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

Not Applicable

Completed

• Conditions: Hypoalbuminemia; End Stage Renal Disease; Malnutrition
• Interventions: Dietary Supplement: Protein Food Bar Intelligent Indulgence

• Registration Number: NCT00597025
• Lead Sponsor: Satellite Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2019-04
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Protein Food Bar Intelligent Indulgence	Center hemodialysis patients
Group D	Protein Food Bar Intelligent Indulgence	Peritoneal dialysis patients
Group A	Protein Food Bar Intelligent Indulgence	Center Hemodialysis patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Satellite Healthcare, Inc.; 🇺🇸 Mountain View, California, United States

WellBound, Inc.; 🇺🇸 Mountain View, California, United States