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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04828421
The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects
The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Almeria, Espanha, 04120
- Pablo Roman
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Almeria
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Almería, Almeria, Espanha, 04120
- Universidad de Almería
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La Cañada de San Urbano, Almeria, Espanha, 04120
- Universidad de Almería
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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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Comparador de Placebo: Placebo group
Participants will receive a harmless substance (potato starch) during 10 weeks.
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Placebo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change from Baseline Anxiety at 10 weeks
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change from Baseline Food Habits at 10 weeks
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: PABLO R LOPEZ, Universidad de Almería
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UALBIO2020/001
Plano para dados de participantes individuais (IPD)
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