[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560387":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":68,"collaborators":72,"id":74,"slug":33,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":33,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"NIN Institute","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm Intervention","EXPERIMENTAL","Intervention group: The specialized oral supplement is provided, with the consumption of 1 serving (70g-dissolved in 237 ml natural water) per day in conjunction with individualized nutritional counseling. For 4 months",[13],"Dietary Supplement: Nutritious Shake",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm no Intervention","OTHER","Control group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months",[19],"Behavioral: Nutritional counseling",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Nutritious Shake","Powder 70 g\u002Fd diluted in 237 ml natural water",[9],[27],"NIN",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Nutritional counseling","Specialized nutritional recommendations for CKD",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Paola Azucena Alvarado Pelayo, Bachelor","Hospital Civil Fray Antonio Alcalde","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":33,"email":43},"CONTACT","011 52 3320587471","paola.alvarado@nin.com.mx",{"name":45,"role":41,"phone":46,"phoneExt":33,"email":47},"Ari Cisneros Hernández, Master","011 52 3335762299","aricisneroshernandez@gmail.com.mx",[49],{"facility":37,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Guadalajara","Jalisco","44280","Mexico",{"type":56,"coordinates":57},"Point",[58,59],-103.34749,20.67738,{"lat":59,"lon":58},[62,64],{"name":63,"role":41,"phone":42,"phoneExt":33,"email":43},"Paola Alvarado, Bachelor",{"name":65,"role":41,"phone":66,"phoneExt":33,"email":67},"Ari Cisneros, Master","3335762299","aricisneroshernandez@gmail.com",{"type":38,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":71,"oldNameTitle":33,"oldOrganization":33},"Ari Cisneros-Hernández","Investigador Principal","Hospital Civil de Guadalajara",[73],{"name":71,"class":16},"100560387",false,"NCT06576479","Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD","Validation of the Therapeutic Effect and Safety of a Specialized Oral Supplement on the Nutritional Status and Quality of Life in Patients with Chronic Kidney Disease Without Replacement Therapy: (Grade G3a, G3b, G4 and G5)","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients with diabetic kidney with eGFR \\\u003C60 ml \u002F min \u002F 1.73m2 and ≥15 ml \u002F min \u002F 1.73m2, (stage G3a, G3b and G4 respectively)\n* Patients with protein energy expenditure (defined by serum albumin \\\u003C 3.8 g\u002Fdl)\n* Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake \\\u003C0.6 g\u002Fkg\u002Fd or have a consumption \\\u003C25 kcal\u002Fkg\u002Fd\n* Patients who can read and write (or primary caregiver)\n* Domicile within the metropolitan area\n\nExclusion Criteria:\n\n* Previous hospitalizations in the last month\n* Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, cerebrovascular syndrome, malabsorption syndrome, or allergy to any ingredient in the nutritional supplement)\n* Patients with actual consumption of food supplements and \u002F or keto analogues.\n\nElimination Criteria:\n\n* Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.\n* Failure to take the supplement \\>10% (\\>12 failed doses).\n* Diagnosis of any comorbidity during the intervention period.\n* Initiation of replacement therapy.\n* Identification of adverse effects.\n* Withdrawal of voluntary participation by the patient.\n* Death.","ALL","18 Years","90 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.",[91,92],"Chronic Kidney Diseases","Protein-Energy Malnutrition",[94,95,96],"chronic kidney disease","PEW","nutrition","2024-12-16",{"date":99,"type":100},"2024-12-18","ACTUAL",{"date":102,"type":100},"2018-07-10",{"date":104,"type":85},"2025-03",{"name":5,"class":6},1]