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Completed

NCT Number: NCT04828421

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

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

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Key information

Conditions

Age range

56 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almeria, Almería, Almeria, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lactobacillus rhamnosus and Bifidobacterium lactis

Dietary Supplement

Probiotics

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change from Baseline Anxiety at 10 weeks

    Time frame: Before and after treatment (10 weeks)

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

  2. Change from Baseline Depression at 10 weeks

    Time frame: Before and after treatment (10 weeks)

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

  3. Change from Baseline General Cognitive Status at 10 weeks

    Time frame: Before and after treatment (10 weeks)

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

  4. Change from Baseline Working Memory at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Digits task, Corsi task

  5. Change from Baseline Planning Ability at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Tower of London test

  6. Change from Baseline Problem-solving ability at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Wisconsin Card Sorting test

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

    Time frame: Before and after treatment (10 weeks)

    Stroop task

  8. Change from Baseline Visual Attention at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Trail Making Test

  9. Change from Baseline Motor impulsivity or inhibitory response at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Go/No-Go task

  10. Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Iowa Gambling Task

Secondary outcomes

  1. Change from Baseline Food Habits at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    "24-hour recall" questionnaire

  2. Change from Baseline Alcohol Use at 10 weeks

    Time frame: Before and after treatment (10 weeks)

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

  3. Change from Baseline Body Composition at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Fat mass. Body fat mass. Fat-free mass. Total body water.

  4. Change from Baseline Physical Activity at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    International Physical Activity Questionnaire

  5. Change from Baseline Stool Consistency at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    The Bristol Scale

  6. Change from Baseline Sleep Quality at 10 weeks

    Time frame: Before and after treatment (10 weeks)

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

  7. Change from Baseline Perceived Stress at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Perceived Stress Questionnaire. Score range: 0-1

  8. Change from Baseline Gastrointestinal Symptom at 10 weeks

    Time frame: Before and after treatment (10 weeks)

    Gastrointestinal Symptom Rating Scale

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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