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Dietary Fiber, Microbiota and Cognitive Function in Healthy Adults (FOCUS)

1 de julho de 2021 atualizado por: John Cryan, University College Cork

An Observational and Interventional Study on the Association Between Dietary Fibre and Cognitive Function in Healthy Volunteers

Dietary fiber is well-known for its many health benefits, including the support of gastrointestinal, metabolic, and mental health. Although studies investigating whole dietary patterns in relation to cognition have demonstrated that diet quality and a healthy dietary pattern are associated with better cognitive performance, the role of dietary fiber in this regard is understudied. In the last decade, the role of the microbiota (trillions of microbes inhabiting the gut) in influencing various aspects of human health, including mental health and behavior, has also become established. Importantly, dietary fiber has been shown to positively affect the microbiota composition.

In this study, the role of dietary fiber in cognition through the lens of the microbiota is investigated. A two-part study including an observational (study 1) and interventional (study 2) arm has been designed. In study 1, the observational arm, 150 healthy individuals (30-60 years of age) will be recruited and grouped into high-fiber (>25 g/day, n=75) and low-fiber (<18 grams/day, n=75) consumers based on habitual dietary intake. Cognitive tasks (attention, episodic memory, decision making), psychological dimensions including impulsivity and emotional reactivity, biological samples (feces, blood, saliva, urine) and questionnaires about general health will be collected. In study 2, the interventional arm, a subgroup (n=60) of individuals from the low-fiber group will further be randomized into an 8-week randomized-controlled, parallel, single-blinded intervention to either receive a high fiber (n=30, aim 30 grams/day) or control (n=30) diet education. During the intervention period, individuals will provide repeated fecal samples in order to assess temporal microbial changes. At the end of the intervention period, individuals will undergo the same testing regarding cognitive and psychological variables and the same biological samples will be collected.

The investigators hypothesize that participants with higher dietary fiber intake at baseline will perform better in the cognitive tasks compared to individuals with low fiber intake, and that this difference can, in part, be mediated by the gut microbiota. Further the investigators hypothesize that through the dietary intervention the microbiota composition will positively shift to include more beneficial microbes and that cognitive performance will improve following the intervention.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Gerard Clarke, PhD
  • Número de telefone: 00353214901721
  • E-mail: G.Clarke@ucc.ie

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

30 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Be able to give written informed consent.
  • Be between 30 and 60 years of age.
  • Be in generally good health as determined by the investigator.

Exclusion Criteria:

  • Are less than 30 and greater than 60 years of age.
  • Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal (GI) [to include functional GI disorders, inflammatory bowel disease, celiac disease, lactose intolerance, food allergies], immunological, psychiatric [to include formal or as determined by MINI Psychiatric interview, diagnosis of current major depression, anxiety disorder, bipolar spectrum disorder, schizophrenia, other DSM-IV Axis I disorder], neurodevelopmental disorders, immunological, metabolic disorders [to include type I or II diabetes], or any condition which contraindicates, in the investigators judgement, entry to the study,
  • Have a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; all psychoactive medications [to include anxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids and opioid pain relievers), laxatives, enemas, antibiotics, anti-coagulants, over-the counter non-steroidal anti-inflammatories (NSAIDS). Participants should have a wash-out period of 4 weeks.
  • Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).
  • Females who are peri-menopausal, menopausal or post-menopausal.
  • Females who are pregnant or planning a pregnancy, or lactating.
  • Participants who are not fluent in English or English is not first language.
  • Are color blind.
  • Have dyslexia or dyscalculia.
  • Are a current habitual daily smoker.
  • Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
  • Participants receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
  • Have a malignant disease or any concomitant end-stage organ disease.
  • Have completed a study in the laboratory in the past 4 years.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: DIET
Participants will receive four individual, approximately 30-minute long dietary education sessions. The participants will receive detailed instructions (including meal plans, information on high fiber foods and serving sizes) on how to consume at least 30 grams of fiber per day.
Outro: High fiber diet
30 grams of fiber per day
Comparador de Placebo: CONTROL
No diet education. Group will spend same amount of time with study dietitian, but discussion is limited to review of current eating habits and minimal input on eating habits with referencing the standard food pyramid.
Outro: Control diet
No diet education and change in diet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cognitive performance - Attention
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Assessment of attention using the Paced Auditory Serial Addition Test (PASAT)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Cognitive performance - Episodic memory
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Assessment of episodic memory using the Modified Rey Auditory Verbal Learning Test (ModRey)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Cognitive performance - Risky decision making
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Assessment of risky decision making using the Cambridge Gambling Task (CGT)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Cognitive performance - Affective decision making
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Assessment of affective decision making using the Iowa Gambling Task (IGT).
Differences between groups at baseline and changes after 8-week of diet intervention in active group

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Microbiota composition and function
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Shotgun sequencing of fecal samples
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Blood inflammatory profile
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Cytokine and chemokine levels (e.g., TNFalpha, IL-10, IL-6) will be measured in lipopolysaccharide stimulated and unstimulated bloods
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Salivary cortisol concentrations
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Morning cortisol awakening response
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Stress assessment
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Perceived Stress Scale (range 0 to 40 with higher scores indicating higher perceived stress)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Anxiety assessment
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
State Trait Anxiety Inventory (range 20-80 with higher scores indicating higher anxiety)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Emotion sensitivity, intensity, and persistence
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
Emotion Reactivity Scale (range 0-84 with higher scores indicating higher dysfunctional emotional reactivity)
Differences between groups at baseline and changes after 8-week of diet intervention in active group
Impulsivity-related traits
Prazo: Differences between groups at baseline and changes after 8-week of diet intervention in active group
UPPS-P Impulsive Behavior Scale (range 59-236 with higher scores indicating higher dysfunctional impulsivity
Differences between groups at baseline and changes after 8-week of diet intervention in active group

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University College Cork

Investigadores

  • Investigador principal: John F Cryan, PhD, APC Microbiome Ireland, University College Cork
  • Investigador principal: Gerard Clarke, PhD, APC Microbiome Ireland, University College Cork

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de julho de 2021

Conclusão Primária (Antecipado)

1 de julho de 2023

Conclusão do estudo (Antecipado)

1 de julho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de julho de 2021

Primeira postagem (Real)

7 de julho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • APC135

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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