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

Satellite Healthcare

Status: Completed

Conditions: Hypoalbuminemia; Malnutrition; End Stage Renal Disease

Treatments: Dietary Supplement: Protein Food Bar Intelligent Indulgence

Study type: Interventional

Funder types: Other

Identifiers

NCT00597025

SR017PB

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 5 patient groups

Group A

Active Comparator group

Description:

Center Hemodialysis patients

Treatment:

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group B

Active Comparator group

Description:

Center hemodialysis patients

Treatment:

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group C

No Intervention group

Description:

Center Hemodialysis Patients

Group D

Active Comparator group

Description:

Peritoneal dialysis patients

Treatment:

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group E

No Intervention group

Description:

Peritoneal dialysis patients