The Cognitive Effects of 6 Weeks Administration With a Probiotic

Study Overview
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Brief Summary
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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+

Official Title
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The Cognitive Effects of 6 Weeks Administration With a Probiotic: a Randomized, Placebo Controlled Proof-of-concept Study in Healthy Elderly Humans

Conditions
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Cognitive Change

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei Lpc-37
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus paracasei Lpc-37<br>Probiotic | Dietary Supplement: Lactobacillus paracasei Lpc-37<br>* Live probiotic bacteria<br>|
| Placebo Comparator: Placebo<br>Inert placebo | Dietary Supplement: Placebo<br>* Inert placebo matched for taste and appearance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic memory score | 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI-state total score | State-trait anxiety inventory 'state' total score (20-80) | 6 weeks | 
| STAI-trait total score | State-trait anxiety inventory 'trait' total score (20-80) | 6 weeks | 
| Accuracy of attention score | This is a composite measure derived from summing the z score accuracy performance on the choice reaction time and Rapid visual information processing tasks (-2 to 2) | 6 weeks | 
| Speed of attention score | This is a composite measure derived from summing the z score reaction times from the choice reaction time and Rapid visual information processing task (-2 to 2) | 6 weeks | 
| Working memory score | This is a composite measure derived from summing the z score accuracy performance on the numeric working memory task and Corsi block-tapping task (-2 to 2) | 6 weeks | 
| Speed of memory score | This is a composite measure derived from summing the z score reaction times on the numeric working memory task, the delayed name / face recall task, the delayed picture recognition task and the delayed word recognition task (-4 to 4) | 6 weeks | 
| Delayed word recall correct | total number of correctly identified words (0-15) | 6 weeks | 
| Delayed word recall errors | total number of error responses | 6 weeks | 
| Picture recognition reaction time | (ms) | 6 weeks | 
| Picture recognition accuracy |  | 6 weeks | 
| Word recognition reaction time | (ms) | 6 weeks | 
| Word recognition accuracy |  | 6 weeks | 
| Name to Face Recall correct responses | number | 6 weeks | 
| Name to Face Recall reaction time | (ms) | 6 weeks | 
| Peg and Ball task Planning time | (ms) | 6 weeks | 
| Peg and Ball task Completion time | (ms) | 6 weeks | 
| Peg and Ball task errors | Number | 6 weeks | 
| Stroop task accuracy |  | 6 weeks | 
| Stroop task reaction time | (ms) | 6 weeks | 
| Immediate word recall task correctly identified words | total number (0-15) | 6 weeks | 
| Immediate word recall task error responses | total number | 6 weeks | 
| Numeric working memory accuracy |  | 6 weeks | 
| Numeric working memory reaction time | (ms) | 6 weeks | 
| Choice reaction time accuracy |  | 6 weeks | 
| Choice reaction time reaction time | (ms) | 6 weeks | 
| Rapid visual information processing accuracy |  | 6 weeks | 
| Rapid visual information processing reaction time | (ms) | 6 weeks | 
| Rapid visual information processing false alarms | number | 6 weeks | 
| Corsi blocks accuracy | Average scores from the last five correctly completed trials from the Corsi block-tapping task | 6 weeks | 
| Rapid visual information processing accuracy | (%) - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Rapid visual information processing reaction time | (ms) - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Rapid visual information processing false alarms | number - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Serial 3 subtractions total responses | number- calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Serial 3 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Serial 7 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Serial 7 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Mental fatigue | visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Alertness | visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery | 6 weeks | 
| Alert | derived from Bond Lader visual analogue scale | 6 weeks | 
| Content | derived from Bond Lader visual analogue scale | 6 weeks | 
| Calm | derived from Bond Lader visual analogue scale | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut-brain axis, cognitve demand battery, probiotics