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

Last updated: July 15, 2024
Sponsor: University College Cork
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Fermented Foods

Control

Combined Diet

Clinical Study ID

NCT05931562
APC 150b
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 boweldisease, 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 anycondition which contraindicates, in the investigators judgement, entry to the study,

  • Have a condition or taking a medication that the investigator believes wouldinterfere with the objectives of the study, pose a safety risk, or confound theinterpretation of the study results; all psychoactive medications [to includeanxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally actingcorticosteroids, 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 aftercessation 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 poorattendees or unlikely for any reason to be able to comply with the trial.

  • Subjects receiving treatment involving experimental drugs. If the subject has beenin a recent experimental trial, these must have been completed not less than 30 daysprior 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.

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Fermented Foods
Phase:
Study Start date:
July 14, 2022
Estimated Completion Date:
July 31, 2026

Study Description

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.

Connect with a study center

  • APC Microbiome Ireland

    Cork, T12YT20
    Ireland

    Active - Recruiting

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