protocolSection identificationModule nctId: NCT06377293, orgStudyIdInfo id: FEMH-IRB-TSAI2024, briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Far Eastern Memorial Hospital, class: OTHER, descriptionModule briefSummary: In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients., conditionsModule conditions: End-Stage Kidney Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A randomized, active-controlled trial with cross-over design, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Laboratory technicians who assess the study outcomes will be masked, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dialysis-specific therapeutic diet, outcomesModule primaryOutcomes measure: Concentrations of intact fibroblast growth factor 23 (pg/mL), secondaryOutcomes measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL), secondaryOutcomes measure: Concentrations of phosphate (mg/dL), secondaryOutcomes measure: Concentrations of calcium (mg/dL), secondaryOutcomes measure: Concentrations of intact parathyroid hormone (pg/mL), secondaryOutcomes measure: Concentrations of bone-specific alkaline phosphatase (μg/L), secondaryOutcomes measure: Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL), secondaryOutcomes measure: Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml), secondaryOutcomes measure: Concentrations of alkaline phosphatase (ALP) (IU/L), secondaryOutcomes measure: Concentrations of free indoxyl sulfate (mg/L), secondaryOutcomes measure: Concentrations of free p-cresol sulfate (mg/L), secondaryOutcomes measure: Concentrations of pre-albumin (g/dL), secondaryOutcomes measure: Concentrations of albumin (g/dL), secondaryOutcomes measure: Concentrations of C-reactive protein (mg/dL), secondaryOutcomes measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells, secondaryOutcomes measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells, secondaryOutcomes measure: Absolute number (per μl blood) of monocytes, secondaryOutcomes measure: Concentrations of fetuin-A (μg/ml), secondaryOutcomes measure: Concentrations of trimethylamine-N-oxide (TMAO) (μM), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False