Protein Supplementation in Dialysis Patients

NCT01855295 | Completed

• 1 other identifier: IRB_00036763
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum albumin is a strong predictor of morbidity and mortality in dialysis patients. Hypercatabolism induced by inflammation is widely considered the cause of uremic malnutrition even though there is no clear evidence that hemodialysis patients with elevated C-reactive protein (CRP) levels are at greater risk of losing weight or muscle mass. Conversely, there is little data on whether dialysis patients with malnutrition and elevated C-reactive protein levels would gain muscle mass with protein supplementation. The hypothesis is that protein supplementation during dialysis will improve muscle mass, functional status and quality of life in inflamed malnourished hemodialysis patients. Therefore, the objectives of the current proposal are to examine in malnourished (body mass index \< 23 kg/m2 or serum creatinine \< 8 mg/dL) hemodialysis patients with inflammation (high sensitivity CRP \> 3 mg/dL), the effects of protein supplementation on

1. 1.Muscle mass as determined by creatinine kinetics
2. 2.Functional status as assessed by 6 min walk
3. 3.Quality of life as assessed by Short Form -12 survey

Conditions

End Stage Renal Disease

Keywords

Dialysis; End Stage Renal Disease; Protein supplementation; Inflammation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Protein Stores as measured by mid arm circumference (cm)

  Triceps skin fold thickness and mid-arm muscle arm circumference are measured to assess protein stores.

  Baseline to 24 weeks

Study Arms (1)

Protein Supplementation

EXPERIMENTAL

Hemodialysis patients with inflammation and low body mas index to receive protein dietary advice and protein supplements while on dialysis

Dietary Supplement: Protein Supplement

Interventions

Protein Supplement DIETARY_SUPPLEMENT

During the treatment phase, study subjects are advised to increase protein intake to 1.2 g/kg/day for 12 weeks. In addition to any protein supplementation the participant is on, supervised supplementation on each dialysis session is provided. Each participant receives 45 grams of liquid protein supplement (Provide Sugar Free produced by Provide Nutrition LC) at each dialysis treatment for additional 12 weeks for total study duration of 24 weeks.

Protein Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects (men and women) on hemodialysis for at least 3 months
• Inflammation (high sensitivity CRP \> 3 mg/dL)
• Body Mass Index \< 23 kg/m2; or low muscle mass as evidenced by serum creatinine \< 8 mg/dL in the presence of anuria (urine output \< 200 ml/d) and adequate dialysis (Urea Reduction Ratio \> 65%).

You may not qualify if:

• Pregnant subjects
• Subjects who are prisoners

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Medicine

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 16, 2013
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2012
• Last Updated: August 11, 2016

Record last verified: 2016-08