[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659881":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":47,"studyPopulation":34,"armGroups":48,"interventions":66,"overallOfficials":77,"centralContacts":81,"locations":86,"responsibleParty":101,"collaborators":34,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":34,"enrollmentInfo":114,"targetDuration":34,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":127,"whyStopped":34,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universidad Católica San Antonio de Murcia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change in joint pain intensity measured by visual analog scale","Joint pain intensity will be measured using a 10-cm visual analog scale. The participant marks pain intensity from 0, no pain, to 10, worst imaginable pain. The primary endpoint is change from baseline in VAS pain score.","Baseline to 16 weeks",[14,18,21,24,28,31],{"measure":15,"description":16,"timeFrame":17},"Change in knee-related quality of life measured by KOOS","KOOS evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0 to 100 scale, where 0 represents extreme knee problems and 100 represents no knee problems.","Baseline to 16 weeks; also assessed at 30, 60, and 90 days",{"measure":19,"description":20,"timeFrame":17},"Change in pain, stiffness, and physical function measured by WOMAC","The Western Ontario and McMaster Universities Osteoarthritis Index assesses pain, stiffness, and physical function in participants with knee osteoarthritis.",{"measure":22,"description":23,"timeFrame":12},"Change in concomitant analgesic medication use","Daily prescribed and rescue analgesic medication use will be recorded to evaluate changes in the need for analgesic medication.",{"measure":25,"description":26,"timeFrame":27},"Change in knee muscle function by dynamometry","Isometric and isokinetic knee muscle function will be measured with a Biodex System 3 dynamometer in the painful knee, including extension and flexion assessments.","Baseline, 8 weeks, and 16 weeks",{"measure":29,"description":30,"timeFrame":27},"Change in biomarkers of cartilage degradation","Cartilage degradation biomarkers, including serum COMP and urinary CTX-II, will be assessed to monitor cartilage catabolism and treatment response.",{"measure":32,"description":33,"timeFrame":12},"Product safety assessed by blood safety analysis and adverse events","Safety will be evaluated using biochemical and hematological blood analysis of renal and hepatic function and by collection of adverse events during the study.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Randomized, controlled, double-blind clinical trial with three parallel arms: Nuvicol II, Nuvicol SII, and placebo. Participants consume the assigned product once daily for 4 months.","TREATMENT",{"masking":41,"maskingDescription":42,"whoMasked":43},"TRIPLE","Double-blind trial. Participants, investigators, and outcomes assessors\u002Fdata analysts are masked. Products are identical in appearance and coded for the clinical trial.",[44,45,46],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Participants diagnosed with osteoarthritis and persistent knee pain will be randomized in equal proportion to one of three parallel arms: Nuvicol II, Nuvicol SII, or placebo. The study product will be consumed once daily for 4 months. Assessments include baseline laboratory visits, home controls at approximately 30 and 90 days, an intermediate visit at approximately 60 days, and a final visit at approximately 120 days. The primary efficacy assessment is joint pain measured with a visual analog scale. Secondary assessments include KOOS and WOMAC questionnaires, concomitant analgesic medication use, knee muscle function by isometric and isokinetic dynamometry, biomarkers of cartilage degradation, blood safety analysis, and adverse events.",[49,55,60],{"label":50,"type":51,"description":52,"interventionNames":53},"Nuvicol II","EXPERIMENTAL","Participants receive Nuvicol II, undenatured type II collagen from chicken source, 40 mg once daily for 4 months.",[54],"Dietary Supplement: Nuvicol II",{"label":56,"type":51,"description":57,"interventionNames":58},"Nuvicol SII","Participants receive Nuvicol SII, undenatured type II collagen from salmon source, 40 mg once daily for 4 months.",[59],"Dietary Supplement: Nuvicol SII",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo capsules containing maltodextrin and magnesium stearate once daily for 4 months.",[65],"Dietary Supplement: Placebo",[67,71,74],{"type":68,"name":61,"description":69,"armGroupLabels":70,"otherNames":34},"DIETARY_SUPPLEMENT","Matching placebo capsules containing maltodextrin and magnesium stearate, orally once daily for 4 months.",[61],{"type":68,"name":50,"description":72,"armGroupLabels":73,"otherNames":34},"Undenatured type II collagen from chicken source, 40 mg orally once daily for 4 months.",[50],{"type":68,"name":56,"description":75,"armGroupLabels":76,"otherNames":34},"Undenatured type II collagen from salmon source, 40 mg orally once daily for 4 months.",[56],[78],{"name":79,"affiliation":5,"role":80},"Javier Marhuenda, PhD","PRINCIPAL_INVESTIGATOR",[82],{"name":79,"role":83,"phone":84,"phoneExt":34,"email":85},"CONTACT","+34 618","jmarhuenda@ucam.edu",[87],{"facility":88,"status":34,"city":89,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"UCAM HiTech - Unidad de Estudios Clínicos","Murcia","30107","Spain","ES",{"type":94,"coordinates":95},"Point",[96,97],-1.13004,37.98704,{"lat":97,"lon":96},[100],{"name":79,"role":83,"phone":34,"phoneExt":34,"email":34},{"type":80,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Javier Marhuenda","Principal Investigator","100659881","undenatured-type-ii-collagen-for-knee-osteoarthritis-pain-100659881",false,"NCT07870967","Undenatured Type II Collagen for Knee Osteoarthritis Pain","Randomized Clinical Trial to Analyze the Efficacy and Safety of Undenatured Type II Collagen Product on Joint Pain in Patients Diagnosed With Osteoarthritis","FLEXICOL","Inclusion Criteria:\n\n* Age over 30 years.\n* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified American College of Rheumatology criteria.\n* Persistent knee pain associated with osteoarthritis with a baseline VAS pain assessment score of at least 30 mm.\n* Subjects must not have narcotic or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.\n\nExclusion Criteria:\n\n* Serious or terminal illnesses.\n* Allergy or hypersensitivity to any component of the product under study.\n* Vegan or vegetarian diet.\n* Current use of glucosamine, chondroitin sulfate, collagen, hyaluronic infiltrations, or any supplement indicated for joint health.\n* Chronic inflammatory diseases affecting the musculoskeletal system, including rheumatoid arthritis, gout, pseudogout, Paget disease, or chronic pain syndrome.\n* Body mass index above 32 kg\u002Fm2.\n* Participation in any other research during the last 3 months.\n* Pregnant, planning pregnancy during the study, lactating, or breastfeeding.\n* Biological childbearing potential without continuous effective contraception as determined by the investigator.\n* Inability to understand the research study.","ALL","31 Years",{"count":115,"type":116},120,"ESTIMATED","INTERVENTIONAL",[119],"NA","This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II, Nuvicol SII, or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.",[122],"Osteoarthritis, Knee",[124,125,126],"Joint Pain","Undenatured Type II Collagen","Visual Analog Scale","NOT_YET_RECRUITING","2026-10-06",{"date":130,"type":131},"2026-10-13","ACTUAL",{"date":133,"type":116},"2027-03",{"date":135,"type":116},"2027-07",{"name":5,"class":6},1]