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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus rhamnosus and Bifidobacterium lactis

Detailed Description

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
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 04120
    • Pablo Roman
  • Almeria
    • Almería, Almeria, Spain, 04120
      • Universidad de Almeria
    • La Cañada de San Urbano, Almeria, Spain, 04120
      • Universidad de Almeria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 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; Probiotics
Placebo Comparator: Placebo group; Participants will receive a harmless substance (potato starch) during 10 weeks.	Dietary supplement: Placebo; Placebo

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universidad de Almeria
• Investigators: Principal Investigator: PABLO R LOPEZ, Universidad de Almeria

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; Probiotics; Aging; Emotional; Cognitive
• Other Study ID Numbers: UALBIO2020/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No