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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
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
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
Satellite Healthcare, Inc.
Mountain View, California, United States
WellBound, Inc.
Mountain View, California, United States
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.
Time frame: 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.
Time frame: Each month for 3 months
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
Time frame: 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.
Time frame: Each month for 3 months
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Time frame: Each month for 3 months
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