[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532439":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":37,"armGroups":46,"interventions":61,"overallOfficials":37,"centralContacts":66,"locations":76,"responsibleParty":116,"collaborators":120,"id":138,"slug":37,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":37,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":37,"enrollmentInfo":146,"targetDuration":37,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":79,"whyStopped":37,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Wageningen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Dietary fiber intake","Change in dietary fiber intake is assessed via two 24hr dietary recalls.","3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).",[14,17,20,23,26,29,33],{"measure":15,"description":16,"timeFrame":12},"Stool pattern","Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart.",{"measure":18,"description":19,"timeFrame":12},"Gastrointestinal symptoms","Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome.",{"measure":21,"description":22,"timeFrame":12},"Health-related quality of life","Change in quality of life measured with the European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30 \\& CR29). Global and functional health-related quality of life will be calculated, for which higher scores indicate better quality of life. Also symptom scales will be calculated, for which higher scores indicate higher presence or severity of a symptom.",{"measure":24,"description":25,"timeFrame":12},"Fecal gut microbiota composition","Measured using 16S rRNA amplicon sequencing in fecal samples.",{"measure":27,"description":28,"timeFrame":12},"Fecal microbial metabolite levels","Change in SCFA and indole concentrations determined by GC-MS\u002FMS and LC-MS\u002FMS in fecal samples.",{"measure":30,"description":31,"timeFrame":32},"Plasma microbial metabolite levels","Change in SCFA and indole concentrations will be determined by GC-MS\u002FMS and LC-MS\u002FMS in blood samples.","2 time points: T0 (at baseline) and T2 (at the end of intervention period, on average after 4 weeks).",{"measure":34,"description":35,"timeFrame":36},"Length of hospital stay","Time between surgery and hospital discharge in number of days based on data from medical records.","From date of surgery until date of hospital discharge, assessed up to 90 days after surgery.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm. Multicenter study conducted in collaboration with three participating hospitals, including Hospital Gelderse Vallei (Ede), Meander Medical Center (Amersfoort), and Rijnstate Hospital (Arnhem)","PREVENTION",{"masking":44,"maskingDescription":37,"whoMasked":37},"NONE","Rationale: Postoperative complications, affecting up to 50% of the patients with colorectal cancer (CRC) undergoing surgery, are associated with impaired quality of life and higher mortality rates. The investigators have previously shown an association between a higher preoperative dietary fiber intake and a lower risk of postoperative complications. Before large interventions aiming to evaluate potential causal relationships between dietary fiber and postoperative complications can be implemented, feasibility of increasing dietary fiber intake before CRC surgery needs to be explored.\n\nObjective: To investigate the feasibility of increasing preoperative dietary fiber intake in CRC patients undergoing surgery via 1) personalized dietary advice (Vezel-UP tool), or 2) vegetable product containing natural fibers compared to 3) habitual diet (control group). Secondary objectives will be considered to generate preliminary (biological) data to support the design of a future large-scale intervention studies.\n\nStudy design: A randomized controlled trial with three groups: 1) Vezel-UP group, 2) vegetable product group, and 3) control group. The intervention period equals the time between diagnosis and surgery, which is on average \\~4 weeks but will vary between individual patients depending on their characteristics (e.g., physical condition and tumor location) and waiting list.\n\nStudy population: 54 CRC patients who will undergo elective tumor resection.