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

Universidad de Almeria

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04828421

UALBIO2020/001

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 56+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks.

Treatment:

Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis

Placebo group

Placebo Comparator group

Description:

Participants will receive a harmless substance (potato starch) during 10 weeks.

Treatment:

Dietary Supplement: Placebo