NCT02194114

Dietary Protein Requirements in Hemodialysis Patients

Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.

Detailed description

A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend = 1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of insufficient duration, that were usually carried out with obsolete types of dialysis therapy. We will examine the response to different levels of dietary protein intake (0.6-1.3 g protein/kg/day) under classical balance techniques with carefully controlled dietary intakes, living, conditions, and collection of nitrogen outputs and carefully measured nitrogen intakes and outputs.

Conditions

• Chronic Renal Failure
• End-Stage Renal Disease

Interventions

Type	Name	Description
OTHER	Protein Diet	Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2014-07-18
• Last updated: 2014-07-18

Locations

1 site across 1 country: United States