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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05931562
Acronym
NMB
Enrollment
200
Registered
2023-07-05
Start date
2022-07-14
Completion date
2026-07-31
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microbiota-gut-brain axis, Diet, Cognition, Stress, Dietary Fibre, Fermented foods

Brief 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.

Detailed 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.

Interventions

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

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

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.

OTHERControl

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

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Randomized-controlled, parallel, single-blinded design

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Trait stress/mood: self-reportChange from baseline at 8 weeksself-report questionnaires
Trait stress/mood: hypothalamic-pituitary-adrenal axis activityChange from baseline at 8 weeksCortisol from saliva samples
Responses to acute stress: self-reportChange from baseline at 8 weeksSelf-report questionnaires
Responses to acute stress: sympathetic-adrenal-medullary pathway activityChange from baseline at 8 weeksGalvanic skin response taken from the skin on the hand
Responses to acute stress: hypothalamic-pituitary-adrenal axis activityChange from baseline at 8 weeksCortisol from saliva samples

Secondary

MeasureTime frameDescription
Cognitive performance: visual pattern recognition memoryChange from baseline at 8 weeksPattern Recognition Memory
Cognitive performance: cognitive flexibilityChange from baseline at 8 weeksIntra-Extra Dimensional Set Shifting
Cognitive performance: social cognitionChange from baseline at 8 weeksEmotion Recognition Task
Cognitive performance: working memoryChange from baseline at 8 weeksSpatial Working Memory
Microbiota composition and functionChange from baseline at 8 weeksShotgun metagenomics of fecal samples
Microbial and host metabolomicsChange from baseline at 8 weeksUntargeted metabolomics analysis
InflammationChange from baseline at 8 weeksInflammatory markers in lipopolysaccharide stimulated and unstimulated bloods
Cognitive performance: affective perceptual biasChange from baseline at 8 weeksEmotional Bias Task
Cognitive performance: episodic memoryChange from baseline at 8 weeksModified Rey Auditory Verbal Learning Test (ModRey)
Cognitive performance: decision makingChange from baseline at 8 weeksIowa Gambling Task
Cognitive performance: emotional inhibitionChange from baseline at 8 weeksEmotional Stroop
Cognitive performance: sustained attentionChange from baseline at 8 weeksRapid Visual Information Processing

Countries

Ireland

Contacts

Primary ContactElizabeth Schneider, PhD
eschneider@ucc.ie(+353) 021 4901721
Backup ContactRevathy Munuswamy
RMunuswamy@ucc.ie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026