Dietary Fiber, Microbiota and Cognitive Function in Healthy Adults (FOCUS)
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gerard Clarke, PhD
- 전화번호: 00353214901721
- 이메일: G.Clarke@ucc.ie
연구 연락처 백업
- 이름: Kirsten Berding, PhD
- 전화번호: 00353214901721
- 이메일: kirsten.berdingharold@ucc.ie
연구 장소
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Cork, 아일랜드
- 모병
- APC Microbiome Ireland, University College Cork
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연락하다:
- John F Cryan, PhD
- 이메일: j.cryan@ucc.ie
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연락하다:
- Kirsten Berding, PhD
- 이메일: kirsten.berdingharold@ucc.ie
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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30 grams of fiber per day
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위약 비교기: 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.
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No diet education and change in diet
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cognitive performance - Attention
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Assessment of attention using the Paced Auditory Serial Addition Test (PASAT)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Cognitive performance - Episodic memory
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Assessment of episodic memory using the Modified Rey Auditory Verbal Learning Test (ModRey)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Cognitive performance - Risky decision making
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Assessment of risky decision making using the Cambridge Gambling Task (CGT)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Cognitive performance - Affective decision making
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Assessment of affective decision making using the Iowa Gambling Task (IGT).
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microbiota composition and function
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Shotgun sequencing of fecal samples
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Blood inflammatory profile
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Cytokine and chemokine levels (e.g., TNFalpha, IL-10, IL-6) will be measured in lipopolysaccharide stimulated and unstimulated bloods
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Salivary cortisol concentrations
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Morning cortisol awakening response
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Stress assessment
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Perceived Stress Scale (range 0 to 40 with higher scores indicating higher perceived stress)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Anxiety assessment
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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State Trait Anxiety Inventory (range 20-80 with higher scores indicating higher anxiety)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Emotion sensitivity, intensity, and persistence
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Emotion Reactivity Scale (range 0-84 with higher scores indicating higher dysfunctional emotional reactivity)
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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Impulsivity-related traits
기간: Differences between groups at baseline and changes after 8-week of diet intervention in active group
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UPPS-P Impulsive Behavior Scale (range 59-236 with higher scores indicating higher dysfunctional impulsivity
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Differences between groups at baseline and changes after 8-week of diet intervention in active group
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공동 작업자 및 조사자
수사관
- 수석 연구원: John F Cryan, PhD, APC Microbiome Ireland, University College Cork
- 수석 연구원: Gerard Clarke, PhD, APC Microbiome Ireland, University College Cork
간행물 및 유용한 링크
일반 간행물
- Berding K, Carbia C, Cryan JF. Going with the grain: Fiber, cognition, and the microbiota-gut-brain-axis. Exp Biol Med (Maywood). 2021 Apr;246(7):796-811. doi: 10.1177/1535370221995785. Epub 2021 Feb 28.
- Cryan JF, O'Riordan KJ, Cowan CSM, Sandhu KV, Bastiaanssen TFS, Boehme M, Codagnone MG, Cussotto S, Fulling C, Golubeva AV, Guzzetta KE, Jaggar M, Long-Smith CM, Lyte JM, Martin JA, Molinero-Perez A, Moloney G, Morelli E, Morillas E, O'Connor R, Cruz-Pereira JS, Peterson VL, Rea K, Ritz NL, Sherwin E, Spichak S, Teichman EM, van de Wouw M, Ventura-Silva AP, Wallace-Fitzsimons SE, Hyland N, Clarke G, Dinan TG. The Microbiota-Gut-Brain Axis. Physiol Rev. 2019 Oct 1;99(4):1877-2013. doi: 10.1152/physrev.00018.2018.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- APC135
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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