An interventional study of Therapeutic diet in End Stage Renal Disease on Dialysis, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Far Eastern Memorial Hospital · Not applicable, Interventional, and Treatment
Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. The investigators hypothesize that therapeutic diet intervention reverses altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. In this study, the investigators crafted 7-day special healthy diet to illustrate the clinical implications of therapeutic diet for dialysis patients.
The risk of cardiovascular disease (CVD) and mortality in patients with end-stage kidney disease (ESKD) is far greater than those in the general population. Emerging evidence suggests that unhealthy diet causes altered mineral metabolism, disturbance of gut microbiota (dysbiosis) with elevated uremic toxin level, immune dysregulation, and inflammation; these abnormalities are strongly related to development of CVD. Little is known about the relationship between therapeutic diet intervention and cardiovascular risk in patients with ESKD. Recently, the study of the investigators showed that ESKD patients undergoing hemodialysis who consumed very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, experienced an extra reduction of serum phosphorus level by 0.61 mg/dL compared with that of low-phosphate diet, PPR value of 10 mg/g.
The aim of the study is to explore the effect of 7-day therapeutic diet intervention on changes of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation, highlighting the important role of dietary modification in dialysis population.
It is to conduct a randomized controlled trial with cross-over design at a hemodialysis unit of tertiary teaching hospital in Northern Taiwan. Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis and serum intact parathyroid hormone less than 800 pg/mL will be included. Participants will be randomly assigned into two groups: those in group A will receive study diet for 7 days, followed by 4-week washout period and then receive 7-day usual diet. The opposite order of diets will be prescribed in group B. The study meals are prepared in the hospital cafeteria. Dietary compositions of the study diets were analyzed before the start of the study. The study outcome measures are difference in change-from-baseline values of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation between the therapeutic diet and the usual diet.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 32 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study:
7-day therapeutic diet intervention as experimental group
Other: Therapeutic diet
7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet
A special healthy diet for dialysis patients
Also known as: Dietary therapy
Concentrations of intact fibroblast growth factor 23 (pg/mL)
Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of phosphate (mg/dL)
Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of calcium (mg/dL)
Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of intact parathyroid hormone (pg/mL)
Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of free indoxyl sulfate (mg/L)
Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of free p-cresol sulfate (mg/L)
Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of pre-albumin (g/dL)
Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of albumin (g/dL)
Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet
Time frame: 7 days
Concentrations of C-reactive protein (mg/dL)
Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet
Time frame: 7 days
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
Difference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between therapeutic diet and usual diet
Time frame: 7 days
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
Difference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between therapeutic diet and usual diet
Time frame: 7 days
Absolute number (per μl blood) of monocytes
Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet
Time frame: 7 days
Percentage (%) of CD4+ (cluster of differentiation 4) T cells
Difference in change-from-baseline percentage (%) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet
Time frame: 7 days
Percentage (%) of CD8+ (cluster of differentiation 8) T cells
Difference in change-from-baseline percentage (%) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet
Time frame: 7 days
Percentage (%) of monocytes
Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet
Time frame: 7 days
Plan to share: Yes — Individual-level deidentified participant data will be made available by the corresponding author of the paper upon request by email. The data will be available for 3 years after formal publication.
Supporting information: Study protocol
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Far Eastern Memorial Hospital