- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931562
The Impact of Diet on the Gut-Microbiota-Brain Axis (NMB)
An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Schneider, PhD
- Phone Number: (+353) 021 4901721
- Email: eschneider@ucc.ie
Study Contact Backup
- Name: Revathy Munuswamy
- Email: RMunuswamy@ucc.ie
Study Locations
-
-
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Cork, Ireland, T12YT20
- Recruiting
- APC Microbiome Ireland
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Principal Investigator:
- John F Cryan, PhD
-
Contact:
- Revathy Munuswamy, PhD
- Phone Number: (+353) 021 4901721
- Email: RMunuswamy@ucc.ie
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Sub-Investigator:
- Gerard Clarke, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE).
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Participants will recieve dietary education based on the Irish healthy food pyramid.
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Experimental: Fermented Foods
Fermented foods diet (4-6 portions/day)
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Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
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Experimental: High Fibre
High fibre diet (24-35 grams/day)
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Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
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Experimental: Combined Diet
Combined diet high in fibre and fermented foods (fibre aim 24-35 grams/day, fermented foods aim 4-6 portions/day)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trait stress/mood: self-report
Time Frame: Change from baseline at 8 weeks
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self-report questionnaires
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Change from baseline at 8 weeks
|
Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
Time Frame: Change from baseline at 8 weeks
|
Cortisol from saliva samples
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Change from baseline at 8 weeks
|
Responses to acute stress: self-report
Time Frame: Change from baseline at 8 weeks
|
Self-report questionnaires
|
Change from baseline at 8 weeks
|
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
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Change from baseline at 8 weeks
|
Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
Time Frame: Change from baseline at 8 weeks
|
Cortisol from saliva samples
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Change from baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance: working memory
Time Frame: Change from baseline at 8 weeks
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Spatial Working Memory
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Change from baseline at 8 weeks
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Cognitive performance: episodic memory
Time Frame: Change from baseline at 8 weeks
|
Modified Rey Auditory Verbal Learning Test (ModRey)
|
Change from baseline at 8 weeks
|
Cognitive performance: decision making
Time Frame: Change from baseline at 8 weeks
|
Iowa Gambling Task
|
Change from baseline at 8 weeks
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Cognitive performance: emotional inhibition
Time Frame: Change from baseline at 8 weeks
|
Emotional Stroop
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Change from baseline at 8 weeks
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Cognitive performance: sustained attention
Time Frame: Change from baseline at 8 weeks
|
Rapid Visual Information Processing
|
Change from baseline at 8 weeks
|
Cognitive performance: visual pattern recognition memory
Time Frame: Change from baseline at 8 weeks
|
Pattern Recognition Memory
|
Change from baseline at 8 weeks
|
Cognitive performance: cognitive flexibility
Time Frame: Change from baseline at 8 weeks
|
Intra-Extra Dimensional Set Shifting
|
Change from baseline at 8 weeks
|
Cognitive performance: social cognition
Time Frame: Change from baseline at 8 weeks
|
Emotion Recognition Task
|
Change from baseline at 8 weeks
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Cognitive performance: affective perceptual bias
Time Frame: Change from baseline at 8 weeks
|
Emotional Bias Task
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Change from baseline at 8 weeks
|
Microbiota composition and function
Time Frame: Change from baseline at 8 weeks
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Shotgun metagenomics of fecal samples
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Change from baseline at 8 weeks
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Microbial and host metabolomics
Time Frame: Change from baseline at 8 weeks
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Untargeted metabolomics analysis
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Change from baseline at 8 weeks
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Inflammation
Time Frame: Change from baseline at 8 weeks
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Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods
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Change from baseline at 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Cryan, PhD, APC Microbiome Ireland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APC 150b
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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