Dietary Therapy in Dialysis Patients

March 15, 2022 updated by: Wan-Chuan Tsai, Far Eastern Memorial Hospital

Short-Term Effects of Therapeutic Diet 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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New Taipei City, Taiwan
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study diet
7-day therapeutic diet intervention as experimental group
A special healthy diet for dialysis patients
Other Names:
  • Dietary therapy
No Intervention: Usual diet
7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
Concentrations of phosphate (mg/dL)
Time Frame: 7 days
Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet
7 days
Concentrations of calcium (mg/dL)
Time Frame: 7 days
Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet
7 days
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
7 days
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
7 days
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 days
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
7 days
Concentrations of albumin (g/dL)
Time Frame: 7 days
Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet
7 days
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
7 days
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
7 days
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
7 days
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
7 days
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
7 days
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
7 days
Percentage (%) of monocytes
Time Frame: 7 days
Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual-level deidentified participant data will be made available by the corresponding author of the paper upon request by email. The data will be available for 3 years after formal publication.

IPD Sharing Time Frame

The data will become available after completing the study for 1 year and for 3 years after formal publication.

IPD Sharing Access Criteria

Data will be made available by the corresponding author of the paper upon request by email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease on Dialysis

Clinical Trials on Therapeutic diet

3
Subscribe