Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients

NCT06377293 | Active Not Recruiting

• 1 other identifier: FEMH-IRB-TSAI2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, metabolomics, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, metabolic abnormalities, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients.

Conditions

End-Stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (21)

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

  4 weeks

• Concentrations of phosphate (mg/dL)

  4 weeks

• Concentrations of calcium (mg/dL)

  4 weeks

• Concentrations of intact parathyroid hormone (pg/mL)

  4 weeks

• Concentrations of bone-specific alkaline phosphatase (μg/L)

  4 weeks

Study Arms (2)

Study diet

EXPERIMENTAL

4-week therapeutic diet intervention as experimental group

Other: Dialysis-specific therapeutic diet

Usual diet

NO INTERVENTION

4-week usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet

Interventions

Dialysis-specific therapeutic diet OTHER

A healthy diet for dialysis patients

Study diet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with aged older than 20 years
• End-stage kidney disease (ESKD) undergoing maintenance dialysis for more than three months
• Must have adequate dialysis
• Good dietary compliance

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banciao Dist., 220, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 29420827 BACKGROUND

• Tsai WC, Peng YS, Wu HY, Hsu SP, Chiu YL, Liu LC, Tsai SM, Chien KL. Accuracy of a Nutrient Database in Estimating the Dietary Phosphorus-to-Protein Ratio and Using a Boiling Method in Low-Phosphate Hospital Diets. Sci Rep. 2018 Oct 15;8(1):15246. doi: 10.1038/s41598-018-33657-8.

  PMID: 30323203 BACKGROUND

• 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.

  PMID: 31519550 BACKGROUND

• Tsai WC, Wu HY, Chiu YL, Yang JY, Pai MF, Wu YR, Lin WY, Hung KY, Chien KL, Hsu SP, Peng YS. Acute effects of dietary phosphorus intake on markers of mineral metabolism in hemodialysis patients: post hoc analysis of a randomized crossover trial. Ren Fail. 2021 Dec;43(1):141-148. doi: 10.1080/0886022X.2020.1870138.

  PMID: 33427559 BACKGROUND

• Tsai WC, Hsu SP, Chiu YL, Wu HY, Luan CC, Yang JY, Pai MF, Lin CJ, Lin WY, Sun WH, Peng YS. Short-Term Effects of a Therapeutic Diet on Biochemical Parameters in Hemodialysis Patients: A Randomized Crossover Trial. J Ren Nutr. 2023 Nov;33(6):731-739. doi: 10.1053/j.jrn.2023.04.003. Epub 2023 Apr 27.

  PMID: 37120127 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wan-Chuan Tsai, M.D., Ph.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians who assess the study outcomes will be masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: A randomized, active-controlled trial with cross-over design

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available after completing the study for 1 year and for 3 years after formal publication.
• Access Criteria: Data will be made available by the corresponding author of the paper upon request by email.

Locations

TW (1)