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Nutritional Interventions in Peritoneal Dialysis Patients with Hypoalbuminemia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04546958
Enrollment
33
Registered
2020-09-14
Start date
2020-10-02
Completion date
2024-12-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease on Dialysis

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTWhey protein supplements

Nutritional counseling and whey protein supplements for 3 months

OTHERNutritional counseling

Nutritional counseling by dietitians for 3 months

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Laboratory technicians who assess the study outcomes will be masked

Intervention model description

A randomized, active-controlled trial with cross-over design

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concentrations of albumin (g/dL)3 monthsDifference in change-from-baseline albumin (g/dL) between two intervention arms

Secondary

MeasureTime frameDescription
Concentrations of C-reactive protein (mg/dL)3 monthsDifference in change-from-baseline C-reactive protein (mg/dL) between two intervention arms
Concentrations of phosphate (mg/dL)3 monthsDifference in change-from-baseline phosphate (mg/dL) between two intervention arms
Concentrations of blood urea nitrogen (mg/dL)3 monthsDifference in change-from-baseline blood urea nitrogen (mg/dL) between two intervention arms
Concentrations of free indoxyl sulfate (mg/L)3 monthsDifference in change-from-baseline free indoxyl sulfate (mg/L) between two intervention arms
Concentrations of free p-cresol sulfate (mg/L)3 monthsDifference in change-from-baseline free p-cresol sulfate (mg/L) between two intervention arms
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells3 monthsDifference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between two intervention arms
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells3 monthsDifference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between two intervention arms
Absolute number (per μl blood) of monocytes3 monthsDifference in change-from-baseline absolute number (per μl blood) of monocytes between two intervention arms
Percentage (%) of CD4+ (cluster of differentiation 4) T cells3 monthsDifference in change-from-baseline percentage (%) of CD4+ T cells between two intervention arms
Concentrations of pre-albumin (g/dL)3 monthsDifference in change-from-baseline pre-albumin (g/dL) between two intervention arms
Percentage (%) of monocytes3 monthsDifference in change-from-baseline percentage (%) of monocytes between two intervention arms
Lean tissue mass (kg)3 monthsDifference in change-from-baseline lean tissue mass (kg) between two intervention arms
Fat tissue mass (kg)3 monthsDifference in change-from-baseline fat tissue index (kg) between two intervention arms
Lean tissue index (kg/m2)3 monthsDifference in change-from-baseline lean tissue index (kg/m2) between two intervention arms
Fat tissue index (kg/m2)3 monthsDifference in change-from-baseline fat tissue index (kg/m2) between two intervention arms
Percentage (%) of body fat mass3 monthsDifference in change-from-baseline percentage (%) of body fat mass between two intervention arms
Percentage (%) of excess body fat3 monthsDifference 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
Percentage (%) of obesity3 monthsDifference in change-from-baseline percentage (%) of obesity between two intervention arms. Obesity is defined as body mass index \> 24.
Percentage (%) of CD8+ (cluster of differentiation 8) T cells3 monthsDifference in change-from-baseline percentage (%) of CD8+ T cells between two intervention arms

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026