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NCT Number: NCT05931536

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

APC Microbiome Ireland

Cork, T12YT20, Ireland

Location status: Recruiting

Location contact

Gerard Clarke, PhD

SUB_INVESTIGATOR

John F Cryan, PhD

PRINCIPAL_INVESTIGATOR

Revathy Munuswamy, PhD

CONTACT

[email protected]

(+353) 021 4901721

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary fibre

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.

Primary outcomes

  1. Trait stress/mood: self-report

    Time frame: Compared at baseline

    Self-report questionnaires

  2. Trait stress/mood: hypothalamic-pituitary-adrenal axis activity

    Time frame: Compared at baseline

    Cortisol from saliva samples

  3. Responses to acute stress: self-report

    Time frame: Compared at baseline

    Self-report questionnaires

  4. Responses to acute stress: hypothalamic-pituitary-adrenal axis activity

    Time frame: Compared at baseline

    Cortisol from saliva samples

  5. Responses to acute stress: sympathetic-adrenal-medullary pathway activity

    Time frame: Compared at baseline

    Galvanic skin response taken from the skin on the hand

Secondary outcomes

  1. Cognitive performance: working memory

    Time frame: Compared at baseline

    Spatial Working Memory

  2. Cognitive performance: episodic memory

    Time frame: Compared at baseline

    Modified Rey Auditory Verbal Learning Test (ModRey)

  3. Cognitive performance: decision making

    Time frame: Compared at baseline

    Iowa Gambling Task

  4. Cognitive performance: emotional inhibition

    Time frame: Compared at baseline

    Emotional stroop

  5. Cognitive performance: sustained attention

    Time frame: Compared at baseline

    Rapid Visual Information Processing

  6. Cognitive performance: visual pattern recognition memory

    Time frame: Compared at baseline

    Pattern Recognition Memory

  7. Cognitive performance: cognitive flexibility

    Time frame: Compared at baseline

    Intra-Extra Dimensional Set Shifting

  8. Cognitive performance: social cognition

    Time frame: Compared at baseline

    Emotion Recognition Task

  9. Cognitive performance: affective perceptual bias

    Time frame: Compared at baseline

    Emotional Bias Task

  10. Microbiota composition and function

    Time frame: Compared at baseline

    Shotgun metagenomics of fecal samples

  11. Microbial and host metabolites

    Time frame: Compared at baseline

    Untargeted metabolomics analysis in fecal and urine samples

  12. Inflammation

    Time frame: Compared at baseline

    Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Schneider, PhD

CONTACT

[email protected]

(+353) 021 4901721

Revathy Munuswamy, PhD

CONTACT

[email protected]

(+353) 021 4901721

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults

Acronym: NMB

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2023
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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