Clinical trial NCT04505462: Dietary Therapy in Dialysis Patients
Official title: Short-Term Effects of Therapeutic Diet in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Therapeutic diet
Mineral metabolism
Uremic toxins
Inflammation
Immune
End-stage kidney disease
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, active-controlled trial with cross-over design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis, serum intact parathyroid hormone less than 800 pg/mL and good dietary compliance

Exclusion Criteria:

* Patients who meet any of the following criteria will be excluded from the study:

  1. Serum albumin level less than 2.5 g/dL
  2. Hospitalization within the past 4 weeks
  3. Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks
  4. History of psychiatric disorders
  5. Having mental retardation
  6. Those who dislike of the study meals
  7. Soft diet requirement
  8. Vegetarian

Primary outcomes:
measure: Concentrations of intact fibroblast growth factor 23 (pg/mL)
timeFrame: 7 days
Secondary outcomes:
measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
timeFrame: 7 days
measure: Concentrations of phosphate (mg/dL)
timeFrame: 7 days
measure: Concentrations of calcium (mg/dL)
timeFrame: 7 days
measure: Concentrations of intact parathyroid hormone (pg/mL)
timeFrame: 7 days
measure: Concentrations of free indoxyl sulfate (mg/L)
timeFrame: 7 days
measure: Concentrations of free p-cresol sulfate (mg/L)
timeFrame: 7 days
measure: Concentrations of pre-albumin (g/dL)
timeFrame: 7 days
measure: Concentrations of albumin (g/dL)
timeFrame: 7 days
measure: Concentrations of C-reactive protein (mg/dL)
timeFrame: 7 days
measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
timeFrame: 7 days
measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
timeFrame: 7 days
measure: Absolute number (per μl blood) of monocytes
timeFrame: 7 days
measure: Percentage (%) of CD4+ (cluster of differentiation 4) T cells
timeFrame: 7 days
measure: Percentage (%) of CD8+ (cluster of differentiation 8) T cells
timeFrame: 7 days
measure: Percentage (%) of monocytes
timeFrame: 7 days
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Wan-Chuan Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Yang JY, Chen HY, Pai MF, Lin WY, Hung KY, Chu FY, Tsai SM, Chien KL. Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1475-1483. doi: 10.2215/CJN.04250419. Epub 2019 Sep 13.
citation: Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Chen HY, Yang JY, Ko MJ, Pai MF, Tu YK, Hung KY, Chien KL. Effects of lower versus higher phosphate diets on fibroblast growth factor-23 levels in patients with chronic kidney disease: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Nov 1;33(11):1977-1983. doi: 10.1093/ndt/gfy005.