Dietary Protein Requirements in Hemodialysis 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.

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein Diet

Other

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 outcomes

Nitrogen Balance

Time frame: One year

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Jul 18, 2014
Registry last updated: Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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