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
Verified date | September 2023 |
Source | Far Eastern Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Taiwan,
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 |
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