Protein Supplementation in Dialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 73
- Primary Endpoint
- Protein Stores as measured by mid arm circumference (cm)
Study Overview
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
- Muscle mass as determined by creatinine kinetics
- Functional status as assessed by 6 min walk
- Quality of life as assessed by Short Form -12 survey
Detailed Description
Design: Open labeled trial.
Recruitment and Randomization: Men and women aged 18 or older receiving care at the University of Utah dialysis centers.
Study procedures: Men and women on hemodialysis for at least for 3 months with malnutrition (defined as Body Mass Index less than 23 kg/m2 or serum creatinine < 8 mg/dL) will be approached to determine whether they want to participate in the study. If they are interested, the study purpose and procedures will be explained and informed consent obtained. 5 ml of screening blood will be obtained before dialysis to measure CRP. If it is greater than > 3 mg/dL, that individual will be eligible to participate in the study. Participants will be asked to complete a brief questionnaire on demographics (age, gender, race, education), comorbid conditions, physical activity level and quality of life. Height, weight, and waist circumference will be measured. Relevant data on dialysis, medications, laboratory markers will be obtained from the electronic medical records.
The investigators anticipate to obtain screening blood draw in about 80 participants and that about half of these will have elevated CRP and qualify to participate in the study. The 40 participants will receive dietary advice to increase protein intake to 1.2 g/kg/day and monitored for 12 weeks. Then, each participant will receive 45 grams of liquid protein supplement at each dialysis treatment for additional 12 weeks for total study duration of 24 weeks. Compliance and tolerance of the supplement will be monitored.
Protein supplementation such as Boost, Procel or liquid supplements is used regularly in dialysis patients. The protein supplement used in the study is Provide Sugar Free produced by Provide Nutrition LC. The Food and Drug Administration regulates it as a nutrition supplement. It is a liquid supplement made from enzyme hydrolyzed collagen protein. This supplement is used in malnutrition, bariatric surgery, dialysis, poor appetite, and wound care. The investigators chose this supplement because the investigators were able to get it at a reduced cost. There is no data available to show that this supplement is better or worse than any other supplements currently available. The manufacturer states that the sugar free Provide is phosphorous free. However, the investigators will monitor phosphorous levels in the study patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Protein Stores as measured by mid arm circumference (cm)
Time Frame: Baseline to 24 weeks
Triceps skin fold thickness and mid-arm muscle arm circumference are measured to assess protein stores.
Secondary Outcomes
No secondary outcomes reported
Investigators
Srinvasan Beddhu
MD, Professor of Medicine
University of Utah