Chronic Renal Failure, End-Stage Renal Disease
Conditions
Keywords
Chronic Renal Failure, End-Stage Renal Disease, Nitrogen Balance, Dietary Protein Intake
Brief 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.
Interventions
OTHERProtein 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.
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages from 30 years through 65 years * Both men and women and all ethnic and racial groups * Treatment with MHD for 6 months or greater * Hemoglobin of at least 11 g/dL * Neurological examination indicating no severe neuropathy * A negative test for peripheral arterial occlusive disease
Exclusion criteria
* Obesity: body weight greater than \>115% of standard * History of active cancer other than basal cell carcinoma * Symptomatic severe ischemic heart disease, uncontrolled serious dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputations of the lower extremities * Insulin dependent or insulin independent diabetes mellitus * Severe lung or liver disease, uncontrolled asthma, active vasculitis. Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses * Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol * Alcohol or other recreational drug abuse * Patients who received L-carnitine or anabolic hormones within the previous 6 months * Pregnancy * Patients who are physically and/or psychologically incapable of undergoing the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nitrogen Balance | One year |
Countries
United States
Outcome results
None listed