The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
研究概览
简要总结
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
详细描述
Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.
Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.
The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be aged 55 years or over,
- •voluntarily agree to participate in the study in accordance with the Helsinki declaration,
- •not be participating in another study that could interfere with the results.
排除标准
- •suffer from any serious mental illness other than depression and anxiety,
- •score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
- •be using medications that affect cognition,
- •taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
- •have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).
研究组 & 干预措施
Probiotic group
Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks.
干预措施: Lactobacillus rhamnosus and Bifidobacterium lactis (Dietary Supplement)
Placebo group
Participants will receive a harmless substance (potato starch) during 10 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
时间窗: Before and after treatment (10 weeks)
Iowa Gambling Task
Change from Baseline Depression at 10 weeks
时间窗: Before and after treatment (10 weeks)
The Beck Depression Inventory. Score range: 0-63.
Change from Baseline General Cognitive Status at 10 weeks
时间窗: Before and after treatment (10 weeks)
Mini-Mental State Examination. Score range: 0-35
Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
时间窗: Before and after treatment (10 weeks)
Go/No-Go task
Change from Baseline Planning Ability at 10 weeks
时间窗: Before and after treatment (10 weeks)
Tower of London test
Change from Baseline Problem-solving ability at 10 weeks
时间窗: Before and after treatment (10 weeks)
Wisconsin Card Sorting test
Change from Baseline Visual Attention at 10 weeks
时间窗: Before and after treatment (10 weeks)
Trail Making Test
Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
时间窗: Before and after treatment (10 weeks)
Stroop task
Change from Baseline Anxiety at 10 weeks
时间窗: Before and after treatment (10 weeks)
The State-Trait Anxiety Inventory. Score range: 20-80
Change from Baseline Working Memory at 10 weeks
时间窗: Before and after treatment (10 weeks)
Digits task, Corsi task
次要结局
- Change from Baseline Body Composition at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Gastrointestinal Symptom at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Food Habits at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Sleep Quality at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Stool Consistency at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Perceived Stress at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Alcohol Use at 10 weeks(Before and after treatment (10 weeks))
- Change from Baseline Physical Activity at 10 weeks(Before and after treatment (10 weeks))
研究者
Pablo Román López
Principal Investigator, Vicedean of Nursing
Universidad de Almeria