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

NCT ID: NCT05931536

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2025-07-14

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.

Conditions

Healthy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Low fibre consumers

Healthy adults consuming less than or equal to 18 grams of fibre per day.

Dietary fibre

Intervention Type: OTHER

Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.

Moderate fibre consumers

Healthy adults consuming between 18.1-24.9 grams of fibre per day.

Dietary fibre

Intervention Type: OTHER

Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.

High fibre consumers

Healthy adults consuming greater than or equal to 25 grams of fibre per day.

Dietary fibre

Intervention Type: OTHER

Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.

Interventions

Dietary fibre

Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John F Cryan, PhD

Role: PRINCIPAL_INVESTIGATOR

APC Microbiome Irealnd

Locations

APC Microbiome Ireland

Cork, , Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Elizabeth Schneider, PhD

Role: CONTACT

eschneider@ucc.ie

(+353) 021 4901721

Revathy Munuswamy, PhD

Role: CONTACT

RMunuswamy@ucc.ie

(+353) 021 4901721

Facility Contacts

Revathy Munuswamy, PhD

Role: primary

RMunuswamy@ucc.ie

(+353) 021 4901721

Other Identifiers

APC150a

Identifier Type: -

Identifier Source: org_study_id