Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease

End Stage Renal Disease Clinical Trial

Official title: Protein Intake, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease (CKD)

Status Completed

Clinical Trial Summary

National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.

The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.

Clinical Trial Description

It is hypothesized that in the dialysis population overall: (1) Protein intake is a major determinant of muscle mass while inflammation, oxidative stress and metabolic acidosis play a lesser role; (2) Malnutrition is not an uremic cardiovascular risk factor hence low protein intake does not cause cardiovascular disease; and (3) In the other extreme, high protein intake is also not a major cause of cardiovascular disease since high serum phosphorus associated with high protein intake can usually be controlled by the use of phosphorus binders in routine clinical practice.

The specific aims of this proposal are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake (TPI) in grams/day, or dietary protein intake (DPI) normalized to body weight in grams/kilogram/day) with

1. Nutritional status (mid-thigh muscle mass as measured by Magnetic Resonance Imaging ) and functional status (6-min walk) and

2. Arterial stiffness (aortic pulse wave velocity)

Understanding the relationship between protein intake with body composition (muscle mass) and intermediate cardiovascular outcomes (arterial stiffness) in stage 5 CKD patients in hemodialysis is of great scientific and practical significance ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

• NCT number: NCT00566670
• Study type: Observational
• Source: University of Utah
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Completion date: October 2015