Lactobacillus rhamnosus and Bifidobacterium lactis
Dietary SupplementProbiotics
NCT Number: NCT04828421
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
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Notify Me56 year and older
All sexes
Interventional
Not applicable
Universidad de Almeria, Almería, Almeria, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotics
Placebo
Time frame: Before and after treatment (10 weeks)
The State-Trait Anxiety Inventory. Score range: 20-80
Time frame: Before and after treatment (10 weeks)
The Beck Depression Inventory. Score range: 0-63.
Time frame: Before and after treatment (10 weeks)
Mini-Mental State Examination. Score range: 0-35
Time frame: Before and after treatment (10 weeks)
Digits task, Corsi task
Time frame: Before and after treatment (10 weeks)
Tower of London test
Time frame: Before and after treatment (10 weeks)
Wisconsin Card Sorting test
Time frame: Before and after treatment (10 weeks)
Stroop task
Time frame: Before and after treatment (10 weeks)
Trail Making Test
Time frame: Before and after treatment (10 weeks)
Go/No-Go task
Time frame: Before and after treatment (10 weeks)
Iowa Gambling Task
Time frame: Before and after treatment (10 weeks)
"24-hour recall" questionnaire
Time frame: Before and after treatment (10 weeks)
The Alcohol Use Disorders Identification Test. Score range: 0-40
Time frame: Before and after treatment (10 weeks)
Fat mass. Body fat mass. Fat-free mass. Total body water.
Time frame: Before and after treatment (10 weeks)
International Physical Activity Questionnaire
Time frame: Before and after treatment (10 weeks)
The Bristol Scale
Time frame: Before and after treatment (10 weeks)
The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21
Time frame: Before and after treatment (10 weeks)
Perceived Stress Questionnaire. Score range: 0-1
Time frame: Before and after treatment (10 weeks)
Gastrointestinal Symptom Rating Scale
Universidad de Almeria
Other
The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial
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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