Dietary Protein Requirements in Hemodialysis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: End-Stage Renal Disease; Chronic Renal Failure
• Intervention / Treatment: Other: Protein Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Protein Intake; One treatment Arm; Protein Diet: All patients will be fed the following five diets, in random order, each for 17-19 days: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nitrogen Balance	One year

Collaborators and Investigators

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Investigators: Principal Investigator: Joel D Kopple, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Publications and helpful links

General Publications

• Shah A, Bross R, Shapiro BB, Morrison G, Kopple JD. Dietary energy requirements in relatively healthy maintenance hemodialysis patients estimated from long-term metabolic studies. Am J Clin Nutr. 2016 Mar;103(3):757-65. doi: 10.3945/ajcn.115.112995. Epub 2016 Feb 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Renal Failure; Nitrogen Balance; End-Stage Renal Disease; Dietary Protein Intake
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 10602 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)