Dietary Therapy in Dialysis Patients

Short-Term Effects of Therapeutic Diet in Dialysis Patients

Sponsors

Lead Sponsor: Far Eastern Memorial Hospital

Source Far Eastern Memorial Hospital
Brief 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.

Overall Status Not yet recruiting
Start Date October 7, 2020
Completion Date June 30, 2021
Primary Completion Date December 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Concentrations of intact fibroblast growth factor 23 (pg/mL) 7 days
Secondary Outcome
Measure Time Frame
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) 7 days
Concentrations of phosphate (mg/dL) 7 days
Concentrations of calcium (mg/dL) 7 days
Concentrations of intact parathyroid hormone (pg/mL) 7 days
Concentrations of free indoxyl sulfate (mg/L) 7 days
Concentrations of free p-cresol sulfate (mg/L) 7 days
Concentrations of pre-albumin (g/dL) 7 days
Concentrations of albumin (g/dL) 7 days
Concentrations of C-reactive protein (mg/dL) 7 days
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells 7 days
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells 7 days
Absolute number (per μl blood) of monocytes 7 days
Percentage (%) of CD4+ (cluster of differentiation 4) T cells 7 days
Percentage (%) of CD8+ (cluster of differentiation 8) T cells 7 days
Percentage (%) of monocytes 7 days
Enrollment 34
Condition
Intervention

Intervention Type: Other

Intervention Name: Therapeutic diet

Description: A special healthy diet for dialysis patients

Arm Group Label: Study diet

Other Name: Dietary therapy

Eligibility

Criteria:

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wan-Chuan Tsai, M.D., Ph.D. Principal Investigator Far Eastern Memorial Hospital
Overall Contact

Last Name: Wan-Chuan Tsai, M.D., Ph.D.

Phone: +886277281780

Email: [email protected]

Location
Facility: Far Eastern Memorial Hospital
Location Countries

Taiwan

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Far Eastern Memorial Hospital

Investigator Full Name: Wan-Chuan Tsai

Investigator Title: Principal Investigator, Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Study diet

Type: Experimental

Description: 7-day therapeutic diet intervention as experimental group

Label: Usual diet

Type: No Intervention

Description: 7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

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

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Laboratory technicians who assess the study outcomes will be masked

Source: ClinicalTrials.gov