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Dietary Protein Requirements in Hemodialysis Patients

Primary Purpose

Chronic Renal Failure, End-Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Diet
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Renal Failure focused on measuring Chronic Renal Failure, End-Stage Renal Disease, Nitrogen Balance, Dietary Protein Intake

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Protein Intake

Arm Description

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.

Outcomes

Primary Outcome Measures

Nitrogen Balance

Secondary Outcome Measures

Full Information

First Posted
July 16, 2014
Last Updated
July 16, 2014
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02194114
Brief Title
Dietary Protein Requirements in Hemodialysis Patients
Official Title
Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, End-Stage Renal Disease
Keywords
Chronic Renal Failure, End-Stage Renal Disease, Nitrogen Balance, Dietary Protein Intake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Protein Intake
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Protein Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nitrogen Balance
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel D Kopple, MD
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26864370
Citation
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.
Results Reference
derived

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Dietary Protein Requirements in Hemodialysis Patients

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