[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease-stage-3a\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease-stage-3a":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100476836","low-protein-diet-with-low-protein-foods-versus-a-lpd-without-lp-foods-in-patients-with-chronic-kidney-disease-ckd-100476836",false,"NCT05489120","Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)","Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study","Inclusion Criteria:\n\n* CKD patient stage 3a-5 (\\\u003C60 ml\u002Fmin\u002F1.73 m² estimated by CKD-EPI formula) and not on dialysis,\n* With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),\n* Above 1g protein\u002F kg bw (ideal body weight),\n* LPD-naïve patient,\n* Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),\n* Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),\n* Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),\n* Having given their informed written consent regarding its participation to the protocol.\n\nExclusion Criteria:\n\n* Patient for whom dialysis or transplantation is planned\u002Fexpected within the next 12 months\n* Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),\n* Uncontrolled Diabetes (HbA1C \\>8.5%),\n* Active cancer (including a 5 years remission period),\n* Psychiatric disorders or inability to follow the protocol,\n* Evidence of any active infectious or uncontrolled inflammatory diseases,\n* Inability to provide blood samples (poor venous capital),\n* Inability to perform correct 24-hours urine collection,\n* Any change of the chronic medication within 1 month before screening,\n* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and\u002For the participation of the subject in the study according to the opinion of the investigator,\n* Patient with an active implanted medical device\n* Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.\n* Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.","ALL","18 Years",{"count":19,"type":20},244,"ESTIMATED","INTERVENTIONAL",[23],"NA","The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease\u002Fdeath and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein\u002F kg body weight\u002Fday is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.",[26,27,28,29],"Chronic Kidney Disease Stage 3B","Chronic Kidney Disease stage4","Chronic Kidney Disease Stage 5","Chronic Kidney Disease Stage 3A",[31,32,33,34,35,36],"low-protein diet","low-protein foods","FLAVIS","compliance","effectiveness","safety","RECRUITING","2025-01-27",{"date":40,"type":41},"2025-01-29","ACTUAL",{"date":43,"type":41},"2022-11-06",{"date":45,"type":20},"2026-03",{"name":47,"class":48},"Dr. Schär AG \u002F SPA","INDUSTRY",21]