Does Alcohol Consumption Moderate the Effects of Probiotic Supplementation on Cognitive and Gastrointestinal Outcomes in a Non-clinical Sample?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0
研究概览
简要总结
The aim of this clinical trial is to investigate whether taking probiotics can improve thinking ability and digestive symptoms in healthy adults, and whether these effects depend on how often someone drinks alcohol. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours.
The main questions it aims to answer are:
- Do probiotics improve everyday thinking, attention, and memory?
- Do probiotics reduce digestion issues or discomfort?
- Does how often someone drinks alcohol affect how much they benefit from probiotics?
- Do probiotics modulate alcohol cravings?
- Do probiotics improve mood, stress, and anxiety levels?
- Do probiotics influence drinking behaviour?
- Do probiotics influence eating behaviour?
Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study.
Participants will:
- Take either a probiotic supplement or a placebo every day for 8 weeks
- Complete online questionnaires about their mood, thinking, eating and drinking behaviours, and digestive health at the start and end of the study
- Provide basic lifestyle and demographic information
This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health, and other wellbeing outcomes in generally healthy adults - and whether these benefits vary depending on how often someone drinks alcohol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Participants under 18 years of age
- •Regular use of probiotics or prebiotics (in supplements or foods) within the past 4 weeks
- •Antibiotic use within the past 4 weeks
- •Chronic gastrointestinal disorders (e.g. Irritable Bowel Syndrome, Crohn's disease, etc)
- •Major psychiatric conditions diagnosed (e.g., bipolar disorder, schizophrenia, etc)
- •Current pregnancy or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
Placebo Group
干预措施: Placebo Arm (Dietary Supplement)
Probiotic Group
干预措施: Probiotic Arm (Dietary Supplement)
结局指标
主要结局
85 non-clinical participants assessed for Everyday Cognitive Failures by Cognitive Failures Questionnaire 2.0
时间窗: From enrollment to the end of the treatment at 8 weeks
Everyday cognitive functioning will be assessed using the Cognitive Failures Questionnaire 2.0 (CFQ 2.0), a 15-item self-report questionnaire measuring the frequency of cognitive lapses in daily life (e.g., memory, attention, and action errors). Each item is rated on a 5-point scale. Total scores are calculated by summing all item responses, yielding a score ranging from 0 to 60. Performance will be measured as the total CFQ 2.0 score (range 0-60), with higher scores indicating greater frequency of cognitive failures.
85 non-clinical participants assessed for Gastrointestinal Symptoms by Gastrointestinal Symptom Rating Scale
时间窗: From enrollment to the end of the treatment at 8 weeks
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report questionnaire evaluating the severity of common gastrointestinal symptoms. Each item is rated on a 7-point Likert scale, with higher scores indicating more severe symptoms. Total scores are calculated by summing all item responses, yielding a score ranging from 15 to 105. Performance will be measured as the total GSRS score (range 15-105), with higher scores indicating greater gastrointestinal symptom severity. Domain scores may also be calculated by averaging relevant items to assess specific symptom clusters.
次要结局
- 85 non-clinical participants assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire(From enrollment to the end of the treatment at 8 weeks)
- 85 non-clinical participants assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12(From enrollment to the end of the treatment at 8 weeks)
- 85 non-clinical participants assessed for Alcohol Craving by Penn Alcohol Craving Scale(From enrollment to the end of the treatment at 8 weeks)
研究者
Kim-Marie Gehrke
Doctoral Research Student
Loughborough University