[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475658":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":43,"locations":53,"responsibleParty":79,"collaborators":82,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":42,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":56,"whyStopped":42,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Wageningen University","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Highest fiber dose","EXPERIMENTAL","This arm receives the highest dose of the intervention product, which is 15g dried vegetable per day divided into two portions of each 7.5g, which are consumed during the course of the day in the food of choice.",[13],"Dietary Supplement: Dried chicory root particles",{"label":15,"type":10,"description":16,"interventionNames":17},"Medium fiber dose","This arm receives the highest dose of the intervention product, which is 10g dried vegetable per day divided into two portions of each 5.0g, which are consumed during the course of the day in the food of choice.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Lowest fiber dose","This arm receives the highest dose of the intervention product, which is 5g dried vegetable per day divided into two portions of each 2.5g, which are consumed during the course of the day in the food of choice.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Control","PLACEBO_COMPARATOR","This arm is the control arm receiving as placebo rice puff particles each day, whose amount corresponds iso-calorically to the medium fiber dosage (\\~ 21 kcal\u002Fday).",[27],"Other: Placebo",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Dried chicory root particles","The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\\~3mm).",[9,19,15],[35],"brand name: WholeFiber™",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo","The control arm receives a placebo consisting of rice puff particles.",[23],[41],"Rice puff particles",null,[44,49],{"name":45,"role":46,"phone":47,"phoneExt":42,"email":48},"Edith JM Feskens, Prof. dr","CONTACT","+31317482567","edith.feskens@wur.nl",{"name":50,"role":46,"phone":51,"phoneExt":42,"email":52},"Sofie CC van der Zalm, MSc","+31618417162","vezel@wur.nl",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Wageningen University & Research, Division of Human Nutrition & Health","RECRUITING","Wageningen","Gelderland","6708 WE","Netherlands","NL",{"type":63,"coordinates":64},"Point",[65,66],5.66667,51.97,{"lat":66,"lon":65},[69,72,76],{"name":50,"role":46,"phone":70,"phoneExt":42,"email":71},"+31 6 18 41 71 62","sofie.vanderzalm@wur.nl",{"name":73,"role":46,"phone":74,"phoneExt":42,"email":75},"Marie-Luise Puhlmann, MSc","+31 6 38 03 11 29","marie-luise.puhlmann@wur.nl",{"name":77,"role":78,"phone":42,"phoneExt":42,"email":42},"Edith JM Feskens, Prof. dr.","PRINCIPAL_INVESTIGATOR",{"type":78,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Edith Feskens","Prof. dr. Edith Feskens",[83,86,88,90],{"name":84,"class":85},"WholeFiber BV","UNKNOWN",{"name":87,"class":85},"Wageningen University and Research, Laboratory of Microbiology",{"name":89,"class":85},"Wageningen University and Research, Division of Human Nutrition & Health",{"name":91,"class":6},"Wageningen University and Research","100475658","impact-of-a-dried-vegetable-on-bowel-function-and-gut-microbiota-100475658",false,"NCT05473793","Impact of a Dried Vegetable on Bowel Function and Gut Microbiota","The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues","HappYFiber","Inclusion Criteria:\n\n* 20 - 80 years old\n* Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6\n* Four or less bowel movements per week (low stool frequency) and\u002For\n* Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)\n* Able to read and understand Dutch or English\n\nExclusion Criteria:\n\n* Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and subjects with medically diagnosed constipation (i.e., constipation related to anatomic, medication-related, or readily identifiable physiological causes.)\n* Less than one bowel movement per week during the screening\n* Medical drug use:\n\n  * Antibiotic use within 3 months of the study screenings day\n  * Chronic use of antacids and PPI's\n  * Use of laxatives during the screening\n  * Chronic use of blood glucose lowering medication\n* Consumption of supplements containing fibres (other than laxatives), pro-\u002F post-\u002F synbiotics 1 month before the screening\n* Not willing to provide faecal samples\n* Unable to comply with proper study procedures\n* For women of childbearing age: current or planned pregnancy, lactation\n* Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)\n* Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening\n* Reported slimming or medically prescribed diet\n* Reported macrobiotic lifestyle\n* Personnel the Division of Human Nutrition \\& Health or the Laboratory of Microbiology\n* Current participation in other medical scientific research\n* Not having a general practitioner\n* Not willing to be informed about accidental discoveries in relation to the subjects health",true,"ALL","20 Years","80 Years",{"count":105,"type":106},160,"ESTIMATED","INTERVENTIONAL",[109],"NA","A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.",[112],"Bowel Function Dissatisfaction",[114,115,116,117,118,119],"bowel function issues","constipation","gut microbiota","fiber intake","vegetable","intrinsic fiber","2025-02-22",{"date":122,"type":123},"2025-02-25","ACTUAL",{"date":125,"type":123},"2022-08-22",{"date":127,"type":106},"2025-06",{"name":5,"class":6},1]