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

1. juli 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Gerard Clarke, PhD
  • Telefonnummer: 00353214901721
  • E-post: G.Clarke@ucc.ie

Studer Kontakt Backup

Studiesteder

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

30 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: High fiber diet
30 grams of fiber per day
Placebo komparator: 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.
Annen: Control diet
No diet education and change in diet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cognitive performance - Attention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Microbiota composition and function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

University College Cork

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Forventet)

1. juli 2021

Primær fullføring (Forventet)

1. juli 2023

Studiet fullført (Forventet)

1. juli 2023

Datoer for studieregistrering

Først innsendt

8. juni 2021

Først innsendt som oppfylte QC-kriteriene

1. juli 2021

Først lagt ut (Faktiske)

7. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • APC135

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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