Clinical trial NCT05931536: The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota
Official title: The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Microbiota-gut-brain axis
Diet
Cognition
Stress
Dietary fibre
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers consuming varying amounts of dietary fibre.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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/m2.
* Be in generally good health as determined by the investigator.

Exclusion Criteria:

* Are less than 18 and greater than 50 years of age.
* Have a BMI below 18.5 or above 29.9 Kg/m2.
* 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.

Primary outcomes:
measure: Trait stress/mood: self-report
timeFrame: Compared at baseline
measure: Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
timeFrame: Compared at baseline
measure: Responses to acute stress: self-report
timeFrame: Compared at baseline
measure: Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
timeFrame: Compared at baseline
measure: Responses to acute stress: sympathetic-adrenal-medullary pathway activity
timeFrame: Compared at baseline
Secondary outcomes:
measure: Cognitive performance: working memory
timeFrame: Compared at baseline
measure: Cognitive performance: episodic memory
timeFrame: Compared at baseline
measure: Cognitive performance: decision making
timeFrame: Compared at baseline
measure: Cognitive performance: emotional inhibition
timeFrame: Compared at baseline
measure: Cognitive performance: sustained attention
timeFrame: Compared at baseline
measure: Cognitive performance: visual pattern recognition memory
timeFrame: Compared at baseline
measure: Cognitive performance: cognitive flexibility
timeFrame: Compared at baseline
measure: Cognitive performance: social cognition
timeFrame: Compared at baseline
measure: Cognitive performance: affective perceptual bias
timeFrame: Compared at baseline
measure: Microbiota composition and function
timeFrame: Compared at baseline
measure: Microbial and host metabolites
timeFrame: Compared at baseline
measure: Inflammation
timeFrame: Compared at baseline
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: APC Microbiome Ireland
Study officials:
affiliation: APC Microbiome Irealnd
name: John F Cryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: