The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects
29. maj 2022 opdateret af: Pablo Román López, Universidad de Almeria
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Almeria, Spanien, 04120
- Pablo Roman
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Almeria
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Almería, Almeria, Spanien, 04120
- Universidad de Almeria
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La Cañada de San Urbano, Almeria, Spanien, 04120
- Universidad de Almeria
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
56 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Probiotics
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Placebo komparator: Placebo group
Participants will receive a harmless substance (potato starch) during 10 weeks.
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Placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline Anxiety at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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The State-Trait Anxiety Inventory.
Score range: 20-80
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Before and after treatment (10 weeks)
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Change from Baseline Depression at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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The Beck Depression Inventory.
Score range: 0-63.
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Before and after treatment (10 weeks)
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Change from Baseline General Cognitive Status at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Mini-Mental State Examination.
Score range: 0-35
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Before and after treatment (10 weeks)
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Change from Baseline Working Memory at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Digits task, Corsi task
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Before and after treatment (10 weeks)
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Change from Baseline Planning Ability at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Tower of London test
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Before and after treatment (10 weeks)
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Change from Baseline Problem-solving ability at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Wisconsin Card Sorting test
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Before and after treatment (10 weeks)
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Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Stroop task
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Before and after treatment (10 weeks)
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Change from Baseline Visual Attention at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Trail Making Test
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Before and after treatment (10 weeks)
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Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Go/No-Go task
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Before and after treatment (10 weeks)
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Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Iowa Gambling Task
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Before and after treatment (10 weeks)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline Food Habits at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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"24-hour recall" questionnaire
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Before and after treatment (10 weeks)
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Change from Baseline Alcohol Use at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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The Alcohol Use Disorders Identification Test.
Score range: 0-40
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Before and after treatment (10 weeks)
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Change from Baseline Body Composition at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Fat mass.
Body fat mass.
Fat-free mass.
Total body water.
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Before and after treatment (10 weeks)
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Change from Baseline Physical Activity at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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International Physical Activity Questionnaire
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Before and after treatment (10 weeks)
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Change from Baseline Stool Consistency at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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The Bristol Scale
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Before and after treatment (10 weeks)
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Change from Baseline Sleep Quality at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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The Pittsburgh Sleep Quality Index Questionnaire.
Score range: 0-21
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Before and after treatment (10 weeks)
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Change from Baseline Perceived Stress at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Perceived Stress Questionnaire.
Score range: 0-1
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Before and after treatment (10 weeks)
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Change from Baseline Gastrointestinal Symptom at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
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Gastrointestinal Symptom Rating Scale
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Before and after treatment (10 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: PABLO R LOPEZ, Universidad de Almeria
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. juli 2020
Primær færdiggørelse (Faktiske)
30. april 2022
Studieafslutning (Faktiske)
30. april 2022
Datoer for studieregistrering
Først indsendt
29. marts 2021
Først indsendt, der opfyldte QC-kriterier
31. marts 2021
Først opslået (Faktiske)
2. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- UALBIO2020/001
Plan for individuelle deltagerdata (IPD)
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