[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510832":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":79,"collaborators":34,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":34,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":60,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University College Cork","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Participants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE).",[13],"Other: Control",{"label":15,"type":16,"description":17,"interventionNames":18},"Fermented Foods","EXPERIMENTAL","Fermented foods diet (4-6 portions\u002Fday)",[19],"Other: Fermented Foods",{"label":21,"type":16,"description":22,"interventionNames":23},"High Fibre","High fibre diet (24-35 grams\u002Fday)",[24],"Other: High Fibre",{"label":26,"type":16,"description":27,"interventionNames":28},"Combined Diet","Combined diet high in fibre and fermented foods (fibre aim 24-35 grams\u002Fday, fermented foods aim 4-6 portions\u002Fday)",[29],"Other: Combined Diet",[31,35,38,41],{"type":6,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.",[15],null,{"type":6,"name":21,"description":36,"armGroupLabels":37,"otherNames":34},"Participants will recieve dietary education to increase their fibre intake to 24-35g\u002Fday in their normal diet.",[21],{"type":6,"name":26,"description":39,"armGroupLabels":40,"otherNames":34},"Participants will recieve dietary education to increase their fibre intake to 25-30g\u002Fday and include 3 to 4 portions of fermented foods to their normal diet.",[26],{"type":6,"name":9,"description":42,"armGroupLabels":43,"otherNames":34},"Participants will recieve dietary education based on the Irish healthy food pyramid.",[9],[45],{"name":46,"affiliation":47,"role":48},"John Cryan, PhD","APC Microbiome Ireland","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":34,"email":54},"Elizabeth Schneider, PhD","CONTACT","(+353) 021 4901721","eschneider@ucc.ie",{"name":56,"role":52,"phone":34,"phoneExt":34,"email":57},"Revathy Munuswamy","RMunuswamy@ucc.ie",[59],{"facility":47,"status":60,"city":61,"state":34,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Cork","T12YT20","Ireland","IE",{"type":66,"coordinates":67},"Point",[68,69],-8.47061,51.89797,{"lat":69,"lon":68},[72,74,76],{"name":73,"role":52,"phone":53,"phoneExt":34,"email":57},"Revathy Munuswamy, PhD",{"name":75,"role":48,"phone":34,"phoneExt":34,"email":34},"John F Cryan, PhD",{"name":77,"role":78,"phone":34,"phoneExt":34,"email":34},"Gerard Clarke, PhD","SUB_INVESTIGATOR",{"type":80,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100510832","the-impact-of-diet-on-the-gut-microbiota-brain-axis-100510832",false,"NCT05931562","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.","NMB","Inclusion Criteria:\n\n* Be able to give written informed consent.\n* Be between 18 and 50 years of age.\n* Have a body mass index (BMI) between 18.5-29.9 Kg\u002Fm2.\n* Be in generally good health as determined by the investigator.\n\nExclusion Criteria:\n\n* Are less than 18 and greater than 50 years of age.\n* Have a BMI below 18.5 or above 29.9 Kg\u002Fm2.\n* 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,\n* 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.\n* Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).\n* Females who are peri-menopausal, menopausal or post-menopausal.\n* Females who are pregnant or planning a pregnancy, or lactating.\n* Participants who are not fluent in English.\n* Are colour blind.\n* Have dyslexia or dyscalculia.\n* Are a current habitual daily smoker.\n* 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.\n* 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.\n* Have a malignant disease or any concomitant end-stage organ disease.\n* Have completed a study in our laboratory in the past 4 years.",true,"ALL","18 Years","50 Years",{"count":94,"type":95},200,"ESTIMATED","INTERVENTIONAL",[98],"NA","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.",[101],"Healthy",[103,104,105,106,107,108],"Microbiota-gut-brain axis","Diet","Cognition","Stress","Dietary Fibre","Fermented foods","2024-07-15",{"date":111,"type":112},"2024-07-16","ACTUAL",{"date":114,"type":112},"2022-07-14",{"date":116,"type":95},"2026-07",{"name":5,"class":6},1]