The Impact of Diet on the Gut-Microbiota-Brain Axis

Launched by UNIVERSITY COLLEGE CORK · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how changes in diet can affect our brain, stress levels, and the bacteria in our gut. Specifically, it looks at healthy adults who currently eat low-fiber diets and will participate in an 8-week dietary program. The researchers hope to learn if improving diet can enhance brain function and reduce stress.

To be eligible for this study, participants need to be between 18 and 50 years old and have a healthy weight, defined by a body mass index (BMI) of 18.5 to 29.9. They should also be in good health without any major illnesses or conditions that might interfere with the study. Throughout the trial, participants will follow a specific diet and may have their cognitive function and gut health assessed. It's important to know that certain medications and health conditions might prevent someone from joining the study, so potential participants should discuss any concerns with the study team.

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.