HealthyNMBNCT05931536
The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota
An observational study of Healthy, run by University College Cork at 1 site in Ireland.
Trial summary
This study aims to investigate the relationship between diet and the microbiota-gut-brain axis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary fibre
- How many people
- 350 participants
- Where
- 1 siteIreland
- Study dates
- 14 Jul 2022to 14 Jul 2025
- Phase
- Observational
- 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
- Adult
Study population: Healthy adult volunteers consuming varying amounts of dietary fibre.
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.
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: The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults
This study aims to investigate the relationship between diet and the microbiota-gut-brain axis.
Read the detailed description
Dietary fibre is well-known for its many health benefits, including the support of gastrointestinal, metabolic, and mental health. Although studies investigating whole dietary patterns in relation to cognition have demonstrated that diet quality and a healthy dietary pattern are associated with better cognitive performance, the role of dietary fibre in this regard is understudied. It is now understood that the gut microbiota (trillions of microbes inhabiting the gastrointestinal tract) communicates bidirectionally with the brain to influence mental health and cognition. Importantly, dietary fibre has been shown to positively affect the microbiota composition. The aim of this study is to understand the effects of dietary fibre on the microbiota-gut-brain axis.
Using a cross-sectional design, habitual low fibre (<=18 grams/day, n=200), moderate fibre (18.1-24.9 grams/day, n=75), and high fibre (=>25 g/day, n=75) consumers will be compared at baseline on measures of cognition, responses to acute and chronic stress, and biological markers of the microbiota-gut-brain axis.
The investigators hypothesize that participants with higher dietary fibre intake at baseline will perform better in the cognitive tasks compared to individuals with low fibre intake, and that this difference can, in part, be mediated by the gut microbiota.
- Conditions
- Healthy
- Being tested
- Dietary fibre
- Keywords
- Microbiota-gut-brain axis, Diet, Cognition, Stress, Dietary fibre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fibreOther
Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Low fibre consumers | Healthy adults consuming less than or equal to 18 grams of fibre per day. Receives: Other: Dietary fibre | |
| Moderate fibre consumers | Healthy adults consuming between 18.1-24.9 grams of fibre per day. Receives: Other: Dietary fibre | |
| High fibre consumers | Healthy adults consuming greater than or equal to 25 grams of fibre per day. Receives: Other: Dietary fibre |
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: Compared at baseline
Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
Cortisol from saliva samples
Measured: Compared at baseline
Responses to acute stress: self-report
Self-report questionnaires
Measured: Compared at baseline
Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
Cortisol from saliva samples
Measured: Compared at baseline
Responses to acute stress: sympathetic-adrenal-medullary pathway activity
Galvanic skin response taken from the skin on the hand
Measured: Compared at baseline
Secondary outcomes (12)
Cognitive performance: working memory
Spatial Working Memory
Measured: Compared at baseline
Cognitive performance: episodic memory
Modified Rey Auditory Verbal Learning Test (ModRey)
Measured: Compared at baseline
Cognitive performance: decision making
Iowa Gambling Task
Measured: Compared at baseline
Cognitive performance: emotional inhibition
Emotional stroop
Measured: Compared at baseline
Cognitive performance: sustained attention
Rapid Visual Information Processing
Measured: Compared at baseline
Cognitive performance: visual pattern recognition memory
Pattern Recognition Memory
Measured: Compared at baseline
Cognitive performance: cognitive flexibility
Intra-Extra Dimensional Set Shifting
Measured: Compared at baseline
Cognitive performance: social cognition
Emotion Recognition Task
Measured: Compared at baseline
Cognitive performance: affective perceptual bias
Emotional Bias Task
Measured: Compared at baseline
Microbiota composition and function
Shotgun metagenomics of fecal samples
Measured: Compared at baseline
Microbial and host metabolites
Untargeted metabolomics analysis in fecal and urine samples
Measured: Compared at baseline
Inflammation
Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods
Measured: Compared at baseline
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 completion14 Jul 2025 (estimated)
- Study completion14 Jul 2025 (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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F Cryan, PhD, Principal investigator, APC Microbiome Irealnd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931536
- Sponsor's protocol ID
- APC150a
- Acronym
- NMB
- Status last verified
- Sep 2024
- First submitted
- 12 Jun 2023
- Last updated
- 24 Sep 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT05931536
- Acronym / sponsor ID
- NMB / APC150a
- Conditions
- Healthy
- Keywords
- Microbiota-gut-brain axis, Diet, Cognition, Stress, Dietary fibre
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 14 Jul 2025 (estimated)
- Study completion
- 14 Jul 2025 (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 relationship between diet and the microbiota-gut-brain axis.
