Dietary Therapy in Dialysis Patients

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

Short-Term Effects of Therapeutic Diet in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505462
• Other study ID #: FEMH-IRB-109112-F
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 1, 2022
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Other:
• Therapeutic diet
A special healthy diet for dialysis patients

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Secondary	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	7 days
Secondary	Concentrations of phosphate (mg/dL)	Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet	7 days
Secondary	Concentrations of calcium (mg/dL)	Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet	7 days
Secondary	Concentrations of intact parathyroid hormone (pg/mL)	Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet	7 days
Secondary	Concentrations of free indoxyl sulfate (mg/L)	Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet	7 days
Secondary	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	7 days
Secondary	Concentrations of pre-albumin (g/dL)	Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet	7 days
Secondary	Concentrations of albumin (g/dL)	Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet	7 days
Secondary	Concentrations of C-reactive protein (mg/dL)	Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet	7 days
Secondary	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	7 days
Secondary	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	7 days
Secondary	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	7 days
Secondary	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	7 days
Secondary	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	7 days
Secondary	Percentage (%) of monocytes	Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet	7 days