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

Universidad de Almeria36 enrolled

Overview

This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

Lactobacillus rhamnosus and Bifidobacterium lactisDIETARY_SUPPLEMENT

Probiotics

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 56 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (3)

Universidad de Almeria

Almería, Almeria, Spain

Universidad de Almeria

La Cañada de San Urbano, Almeria, Spain

Pablo Roman

Almería, Spain

Outcomes

Primary Outcomes

Change from Baseline Anxiety at 10 weeks

The State-Trait Anxiety Inventory. Score range: 20-80

Time frame: Before and after treatment (10 weeks)

Change from Baseline Depression at 10 weeks

The Beck Depression Inventory. Score range: 0-63.

Time frame: Before and after treatment (10 weeks)

Change from Baseline General Cognitive Status at 10 weeks

Mini-Mental State Examination. Score range: 0-35

Time frame: Before and after treatment (10 weeks)

Change from Baseline Working Memory at 10 weeks

Digits task, Corsi task

Time frame: Before and after treatment (10 weeks)

Change from Baseline Planning Ability at 10 weeks

Tower of London test

Time frame: Before and after treatment (10 weeks)

Change from Baseline Problem-solving ability at 10 weeks

Wisconsin Card Sorting test

Time frame: Before and after treatment (10 weeks)

Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks

Stroop task

Time frame: Before and after treatment (10 weeks)

Change from Baseline Visual Attention at 10 weeks

Trail Making Test

Time frame: Before and after treatment (10 weeks)

Change from Baseline Motor impulsivity or inhibitory response at 10 weeks

Data from ClinicalTrials.gov

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Secondary Outcomes

Change from Baseline Food Habits at 10 weeks

"24-hour recall" questionnaire

Time frame: Before and after treatment (10 weeks)

Change from Baseline Alcohol Use at 10 weeks

The Alcohol Use Disorders Identification Test. Score range: 0-40

Time frame: 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.

Time frame: Before and after treatment (10 weeks)

Change from Baseline Physical Activity at 10 weeks

International Physical Activity Questionnaire

Time frame: Before and after treatment (10 weeks)

Change from Baseline Stool Consistency at 10 weeks

The Bristol Scale

Time frame: Before and after treatment (10 weeks)

Change from Baseline Sleep Quality at 10 weeks

The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21

Time frame: Before and after treatment (10 weeks)

Change from Baseline Perceived Stress at 10 weeks

Perceived Stress Questionnaire. Score range: 0-1

Time frame: Before and after treatment (10 weeks)

Change from Baseline Gastrointestinal Symptom at 10 weeks

Gastrointestinal Symptom Rating Scale

Time frame: Before and after treatment (10 weeks)