- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01855295
Protein Supplementation in Dialysis Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Pre-dialysis blood sample (15 ml in lithium heparin tube) and post dialysis blood sample (5 ml in lithium heparin tube) will be drawn at baseline, 4, 12, 16 and 20 weeks. Pre and post dialysis creatinine along with 44-hour urine collection for creatinine will be obtained at baseline 4, 12, 16 and 24 weeks for estimating muscle mass using creatinine kinetics. Short Form -12 survey for quality of life will be obtained at baseline 4, 12, 16, and 24 weeks. Distances walked during in 6-minutes will be recorded at baseline, 4, 12, 16 and 24 weeks.
Assays of Serum analytes:
- Interleukin-6 (IL-6): The measurement of serum IL-6 will be performed using an IMMULITE 1000 analyzer and reagents from Diagnostic Products Corporation. The performance characteristics of this immunoassay include an analytic measurement range of 2 to 1000 pg/mL, imprecision of <7.6% from 88 to 1000 pg/mL, and a reference interval of <6 pg/mL.
- Tumor necrosis factor-alpha (TNF-alpha): The measurement of serum TNF- alpha will be performed using an IMMULITE 1000 analyzer and reagents from Diagnostic Products Corporation. The performance characteristics of this immunoassay include an analytic measurement range of 2 to 1000 pg/mL, imprecision of <6.6% from 17 to 788 pg/mL, and a reference interval of <8 pg/mL.
- high sensitivity CRP: The measurement of serum C-reactive protein will be performed using the FDA-cleared Roche Tina-quant latex high sensitivity kit on a Roche MODULAR P analyzer. The performance characteristics of this turbidimetric assay include an analytic measurement range of 0.1 to 20 mg/L and imprecision of <5.8%.
- Insulin: The measure of insulin will be performed using a Diagnostic Products Corporation kit on an IMMULITE 2000 analyzer. The performance characteristics of this immunoassay include an analytic measurement range of 2 to 300 mIU/L , imprecision of <7.4% from 8 to 291 mIU/L, and a fasting reference interval of <29 mIU/L.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- 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%).
Exclusion criteria
- Pregnant subjects
- Subjects who are prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein Supplementation
Hemodialysis patients with inflammation and low body mas index to receive protein dietary advice and protein supplements while on dialysis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00036763
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Renal Disease
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Changhai Hospital; Shanghai Zhongshan Hospital; RenJi Hospital; Ruijin Hospital; Shanghai... and other collaboratorsCompleted
-
Clinical Research Center for End Stage Renal Disease...Kyungpook National University Hospital; Medical Research Collaborating Center... and other collaboratorsActive, not recruitingEnd-Stage Renal DiseaseKorea, Republic of
-
Medtronic - MITGCompletedEnd-stage Renal DiseaseGermany
-
China Medical University HospitalUnknown
-
Guangdong Provincial Hospital of Traditional Chinese...Ministry of Science and Technology of the People´s Republic of ChinaUnknown
-
University of California, San FranciscoCompletedEnd-stage Renal DiseaseUnited States
-
Mark A. LumleyHenry Ford Health SystemCompleted
Clinical Trials on Protein Supplement
-
McMaster UniversityRecruitingHealthy | Muscle Disuse AtrophyCanada
-
Icahn School of Medicine at Mount SinaiCompletedGrowth in Premature InfantsUnited States
-
Texas Tech UniversityEHP LabsCompletedBody Weight Changes | Body Composition Changes | Anthropometric Changes | Metabolism Changes | Hemodynamic ChangesUnited States
-
Hospital Universitari Vall d'Hebron Research InstituteNot yet recruiting
-
University of ExeterCompleted
-
Concordia University, MontrealActive, not recruitingObesity | Obesity; EndocrineCanada
-
Kamshad Raiszadeh, MDUniversity of California, San DiegoSuspended
-
Near East University, TurkeyCompletedTo Study the Effects of Protein Supplements on Blood TestsCyprus
-
Peking Union Medical College HospitalNot yet recruiting
-
Arthur van ZantenRousselot BVBA; Intensive Care Research Foundation, Gelderse Vallei HospitalRecruitingCritical Illness | Intensive Care Unit Acquired WeaknessNetherlands