[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639993":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":65,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Ulster","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Inulin and B-vitamins","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: Inulin and B-vitamins",{"label":15,"type":10,"description":11,"interventionNames":16},"Inulin only",[17],"Dietary Supplement: Inulin",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR",[22],"Dietary Supplement: Placebo",[24,28,32],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"DIETARY_SUPPLEMENT","A functional beverage containing inulin (7.5 g per serving) combined with B-vitamins folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg).",[9],{"type":25,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Inulin","A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.",[15],{"type":25,"name":19,"description":33,"armGroupLabels":34,"otherNames":11},"A control\u002Fplacebo drink with similar energy content (\\~182 kJ \u002F 43 kcal\u002F per serving) but without the additional nutrient provision.",[19],[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Shane Gordon, PhD","CONTACT","+44 28 7012 3035","S.Gordon2@ulster.ac.uk",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Human Intervention Studies Unit","RECRUITING","Coleraine","County Londonderry","BT521SA","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-6.66667,55.13333,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":11,"email":60},"Julie Sittlington, PhD","+44 28 7012 4101","jj.sittlington@ulster.ac.uk",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Leane Hoey","Dr",[66,69,71],{"name":67,"class":68},"ABC Nutritionals","UNKNOWN",{"name":70,"class":68},"Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands",{"name":72,"class":6},"University of Leeds","100639993","effect-of-a-food-intervention-with-a-prebiotic-alone-or-combined-with-b-vitamins-on-gut-microbiota-diversity-inflammation-and-mental-health-outcomes-in-older-adults-gutfood-100639993",false,"NCT07592975","Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults (GutFood)","'GutFood' - Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults","Inclusion Criteria:\n\n* Community-dwelling\n* Non or low consumers (≤ 4 portions\u002Fweek) of foods\u002Fbeverages fortified with B-vitamins\n* Individuals with the capacity to provide informed consent\n\nExclusion Criteria:\n\n* B12 injection users\n* Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics)\n* Taking medications that interfere with B-vitamin metabolism\n* Currently taking antibiotics\n* GI disease (Crohn's, coeliac)\n* Serious chronic disease (e.g. cancer, liver disease)",true,"ALL","50 Years",{"count":84,"type":85},84,"ESTIMATED","INTERVENTIONAL",[88],"NA","Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes. Nutritional inadequacies, including low dietary fibre intake and suboptimal B-vitamin status, are common in older adults and may contribute to these age-related health issues. Research suggests that increasing dietary fibre intake, particularly through prebiotics such as inulin, may help to improve gut health. In addition, B-vitamins have been linked to both gut and mental health, although their combined effects with prebiotics are not well understood.\n\nWith the assistance of a food company, the investigators have developed a functional drink enriched with chicory inulin, alone or in combination with B-vitamins. Therefore, the investigators plan to conduct a 12-week randomised, double-blind, placebo-controlled trial to test the effect of this functional drink on gut health outcomes, nutritional status, inflammation, and mental health in adults aged 50 years and older.",[91],"Biomarkers of B-vitamin Status and Gut Microbiome Composition",[93,94,95,96,29],"Functional food","Healthy ageing","B-vitamin status","Gut microbes","2026-05-11",{"date":99,"type":100},"2026-05-18","ACTUAL",{"date":99,"type":85},{"date":103,"type":85},"2026-12",{"name":5,"class":6},1]