Back to resultsImpact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Primary Purpose
End Stage Renal Disease, Hypoalbuminemia, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Food Bar Intelligent Indulgence
Protein Food Bar Intelligent Indulgence
Protein Food Bar Intelligent Indulgence
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Malnutrition, Hypoalbuminemia, Dietary Supplements, Hemodialysis, Peritoneal Dialysis
Eligibility Criteria
Inclusion Criteria:
- Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
- 18 years of age or older.
- Must have a reasonable expectation of remaining on treatment for at least 3 months.
- Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study.
- Must be able to understand and sign the informed consent.
- Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.
Exclusion Criteria:
- Allergy to protein, milk, nuts or wheat.
- Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
- Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L.
- Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
- Hospitalization for an infectious condition within 4 weeks prior to study entry.
- Planned surgery within the three month study period including planned kidney transplantation.
Sites / Locations
- Satellite Healthcare, Inc.
- WellBound, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
No Intervention
Active Comparator
No Intervention
Arm Label
Group A
Group B
Group C
Group D
Group E
Arm Description
Center Hemodialysis patients
Center hemodialysis patients
Center Hemodialysis Patients
Peritoneal dialysis patients
Peritoneal dialysis patients
Outcomes
Primary Outcome Measures
The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.
Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.
Secondary Outcome Measures
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00597025
Brief Title
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Official Title
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satellite Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hypoalbuminemia, Malnutrition
Keywords
Malnutrition, Hypoalbuminemia, Dietary Supplements, Hemodialysis, Peritoneal Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Center Hemodialysis patients
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Center hemodialysis patients
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Center Hemodialysis Patients
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Peritoneal dialysis patients
Arm Title
Group E
Arm Type
No Intervention
Arm Description
Peritoneal dialysis patients
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Food Bar Intelligent Indulgence
Intervention Description
Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Food Bar Intelligent Indulgence
Intervention Description
Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Food Bar Intelligent Indulgence
Intervention Description
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
Primary Outcome Measure Information:
Title
The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.
Time Frame
Each month for the three months.
Title
Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.
Time Frame
Each month for 3 months
Secondary Outcome Measure Information:
Title
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
Time Frame
Month 3
Title
Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.
Time Frame
Each month for 3 months
Title
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Time Frame
Each month for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
18 years of age or older.
Must have a reasonable expectation of remaining on treatment for at least 3 months.
Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study.
Must be able to understand and sign the informed consent.
Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.
Exclusion Criteria:
Allergy to protein, milk, nuts or wheat.
Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L.
Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
Hospitalization for an infectious condition within 4 weeks prior to study entry.
Planned surgery within the three month study period including planned kidney transplantation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Schiller-Moran, MD
Organizational Affiliation
Satellite Healthcare, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Healthcare, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States
Facility Name
WellBound, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States
12. IPD Sharing Statement
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Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
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