[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627864":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":37,"enrollmentInfo":78,"targetDuration":37,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":45,"whyStopped":37,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD","EXPERIMENTAL","Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement",[13],"Dietary Supplement: Ren-Nu and KetoCitra",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Ren-Nu and KetoCitra","This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters",[9],[21,22,23],"Continuous glucose monitoring","intermittent fasting","Nutritional counseling",[25,28],{"name":26,"affiliation":5,"role":27},"Richard Fatica, MD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":31},"Thomas Weimbs, PhD","Santa Barbara Nutrients","STUDY_DIRECTOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Chloe Booth","CONTACT","216-444-5053",null,"boothc2@ccf.org",{"name":26,"role":35,"phone":40,"phoneExt":37,"email":41},"216-445-9953","faticar@ccf.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58,59,60],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"name":26,"role":35,"phone":40,"phoneExt":37,"email":41},{"name":26,"role":27,"phone":37,"phoneExt":37,"email":37},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","Richard Fatica","Vice Chairman Department of Kidney Medicine",[66],{"name":30,"class":67},"UNKNOWN","100627864","metabolic-impacts-of-ren-nu-a-dietary-program-for-polycystic-kidney-disease-100627864",false,"NCT07454174","Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease","Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease","PKD-KETO","Inclusion Criteria:\n\n* Adult (18 years or older)\n\n  * Diagnosis of ADPKD by a physician.\n  * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m2 at screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n  * Appropriate control of blood pressure (i.e. entry reading \\\u003C140\u002F90) including the use of BP medications for diagnosis of hypertension.\n  * BMI ≥ 25 (accounting for muscle mass)\n  * Own an at-home blood pressure monitor (no brand requirements)\n  * Able to complete study-related activities (e.g., attend online classes, complete questionnaires, and proper use of medical devices)\n\nExclusion Criteria:\n\n* Intolerance or allergy to any of the ingredients in the provided medical food\n\n  * Severe or rare underlying health conditions may cause a safety risk when taking the medical food. Those underlying health conditions will be assessed by the enrolling physician and include but are not limited to:\n\n    * History of hyperkalemia\n    * Heart failure\n    * Liver cirrhosis\n    * Chronic kidney disease stage 4 or greater, or other renal condition that severely impairs bone mineral homeostasis.\n    * HIV infection\n    * Chronic drug or alcohol abuse\n    * Chronic malabsorption syndrome\n    * Malignancy (non-melanoma skin cancer exempted)\n    * Autoimmune disease\n    * Pregnant, planning to be pregnant, or nursing during the course of the study\n    * Chronic history of recurrent urinary tract infections (UTI) (≥ 3 UTIs per year)\n    * Diagnosis of aneurysm\n    * Indigestion due to hypochlorhydria (low stomach acid)\n    * Any other condition, that in the opinion of the enrolling physician, makes the subject an unsuitable candidate for the study.\n  * Current use of any of the following medications or supplements which could affect safety or compliance with this study:\n\n    * The medical food, KetoCitra®.\n    * Urine alkalizing agents such as sodium bicarbonate or potassium citrate\n    * Citrate treatments\n    * Immunosuppressive treatment\n    * Tolvaptan\n    * Potassium-sparing diuretics\n    * Somatostatin analogs\n    * Aluminum-containing supplements or medications such as aluminum antacids (e.g. Maalox) or aluminum-based phosphate binders.\n    * SGLT2 inhibitors\n  * Participation in another therapeutic intervention trial.\n  * Following a highly specialized or extreme diet that is incompatible with the interventional nutrition program (e.g. carnivore, very high protein diet for elite athletes, etc.)\n  * Food sensitivities or allergies that are incompatible with the interventional nutrition program.\n  * The subject is already adhering to a form of a ketogenic diet or related fasting regimen.\n  * Current or past history of disordered eating or feeding behaviors.\n  * History of gastric bypass.\n  * Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's, or Gallbladder Disease.","ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"NA","This is a 16 week pilot study of the impact of a nutritionist led ketogenic diet (Ren-Nu) supplemented with the medical food KetoCitra on autosomal dominant polycystic kidney disease.",[86],"Autosomal Dominant Polycystic Kidney Disease (ADPKD)",[88,89,90,91,92],"ADPKD","polycystic kidneys","Ren-Nu","KetoCitra","Keto diet","2026-03-03",{"date":95,"type":96},"2026-03-06","ACTUAL",{"date":98,"type":96},"2026-02-25",{"date":100,"type":80},"2028-02",{"name":63,"class":6},1]