Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in score on Response to Stressful Events Scale
研究概览
简要总结
This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55-75 years
- •Able to speak and read English
排除标准
- •History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
- •Antibiotic use in the past 30 days;
- •History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
- •History of alcohol or illicit drug dependence;
- •History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
- •Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
- •Likely immunosuppression (e.g. chemotherapy treatment);
- •Regular use of other pre- or probiotic supplements in the past 30 days;
- •Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.
结局指标
主要结局
Change in score on Response to Stressful Events Scale
时间窗: Baseline and 12 week follow up
Emotion regulation
Change in score on OECD Life Satisfaction scale (short)
时间窗: Baseline and 12 week follow up
Subjective wellbeing - general
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
时间窗: Baseline and 12 week follow up
Depressive symptoms
Change in score on Positive and Negative Affect Schedule
时间窗: Baseline and 12 week follow up
Fluctuations in affect
Change in score on Connor-Davidson Resilience Scale
时间窗: Baseline and 12 week follow up
Emotional resilience
Change in score on State-Trait Anxiety Inventory
时间窗: Baseline and 12 week follow up
Anxiety symptoms
Change in score on Perceived Stress Scale
时间窗: Baseline and 12 week follow up
Subjective stress
Change in score on Profile of Mood States
时间窗: Baseline and 12 week follow up
Fluctuations in affect - acute
Change in score on Warwick-Edinburgh Mental Well-Being Scale
时间窗: Baseline and 12 week follow up
Subjective wellbeing
次要结局
- Change in SF-36 scores(Baseline and 12 week follow up)
- Change in HbA1c and fasting glucose values(Baseline and 12 week follow up)
- Change in C-reactive protein, Interleukin-6, and TNF-alpha values(Baseline and 12 week follow up)
- Change in Pittsburgh Sleep Quality Index scores(Baseline and 12 week follow up)
- Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores(Baseline and 12 week follow up)
- Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores(Baseline and 12 week follow up)
- Change in Pattern Comparison Processing Speed Test scores(Baseline and 12 week follow up)
- Change in Gastrointestinal Symptom Rating Scale scores(Baseline and 12 week follow up)
- Change in waking cortisol levels(Baseline and 12 week follow up)
- Change in Total Cholesterol, HDL, LDL, and VLDL values(Baseline and 12 week follow up)
- Change in composition of the gut microbiome(Baseline and 12 week follow up)
- Change in oral microbiome composition(Baseline and 12 week follow up)
研究者
John Gunstad
Professor
Kent State University