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NCT Number: NCT04505462

Dietary Therapy in Dialysis Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Serum albumin level less than 2.5 g/dL
  • Hospitalization within the past 4 weeks
  • Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks
  • History of psychiatric disorders
  • Having mental retardation
  • Those who dislike of the study meals
  • Soft diet requirement
  • Vegetarian

Treatment and study plan

Therapeutic diet

Other

A special healthy diet for dialysis patients

Other names: Dietary therapy

Primary outcomes

  1. Concentrations of intact fibroblast growth factor 23 (pg/mL)

    Time frame: 7 days

    Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet

Secondary outcomes

  1. Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)

    Time frame: 7 days

    Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet

  2. Concentrations of phosphate (mg/dL)

    Time frame: 7 days

    Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet

  3. Concentrations of calcium (mg/dL)

    Time frame: 7 days

    Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet

  4. Concentrations of intact parathyroid hormone (pg/mL)

    Time frame: 7 days

    Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet

  5. Concentrations of free indoxyl sulfate (mg/L)

    Time frame: 7 days

    Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet

  6. Concentrations of free p-cresol sulfate (mg/L)

    Time frame: 7 days

    Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet

  7. Concentrations of pre-albumin (g/dL)

    Time frame: 7 days

    Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet

  8. Concentrations of albumin (g/dL)

    Time frame: 7 days

    Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet

  9. Concentrations of C-reactive protein (mg/dL)

    Time frame: 7 days

    Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet

  10. Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells

    Time frame: 7 days

    Difference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between therapeutic diet and usual diet

  11. Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells

    Time frame: 7 days

    Difference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between therapeutic diet and usual diet

  12. Absolute number (per μl blood) of monocytes

    Time frame: 7 days

    Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet

  13. Percentage (%) of CD4+ (cluster of differentiation 4) T cells

    Time frame: 7 days

    Difference in change-from-baseline percentage (%) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet

  14. Percentage (%) of CD8+ (cluster of differentiation 8) T cells

    Time frame: 7 days

    Difference in change-from-baseline percentage (%) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet

  15. Percentage (%) of monocytes

    Time frame: 7 days

    Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Short-Term Effects of Therapeutic Diet in Dialysis Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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