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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gerard Clarke, PhD
- 電話番号：00353214901721
- メール：G.Clarke@ucc.ie
研究連絡先のバックアップ
- 名前：Kirsten Berding, PhD
- 電話番号：00353214901721
- メール：kirsten.berdingharold@ucc.ie
研究場所
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Cork、アイルランド
- 募集
- APC Microbiome Ireland, University College Cork
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コンタクト：
- John F Cryan, PhD
- メール：j.cryan@ucc.ie
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コンタクト：
- Kirsten Berding, PhD
- メール：kirsten.berdingharold@ucc.ie
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive performance - Attention
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Microbiota composition and function
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：John F Cryan, PhD、APC Microbiome Ireland, University College Cork
- 主任研究者：Gerard Clarke, PhD、APC Microbiome Ireland, University College Cork
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- APC135
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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