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

29. mai 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

36

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Almeria, Spania, 04120
        • Pablo Roman
    • Almeria
      • Almería, Almeria, Spania, 04120
        • Universidad de Almería
      • La Cañada de San Urbano, Almeria, Spania, 04120
        • Universidad de Almería

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

56 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Lactobacillus rhamnosus and Bifidobacterium lactis
Probiotics
Placebo komparator: Placebo group
Participants will receive a harmless substance (potato starch) during 10 weeks.
Kosttilskudd: Placebo
Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Anxiety at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
The State-Trait Anxiety Inventory. Score range: 20-80
Before and after treatment (10 weeks)
Change from Baseline Depression at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
The Beck Depression Inventory. Score range: 0-63.
Before and after treatment (10 weeks)
Change from Baseline General Cognitive Status at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Mini-Mental State Examination. Score range: 0-35
Before and after treatment (10 weeks)
Change from Baseline Working Memory at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Digits task, Corsi task
Before and after treatment (10 weeks)
Change from Baseline Planning Ability at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Tower of London test
Before and after treatment (10 weeks)
Change from Baseline Problem-solving ability at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Wisconsin Card Sorting test
Before and after treatment (10 weeks)
Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Stroop task
Before and after treatment (10 weeks)
Change from Baseline Visual Attention at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Trail Making Test
Before and after treatment (10 weeks)
Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Go/No-Go task
Before and after treatment (10 weeks)
Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Iowa Gambling Task
Before and after treatment (10 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Food Habits at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
"24-hour recall" questionnaire
Before and after treatment (10 weeks)
Change from Baseline Alcohol Use at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
The Alcohol Use Disorders Identification Test. Score range: 0-40
Before and after treatment (10 weeks)
Change from Baseline Body Composition at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Fat mass. Body fat mass. Fat-free mass. Total body water.
Before and after treatment (10 weeks)
Change from Baseline Physical Activity at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
International Physical Activity Questionnaire
Before and after treatment (10 weeks)
Change from Baseline Stool Consistency at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
The Bristol Scale
Before and after treatment (10 weeks)
Change from Baseline Sleep Quality at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21
Before and after treatment (10 weeks)
Change from Baseline Perceived Stress at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Perceived Stress Questionnaire. Score range: 0-1
Before and after treatment (10 weeks)
Change from Baseline Gastrointestinal Symptom at 10 weeks
Tidsramme: Before and after treatment (10 weeks)
Gastrointestinal Symptom Rating Scale
Before and after treatment (10 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad de Almeria

Etterforskere

  • Hovedetterforsker: PABLO R LOPEZ, Universidad de Almería

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. juli 2020

Primær fullføring (Faktiske)

30. april 2022

Studiet fullført (Faktiske)

30. april 2022

Datoer for studieregistrering

Først innsendt

29. mars 2021

Først innsendt som oppfylte QC-kriteriene

31. mars 2021

Først lagt ut (Faktiske)

2. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • UALBIO2020/001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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