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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Gerard Clarke, PhD
- 电话号码：00353214901721
- 邮箱：G.Clarke@ucc.ie
研究联系人备份
- 姓名：Kirsten Berding, PhD
- 电话号码：00353214901721
- 邮箱：kirsten.berdingharold@ucc.ie
学习地点
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Cork、爱尔兰
- 招聘中
- APC Microbiome Ireland, University College Cork
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接触：
- John F Cryan, PhD
- 邮箱：j.cryan@ucc.ie
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接触：
- Kirsten Berding, PhD
- 邮箱：kirsten.berdingharold@ucc.ie
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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安慰剂比较：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cognitive performance - Attention
大体时间：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
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Microbiota composition and function
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：John F Cryan, PhD、APC Microbiome Ireland, University College Cork
- 首席研究员：Gerard Clarke, PhD、APC Microbiome Ireland, University College Cork
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
High fiber diet的临床试验
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University of AarhusAarhus University Hospital; Zimmer Biomet; Kolding Sygehus完全的