Nutritional Interventions in Peritoneal Dialysis Patients With Hypoalbuminemia

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04546958
• Other study ID #: FEMH-IRB-109116-F
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Whey protein supplements
Nutritional counseling and whey protein supplements for 3 months

Other:
• Nutritional counseling
Nutritional counseling by dietitians for 3 months

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of albumin (g/dL)	Difference in change-from-baseline albumin (g/dL) between two intervention arms	3 months
Secondary	Concentrations of pre-albumin (g/dL)	Difference in change-from-baseline pre-albumin (g/dL) between two intervention arms	3 months
Secondary	Concentrations of C-reactive protein (mg/dL)	Difference in change-from-baseline C-reactive protein (mg/dL) between two intervention arms	3 months
Secondary	Concentrations of phosphate (mg/dL)	Difference in change-from-baseline phosphate (mg/dL) between two intervention arms	3 months
Secondary	Concentrations of blood urea nitrogen (mg/dL)	Difference in change-from-baseline blood urea nitrogen (mg/dL) between two intervention arms	3 months
Secondary	Concentrations of free indoxyl sulfate (mg/L)	Difference in change-from-baseline free indoxyl sulfate (mg/L) between two intervention arms	3 months
Secondary	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
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 two intervention arms	3 months
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 two intervention arms	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage (%) of monocytes	Difference in change-from-baseline percentage (%) of monocytes between two intervention arms	3 months
Secondary	Lean tissue mass (kg)	Difference in change-from-baseline lean tissue mass (kg) between two intervention arms	3 months
Secondary	Fat tissue mass (kg)	Difference in change-from-baseline fat tissue index (kg) between two intervention arms	3 months
Secondary	Lean tissue index (kg/m2)	Difference in change-from-baseline lean tissue index (kg/m2) between two intervention arms	3 months
Secondary	Fat tissue index (kg/m2)	Difference in change-from-baseline fat tissue index (kg/m2) between two intervention arms	3 months
Secondary	Percentage (%) of body fat mass	Difference in change-from-baseline percentage (%) of body fat mass between two intervention arms	3 months
Secondary	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
Secondary	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