Skip to main content
Clinical Trials/NCT05931536
NCT05931536
Recruiting
Not Applicable

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

University College Cork1 site in 1 country350 target enrollmentJuly 14, 2022
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University College Cork
Enrollment
350
Locations
1
Primary Endpoint
Responses to acute stress: self-report
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 14, 2022
End Date
July 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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/m
  • 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/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.

Outcomes

Primary Outcomes

Responses to acute stress: self-report

Time Frame: Compared at baseline

Self-report questionnaires

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

Time Frame: Compared at baseline

Cortisol from saliva samples

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

Time Frame: Compared at baseline

Cortisol from saliva samples

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

Time Frame: Compared at baseline

Galvanic skin response taken from the skin on the hand

Trait stress/mood: self-report

Time Frame: Compared at baseline

Self-report questionnaires

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials