HealthyNMBNCT05931562
The Impact of Diet on the Gut-Microbiota-Brain Axis
A study testing Fermented Foods, High Fibre and Combined Diet in people with Healthy, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented Foods, High Fibre and Combined Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 14 Jul 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Revathy Munuswamy contact
Ireland1 site, 1 recruiting
- Recruiting
APC Microbiome Ireland
Cork, T12YT20
Revathy Munuswamy, PhD, (+353) 021 4901721, RMunuswamy@ucc.ie
John F Cryan, PhD
About this study
Official title: An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Fermented Foods, High Fibre, Combined Diet, Control
- Keywords
- Microbiota-gut-brain axis, Diet, Cognition, Stress, Dietary Fibre, Fermented foods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented FoodsOther
Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
High FibreOther
Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
Combined DietOther
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.
ControlOther
Participants will recieve dietary education based on the Irish healthy food pyramid.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE). Receives: Other: Control |
| Fermented Foods | Experimental | Fermented foods diet (4-6 portions/day) Receives: Other: Fermented Foods |
| High Fibre | Experimental | High fibre diet (24-35 grams/day) Receives: Other: High Fibre |
| Combined Diet | Experimental | Combined diet high in fibre and fermented foods (fibre aim 24-35 grams/day, fermented foods aim 4-6 portions/day) Receives: Other: Combined Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trait stress/mood: self-report
self-report questionnaires
Measured: Change from baseline at 8 weeks
Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
Cortisol from saliva samples
Measured: Change from baseline at 8 weeks
Responses to acute stress: self-report
Self-report questionnaires
Measured: Change from baseline at 8 weeks
Responses to acute stress: sympathetic-adrenal-medullary pathway activity
Galvanic skin response taken from the skin on the hand
Measured: Change from baseline at 8 weeks
Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
Cortisol from saliva samples
Measured: Change from baseline at 8 weeks
Secondary outcomes (12)
Cognitive performance: working memory
Spatial Working Memory
Measured: Change from baseline at 8 weeks
Cognitive performance: episodic memory
Modified Rey Auditory Verbal Learning Test (ModRey)
Measured: Change from baseline at 8 weeks
Cognitive performance: decision making
Iowa Gambling Task
Measured: Change from baseline at 8 weeks
Cognitive performance: emotional inhibition
Emotional Stroop
Measured: Change from baseline at 8 weeks
Cognitive performance: sustained attention
Rapid Visual Information Processing
Measured: Change from baseline at 8 weeks
Cognitive performance: visual pattern recognition memory
Pattern Recognition Memory
Measured: Change from baseline at 8 weeks
Cognitive performance: cognitive flexibility
Intra-Extra Dimensional Set Shifting
Measured: Change from baseline at 8 weeks
Cognitive performance: social cognition
Emotion Recognition Task
Measured: Change from baseline at 8 weeks
Cognitive performance: affective perceptual bias
Emotional Bias Task
Measured: Change from baseline at 8 weeks
Microbiota composition and function
Shotgun metagenomics of fecal samples
Measured: Change from baseline at 8 weeks
Microbial and host metabolomics
Untargeted metabolomics analysis
Measured: Change from baseline at 8 weeks
Inflammation
Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start14 Jul 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized-controlled, parallel, single-blinded design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Cryan, PhD, Principal investigator, APC Microbiome Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931562
- Sponsor's protocol ID
- APC 150b
- Acronym
- NMB
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05931562
- Acronym / sponsor ID
- NMB / APC 150b
- Conditions
- Healthy
- Keywords
- Microbiota-gut-brain axis, Diet, Cognition, Stress, Dietary Fibre, Fermented foods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized-controlled, parallel, single-blinded design
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlParticipants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE). |
| Fermented Foods | Experimental | Other: Fermented FoodsFermented foods diet (4-6 portions/day) |
| High Fibre | Experimental | Other: High FibreHigh fibre diet (24-35 grams/day) |
| Combined Diet | Experimental | Other: Combined DietCombined diet high in fibre and fermented foods (fibre aim 24-35 grams/day, fermented foods aim 4-6 portions/day) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented FoodsParticipants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet. | Other | Fermented Foods |
| High FibreParticipants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet. | Other | High Fibre |
| Combined DietParticipants 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. | Other | Combined Diet |
| ControlParticipants will recieve dietary education based on the Irish healthy food pyramid. | Other | Control |
Primary outcome
Trait stress/mood: self-report
Time frame: Change from baseline at 8 weeks
self-report questionnaires
Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
Time frame: Change from baseline at 8 weeks
Cortisol from saliva samples
Responses to acute stress: self-report
Time frame: Change from baseline at 8 weeks
Self-report questionnaires
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
Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
Time frame: Change from baseline at 8 weeks
Cortisol from saliva samples
12 secondary outcomes
Cognitive performance: working memory
Time frame: Change from baseline at 8 weeks
Cognitive performance: episodic memory
Time frame: Change from baseline at 8 weeks
Cognitive performance: decision making
Time frame: Change from baseline at 8 weeks
Cognitive performance: emotional inhibition
Time frame: Change from baseline at 8 weeks
Cognitive performance: sustained attention
Time frame: Change from baseline at 8 weeks
Cognitive performance: visual pattern recognition memory
Time frame: Change from baseline at 8 weeks
Cognitive performance: cognitive flexibility
Time frame: Change from baseline at 8 weeks
Cognitive performance: social cognition
Time frame: Change from baseline at 8 weeks
Cognitive performance: affective perceptual bias
Time frame: Change from baseline at 8 weeks
Microbiota composition and function
Time frame: Change from baseline at 8 weeks
Microbial and host metabolomics
Time frame: Change from baseline at 8 weeks
Inflammation
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Revathy Munuswamy contact
John Cryan, PhD principal investigator
APC Microbiome Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Foods, High Fibre and Combined Diet in people with Healthy, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Schneider, PhD ((+353) 021 4901721, eschneider@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trait stress/mood: self-report (time frame: Change from baseline at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.