[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572827":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":30,"locations":39,"responsibleParty":64,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":41,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Reading","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Carrageenan gummy","EXPERIMENTAL","Gummies have been produced using carrageenan as a gelling agent. Each dose will consist of two carrageenan containing gummies",[13],"Other: Carrageenan gummy sweet",{"label":15,"type":10,"description":16,"interventionNames":17},"Prebiotic arm","The prebiotic fibre, inulin, has been added into the carrageenan gummies. Each dose with consist of two gummy sweets.",[18],"Other: Carrageenan and inulin gummy sweet",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","An alternative gelling agent, agar has been added to the gummy sweets as a placebo.",[24],"Other: Placebo agar agar gummy",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Carrageenan gummy sweet","Gummy sweet containing carrageenan and agar as the gelling agents.",[9],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Carrageenan and inulin gummy sweet","Gummy sweet containing agar and carrageenan as gelling agents, with added inulin.",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Placebo agar agar gummy","Gummy sweet containing agar as gelling agents.",[20],[40],{"facility":5,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Reading","rg66ah","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-0.97113,51.45625,{"lat":50,"lon":49},[53,58,62,63],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"Hannah Thomas, MSc Human Nutrition","CONTACT","07528804446","hannah.thomas@pgr.reading.ac.uk",{"name":59,"role":55,"phone":60,"phoneExt":30,"email":61},"Anisha Wijeyesekera, PhD","+44 (0) 118 378 6648","a.wijeyesekera@reading.ac.uk",{"name":54,"role":55,"phone":30,"phoneExt":30,"email":30},{"name":59,"role":55,"phone":30,"phoneExt":30,"email":30},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Hannah Thomas","Miss",[69],{"name":70,"class":71},"Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium","UNKNOWN","100572827","investigating-the-impact-of-the-seaweed-derived-food-additive-carrageenan-on-the-human-gut-microbiome-100572827",false,"NCT06738329","Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome","Inclusion Criteria:\n\n* Healthy individuals\n\nExclusion Criteria:\n\n* Prescribed antibiotics in the last 3 months\n* Individuals with any gut disorders such as IBS or IBD\n* individuals with any food allergies or intolerances\n* Individuals who regularly consume pre or probiotics",true,"ALL","18 Years","55 Years",{"count":83,"type":84},99,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo. The primary purpose is to assess whether consumption of a carrageenan containing product for 4 weeks can alter the bacterial composition of the gut microbiome in healthy individuals and whether the addition of a prebiotic fibre, inulin, to the product has an enhanced beneficial impact of the gut composition. The main questions to answer are:\n\nDoes the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)? Participants will be asked to consume 2 gummy sweets for 4 week period and provide stool and urine samples on 3 occasions over a 9 week period.\n\nDoes the consumption of a confectionary item containing carrageenan and inulin improve gastrointestinal comfort measured using overall SHS-GI score when compared to baseline measurements recorded during run in period?",[90,91],"Gut Microbiome","Healthy Donors",[93,94,95,96],"Carrageenan","Gut microbiome","Gut health","food additive","2024-12-12",{"date":99,"type":100},"2024-12-17","ACTUAL",{"date":102,"type":100},"2024-10-01",{"date":104,"type":84},"2025-05-30",{"name":5,"class":6},1]