• Increase in visceral protein stores as measured by serum albumin [ Time Frame: 3 months minimum; 6 months max ] [ Designated as safety issue: No ]
  

Fifty patients identified as having poor nutrition by the following criteria:

1. Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.

2. one of the four following criteria:

   1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
   2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
   3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month

   4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

      1. Serum transferrin concentration less than 225 mg/dl
      2. Serum prealbumin concentration less than 32 mg/dl

will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.

Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.

Inclusion Criteria:

• On hemodialysis
• Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V >1.2)
• Patient or next of kin able to sign consent form
• Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.

• Sub-optimal nutritional status identified by one of the four following criteria:

  1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
  2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
  3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month

  4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

     1. Serum transferrin concentration less than 225 mg/dl
     2. Serum prealbumin concentration less than 32 mg/dl
• Patient is able to transfer with minimal or no assistance.
• Not taking a caloric nutritional supplement for the last 30 days (e.g. Nepro, ProStat, Boost,etc).

Exclusion Criteria:

• Active auto-immune, inflammatory or infectious disease
• Documented malignancy within the last 12 months
• Patients on unusual dietary restrictions
• Life-expectancy less than 6 months
• Inability to tolerate nutritional supplements
• Patient does not exceed the DEXA machine weight limit.