Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-07-14
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
SINGLE
Study Groups
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Control
Participants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE).
Control
Participants will recieve dietary education based on the Irish healthy food pyramid.
Fermented Foods
Fermented foods diet (4-6 portions/day)
Fermented Foods
Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
High Fibre
High fibre diet (24-35 grams/day)
High Fibre
Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
Combined Diet
Combined diet high in fibre and fermented foods (fibre aim 24-35 grams/day, fermented foods aim 4-6 portions/day)
Combined 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.
Interventions
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Fermented Foods
Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
High Fibre
Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
Combined 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.
Control
Participants will recieve dietary education based on the Irish healthy food pyramid.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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University College Cork
OTHER
Responsible Party
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Principal Investigators
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John Cryan, PhD
Role: PRINCIPAL_INVESTIGATOR
APC Microbiome Ireland
Locations
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APC Microbiome Ireland
Cork, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APC 150b
Identifier Type: -
Identifier Source: org_study_id
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