Exploring how diet affects brain health through gut bacteria
The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults
This study is testing whether eating more fiber can improve brain health and thinking skills by looking at how it affects gut bacteria in people aged 18 to 50.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Locations | 1 site (Cork) |
| Trial ID | NCT05931536 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between dietary fibre intake and its effects on cognition, stress responses, and the gut microbiota. Participants aged 18 to 50 will be categorized based on their habitual fibre consumption into low, moderate, and high fibre groups. The study aims to determine if higher dietary fibre intake correlates with better cognitive performance and if this relationship is mediated by changes in gut microbiota composition. By utilizing a cross-sectional design, the study will assess various cognitive tasks and biological markers related to the microbiota-gut-brain axis.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 50 with a BMI between 18.5 and 29.9.
Not a fit: Patients with significant acute or chronic illnesses, including psychiatric or gastrointestinal disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations that enhance cognitive health and stress management.
How similar studies have performed: While the relationship between diet and cognition has been explored, the specific focus on dietary fibre's role in the microbiota-gut-brain axis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cork
- APC Microbiome Ireland — Cork, Ireland (Recruiting)
Study contacts
- Principal investigator: John F Cryan, PhD — APC Microbiome Irealnd
- Study coordinator: Elizabeth Schneider, PhD
- Email: eschneider@ucc.ie
- Phone: (+353) 021 4901721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.