The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects

Study Overview
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Brief Summary
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This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

Detailed Description
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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.

Official Title
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The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 56 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks. | Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis<br>* Probiotics<br>|
| Placebo Comparator: Placebo group<br>Participants will receive a harmless substance (potato starch) during 10 weeks. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Anxiety at 10 weeks | The State-Trait Anxiety Inventory. Score range: 20-80 | Before and after treatment (10 weeks) | 
| Change from Baseline Depression at 10 weeks | The Beck Depression Inventory. Score range: 0-63. | Before and after treatment (10 weeks) | 
| Change from Baseline General Cognitive Status at 10 weeks | Mini-Mental State Examination. Score range: 0-35 | Before and after treatment (10 weeks) | 
| Change from Baseline Working Memory at 10 weeks | Digits task, Corsi task | Before and after treatment (10 weeks) | 
| Change from Baseline Planning Ability at 10 weeks | Tower of London test | Before and after treatment (10 weeks) | 
| Change from Baseline Problem-solving ability at 10 weeks | Wisconsin Card Sorting test | Before and after treatment (10 weeks) | 
| Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks | Stroop task | Before and after treatment (10 weeks) | 
| Change from Baseline Visual Attention at 10 weeks | Trail Making Test | Before and after treatment (10 weeks) | 
| Change from Baseline Motor impulsivity or inhibitory response at 10 weeks | Go/No-Go task | Before and after treatment (10 weeks) | 
| Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks | Iowa Gambling Task | Before and after treatment (10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Food Habits at 10 weeks | 24-hour recall questionnaire | Before and after treatment (10 weeks) | 
| Change from Baseline Alcohol Use at 10 weeks | The Alcohol Use Disorders Identification Test. Score range: 0-40 | Before and after treatment (10 weeks) | 
| Change from Baseline Body Composition at 10 weeks | Fat mass. Body fat mass. Fat-free mass. Total body water. | Before and after treatment (10 weeks) | 
| Change from Baseline Physical Activity at 10 weeks | International Physical Activity Questionnaire | Before and after treatment (10 weeks) | 
| Change from Baseline Stool Consistency at 10 weeks | The Bristol Scale | Before and after treatment (10 weeks) | 
| Change from Baseline Sleep Quality at 10 weeks | The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21 | Before and after treatment (10 weeks) | 
| Change from Baseline Perceived Stress at 10 weeks | Perceived Stress Questionnaire. Score range: 0-1 | Before and after treatment (10 weeks) | 
| Change from Baseline Gastrointestinal Symptom at 10 weeks | Gastrointestinal Symptom Rating Scale | Before and after treatment (10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Cognitive, Emotional, Aging, Elderly