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

NCT ID: NCT00597025

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

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.

Conditions

End Stage Renal Disease; Hypoalbuminemia; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Center Hemodialysis patients

Group Type: ACTIVE_COMPARATOR

Protein Food Bar Intelligent Indulgence

Intervention Type: DIETARY_SUPPLEMENT

Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

Group B

Center hemodialysis patients

Group Type: ACTIVE_COMPARATOR

Protein Food Bar Intelligent Indulgence

Intervention Type: DIETARY_SUPPLEMENT

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

Group C

Center Hemodialysis Patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group D

Peritoneal dialysis patients

Group Type: ACTIVE_COMPARATOR

Protein Food Bar Intelligent Indulgence

Intervention Type: DIETARY_SUPPLEMENT

Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.

Group E

Peritoneal dialysis patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protein Food Bar Intelligent Indulgence

Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satellite Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte Schiller-Moran, MD

Role: PRINCIPAL_INVESTIGATOR

Satellite Healthcare, Inc.

Locations

Satellite Healthcare, Inc.

Mountain View, California, United States

WellBound, Inc.

Mountain View, California, United States

Countries

United States

Other Identifiers

SR017PB

Identifier Type: -

Identifier Source: org_study_id