Clinical trial NCT04828421: The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Probiotics
Cognitive
Emotional
Aging
Elderly
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 36
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline Anxiety at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Depression at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline General Cognitive Status at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Working Memory at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Planning Ability at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Problem-solving ability at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Visual Attention at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
timeFrame: Before and after treatment (10 weeks)
Secondary outcomes:
measure: Change from Baseline Food Habits at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Alcohol Use at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Body Composition at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Physical Activity at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Stool Consistency at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Sleep Quality at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Perceived Stress at 10 weeks
timeFrame: Before and after treatment (10 weeks)
measure: Change from Baseline Gastrointestinal Symptom at 10 weeks
timeFrame: Before and after treatment (10 weeks)
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
state: Almeria
city: La Cañada de San Urbano
country: Spain
facility: Universidad de Almeria
state: Almeria
city: Almeria
country: Spain
facility: Pablo Roman
Study officials:
affiliation: Universidad de Almeria
name: PABLO R LOPEZ
role: PRINCIPAL_INVESTIGATOR
References: