Nutritional Interventions in Peritoneal Dialysis Patients With Hypoalbuminemia

Clinical Implication of Nutritional Counseling and Whey Protein Supplements in Patients on Peritoneal Dialysis With Hypoalbuminemia

Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in patients on peritoneal dialysis (PD). The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known. The investigators hypothesize that higher dietary protein intake has a greater beneficial effect on nutritional status in hypoalbuminemic PD patients. In particular, 1.5 g/kg protein intake provides a better beneficial effect than 1.2 g/kg protein intake.

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Other: Nutritional counseling; Dietary supplement: Whey protein supplements

Detailed Description

Hypoalbuminemia is common and is strongly associated with an increased risk for mortality in patients with end-stage kidney disease (ESKD). Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in PD patients. Although there is an increased daily calorie intake from absorption of dialysate glucose concentration, hypoalbuminemia ensues in a substantial number of PD patients. There is concern that a disproportionately increasing calorie intake from dialysate glucose with no change in dietary protein intake causes weight gain which in turn worsens sarcopenic obesity in PD patients. Achieving adequate dietary protein intake should be the priority in the management of hypoalbuminemia. It is feasible for PD patients to increase dietary protein intake through protein supplements. Among nutritional supplements, whey protein has several positive effects on carbohydrate metabolism, muscle building, immune function, and human health in various areas of disease, supported by well-performed studies. There are limited data available regarding the effects of nutritional counseling and whey protein supplements on the nutritional, body compositional status and immune function of PD patients with hypoalbuminemia. The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known.

The aims of the study are to investigate the optimal dietary protein intake and to examine the effects of whey protein supplement on the change of nutritional, body composition and immune function in PD patients with hypoalbuminemia. Specifically, the investigators will compare the effect of nutritional counseling (1.2 g/kg protein intake) with that of nutritional counseling and whey protein supplement (1.5 g/kg protein intake) regarding the changes of nutritional, body composition parameters and immune function in PD patients. This is a quality improvement program to cope with the fact that the proportion of hypoalbuminemic PD patients sometimes does not meet the requirements set by Joint Commission of Taiwan, and to improve the nutritional status of PD patients in a feasible way of daily clinical practice.

The investigators are going to conduct a randomized, controlled trial with cross-over design. Subjects with ESKD undergoing maintenance PD for more than three months, adequate dialysis, and hypoalbuminemia will be recruited. Those with non-dietary cause of hypoalbuminemia including untreated fluid overload, uncorrected metabolic acidosis, having active infection or inflammation, hospitalization within the past 4 weeks, having gastrointestinal bleeding, those who cannot cooperate with the dietary record, those who have poor adherence to whey protein consumption, history of psychiatric disorders and having mental retardation will be excluded. Participants will receive nutritional counseling with whey protein supplement or nutritional counseling alone for 3-month period, separated by 3-month washout period. The study outcome measures are difference in change-from-baseline nutritional, body composition parameters and immune function between the two study periods.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan-Chuan Tsai, M.D., Ph.D.; Phone Number: +886277281780; Email: mkks618@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged greater than or equal to 20 years
2. Having end-stage kidney disease and having undergone maintenance PD for more than three months
3. Having adequate dialysis (weekly Kt/V greater than or equal to 1.7)
4. Serum albumin levels lower than 4.0 g/dL, measured by bromocresol green assay

Exclusion Criteria:

1. Untreated fluid overload
2. Uncorrected metabolic acidosis
3. Having active infection or inflammation
4. Hospitalization within the past 4 weeks
5. Having gastrointestinal bleeding
6. those who cannot cooperate with the dietary record
7. those who have poor adherence to whey protein consumption
8. History of psychiatric disorders
9. Having mental retardation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutritional counseling arm; Nutritional counseling, targeting daily protein intake 1.2 g/kg Dietitian will provide one-to-one dietary education, 30 minutes duration, on a monthly basis	Other: Nutritional counseling; Nutritional counseling by dietitians for 3 months
Experimental: Nutritional counseling plus whey protein supplements arm; Nutritional counseling plus whey protein supplements, targeting daily protein intake 1.5 g/kg In addition to receiving nutritional counseling, participants are instructed to take an additional whey protein supplement at the dose of ~0.3 g/kg protein intake.	Other: Nutritional counseling; Nutritional counseling by dietitians for 3 months; Dietary supplement: Whey protein supplements; Nutritional counseling and whey protein supplements for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of albumin (g/dL)	Difference in change-from-baseline albumin (g/dL) between two intervention arms	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of pre-albumin (g/dL)	Difference in change-from-baseline pre-albumin (g/dL) between two intervention arms	3 months
Concentrations of C-reactive protein (mg/dL)	Difference in change-from-baseline C-reactive protein (mg/dL) between two intervention arms	3 months
Concentrations of phosphate (mg/dL)	Difference in change-from-baseline phosphate (mg/dL) between two intervention arms	3 months
Concentrations of blood urea nitrogen (mg/dL)	Difference in change-from-baseline blood urea nitrogen (mg/dL) between two intervention arms	3 months
Concentrations of free indoxyl sulfate (mg/L)	Difference in change-from-baseline free indoxyl sulfate (mg/L) between two intervention arms	3 months
Concentrations of free p-cresol sulfate (mg/L)	Difference in change-from-baseline free p-cresol sulfate (mg/L) between two intervention arms	3 months
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 two intervention arms	3 months
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 two intervention arms	3 months
Absolute number (per μl blood) of monocytes	Difference in change-from-baseline absolute number (per μl blood) of monocytes between two intervention arms	3 months
Percentage (%) of CD4+ (cluster of differentiation 4) T cells	Difference in change-from-baseline percentage (%) of CD4+ T cells between two intervention arms	3 months
Percentage (%) of CD8+ (cluster of differentiation 8) T cells	Difference in change-from-baseline percentage (%) of CD8+ T cells between two intervention arms	3 months
Percentage (%) of monocytes	Difference in change-from-baseline percentage (%) of monocytes between two intervention arms	3 months
Lean tissue mass (kg)	Difference in change-from-baseline lean tissue mass (kg) between two intervention arms	3 months
Fat tissue mass (kg)	Difference in change-from-baseline fat tissue index (kg) between two intervention arms	3 months
Lean tissue index (kg/m2)	Difference in change-from-baseline lean tissue index (kg/m2) between two intervention arms	3 months
Fat tissue index (kg/m2)	Difference in change-from-baseline fat tissue index (kg/m2) between two intervention arms	3 months
Percentage (%) of body fat mass	Difference in change-from-baseline percentage (%) of body fat mass between two intervention arms	3 months
Percentage (%) of excess body fat	Difference in change-from-baseline percentage (%) of excess body fat between two intervention arms. Excess body fat is defined as fat percentage > 25 % for men or > 35 % for women	3 months
Percentage (%) of obesity	Difference in change-from-baseline percentage (%) of obesity between two intervention arms. Obesity is defined as body mass index > 24.	3 months

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Wan-Chuan Tsai, M.D., Ph.D., Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Blood Protein Disorders; Renal Insufficiency, Chronic; Hypoproteinemia; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Hypoalbuminemia
• Other Study ID Numbers: FEMH-IRB-109116-F

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