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临床试验/NCT05931536
NCT05931536招募中不适用

The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults

University College Cork1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
1
主要终点
Responses to acute stress: self-report

研究概览

简要总结

This study aims to investigate the relationship between diet and the microbiota-gut-brain axis.

详细描述

Dietary fibre 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 fibre in this regard is understudied. It is now understood that the gut microbiota (trillions of microbes inhabiting the gastrointestinal tract) communicates bidirectionally with the brain to influence mental health and cognition. Importantly, dietary fibre has been shown to positively affect the microbiota composition. The aim of this study is to understand the effects of dietary fibre on the microbiota-gut-brain axis.

Using a cross-sectional design, habitual low fibre (<=18 grams/day, n=200), moderate fibre (18.1-24.9 grams/day, n=75), and high fibre (=>25 g/day, n=75) consumers will be compared at baseline on measures of cognition, responses to acute and chronic stress, and biological markers of the microbiota-gut-brain axis.

The investigators hypothesize that participants with higher dietary fibre intake at baseline will perform better in the cognitive tasks compared to individuals with low fibre intake, and that this difference can, in part, be mediated by the gut microbiota.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be able to give written informed consent.
  • Be between 18 and 50 years of age.
  • Have a body mass index (BMI) between 18.5-29.9 Kg/m
  • Be in generally good health as determined by the investigator.

排除标准

  • Are less than 18 and greater than 50 years of age.
  • Have a BMI below 18.5 or above 29.9 Kg/m
  • Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal (GI) [to include functional GI disorders, inflammatory bowel disease, coeliac 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). Subjects 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.
  • Are colour 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.
  • Subjects 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 our laboratory in the past 4 years.

结局指标

主要结局

Responses to acute stress: self-report

时间窗: Compared at baseline

Self-report questionnaires

Responses to acute stress: hypothalamic-pituitary-adrenal axis activity

时间窗: Compared at baseline

Cortisol from saliva samples

Trait stress/mood: hypothalamic-pituitary-adrenal axis activity

时间窗: Compared at baseline

Cortisol from saliva samples

Responses to acute stress: sympathetic-adrenal-medullary pathway activity

时间窗: Compared at baseline

Galvanic skin response taken from the skin on the hand

Trait stress/mood: self-report

时间窗: Compared at baseline

Self-report questionnaires

次要结局

  • Cognitive performance: visual pattern recognition memory(Compared at baseline)
  • Cognitive performance: episodic memory(Compared at baseline)
  • Cognitive performance: affective perceptual bias(Compared at baseline)
  • Cognitive performance: working memory(Compared at baseline)
  • Cognitive performance: decision making(Compared at baseline)
  • Cognitive performance: social cognition(Compared at baseline)
  • Cognitive performance: emotional inhibition(Compared at baseline)
  • Cognitive performance: sustained attention(Compared at baseline)
  • Cognitive performance: cognitive flexibility(Compared at baseline)
  • Inflammation(Compared at baseline)
  • Microbiota composition and function(Compared at baseline)
  • Microbial and host metabolites(Compared at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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