Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05931562

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

This study aims to investigate the effects of an 8-week dietary intervention on cognitive function, stress, and the gut microbiota in healthy adults with low fibre intake.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

The gut microbiota communicates bidirectionally with the brain via the microbiota-gut-brain axis to influence various aspects of human physiology, including host metabolism, immune function, behaviour, and cognition. Diet is a key modulator of the microbial composition, suggesting that the microbiota could explain the association between poor nutrition and decreasing health of the population. Dietary fibre is the main energy source for the gut microbiota and fundamentally impacts its composition and function. The microbiota-gut-brain axis has been proposed to mediate some of the effects of dietary fibre on the brain, for example through microbial metabolites (e.g., short-chain fatty acids (SCFA)), regulation of the immune system, and the microbial impact on gut hormones and neurotransmitters. Similarly, intake of fermented foods is positively associated with cognitive health and has been shown to alter the microbiota composition and function and exert an anti-inflammatory effect. However, no studies to date have examined the singular and combined effects of fermented and fibrous foods on the gut microbiota, cognition, and emotion. The present study aims to determine the role of diet on the microbiota-gut-brain axis and mental health.

Using a randomized-controlled, parallel, single-blinded design, participants consuming a habitually low fibre diet (N=200) will undergo an 8-week dietary intervention. Participants will receive one of four diets (n=50 in each group): high fibre (aim 24-35 grams/day), fermented foods (aim 4-6 portions/day), combined diet of fermented foods and high fibre (aim 25-30g/day of fibre and 3-4 servings/day of fermented foods) or control (dietary education according to national Irish guidelines). Cognitive, psychological, and biological measures will be compared at baseline and endpoint. During the intervention period, individuals will provide repeated faecal samples to assess temporal microbial changes.

Who can participate

Healthy volunteers accepted: Yes

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

fermented foods

Other

Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.

High Fibre

Other

Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.

Combined Diet

Other

Participants will recieve dietary education to increase their fibre intake to 25-30g/day and include 3 to 4 portions of fermented foods to their normal diet.

Control

Other

Participants will recieve dietary education based on the Irish healthy food pyramid.

Primary outcomes

  1. Trait stress/mood: self-report

    Time frame: Change from baseline at 8 weeks

    self-report questionnaires

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

    Time frame: Change from baseline at 8 weeks

    Cortisol from saliva samples

  3. Responses to acute stress: self-report

    Time frame: Change from baseline at 8 weeks

    Self-report questionnaires

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

    Time frame: Change from baseline at 8 weeks

    Galvanic skin response taken from the skin on the hand

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

    Time frame: Change from baseline at 8 weeks

    Cortisol from saliva samples

Secondary outcomes

  1. Cognitive performance: working memory

    Time frame: Change from baseline at 8 weeks

    Spatial Working Memory

  2. Cognitive performance: episodic memory

    Time frame: Change from baseline at 8 weeks

    Modified Rey Auditory Verbal Learning Test (ModRey)

  3. Cognitive performance: decision making

    Time frame: Change from baseline at 8 weeks

    Iowa Gambling Task

  4. Cognitive performance: emotional inhibition

    Time frame: Change from baseline at 8 weeks

    Emotional Stroop

  5. Cognitive performance: sustained attention

    Time frame: Change from baseline at 8 weeks

    Rapid Visual Information Processing

  6. Cognitive performance: visual pattern recognition memory

    Time frame: Change from baseline at 8 weeks

    Pattern Recognition Memory

  7. Cognitive performance: cognitive flexibility

    Time frame: Change from baseline at 8 weeks

    Intra-Extra Dimensional Set Shifting

  8. Cognitive performance: social cognition

    Time frame: Change from baseline at 8 weeks

    Emotion Recognition Task

  9. Cognitive performance: affective perceptual bias

    Time frame: Change from baseline at 8 weeks

    Emotional Bias Task

  10. Microbiota composition and function

    Time frame: Change from baseline at 8 weeks

    Shotgun metagenomics of fecal samples

  11. Microbial and host metabolomics

    Time frame: Change from baseline at 8 weeks

    Untargeted metabolomics analysis

  12. Inflammation

    Time frame: Change from baseline at 8 weeks

    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

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.

Acronym: NMB

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2023
Registry last updated
Jul 16, 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.

Published trials that share one or more normalized conditions with this study.