[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639993":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":47,"studyPopulation":47,"armGroups":58,"interventions":73,"overallOfficials":47,"centralContacts":85,"locations":91,"responsibleParty":111,"collaborators":115,"id":123,"slug":47,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":47,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":47,"enrollmentInfo":132,"targetDuration":47,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":94,"whyStopped":47,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Ulster","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":47},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Gut microbiome profile","Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.","12 weeks",{"measure":14,"description":15,"timeFrame":12},"Serum total homocysteine","Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.",{"measure":17,"description":18,"timeFrame":12},"Folate","Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.",{"measure":20,"description":21,"timeFrame":12},"Vitamin B12","Serum total vitamin B12 measured by microbiological assay based on a colistin sulphate-resistant strain of Lactobacillus leichmannii; serum methylmalonic acid measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.",{"measure":23,"description":24,"timeFrame":12},"Vitamin B6","Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.",{"measure":26,"description":27,"timeFrame":12},"Riboflavin","Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac",[29,32,35,38,41,44],{"measure":30,"description":31,"timeFrame":12},"Inflammation","Markers of inflammation (analysed by enzyme-linked immunosorbent assay): C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), tumour necrosis factor (TNF-α).",{"measure":33,"description":34,"timeFrame":12},"Gut microbial metabolites","Faecal short-chain fatty acids (SCFAs)",{"measure":36,"description":37,"timeFrame":12},"Depressive symptoms","Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).",{"measure":39,"description":40,"timeFrame":12},"Anxiety symptoms","Measured using the Hospital Anxiety and Depression Scale (HADS).",{"measure":42,"description":43,"timeFrame":12},"Sleep quality","Measured using the Pittsburgh Sleep Quality Index (PSQI).",{"measure":45,"description":46,"timeFrame":12},"Physiological stress","Serum cortisol concentrations measured as a biomarker of physiological stress.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":47,"timePerspective":47,"maskingInfo":53},"RANDOMIZED","PARALLEL","Twice daily intervention for 12 weeks with one of the following treatments (in powder form):\n\n1. A functional drink containing chicory inulin (7.5 g per serving) combined with B-vitamins: folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg).\n2. A functional drink containing chicory inulin (7.5 g per serving) without additional B-vitamins.\n3. A control\u002Fplacebo drink with similar energy content (\\~182 kJ \u002F 43 kcal\u002F per serving) but without the additional nutrient provision.","PREVENTION",{"masking":54,"maskingDescription":47,"whoMasked":55},"DOUBLE",[56,57],"PARTICIPANT","INVESTIGATOR",[59,64,68],{"label":60,"type":61,"description":47,"interventionNames":62},"Inulin and B-vitamins","ACTIVE_COMPARATOR",[63],"Dietary Supplement: Inulin and B-vitamins",{"label":65,"type":61,"description":47,"interventionNames":66},"Inulin only",[67],"Dietary Supplement: Inulin",{"label":69,"type":70,"description":47,"interventionNames":71},"Placebo","PLACEBO_COMPARATOR",[72],"Dietary Supplement: Placebo",[74,78,82],{"type":75,"name":60,"description":76,"armGroupLabels":77,"otherNames":47},"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).",[60],{"type":75,"name":79,"description":80,"armGroupLabels":81,"otherNames":47},"Inulin","A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.",[65],{"type":75,"name":69,"description":83,"armGroupLabels":84,"otherNames":47},"A control\u002Fplacebo drink with similar energy content (\\~182 kJ \u002F 43 kcal\u002F per serving) but without the additional nutrient provision.",[69],[86],{"name":87,"role":88,"phone":89,"phoneExt":47,"email":90},"Shane Gordon, PhD","CONTACT","+44 28 7012 3035","S.Gordon2@ulster.ac.uk",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Human Intervention Studies Unit","RECRUITING","Coleraine","County Londonderry","BT521SA","United Kingdom","UK",{"type":101,"coordinates":102},"Point",[103,104],-6.66667,55.13333,{"lat":104,"lon":103},[107],{"name":108,"role":88,"phone":109,"phoneExt":47,"email":110},"Julie Sittlington, PhD","+44 28 7012 4101","jj.sittlington@ulster.ac.uk",{"type":112,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"PRINCIPAL_INVESTIGATOR","Leane Hoey","Dr",[116,119,121],{"name":117,"class":118},"ABC Nutritionals","UNKNOWN",{"name":120,"class":118},"Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands",{"name":122,"class":6},"University of Leeds","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":133,"type":134},84,"ESTIMATED","INTERVENTIONAL",[137],"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.",[140],"Biomarkers of B-vitamin Status and Gut Microbiome Composition",[142,143,144,145,79],"Functional food","Healthy ageing","B-vitamin status","Gut microbes","2026-05-11",{"date":148,"type":149},"2026-05-18","ACTUAL",{"date":148,"type":134},{"date":152,"type":134},"2026-12",{"name":5,"class":6},1]