[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627365":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ohio State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"soy-tomato juice","EXPERIMENTAL","4 week run-in phase where they are asked to consume a diet low in soy and lycopene, then they will receive the intervention for 4 weeks.",[13,14],"Dietary Supplement: Soy-tomato juice product","Dietary Supplement: Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIETARY_SUPPLEMENT","Soy-tomato juice product","A high lycopene tomato (with levels 2-3x higher than typical) will be grown at OSU farms, as we have done previously. Tomatoes will be harvested and transported to OSU's Food Industries Center (Columbus, OH) for processing into juice and canned using commercial methods. A soy isoflavone extract will be acquired from a commercial supplier, tested for isoflavone content, and dosed into the juice before canning. Our juice recipe has been formulated and previously tested to ensure palatability. Proximate analysis (i.e., the information found on a nutrition facts panel) will be collected from our final juice, along with carotenoid and soy isoflavone levels to fully characterize our intervention agent.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed","This is a novel dietary supplement.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Spencer Harris","CONTACT","614-293-6255","spencer.harris@osumc.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-82.99879,39.96118,{"lat":45,"lon":44},[48,49,52],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},{"name":50,"role":51,"phone":21,"phoneExt":21,"email":21},"Phil A Hart, MD","PRINCIPAL_INVESTIGATOR",{"name":53,"role":54,"phone":21,"phoneExt":21,"email":21},"Mitchell L Ramsey, MD","SUB_INVESTIGATOR",{"type":51,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Philip Hart","Physician",[59],{"name":60,"class":61},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100627365","phase-1-soy-tomato-juice-to-improve-outcomes-in-pancreatitis-100627365",false,"NCT07447687","Soy Tomato Juice to Improve Outcomes in Pancreatitis","Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1\u002F2 Single Arm Trial","STOP","Inclusion Criteria:\n\n* Diagnosis of definite chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP)\n* Patients should be able to fully understand and participate in all aspects of the study\n\nExclusion Criteria:\n\n* Episode of acute pancreatitis, hospitalization, or endoscopic\u002Fsurgical intervention within 30 days of enrollment\n* Chronic, daily use of systemic immunomodulatory medication for any indication\n* Previous allergic reaction to soy or tomato products\n* Known pregnancy","ALL","18 Years","80 Years",{"count":74,"type":75},35,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","This goal of this clinical trial is to see if people with recurrent acute pancreatitis or chronic pancreatitis can tolerate and regularly drink a tomato juice beverage. Researchers will also measure inflammation and ask participants to report how they feel. Everyone in the study will receive the tomato juice drink, and both participants and researchers will know what is being taken. The investigators expect the drink will be well tolerated, may lower inflammation, and may improve participant-reported symptoms and quality of life.",[82,83],"Recurrent Acute Pancreatitis","Chronic Pancreatitis",[85,86,87,88,89,90,91,92,93,94,5],"Soy","Tomato","Dietary Intervention","abdominal pain","inflammation","lycopene","soy isoflavones","anti-inflammatory diet","medical nutrition","diet","2026-02-26",{"date":97,"type":98},"2026-03-03","ACTUAL",{"date":100,"type":75},"2026-02",{"date":102,"type":75},"2028-06",{"name":5,"class":6},1]