Dietary Therapy in Dialysis Patients
Condition: End Stage Renal Disease on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

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.
    

Intervention name(s): Therapeutic diet
Intervention type(s): Other
Intervention description(s): A special healthy diet for dialysis patients
Other intervention name(s): Dietary therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, active-controlled trial with cross-over design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic diet; Mineral metabolism; Uremic toxins; Inflammation; Immune; End-stage kidney disease