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

1. července 2021 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Očekávaný)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Gerard Clarke, PhD
  • Telefonní číslo: 00353214901721
  • E-mail: G.Clarke@ucc.ie

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: High fiber diet
30 grams of fiber per day
Komparátor placeba: 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.
Jiný: Control diet
No diet education and change in diet

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cognitive performance - Attention
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Microbiota composition and function
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University College Cork

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. července 2021

Primární dokončení (Očekávaný)

1. července 2023

Dokončení studie (Očekávaný)

1. července 2023

Termíny zápisu do studia

První předloženo

8. června 2021

První předloženo, které splnilo kritéria kontroly kvality

1. července 2021

První zveřejněno (Aktuální)

7. července 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. července 2021

Naposledy ověřeno

1. července 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • APC135

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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