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

1 juillet 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Gerard Clarke, PhD
  • Numéro de téléphone: 00353214901721
  • E-mail: G.Clarke@ucc.ie

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 60 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: High fiber diet
30 grams of fiber per day
Comparateur 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.
Autre: Control diet
No diet education and change in diet

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cognitive performance - Attention
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Microbiota composition and function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University College Cork

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 juillet 2021

Achèvement primaire (Anticipé)

1 juillet 2023

Achèvement de l'étude (Anticipé)

1 juillet 2023

Dates d'inscription aux études

Première soumission

8 juin 2021

Première soumission répondant aux critères de contrôle qualité

1 juillet 2021

Première publication (Réel)

7 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • APC135

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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