24 hours and 8 weeks
Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy.
次要结局
- Rey Auditory Verbal Learning Task - Delayed Word Recall(Baseline, 24 hours and 8 weeks)
- Positive and Negative Affect Schedule expanded (PANAS-x)(Baseline, 24 hours and 8 weeks)
- Rey Auditory Verbal Learning Task - Word Recognition(Baseline, 24 hours and 8 weeks)
- Perceived Stress Scale(Baseline and 8 weeks)
- Switching task(Baseline, 24 hours and 8 weeks)
- Centre for Epidemiological Studies Depression Scale (CESD)(Baseline and 8 weeks)
- Go/No Go task(Baseline, 24 hours and 8 weeks)
- Leiden Index of Depression Sensitivity revised (LEIDS-r)(Baseline, 24 hours and 8 weeks)
- State Trait Anxiety Inventory(Baseline, 24 hours and 8 weeks)
研究者
Prof Claire Williams
Professor
University of Reading