NCT03601559已完成不适用
The Cognitive Effects of 6 Weeks Administration With a Probiotic: a Randomized, Placebo Controlled Proof-of-concept Study in Healthy Elderly Humans
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Episodic memory score
研究概览
简要总结
The purpose of this study is to investigate the cognitive and mood effects of a probiotic dietary supplement when taken daily for 42 days in healthy older adults aged 65+
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged ≥ 65 years
- •Willing and able to provide written and informed consent
- •Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- •Agreement to comply with the protocol and study restrictions
- •Available for all study visits
- •In good general health, self-reported and as judged by the Principal Investigator/Clinical advisor based on medical history
- •Fluent in written and spoken English
- •Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period
- •Has a bank account (required for payment)
排除标准
- •Have any pre-existing significant acute or chronic co-existing medical condition / illness which contraindicates, in the Principal Investigator's judgement, entry to the study NOTE: the explicit exceptions to this are controlled (medicated) hypertension, arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progess to screening if they have a condition/illness which would not interact with the active treatments or impede performance
- •History of dementia, stroke and other neurological conditions
- •Traumatic loss of consciousness in the last 12 months
- •History of epilepsy or Parkinson's disease
- •Anxiety, depression or any psychiatric disorder that the Principal Investigator believes would interfere with the objectives of the study and requiring treatment in the last 2 years
- •Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) prescription medications that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers) NOTE: the explicit exceptions to this are hormone replacement treatments for female participants where symptoms are stable, those medications used in the treatment of arthritis, high blood pressure, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening
- •Currently taking (from day of screening onwards) medication or dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as: melatonin, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St. John's Wort or other cognitive enhancing dietary or herbal supplements over the study period
- •Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
- •Daily consumption of concentrated sources of probiotics and / or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic / prebiotic tablets, capsules, drops or powders), including yoghurt or yoghurt drinks
- •Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- •Have a Body Mass Index (BMI) outside of the range 18.5-29.9 kg/m2
- •Have learning difficulties, dyslexia
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- •Current smoker (use of nicotine replacement products, vaping, gum, patches etc)
- •Have a history of alcohol or drug abuse
- •Current misuse of alcohol, drug or prescription medications
- •Excessive caffeine intake (>500 mg per day)
- •Excessive alcohol consumption (drinking on 5 or more days a week or consuming > 6 units of alcohol in a single session on 5 or more days a week) for 3 weeks prior to screening and during the intervention period
- •Contraindication to any substance in the investigational product
- •Principal Investigator believes that the participant may be uncooperative and / or noncompliant and should therefore not participate in the study
- •Participant under legal or administrative supervision
- •Have food intolerances / sensitivities
- •Have any health condition that would prevent fulfilment of the study requirements
- •Are unable or unwilling to complete all the study assessments
- •Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
研究组 & 干预措施
Lactobacillus paracasei Lpc-37
Active Comparator
Probiotic
干预措施: Lactobacillus paracasei Lpc-37 (Dietary Supplement)
Placebo
Placebo Comparator
Inert placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Episodic memory score
时间窗: 6 weeks
This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition (-4 to 4)
次要结局
- Picture recognition reaction time(6 weeks)
- Rapid visual information processing reaction time(6 weeks)
- Rapid visual information processing false alarms(6 weeks)
- STAI-trait total score(6 weeks)
- Accuracy of attention score(6 weeks)
- Numeric working memory accuracy(6 weeks)
- Numeric working memory reaction time(6 weeks)
- Corsi blocks accuracy(6 weeks)
- Serial 3 subtractions total error responses(6 weeks)
- STAI-state total score(6 weeks)
- Peg and Ball task Planning time(6 weeks)
- Peg and Ball task Completion time(6 weeks)
- Stroop task reaction time(6 weeks)
- Rapid visual information processing accuracy(6 weeks)
- Serial 7 subtractions total responses(6 weeks)
- Serial 7 subtractions total error responses(6 weeks)
- Mental fatigue(6 weeks)
- Alertness(6 weeks)
- Alert(6 weeks)
- Speed of memory score(6 weeks)
- Name to Face Recall reaction time(6 weeks)
- Stroop task accuracy(6 weeks)
- Serial 3 subtractions total responses(6 weeks)
- Content(6 weeks)
- Working memory score(6 weeks)
- Delayed word recall correct(6 weeks)
- Delayed word recall errors(6 weeks)
- Word recognition reaction time(6 weeks)
- Name to Face Recall correct responses(6 weeks)
- Peg and Ball task errors(6 weeks)
- Immediate word recall task error responses(6 weeks)
- Choice reaction time reaction time(6 weeks)
- Calm(6 weeks)
- Speed of attention score(6 weeks)
- Picture recognition accuracy(6 weeks)
- Word recognition accuracy(6 weeks)
- Immediate word recall task correctly identified words(6 weeks)
- Choice reaction time accuracy(6 weeks)
研究者
研究点 (1)
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