Detailed description
Dietary fibre is well-known for its many health benefits, including the support of gastrointestinal, metabolic, and mental health. Although studies investigating whole dietary patterns in relation to cognition have demonstrated that diet quality and a healthy dietary pattern are associated with better cognitive performance, the role of dietary fibre in this regard is understudied. It is now understood that the gut microbiota (trillions of microbes inhabiting the gastrointestinal tract) communicates bidirectionally with the brain to influence mental health and cognition. Importantly, dietary fibre has been shown to positively affect the microbiota composition. The aim of this study is to understand the effects of dietary fibre on the microbiota-gut-brain axis.
Using a cross-sectional design, habitual low fibre (<=18 grams/day, n=200), moderate fibre (18.1-24.9 grams/day, n=75), and high fibre (=>25 g/day, n=75) consumers will be compared at baseline on measures of cognition, responses to acute and chronic stress, and biological markers of the microbiota-gut-brain axis.
The investigators hypothesize that participants with higher dietary fibre intake at baseline will perform better in the cognitive tasks compared to individuals with low fibre intake, and that this difference can, in part, be mediated by the gut microbiota.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fibre consumers | – | Other: Dietary fibreHealthy adults consuming less than or equal to 18 grams of fibre per day. |
| Moderate fibre consumers | – | Other: Dietary fibreHealthy adults consuming between 18.1-24.9 grams of fibre per day. |
| High fibre consumers | – | Other: Dietary fibreHealthy adults consuming greater than or equal to 25 grams of fibre per day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy adult volunteers consuming varying amounts of dietary fibre.
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 |
|---|---|---|
| Dietary fibreHabitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian. | Other | High fibre consumers, Low fibre consumers, Moderate fibre consumers |
Primary outcome
Trait stress/mood: self-report
Time frame: Compared at baseline
Self-report questionnaires
Trait stress/mood: hypothalamic-pituitary-adrenal axis activity
Time frame: Compared at baseline
Cortisol from saliva samples
Responses to acute stress: self-report
Time frame: Compared at baseline
Self-report questionnaires
Responses to acute stress: hypothalamic-pituitary-adrenal axis activity
Time frame: Compared at baseline
Cortisol from saliva samples
Responses to acute stress: sympathetic-adrenal-medullary pathway activity
Time frame: Compared at baseline
Galvanic skin response taken from the skin on the hand
12 secondary outcomes
Cognitive performance: working memory
Time frame: Compared at baseline
Cognitive performance: episodic memory
Time frame: Compared at baseline
Cognitive performance: decision making
Time frame: Compared at baseline
Cognitive performance: emotional inhibition
Time frame: Compared at baseline
Cognitive performance: sustained attention
Time frame: Compared at baseline
Cognitive performance: visual pattern recognition memory
Time frame: Compared at baseline
Cognitive performance: cognitive flexibility
Time frame: Compared at baseline
Cognitive performance: social cognition
Time frame: Compared at baseline
Cognitive performance: affective perceptual bias
Time frame: Compared at baseline
Microbiota composition and function
Time frame: Compared at baseline
Microbial and host metabolites
Time frame: Compared at baseline
Inflammation
Time frame: Compared at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
John F Cryan, PhD principal investigator
APC Microbiome Irealnd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 24 Sep 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: Compared at baseline). 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 24 Sep 2024.