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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597025
• Other study ID #: SR017PB
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hypoalbuminemia
• Kidney Failure, Chronic
• Malnutrition

Intervention

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
• 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
• Protein Food Bar Intelligent Indulgence
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.

Locations

Country	Name	City	State
United States	Satellite Healthcare, Inc.	Mountain View	California
United States	WellBound, Inc.	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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