Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; End Stage Renal Disease; Hypoalbuminemia
• Intervention / Treatment: Dietary supplement: Protein Food Bar Intelligent Indulgence; Dietary supplement: Protein Food Bar Intelligent Indulgence; Dietary supplement: Protein Food Bar Intelligent Indulgence

• Study Type: Interventional
• Enrollment (Anticipated): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94041
      • Satellite Healthcare, Inc.
    • Mountain View, California, United States, 94041
      • WellBound, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Center Hemodialysis patients	Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months; Dietary supplement: Protein Food Bar Intelligent Indulgence; 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; Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
Active Comparator: Group B; Center hemodialysis patients	Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months; Dietary supplement: Protein Food Bar Intelligent Indulgence; 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; Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
No Intervention: Group C; Center Hemodialysis Patients
Active Comparator: Group D; Peritoneal dialysis patients	Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months; Dietary supplement: Protein Food Bar Intelligent Indulgence; 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; Dietary supplement: Protein Food Bar Intelligent Indulgence; Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
No Intervention: Group E; Peritoneal dialysis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Each month for the three months.
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.	Each month for 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period	Month 3
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.	Each month for 3 months
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored	Each month for 3 months

Collaborators and Investigators

• Sponsor: Satellite Healthcare
• Investigators: Principal Investigator: Brigitte Schiller-Moran, MD, Satellite Healthcare, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (Estimate): January 17, 2008

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialysis; Malnutrition; Dietary Supplements; Peritoneal Dialysis; Hypoalbuminemia
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Nutrition Disorders; Blood Protein Disorders; Renal Insufficiency, Chronic; Hypoproteinemia; Kidney Failure, Chronic; Malnutrition; Hypoalbuminemia
• Other Study ID Numbers: SR017PB