\n\nMain study parameters\u002Fendpoints: The primary outcome is the change in dietary fiber intake, which is assessed via two 24hr dietary recalls at baseline and during and after the intervention. Secondary parameters are stool pattern, gastrointestinal symptoms, quality of life, fecal microbiota composition, fecal and plasma microbial metabolites levels (i.e., SCFA and indoles), and length of hospital stay.",[47,53,57],{"label":48,"type":49,"description":50,"interventionNames":51},"Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intake","EXPERIMENTAL","Subjects will receive personalized dietary advice (PDA) based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a previously developed algorithm, the PDA provides fiber-rich alternatives for currently used low-fiber products, close to subjects' current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal.",[52],"Other: Dietary intervention",{"label":54,"type":49,"description":55,"interventionNames":56},"Vegetable product (dried chicory root) to increase dietary fiber intake","Subjects will consume 2 sachets with each 7.5 g of dried cubes of chicory root, which equals a total of 12.3 g of dietary fiber per day. Subjects can choose when and how they consume the vegetable product, for example sprinkle it over their meal, or include in existing recipes.",[52],{"label":58,"type":59,"description":60,"interventionNames":37},"Control","NO_INTERVENTION","Subjects will follow their habitual diet during the preoperative period.",[62],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":37},"Dietary intervention","Increase dietary fiber intake",[48,54],[67,72],{"name":68,"role":69,"phone":70,"phoneExt":37,"email":71},"Niels Klaassen, MSc","CONTACT","+ 31 (0) 317 487 265","niels.klaassen@wur.nl",{"name":73,"role":69,"phone":74,"phoneExt":37,"email":75},"Dieuwertje EG Kok, PhD","+ 31 (0) 317 485 901","dieuwertje.kok@wur.nl",[77,93,104],{"facility":78,"status":79,"city":80,"state":81,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Rijnstate","RECRUITING","Arnhem","Gelderland","Netherlands","NL",{"type":85,"coordinates":86},"Point",[87,88],5.91111,51.98,{"lat":88,"lon":87},[91],{"name":92,"role":69,"phone":37,"phoneExt":37,"email":37},"N. Hugen, MD, PhD",{"facility":94,"status":79,"city":95,"state":81,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Ziekenhuis Gelderse Vallei","Ede",{"type":85,"coordinates":97},[98,99],5.65833,52.03333,{"lat":99,"lon":98},[102],{"name":103,"role":69,"phone":37,"phoneExt":37,"email":37},"P. M. Kruyt, MD",{"facility":105,"status":79,"city":106,"state":107,"zip":37,"country":82,"countryCode":83,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Meander Medisch Centrum","Amersfoort","Utrecht",{"type":85,"coordinates":109},[110,111],5.3875,52.155,{"lat":111,"lon":110},[114],{"name":115,"role":69,"phone":37,"phoneExt":37,"email":37},"G. Abis, MD, PhD",{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Dieuwertje Kok","Associate Professor, PhD",[121,123,126,128,130,132,134,136],{"name":122,"class":6},"Gelderse Vallei Hospital",{"name":124,"class":125},"VLAG Graduate School","UNKNOWN",{"name":127,"class":125},"Alliance TU\u002Fe, WUR, UU, UMC Utrecht (EWUU)",{"name":129,"class":125},"Nutrition & Healthcare Alliance",{"name":131,"class":125},"WholeFiber BV",{"name":133,"class":125},"Wageningen Food and Biobased Research (WFBR)",{"name":135,"class":6},"Meander Medical Center",{"name":137,"class":6},"Rijnstate Hospital","100532439",false,"NCT06212817","Dietary Fiber Before Colorectal Cancer Surgery","FiberUP in Clinical Practice: Increasing Preoperative Dietary Fiber Intake in Colorectal Cancer Patients.","Inclusion Criteria:\n\n* Age ≥18 years;\n* Being diagnosed with CRC and planned to undergo elective CRC resection;\n\nExclusion Criteria:\n\n* Previously have had a large abdominal resection, excluding appendectomy and cholecystectomy;\n* Diagnosed with Crohn's disease, Ulcerative Colitis, Celiac Disease;\n* Currently having a stoma;\n* Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.);\n* Currently following a strict diet and unwilling or unable to change (e.g., gluten free or ketogenic diet);\n* Currently using fiber supplements, prebiotics and\u002For probiotics and unwilling to stop using these for the duration of the intervention;\n* Having a habitual dietary fiber intake \\>30 g\u002Fday for women and \\>40 g\u002Fday for men, measured with a food frequency questionnaire;\n* Dementia or other cognitive disabilities that makes it impossible to fill out questionnaires correctly;\n* Illiteracy (inability to read and understand Dutch).","ALL","18 Years",{"count":147,"type":148},54,"ESTIMATED","INTERVENTIONAL",[151],"NA","The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).",[154],"Colorectal Cancer",[156,157,158,159,160,161],"Dietary fiber","Postoperative complications","Surgery","Gut microbiota","Colorectal cancer","Prehabilitation","2025-11-14",{"date":164,"type":165},"2025-11-18","ACTUAL",{"date":167,"type":165},"2024-04-29",{"date":169,"type":148},"2026-05",{"name":5,"class":6},3]