Probiotics Effect on Mental Wellness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Mental wellbeing
研究概览
简要总结
The goal of this clinical trial is to compare the effect of a probiotic strain on mental wellbeing in moderately stressed, healthy, adults in the general population. The main question it aims to answer is
• what is the impact of probiotic consumption on overall mental wellbeing? Participants will consume one probiotic or placebo capsule per day, answer a set of questionnaire (at 3 time points) and wear a wearable device for the total duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, 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
- •Adults aged between 18-60 years old
- •Currently living in the US.
- •Have access to a smart phone, internet and computer.
- •Report moderate levels of perceived stress.
排除标准
- •Are currently taking medication for depression or anxiety
- •Have had antibiotics within the previous month
- •Have an allergy to coconut
研究组 & 干预措施
Control
干预措施: Placebo (Dietary Supplement)
Probiotic Arm
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Change in Mental wellbeing
时间窗: 4 weeks
Improvement in mental wellbeing will be measured using the Oxford Happiness Questionnaire (OHQ). The Oxford Happiness Inventory was devised as a broad measure of personal happiness. The OHQ has a total of 29 items. Each item is scored on a Likert scale from 1 to 6 (1=strongly disagree; 2=moderately disagree; 3=slightly disagree; 4=slightly agree; 5=moderately agree; 6=strongly agree). Some items are phrased positively and others negatively. Such that negative items (1, 3, 12, 13, 16, 18, 21 and 29) should be scored in reverse (Hills \& Argyle, 2002). The total score is then divided by 29. Interpretation of the final score is as follows: A final score between 1 to 2 is considered "not happy"; between 2 and 3 is "somewhat unhappy"; between 3 and 4 is considered "Neutral"; 4 is "somewhat or moderately happy"; between 4 and 5 is "rather happy"; between 5 and 6 is "very happy"; 6 is "too happy".
次要结局
- Change in Stress scores(4 weeks)
- Change in Depression scores(4 weeks)
- Change in Salivary cortisol(4 weeks)
- Change in anxiety scores(4 weeks)