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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828421
• Other study ID #: UALBIO2020/001
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 56 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus and Bifidobacterium lactis
Probiotics
• Placebo
Placebo

Locations

Country	Name	City	State
Spain	Pablo Roman	Almeria
Spain	Universidad de Almeria	Almería	Almeria
Spain	Universidad de Almeria	La Cañada de San Urbano	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Anxiety at 10 weeks	The State-Trait Anxiety Inventory. Score range: 20-80	Before and after treatment (10 weeks)
Primary	Change from Baseline Depression at 10 weeks	The Beck Depression Inventory. Score range: 0-63.	Before and after treatment (10 weeks)
Primary	Change from Baseline General Cognitive Status at 10 weeks	Mini-Mental State Examination. Score range: 0-35	Before and after treatment (10 weeks)
Primary	Change from Baseline Working Memory at 10 weeks	Digits task, Corsi task	Before and after treatment (10 weeks)
Primary	Change from Baseline Planning Ability at 10 weeks	Tower of London test	Before and after treatment (10 weeks)
Primary	Change from Baseline Problem-solving ability at 10 weeks	Wisconsin Card Sorting test	Before and after treatment (10 weeks)
Primary	Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks	Stroop task	Before and after treatment (10 weeks)
Primary	Change from Baseline Visual Attention at 10 weeks	Trail Making Test	Before and after treatment (10 weeks)
Primary	Change from Baseline Motor impulsivity or inhibitory response at 10 weeks	Go/No-Go task	Before and after treatment (10 weeks)
Primary	Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks	Iowa Gambling Task	Before and after treatment (10 weeks)
Secondary	Change from Baseline Food Habits at 10 weeks	"24-hour recall" questionnaire	Before and after treatment (10 weeks)
Secondary	Change from Baseline Alcohol Use at 10 weeks	The Alcohol Use Disorders Identification Test. Score range: 0-40	Before and after treatment (10 weeks)
Secondary	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)
Secondary	Change from Baseline Physical Activity at 10 weeks	International Physical Activity Questionnaire	Before and after treatment (10 weeks)
Secondary	Change from Baseline Stool Consistency at 10 weeks	The Bristol Scale	Before and after treatment (10 weeks)
Secondary	Change from Baseline Sleep Quality at 10 weeks	The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21	Before and after treatment (10 weeks)
Secondary	Change from Baseline Perceived Stress at 10 weeks	Perceived Stress Questionnaire. Score range: 0-1	Before and after treatment (10 weeks)
Secondary	Change from Baseline Gastrointestinal Symptom at 10 weeks	Gastrointestinal Symptom Rating Scale	Before and after treatment (10 weeks)