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

Sponsor
University College Cork (Other)
Overall Status
Recruiting
CT.gov ID
NCT05931536
Collaborator
(none)
350
1
23.6
14.8

Study Details

Study Description

Brief Summary

This study aims to investigate the relationship between diet and the microbiota-gut-brain axis.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary fibre

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults
Actual Study Start Date :
Jul 14, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Low fibre consumers

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

Other: 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.

Moderate fibre consumers

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

Other: 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.

High fibre consumers

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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Trait stress/mood: self-report [Compared at baseline]

    Self-report questionnaires

  2. Trait stress/mood: hypothalamic-pituitary-adrenal axis activity [Compared at baseline]

    Cortisol from saliva samples

  3. Responses to acute stress: self-report [Compared at baseline]

    Self-report questionnaires

  4. Responses to acute stress: hypothalamic-pituitary-adrenal axis activity [Compared at baseline]

    Cortisol from saliva samples

  5. Responses to acute stress: sympathetic-adrenal-medullary pathway activity [Compared at baseline]

    Galvanic skin response taken from the skin on the hand

Secondary Outcome Measures

  1. Cognitive performance: working memory [Compared at baseline]

    Spatial Working Memory

  2. Cognitive performance: episodic memory [Compared at baseline]

    Modified Rey Auditory Verbal Learning Test (ModRey)

  3. Cognitive performance: decision making [Compared at baseline]

    Iowa Gambling Task

  4. Cognitive performance: emotional inhibition [Compared at baseline]

    Emotional stroop

  5. Cognitive performance: sustained attention [Compared at baseline]

    Rapid Visual Information Processing

  6. Cognitive performance: visual pattern recognition memory [Compared at baseline]

    Pattern Recognition Memory

  7. Cognitive performance: cognitive flexibility [Compared at baseline]

    Intra-Extra Dimensional Set Shifting

  8. Cognitive performance: social cognition [Compared at baseline]

    Emotion Recognition Task

  9. Cognitive performance: affective perceptual bias [Compared at baseline]

    Emotional Bias Task

  10. Microbiota composition and function [Compared at baseline]

    Shotgun metagenomics of fecal samples

  11. Microbial and host metabolites [Compared at baseline]

    Untargeted metabolomics analysis in fecal and urine samples

  12. Inflammation [Compared at baseline]

    Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 APC Microbiome Ireland Cork Ireland T12YT20

Sponsors and Collaborators

  • University College Cork

Investigators

  • Principal Investigator: John F Cryan, PhD, APC Microbiome Irealnd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College Cork
ClinicalTrials.gov Identifier:
NCT05931536
Other Study ID Numbers:
  • APC150a
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University College Cork

Study Results

No Results Posted as of Jul 5, 2023