End Stage Renal DiseaseNCT01855295
Protein Supplementation in Dialysis Patients
A study testing Protein Supplement in people with End Stage Renal Disease, run by University of Utah.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Protein Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- Pregnant subjects
- Subjects who are prisoners
About this study
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
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Protein Supplement
- Keywords
- Dialysis, End Stage Renal Disease, Protein supplementation, Inflammation, Quality of Life
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplementation | Experimental | Hemodialysis patients with inflammation and low body mas index to receive protein dietary advice and protein supplements while on dialysis Receives: Dietary Supplement: Protein Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinvasan Beddhu, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855295
- Sponsor's protocol ID
- IRB_00036763
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Supplementation in Dialysis Patients
- ClinicalTrials.gov ID
- NCT01855295
- Acronym / sponsor ID
- IRB_00036763
- Conditions
- End Stage Renal Disease
- Keywords
- Dialysis, End Stage Renal Disease, Protein supplementation, Inflammation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein Supplementation | Experimental | Dietary Supplement: Protein SupplementHemodialysis patients with inflammation and low body mas index to receive protein dietary advice and protein supplements while on dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%).
Key exclusion criteria (2 listed)
- Pregnant subjects
- Subjects who are prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein SupplementDuring 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. | Dietary supplement | Protein Supplementation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Supplement in people with End Stage Renal Disease, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Stores as measured by mid arm circumference (cm) (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016; AzTrials last refreshed its copy on 2 Nov 2026.