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Search / Trial NCT05931536

The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota

Launched by UNIVERSITY COLLEGE CORK · Jun 27, 2023

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Microbiota Gut Brain Axis Diet Cognition Stress Dietary Fibre

ClinConnect Summary

This clinical trial is investigating how diet affects our brain health and stress levels by looking at the gut microbiota, which is the community of bacteria and other microorganisms living in our digestive system. The study is currently recruiting participants who are generally healthy adults between the ages of 18 and 50, with a body mass index (BMI) between 18.5 and 29.9. To participate, individuals must be able to provide written consent and meet certain health criteria. Unfortunately, people with specific medical conditions, those who take certain medications, or women who are pregnant or breastfeeding cannot join the study.

Participants in this trial can expect to engage in activities related to diet and health, with the goal of helping researchers better understand the connections between what we eat, how we feel, and our overall brain function. If you’re interested and meet the eligibility criteria, this could be a valuable opportunity to contribute to important research that might benefit many others in the future!

Gender

ALL

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.

About University College Cork

University College Cork (UCC) is a leading research institution located in Ireland, renowned for its commitment to advancing healthcare through innovative clinical research. The university's clinical trial unit is dedicated to conducting high-quality, ethically sound studies that aim to improve patient outcomes and contribute to the scientific understanding of various medical conditions. UCC collaborates with a diverse network of healthcare professionals, researchers, and industry partners to facilitate pioneering trials across multiple therapeutic areas, ensuring adherence to the highest standards of regulatory compliance and patient safety. Through its initiatives, UCC strives to foster advancements in medicine and enhance the overall health of communities both locally and globally.

Locations

Cork, , Ireland

Patients applied

0 patients applied

Trial Officials

John F Cryan, PhD

Principal Investigator

APC Microbiome Irealnd

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported