Nutritive compositions and methods of using same   

Abstract: The invention provides intradialytic parenteral nutrition (IDPN) compositions with low carbohydrate for the treatment of malnutrition in dialysis subjects. In some embodiments, the IDPN compositions are advantageous for the treatment of malnutrition in subjects who are diabetic or suffer from other glucose management related pathologies or subjects who benefit from strict fluid management.

This application claims priority to U.S. Provisional App. No. 61/292,139, filed on Jan. 4, 2010, and U.S. Provisional App. No. 61/292,806, filed on Jan. 6, 2010. Each of the above applications is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The invention provides nutrition supplement compositions for subjects receiving dialysis treatment and methods of using the nutrition supplement compositions. In some embodiments the nutrition supplement compositions comprise reduced levels of carbohydrates and lower volume to reduce complications in subjects. In some cases, the subjects are diabetic or suffer from other glucose management related pathologies, or subjects benefit from strict fluid management.

BACKGROUND OF THE INVENTION

Severe malnutrition remains a problem for subjects receiving maintenance hemodialysis (MHD). Dialysis subjects often have poor appetites and low energy. This malnutrition is reflected in low serum albumin concentrations, a strong predictor of increased morbidity and mortality. (Moore and Lindenfield, Support Line 29(5):7-16 (October 2007)). Subjects are often treated using diet liberalization, oral supplements and enteral feeding. When these methods are not effective intradialytic parenteral nutrition (IDPN) can be utilized for more aggressive nutrition repletion efforts.

IDPN is infused during the hemodialysis procedure. IDPN has been used for decades and has resulted in weight gain and improved protein levels in subjects. (U.S. Publication No. 2005/0148647). During IDPN infusion into a subject, the subject\'s blood glucose must be monitored to avoid problems, such as hyperglycemia and hypoglycemia. Serum bicarbonate and carbon dioxide levels must also be monitored to check for acidosis caused by administration of amino acids.

IDPN is usually administered in one liter of solution, and occasionally micronutrients, like vitamins and minerals are co-administered in or with IDPN. Literature suggests that IDPN is effective in decreasing morbidity and mortality in hemodialysis (MHD) subjects, leads to increased levels of serum albumin and creatinine levels, and increased body weight. (Moore and Celano, Nutrition in Clinical Practice, 20(2):202-212 (2005)). Hypoglycemia is another potential dangerous result of the administration of insulin during IDPN with symptoms of nervousness, sweating, intense hunger, trembling, weakness, palpitations, and trouble speaking.

Problems associated with IDPN include hyperglycemia, complications in subjects with insulin resistance or other problems associated with glucose management, as well as complications in subjects who require strict fluid management. The glucose concentrations administered with IDPN can cause hyperglycemia and hypoglycemia in some subjects. The administration of insulin can sometimes successfully treat this hyperglycemia, but some subjects demonstrate insulin resistance, and might not respond to insulin treatment. (Goldstein and Strom, Journal of Renal Nutrition 1(1):9-22 (January 1991)). Hyperglycemia is a major barrier to effective nutrition support even outside the context of hemodialysis. Many studies report associations between hyperglycemia and increased morbidity and mortality. (McCowen and Bistrian, Nutrition in Clinical Practice, 19(3):235-244 (June 2004)). Moreover, the amount of fluid in typical IDPN treatment is a barrier to use in subjects with strict fluid management.

SUMMARY

In one aspect the invention provides a sterile aqueous composition for parenteral administration comprising between 2 and 26 g of dextrose; and between 12 and 45 g of amino acids; wherein the dosage form is an aqueous composition has a volume less than 450 mL.

In another aspect the invention provides a sterile aqueous composition for parenteral administration comprising between 2 and 26 g of dextrose; between 12 and 45 g of amino acids; and between 8 and 25 g of lipids. In one embodiment the amino acids comprise seventeen amino acids. In another embodiment the seventeen amino acids are lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment an aqueous composition further comprises lipids. In another embodiment the lipids are present in the aqueous composition in an amount between 5 to 30% mass/volume. In another embodiment the lipids are present in the aqueous composition in an amount less than 5% mass/volume. In another embodiment the lipids are present in the aqueous composition in an amount between 5 to 30% mass/volume. In another embodiment the lipids are present in the aqueous composition in an amount less than 5% mass/volume. In another embodiment an aqueous composition further comprises micronutrients. In another embodiment the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition.

In another aspect the invention provides a method for treating or preventing malnutrition in a hemodialysis subject in need thereof comprising formulating an aqueous composition comprising between 0 and 10% mass/volume of dextrose and 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and, optionally, the intended duration of the hemodialysis and parenterally administering said aqueous composition in conjunction with the hemodialysis. In another embodiment, the composition further comprises lipids. In another embodiment, the composition is lipid free. In another embodiment, the composition is carbohydrate free. In one embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 6 months. In another embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 12 months. In another embodiment embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 years. In another embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 5 years. In another embodiment the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 10 years. In another embodiment treating the malnutrition comprises raising said subject\'s albumin levels to at least about 3.8 g/dL. In another embodiment the aqueous composition comprises between 2 and 7% dextrose and between 9 and 16% amino acids. In another embodiment the aqueous composition lacks lipids. In another embodiment the aqueous composition comprises lipids. In another embodiment hemodialysis is performed with a Fresenius 2008 series, a B.Braun Dialog+, a Gambro Phoenix System, a Redy 2000, a Baxter SPS550/1550, an Althin 1000, an Althin Altratouch 1000, an Althin Tina, a Meridian, an Aurora system 1000, a NxStage System, or a Fresinius 2008K dialysis machine. In another embodiment the aqueous composition is introduced into a hemodialysis machine by a venous drip chamber. In another embodiment the subject is administered said aqueous composition 1-5 times per week. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-3 months. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-6 months. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-12 months. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-3 years. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-5 years. In another embodiment the subject is administered said aqueous composition each time said subject undergoes dialysis for 1-10 years. In another embodiment the subject\'s albumin levels increase by 0.2 g/deciliter within three months after the first administration of said composition. In another embodiment the subject\'s albumin levels increase by 0.4 g/deciliter within three months after the first administration of said composition. In another embodiment the subject is a child. In another embodiment the subject is under about 8 years old. In another embodiment the subject is under about 12 years old. In another embodiment the subject is from about 1 to about 18 years old. In another embodiment the subject is from about 5 to about 12 years old. In another embodiment the composition comprises less than 430 mls in volume. In another embodiment the subject is older than 18 years old. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during hemodialysis. In another embodiment the side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during hemodialysis. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject has diabetes. In another embodiment, the subject experiences higher nutrient absorption than a subject being administered a higher-volume composition. In another embodiment, the subject has reduced fluid accumulation during hemodialysis. In another embodiment, the subject accumulates less than 3 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 2 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 1 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 500 ml of fluid during hemodialysis. In another embodiment, the subject accumulates about 0-3 liter of fluid during hemodialysis. In another embodiment, the subject has a lower fluid weight post-hemodialysis then pre-hemodialysis. In another embodiment, the subject loses less than 100 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 250 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 500 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1.5 liters of fluid during hemodialysis. In another embodiment, the subject loses between 0-2 liters of fluid during hemodialysis. In another embodiment, the subject loses between 0-3 liters of fluid during hemodialysis. In another embodiment, the subject loses between 0-4 liters of fluid during hemodialysis. In another embodiment, the subject loses between 0-5 liters of fluid during hemodialysis. In another embodiment, the subject completes the hemodialysis without extra fluid weight. In another embodiment, the subject has a total weight post-hemodialysis that is about the same as the subject\'s weight pre-hemodialysis. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-20% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-15% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-10% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-5% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-25% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-30% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-15% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 10% of their pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the hemodialyis moduylates the blood glucose levels of the subject. In another embodiment, the hemodialyis moduylates the blood glucose levels of the subject. In another embodiment, the subject\'s blood glucose levels vary less than 30% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 30% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 25% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 25% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 20% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 20% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 15% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 15% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 10% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 10% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 5% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 5% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 0-10% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels decrease during dialysis. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 20% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 15% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 5% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 2% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by 0-10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by 0-5% as compared to the subject\'s pre-hemodialysis glucose levels.

In another aspect, the invention provides a method for treating or preventing malnutrition in a hemodialysis subject in need thereof comprising formulating an aqueous composition comprising between 0 to 10% mass/volume of dextrose, 7 to 20% mass/volume of amino acids and less than 5% mass/volume of lipids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis.

In another aspect, the invention provides a method for treating or preventing malnutrition in a hemodialysis pediatric subject in need thereof comprising formulating an aqueous composition comprising between 1 and 10% mass/volume of dextrose and 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In another embodiment the subject has a body mass less than 34 kg.

In another aspect, the invention provides a method of treating or preventing malnutrition in a pediatric hemodialysis subject, the method comprising parenterally administering a sterile aqueous composition to the subject, the composition comprising: an amount of dextrose from about 4 g to about 19 g and an amount of amino acids from about 13.5 g to about 42 g in a total volume of about 124 mL to about 357 mL, wherein the subject has a body mass of from 9 kg to 33 kg, wherein the administering is done at an infusion rate of from 17 mL/hour to 127 mL/hour.

In one embodiment, the invention provides a method of treating or preventing malnutrition in a subject, the method comprising parenterally administering a sterile aqueous composition to the subject, the composition comprising: an amount of dextrose from about 17 g to about 47 g and an amount of amino acids from about 51 g to about 105 g in a total volume of about 329 mL to about 817 mL, wherein the subject has a body mass of from 34 kg to at least 70 kg, wherein the administering is done at an infusion rate of from 45 mL/hour to 290 mL/hour.

In another aspect, the invention provides a method of treating or preventing malnutrition in a hemodialysis subject, the method comprising parenterally administering a sterile aqueous composition to the subject, the composition comprising: an amount of dextrose from about 17 g to about 47 g, an amount of amino acids from about 51 g to about 105 g, and an amount of lipids from 8.6 g about to about 24 in a total volume of about 372 mL to about 937 mL, wherein the subject has a body mass of at least 34 kg, wherein the administering is done at an infusion rate of from 45 mL/hour to 325 mL/hour.

In another aspect, the invention provides a sterile aqueous composition for parenteral administration comprising between 2 and 26 g of dextrose, and between 12 and 45 g of amino acids comprising branched-chain amino acids, wherein the composition is dosage form having a volume less than 450 mL. In another embodiment, the amino acids comprise 1-50% branched amino acids. In another embodiment, the amino acids comprise 1-40% branched amino acids. In another embodiment, the amino acids comprise 1-30% branched amino acids. In another embodiment, the amino acids comprise 1-20% branched amino acids. In another embodiment, the amino acids comprise 1-18% branched amino acids. In another embodiment, the amino acids comprise 1-10% branched amino acids. In another embodiment, the amino acids comprise about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50% branched amino acids. In another embodiment, the amino acids comprise more than 50% branched amino acids. In another embodiment, the amino acids comprise about 2.1-23 g of branched-chain amino acids. In another embodiment, the composition further comprises lipids. In another embodiment, the composition is lipid free. In some embodiments, the lipids are present in the aqueous composition in an amount between 5 to 30% mass/volume. In certain embodiments, the lipids are present in the aqueous composition in an amount less than 5% mass/volume. In another embodiment, the composition further comprises micronutrients. In another embodiment, the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition.

In another aspect, the invention provides a sterile aqueous composition for parenteral administration comprising between 12 and 45 g of amino acids comprising branched-chain amino acids, wherein the composition is dosage form having a volume less than 450 mL. In another embodiment, the amino acids comprise 1-50% branched amino acids. In another embodiment, the amino acids comprise 1-40% branched amino acids. In another embodiment, the amino acids comprise 1-30% branched amino acids. In another embodiment, the amino acids comprise 1-20% branched amino acids. In another embodiment, the amino acids comprise 1-18% branched amino acids. In another embodiment, the amino acids comprise 18-30% branched amino acids. In another embodiment, the amino acids comprise 1-10% branched amino acids. In another embodiment, the amino acids comprise about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50% branched amino acids. In another embodiment, the amino acids comprise more than 50% branched amino acids. In another embodiment, the amino acids comprise about 2.1-23 g of branched-chain amino acids. In another embodiment, the composition further comprises lipids. In another embodiment, the composition is lipid free. In some embodiments, the lipids are present in the aqueous composition in an amount between 5 to 30% mass/volume. In certain embodiments, the lipids are present in the aqueous composition in an amount less than 5% mass/volume. In another embodiment, the composition further comprises micronutrients. In another embodiment, the composition further comprises between 2 and 26 g of dextrose. In another embodiment, the composition further comprises a carbohydrate. In another embodiment, the composition is carbohydrate free. In another embodiment, the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition.

In another aspect, the invention provides for a sterile aqueous composition for parenteral administration comprising less than 0.1 g/mL of dextrose and between 12 and 45 g of amino acids, wherein the composition is a lipid-free dosage form having a volume less than 450 mL. In one embodiment, the amino acids comprise seventeen amino acids. In another embodiment, the seventeen amino acids are lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment, the composition further comprises micronutrients. In another embodiment, the composition is dextrose free. In another embodiment, the composition is carbohydrate free. In another embodiment, the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition.

In another aspect, the invention provides for a method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating an aqueous composition comprising less than 0.1 g/mL of dextrose, and 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In one embodiment, the method comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels to at least 3.8 g/dL. In another embodiment, said subject\'s albumin levels increase by 0.1 g/dL within three months after the first administration of said composition. In another embodiment, said subject\'s albumin levels increase by 0.2 g/dL within three months after the first administration of said composition. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 0.1 g/di to about 10 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 0.5 g/dl to about 5 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 1 g/di to about 5 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 2 g/dl to about 5 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 3 g/dl to about 5 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 4 g/dl to about 10 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 5 g/dl to about 10 g/dL. In another embodiment, the method for treating or preventing malnutrition comprises raising said subject\'s albumin levels from about 3 g/dl to about 10 g/dL within three months after the first administration of said composition. In another embodiment, the composition is less than 450 mL in volume. In another embodiment the subject is under about 8 years old. In another embodiment the subject is under about 12 years old. In another embodiment the subject is from about 1 to about 18 years old. In another embodiment the subject is from about 5 to about 12 years old. In another embodiment the composition comprises less than 430 mls in volume. In another embodiment the subject is older than 18 years old. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during hemodialysis. In another embodiment the side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during hemodialysis. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject has diabetes. In another embodiment, the subject experiences higher nutrient absorption than a subject being administered a higher-volume composition. In another embodiment, the subject has reduced fluid accumulation during hemodialysis. In another embodiment, the subject accumulates less than 3 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 2 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 1 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 500 ml of fluid during hemodialysis. In another embodiment, the subject accumulates about 0-3 liter of fluid during hemodialysis. In another embodiment, the subject has a lower fluid weight post-hemodialysis then pre-hemodialysis. In another embodiment, the subject loses less than 100 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 250 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 500 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1.5 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-2 liter of fluid during hemodialysis. In another embodiment, the subject completes the hemodialysis without extra fluid weight. In another embodiment, the subject has a total weight post-hemodialysis that is about the same as the subject\'s weight pre-hemodialysis. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-20% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-15% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-10% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within 1-5% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a total weight post-hemodialysis that is within about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject\'s pre-hemodialysis total weight. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-25% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-30% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-15% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 10% of their pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within 5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the subject has a post-hemodialysis blood glucose level that is within about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment, the hemodialyis moduylates the blood glucose levels of the subject. In another embodiment, the subject\'s blood glucose levels vary less than 20% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 20% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 10% during-hemodialysis In another embodiment, the subject\'s blood glucose levels vary less than 10% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 5% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 5% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% during-hemodialysis. In another embodiment, the subject\'s blood glucose levels vary less than 0-10% pre-, mid-, and post-hemodialysis. In another embodiment, the subject\'s blood glucose levels decrease during dialysis. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 20% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 15% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 5% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by at least 2% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by 0-10% as compared to the subject\'s pre-hemodialysis glucose levels. In another embodiment, the subject\'s post-hemodialysis blood glucose levels decrease by 0-5% as compared to the subject\'s pre-hemodialysis glucose levels.

In another aspect, the invention provides for a method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating an aqueous composition comprising between 1 and 10% mass/volume of dextrose, 7 to 20% mass/volume of amino acids of which at least 18% of said amino acids are branched-chain amino acids, and less than 5% mass/volume of lipids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In one embodiment the composition is carbohydrate free. In another embodiment the composition is lipid free. In another embodiment the formulating is further based on the intended duration of the hemodialysis. In another embodiment the duration of the hemodialysis is between 2 to 4.5 hrs. In another embodiment the duration of the hemodialysis is between 2.75 to 4 hrs. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels to at least about 3.8 g/dL. In another embodiment the subject\'s albumin levels increase by 0.1 g/deciliter within three months after the first administration of said composition. In another embodiment the subject\'s albumin levels increase by 0.2 g/deciliter within three months after the first administration of said composition. In another embodiment the composition is less than 430 mL in volume. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during dialysis. In another embodiment the side effects side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during dialysis. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-20% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject loses between 0-5 liters of fluid during dialysis. In another embodiment the subject loses between 0-4 liters of fluid during dialysis. In another embodiment the subject loses between 0-3 liters of fluid during dialysis. In another embodiment the subject loses between 0-2 liters of fluid during dialysis. In another embodiment the subject loses between 0-1 liters of fluid during dialysis. In another embodiment the subject has diabetes. In another embodiment the aqueous composition does not comprise lipids. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the subject leaves the hemodialysis without gaining any fluid weight. In another embodiment the treating or preventing malnutrition comprises modulating blood glucose levels of a subject. In another embodiment the blood glucose levels of said subject vary less than 10% from pre-hemodialysis to post-hemodialysis. In another embodiment the blood glucose levels of said subject decrease by at least 2% from pre-hemodialysis to post-hemodialysis.

In another aspect, the invention provides for a method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating an aqueous composition comprising less than 0.1 g/mL of dextrose, and 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In one embodiment the composition is carbohydrate free. In another embodiment the composition is lipid free. In another embodiment the formulating is further based on the intended duration of the hemodialysis. In another embodiment the duration of the hemodialysis is between 2 to 4.5 hrs. In another embodiment the duration of the hemodialysis is between 2.75 to 4 hrs. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels to at least about 3.8 g/dL. In another embodiment the subject\'s albumin levels increase by 0.1 g/deciliter within three months after the first administration of said composition. In another embodiment the subject\'s albumin levels increase by 0.2 g/deciliter within three months after the first administration of said composition. In another embodiment the composition is less than 430 mL in volume. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during dialysis. In another embodiment the side effects side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during dialysis. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-20% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject loses between 0-5 liters of fluid during dialysis. In another embodiment the subject loses between 0-4 liters of fluid during dialysis. In another embodiment the subject loses between 0-3 liters of fluid during dialysis. In another embodiment the subject loses between 0-2 liters of fluid during dialysis. In another embodiment the subject loses between 0-1 liters of fluid during dialysis. In another embodiment the subject has diabetes. In another embodiment the aqueous composition does not comprise lipids. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the subject leaves the hemodialysis without gaining any fluid weight. In another embodiment the treating or preventing malnutrition comprises modulating blood glucose levels of a subject. In another embodiment the blood glucose levels of said subject vary less than 10% from pre-hemodialysis to post-hemodialysis. In another embodiment the blood glucose levels of said subject decrease by at least 2% from pre-hemodialysis to post-hemodialysis.

In another aspect, the invention provides for a method method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating a lipid-free aqueous composition comprising less than 0.1 g/mL of dextrose, and 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis.

In another aspect, the invention provides for a method method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating an aqueous composition that is free of lipid, dextrose, fructose, sucrose, lactose, galactose, mannose, maltose, ribose, arabinose, sorbose, glyceraldehyde, or glycerol, comprising 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In one embodiment the composition is carbohydrate free. In another embodiment the composition is lipid free. In another embodiment the formulating is further based on the intended duration of the hemodialysis. In another embodiment the duration of the hemodialysis is between 2 to 4.5 hrs. In another embodiment the duration of the hemodialysis is between 2.75 to 4 hrs. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels to at least about 3.8 g/dL. In another embodiment the subject\'s albumin levels increase by 0.1 g/deciliter within three months after the first administration of said composition. In another embodiment the subject\'s albumin levels increase by 0.2 g/deciliter within three months after the first administration of said composition. In another embodiment the composition is less than 430 mL in volume. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during dialysis. In another embodiment the side effects side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during dialysis. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-20% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject loses between 0-5 liters of fluid during dialysis. In another embodiment the subject loses between 0-4 liters of fluid during dialysis. In another embodiment the subject loses between 0-3 liters of fluid during dialysis. In another embodiment the subject loses between 0-2 liters of fluid during dialysis. In another embodiment the subject loses between 0-1 liters of fluid during dialysis. In another embodiment the subject has diabetes. In another embodiment the aqueous composition does not comprise lipids. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the subject leaves the hemodialysis without gaining any fluid weight. In another embodiment the treating or preventing malnutrition comprises modulating blood glucose levels of a subject. In another embodiment the blood glucose levels of said subject vary less than 10% from pre-hemodialysis to post-hemodialysis. In another embodiment the blood glucose levels of said subject decrease by at least 2% from pre-hemodialysis to post-hemodialysis.

In another aspect, the invention provides for a method for treating or preventing malnutrition in a hemodialysis subject in need thereof, the method comprising formulating a carbohydrate free and lipid-free aqueous composition comprising 7 to 20% mass/volume of amino acids based on a body mass measurement of the subject and parenterally administering said aqueous composition in conjunction with the hemodialysis. In one embodiment the composition is carbohydrate free. In another embodiment the composition is lipid free. In another embodiment the formulating is further based on the intended duration of the hemodialysis. In another embodiment the duration of the hemodialysis is between 2 to 4.5 hrs. In another embodiment the duration of the hemodialysis is between 2.75 to 4 hrs. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another embodiment the treating or preventing said malnutrition comprises raising said subject\'s albumin levels to at least about 3.8 g/dL. In another embodiment the subject\'s albumin levels increase by 0.1 g/deciliter within three months after the first administration of said composition. In another embodiment the subject\'s albumin levels increase by 0.2 g/deciliter within three months after the first administration of said composition. In another embodiment the composition is less than 430 mL in volume. In another embodiment the subject has reduced side effects associated with infusion of an aqueous composition during dialysis. In another embodiment the side effects side effects are dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, or anxiety. In another embodiment the subject has reduced occurrence of hyperglycemia during dialysis. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-20% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-10% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has a post-hemodialysis blood glucose level that is within 1-5% of the subject\'s pre-hemodialysis blood glucose level. In another embodiment the subject has reduced fluid accumulation during dialysis. In another embodiment the subject loses between 0-5 liters of fluid during dialysis. In another embodiment the subject loses between 0-4 liters of fluid during dialysis. In another embodiment the subject loses between 0-3 liters of fluid during dialysis. In another embodiment the subject loses between 0-2 liters of fluid during dialysis. In another embodiment the subject loses between 0-1 liters of fluid during dialysis. In another embodiment the subject has diabetes. In another embodiment the aqueous composition does not comprise lipids. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the subject leaves the hemodialysis without gaining any fluid weight. In another embodiment the treating or preventing malnutrition comprises modulating blood glucose levels of a subject. In another embodiment the blood glucose levels of said subject vary less than 10% from pre-hemodialysis to post-hemodialysis. In another embodiment the blood glucose levels of said subject decrease by at least 2% from pre-hemodialysis to post-hemodialysis.

In another aspect, the invention provides for a sterile aqueous composition for parenteral administration comprising: between 2 and 26 g of dextrose; and between 12 and 45 g of amino acids, comprising more than 18% branched amino acids; wherein the composition is dosage form having a volume less than 450 mL. In one embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the composition further comprises lipids. In another embodiment the composition is lipid free. In another embodiment the lipids are present in the aqueous composition in an amount between 5 to 30% mass/volume. In another embodiment the lipids are present in the aqueous composition in an amount less than 5% mass/volume. In another embodiment the composition further comprises micronutrients. In another embodiment the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition.

In another aspect, the invention provides for a sterile aqueous composition for parenteral administration comprising: less than 0.1 g/mL of dextrose; and between 12 and 45 g of amino acids, wherein the composition is a lipid-free dosage form having a volume less than 450 mL. In one embodiment the amino acids comprise seventeen amino acids. In another embodiment the seventeen amino acids are lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the composition further comprises micronutrients. In another embodiment the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition. In another embodiment the composition is lipid free. In another embodiment the composition is carbohydrate free.

In another aspect, the invention provides for a sterile aqueous composition for parenteral administration comprising: between 12 and 45 g of amino acids, wherein the composition is a lipid and carbohydrate-free dosage form having a volume less than 450 mL. In one embodiment the amino acids comprise seventeen amino acids. In another embodiment the seventeen amino acids are lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment the amino acids comprise at least 18% branched chain amino acids. In another embodiment the amino acids comprise more than 20% branched amino acids. In another embodiment the amino acids comprise more than 30% branched amino acids. In another embodiment the amino acids comprise more than 40% branched amino acids. In another embodiment the amino acids comprise more than 50% branched amino acids. In another embodiment the composition further comprises micronutrients. In another embodiment the composition is contained within a sterile container suitable for parenteral administration of the aqueous composition. In another embodiment the composition is lipid free. In another embodiment the composition is carbohydrate free.

FIG. 1 describes IDPN compositions administrable over an infusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 2 describes the rates at which an IDPN composition of FIG. 1 is administered during the first and second weeks of therapy.

FIG. 3 describes IDPN compositions administrable over an infusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 4 describes the rates at which an IDPN composition of FIG. 3 is administered during the first and second weeks of therapy.

FIG. 5 describes IDPN compositions administrable over an infusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 6 describes the rates at which an IDPN composition of FIG. 5 is administered during the first and second weeks of therapy.

FIG. 7 describes IDPN compositions administrable over an infusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 8 describes the rates at which an IDPN composition of FIG. 7 is administered during the first and second weeks of therapy.

FIG. 9 describes IDPN compositions administrable over an infusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 10 describes the rates at which an IDPN composition of FIG. 9 is administered during the first and second weeks of therapy.

FIG. 11 describes IDPN compositions administrable over an infusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 12 describes the rates at which an IDPN composition of FIG. 11 is administered during the first and second weeks of therapy.

FIG. 13 describes IDPN compositions administrable over an infusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 14 describes the rates at which an IDPN composition of FIG. 13 is administered during the first and second weeks of therapy.

FIG. 15 describes IDPN compositions administrable over an infusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 16 describes the rates at which an IDPN composition of FIG. 15 is administered during the first and second weeks of therapy.

FIG. 17 describes IDPN compositions administrable over a diffusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 18 describes the rates at which an IDPN composition of FIG. 17 is administered during the first and second weeks of therapy.

FIG. 19 describes IDPN compositions administrable over a diffusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 20 describes the rates at which an IDPN composition of FIG. 19 is administered during the first and second weeks of therapy.

FIG. 21 describes IDPN compositions administrable over a diffusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 22 describes the rates at which an IDPN composition of FIG. 21 is administered during the first and second weeks of therapy.

FIG. 23 describes IDPN compositions administrable over a diffusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 24 describes the rates at which an IDPN composition of FIG. 23 is administered during the first and second weeks of therapy.

FIG. 25 describes lipid-containing IDPN compositions administrable over a diffusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 26 describes the rates at which an IDPN composition of FIG. 25 is administered during the first, second, and third weeks of therapy.

FIG. 27 describes lipid-containing IDPN compositions administrable over a diffusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 28 describes the rates at which an IDPN composition of FIG. 27 is administered during the first, second, and third weeks of therapy.

FIG. 29 describes lipid-containing IDPN compositions administrable over a diffusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 30 describes the rates at which an IDPN composition of FIG. 29 is administered during the first, second, and third weeks of therapy.

FIG. 31 describes lipid-containing IDPN compositions administrable over a diffusion time of 2.75-3.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 32 describes the rates at which an IDPN composition of FIG. 31 is administered during the first, second, and third weeks of therapy.

FIG. 33 describes lipid-containing IDPN compositions administrable over a diffusion time of 3.75-4.0 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 34 describes the rates at which an IDPN composition of FIG. 33 is administered during the first, second, and third weeks of therapy.

FIG. 35 describes lipid-containing IDPN compositions administrable over a diffusion time of 3.25-3.5 hours. The formulation of the IDPN compositions vary by the body mass of the subject to which the IDPN composition is administered.

FIG. 36 describes the rates at which an IDPN composition of FIG. 35 is administered during the first, second, and third weeks of therapy.

FIG. 37 illustrates the serum albumin levels in diabetic subjects of a study described in Example 22. A) describes Group I subjects\' baseline mean levels. B) describes Group I subjects\' 3 month mean levels. C) describes Group II subjects\' baseline mean levels. D) describes Group II subjects\' 3 month mean levels. The y-axis describes serum albumin levels in g/L.

FIG. 38 illustrates the albumin levels in non-diabetic subjects of a study described in Example 23. A) describes Group I subjects\' baseline mean levels. B) describes Group I subjects\' 3 month mean levels. C) describes Group II subjects\' baseline mean levels. D) describes Group II subjects\' 3 month mean levels. The y-axis describes serum albumin levels in g/L.

FIG. 39 illustrates the albumin levels in all subjects of a study described in Example 29. A) describes the low-volume subjects\' baseline mean levels. B) describes the low-volume subjects\' 3 month mean levels. C) describes the high-volume subjects\' baseline mean levels. D) describes the high-volume subjects\' 3 month mean levels. The y-axis describes serum albumin levels in g/L.

FIG. 40 illustrates the albumin levels in the diabetic subjects of a study described in Example 29. A) describes the low-volume diabetic subjects\' baseline mean levels. B) describes the low-volume diabetic subjects\' 3 month mean levels. C) describes the high-volume diabetic subjects\' baseline mean levels. D) describes the high-volume diabetic subjects\' 3 month mean levels. The y-axis describes serum albumin levels in g/L.

FIG. 41 illustrates a chart of the response of subjects receiving the low-volume IDPN composition in Example 29.

FIG. 42 illustrates a chart of the response of subjects receiving the high-volume IDPN composition in Example 29.

FIG. 43 illustrates a chart of the response of diabetic subjects to the low-volume IDPN composition in Example 29.

FIG. 44 illustrates a chart of the response of non-diabetic subjects to the low-volume IDPN composition in Example 29.

DETAILED DESCRIPTION

As used herein, the term “amino acid” refers to any of the twenty genetically-encoded L-a-amino acids unless indicated otherwise.

As used herein, the term “infusion time” refers to the amount of time during which a composition is administered to a subject via dialysis.

As used herein, the term “about” means±10%.

A need exists for an improved IDPN composition for administration to subjects that diminishes hyperglycemia associated with IDPN administration and decreases the need for the administration of insulin with IDPN. Moreover, a need exists for a lower volume IDPN dosage form.

In one embodiment, intradialytic parenteral nutrition (IDPN) compositions with low glucose levels and low composition volume are provided. In some embodiments, the IDPN compositions allow medical personnel to engage in reduced carbohydrate management for MHD subjects when the subjects receive IDPN. In another embodiment, an IDPN composition is effective for treating or preventing malnutrition in a MHD subject with glucose management difficulties, insulin resistance, type I diabetes, type II diabetes, and/or pancreatitis. In another embodiment, administration of an IDPN composition promotes anabolism over catabolism, thereby treating or preventing malnutrition. In some embodiments, an IDPN composition has reduced volume, and in some embodiments, the reduced volume can reduce side effects associated with high infusion volumes. Non-limiting examples of the side effects associated with high infusion volumes include dyspnea, increased respiratory rate, rhonchi, edema, hypertension, hernia, and anxiety. In some embodiments, a subject receiving an IDPN composition experiences reduced symptoms of hyperglycemia.

When performing dialysis, the volume of a fluid infused into a subject can have affects on the subject. For example, different dialysis fluids, differing in volume only, can have differing affects on a subject owing to the differing volumes. Higher volumes can cause complications in subjects, such as increased fluid retention, decreased nutrient absorption, discomfort, longer or additional dialysis treatment times, and operational inconvenience.

One goal of fluid removal during hemodialysis is to return the subject to dry weight by the end of the dialysis session. Dry weight is the lowest post dialysis weight that the subject can tolerate without developing symptoms of hypotension. Dry weight is generally a clinical estimate and the subject may still be over-hydrated. Some subjects do not tolerate fluid removal well, and excess fluid removal results symptoms such as cramps or a fall in blood pressure. For other subjects not removing enough fluid leaves the subject overloaded with fluid, puts strain on the heart, causes high blood pressure high, or leads to difficulties for the next treatment of hemodialysis. In some instances, excess fluid accumulations in dialysis subjects leads to congestive heart failure and hospital admissions. In one embodiment, a dry weight is targeted where the patient will be normally hydrated and fluid removal is at a rate, which keeps the patient comfortable. In some embodiments, the administration of low-volume IDPN compositions results in the achievement of desired fluid removal goals as determined by the dialysis clinician. In some embodiments, after administration of low-volume IDPN compositions, the patient does not leave the dialysis treatment with extra fluid weight.

In some embodiments, administration of low-volume IDPN compositions results in the achievement of desired fluid removal goals for a subject as determined by the dialysis clinician. In other embodiments, low-volume IDPN compositions are administered to a subject, whereby the hemodialysis subject does not have extra fluid weight after dialysis treatment. In another embodiment, low-volume IDPN compositions are administered to a hemodialysis subject, whereby the subject has less extra fluid weight after dialysis treatment as compared to administration with higher-volume IDPN compositions. In another embodiment, the subject has reduced fluid accumulation during hemodialysis. In another embodiment, the subject accumulates less than 3 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 2 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 1 liter of fluid during hemodialysis. In another embodiment, the subject accumulates less than 500 ml of fluid during hemodialysis. In another embodiment, the subject accumulates about 0-3 liter of fluid during hemodialysis. In another embodiment, the subject has a lower fluid weight post-hemodialysis then pre-hemodialysis. In another embodiment, the subject loses less than 100 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 250 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 500 ml of fluid during hemodialysis. In another embodiment, the subject loses less than 1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-1.5 liter of fluid during hemodialysis. In another embodiment, the subject loses between 0-2 liter of fluid during hemodialysis.

In one embodiment a subject is administered a dialysis composition with a reduced volume to provide nutrition to the subject with reduced liquid infusion. In one embodiment, the subject has reduced side effects after infusion of the composition with a reduced volume. In one embodiment, a subject has reduced fluid accumulation after infusion, during hemodialysis, of an IDPN composition with a reduced volume. In one embodiment, the IDPN composition has a low percentage of carbohydrates. In another embodiment, the IDPN composition has a low amount of carbohydrates. In one embodiment, the IDPN composition has a low percentage of an energy source that is not a carbohydrate. In another embodiment, the IDPN composition has a low amount of an energy source that is not a carbohydrate. In another embodiment, the IDPN composition lacks lipids. In another embodiment, the IDPN composition further comprises lipids. In one embodiment, the IDPN composition comprises less than 5% lipids mass/volume.

In one embodiment, the IDPN composition has a volume less than about 750 mL, less than about 700 mL, less than about 650 mL, less than about 600 mL, less than about 590 mL, less than about 580 mL, less than about 570 mL, less than about 560 mL, less than about 550 mL, less than about 540 mL, less than about 530 mL, less than about 520 mL, less than about 510 mL, less than about 500 mL, less than about 490 mL, less than about 480 mL, less than about 470 mL, less than about 460 mL, less than about 450 mL, less than about 440 mL, less than about 430 mL, less than about 420 mL, less than about 410 mL, less than about 400 mL, less than about 390 mL, less than about 380 mL, less than about 370 mL, less than about 360 mL, less than about 350 mL, less than about 340 mL, less than about 330 mL, less than about 320 mL, less than about 310 mL, less than about 300 mL, less than about 250 mL, or less than about 200 mL.

In one embodiment, IDPN compositions are provided for subjects at various stages of life. In another embodiment IDPN compositions are adapted to meet the nutritional needs of subjects across a broad range of ages. In another embodiment, a subject is an adult. In another embodiment, a subject is a young adult. In another embodiment, a subject is a juvenile. In another embodiment, a subject is an adolescent. In another embodiment, a subject is a child. In another embodiment, a subject is eligible to receive pediatric health care. In another embodiment, a subject is a pediatric subject. In another embodiment, a subject is over about 18 years old. In another embodiment, a subject is under about 18 years old. In another embodiment, a subject is under about 12 years old. In another embodiment, a subject is under about 8 years old. In another embodiment, a subject is from about 1 to about 18 years old. In another embodiment, a subject is from about 5 to about 12 years old. In another embodiment, a subject is about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, or about 18 years old. In another embodiment, a subject is a neonatal subject. In another embodiment, a subject is less than about a year old. In another embodiment, a s subject is about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, or about 12 months old. In another embodiment, the subject is diabetic. In another embodiment, the subject is non-diabetic. In another embodiment, the subject is either diabetic or non-diabetic. In another embodiment, the subject has high blood sugar. In another embodiment, the subject has low levels of insulin. In another embodiment, the subject has low levels of insulin because the pancreas makes too little insulin, or is insulin resistant.

In one embodiment, an IDPN composition comprises a carbohydrate and an amino acid. In one embodiment, an IDPN composition consists essentially of amino acids and dextrose in an aqueous solution. In another embodiment, an IDPN composition further comprises lipids. In another embodiment, an IDPN composition comprises micronutrients, such as a vitamin, a trace element and/or a mineral. In another embodiment, an IDPN composition comprises one or more pharmaceutical agents, such as insulin. In another embodiment, one or more pharmaceutical agents are co-administered with an IDPN composition. For example, insulin can be co-administered by any ordinary method of administration, for example, subcutaneous injection. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, and a lipid. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, and a micronutrient, such as a vitamin, a trace element, and/or a mineral. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, a lipid, and a micronutrient, such as a vitamin, a trace element, and/or a mineral. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, and one or more pharmaceutical agents. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, a lipid, and one or more pharmaceutical agents. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, a micronutrient, and one or more pharmaceutical agents. In another embodiment, an IDPN composition comprises a carbohydrate, an amino acid, a lipid, a micronutrient, and one or more pharmaceutical agents.

In one embodiment, an IDPN composition is a solution. In another embodiment, an IDPN composition is homogeneous. In another embodiment, an IDPN composition is the product of contacting a powder with sterile water. In another embodiment, IDPN composition is the product of contacting a powder with saline. In another embodiment, an IDPN composition is a suspension.

In one embodiment, a carbohydrate comprises one or more of dextrose (D-glucose), fructose, sucrose, lactose, galactose, mannose, maltose, ribose, arabinose, sorbose, and glyceraldehyde. In another embodiment, the carbohydrate comprises dextrose. In another embodiment, the carbohydrate is dextrose. In one embodiment, the energy source that is not a carbohydrate is glycerol.

In one embodiment, an IDPN composition comprises an amino acid. In another embodiment, an IDPN composition comprises two or more amino acids. In another embodiment, an IDPN composition comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 amino acids. In another embodiment, an IDPN composition comprises twenty amino acids. In another embodiment, an IDPN composition comprises 17 amino acids. In another embodiment, an IDPN composition comprises amino acids that consist essentially of lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment an IDPN composition comprises one or more amino acids that are not genetically-encoded. In another embodiment, an IDPN composition comprises one or more of alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, imidazole, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, tryptophan, tyrosine, or valine. In another embodiment, an IDPN composition comprises lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment, an IDPN composition comprises amino acids that consist of lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine. In another embodiment, an IDPN composition comprises essential amino acids. In another embodiment, an IDPN composition comprises non-essential amino acids. In another embodiment, an IDPN composition comprises essential and non-essential amino acids. In another embodiment, an IDPN composition comprises amino acids that consist essentially of essential amino acids. In another embodiment, an IDPN composition comprises isoleucine, argenine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, histidine, tyrosine, leucine. In another embodiment, an IDPN composition comprises amino acids that consist essentially of isoleucine, argenine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, histidine, tyrosine, leucine. In another embodiment, an IDPN composition comprises leucine, isoleucine, valine, lysine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, argenine, glycine, proline, serine, and tyrosine. In another embodiment, an IDPN composition comprises amino acids that consist essentially of leucine, isoleucine, valine, lysine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, argenine, glycine, proline, serine, and tyrosine. In another embodiment, an IDPN composition comprises leucine, isoleucine, valine, lysine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, argenine, glycine, proline, serine, and cysteine. In another embodiment, an IDPN composition comprises amino acids that consist essentially of leucine, isoleucine, valine, lysine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, argenine, glycine, proline, serine, and cysteine. In another embodiment, an IDPN composition comprises branched amino acids. In another embodiment, an IDPN composition comprises amino acids that consist essentially of branched amino acids. In another embodiment, an IDPN composition comprises leucine, isoleucine, and valine. In another embodiment, an IDPN composition comprises amino acids that consist essentially of leucine, isoleucine, and valine. In another embodiment an IDPN composition comprises one or more amino acids that are not genetically-encoded. In another embodiment, an IDPN composition comprises one or more amino acids that are unnatural. In another embodiment, an IDPN composition comprises one or more amino acids that are synthetic. In another embodiment, an IDPN composition comprises one or more amino acids that are artificial. In another embodiment, an IDPN composition comprises one or more amino acids that are encoded by a nucleic acid molecule that is natural or unnatural. In another embodiment, an IDPN composition comprises one or more peptides. In another embodiment, an IDPN composition comprises amino acids and peptides. In another embodiment, an IDPN composition comprises one or more proteins. In another embodiment, an IDPN composition comprises amino acids, peptides, and proteins. In another embodiment, a peptide comprises 2, 3, 4, 5, 6, 7, 8, 9, or 10 amino acid residues. In another embodiment, a peptide comprises at least 10 amino acid residues. In another embodiment, an IDPN composition comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 of alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, imidazole, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, tryptophan, tyrosine, and valine.

In one embodiment, the percentage of lysine is less than 10% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of lysine is less than 11% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of lysine is less than 12% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of lysine is less than 13% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of lysine is less than 14% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of lysine is less than 15% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of leucine is less than 10% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of leucine is less than 11% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of leucine is less than 12% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of leucine is less than 9% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of leucine is less than 8% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of phenylalanine is more than 4% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of histidine is less than 8% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of histidine is less than 7% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of methionine is more than 3% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of alanine is more than 8% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of alanine is more than 9% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of alanine is more than 10% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of alanine is more than 11% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of alanine is more than 12% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of proline is more than 4% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of proline is more than 5% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the percentage of serine is less than 6% of the total amount of amino acids contained in the IDPN composition. In another embodiment, the IDPN composition comprises glutamic acid. In another embodiment, the IDPN composition comprises aspartic acid.

In some instances, the effect of severe stress conditions is the depletion of branched amino acids. In certain instances, enriching the IDPN compositions with additional branched amino acids results in the repletion or at least the partial repletion of branched amino acids in a subject. In certain embodiments, an IDPN composition comprises about 70%, about 65%, about 60%, about 55%, about 50%, about 45%, about 40%, about 35%, about 30%, about 25%, about 20%, about 15%, or about 10% branched amino acids of total amino acids. In some embodiments, an IDPN composition comprises more than 70%, more than 65%, more than 60%, more than 55%, more than 50%, more than 45%, more than 40%, more than 35%, more than 30%, more than 25%, more than 20%, or more than 15% branched amino acids of total amino acids. In some embodiments, an IDPN composition comprises between 15% and 50% of branched-chain amino acids of total amino acids. In other embodiments, an IDPN composition comprises between 20% and 50% of branched-chain amino acids of total amino acids. In other embodiments, an IDPN composition comprises between 15% and 30% of branched-chain amino acids of total amino acids. In other embodiments, an IDPN composition comprises between 20% and 50% of branched-chain amino acids of total amino acids. In some embodiments, branched-chain amino acids comprise leucine, isoleucine, valine, or a combination thereof. In certain embodiments, branched-chain amino acids comprise leucine. In other embodiments, branched-chain amino acids comprise isoleucine. In some embodiments, branched-chain amino acids comprise valine. In certain embodiments, branched-chain amino acids comprise valine and leucine. In other embodiments, branched-chain amino acids comprise valine and isoleucine. In some embodiments, branched-chain amino acids comprise leucine and isoleucine. In other embodiments, branched-chain amino acids comprise leucine, isoleucine, and valine. In certain embodiments, branched-chain amino acids comprise unnatural branched amino acids.

In one embodiment, the ratio of the amounts of amino acids is optimized for nutritional value. In another embodiment, the ratio of the amounts of amino acids is optimized for solubility. In another embodiment, the ratio of the amounts of amino acids is optimized for reduction of IDPN composition volume. In another embodiment, the ratio of the amounts of amino acids is optimized for administration.

In one embodiment, an IDPN composition is formulated from an amino acid stock mixture. In another embodiment, an IDPN composition comprises an amount of an amino acid stock mixture. In another embodiment, an IDPN composition comprises a volume of an amino acid stock mixture. In another embodiment, an amino acid stock mixture is an amino acid stock solution. In another embodiment, an IDPN composition comprises an amount of an amino acid stock solution. In another embodiment, an IDPN composition comprises a volume of an amino acid stock solution. In another embodiment, an amino acid stock mixture is an aqueous solution. In another embodiment, an amino acid stock mixture is a non-aqueous mixture. In another embodiment, an amino acid stock mixture is a non-aqueous solution. In another embodiment, an amino acid stock mixture is a solid mixture. In another embodiment, an amino acid stock mixture is a powder. In another embodiment, an amino acid stock mixture is a gel. In another embodiment, an amino acid stock mixture is a paste. In another embodiment, an amino acid stock mixture is a concentrate, wherein the concentrate can be diluted to a target concentration with a solvent, for example, water. In another embodiment, an amino acid stock mixture is crystalline. In another embodiment, an amino acid stock mixture is a heterogeneous mixture. In another embodiment, an amino acid stock mixture is a suspension. In another embodiment, an amino acid stock mixture comprises 20 amino acids. In another embodiment, an amino acid stock mixture comprises 17 amino acids. In another embodiment, an amino acid stock mixture is a concentrated solution. In another embodiment, an amino acid stock mixture has a reduced volume. In another embodiment, an amino acid stock mixture comprises more than about 2.5% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises more than about 2.5% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises less than about 50% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises less than about 50% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises less than about 40% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises less than about 40% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises less than about 30% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises less than about 30% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises less than about 25% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises less than about 25% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 50% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 50% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 40% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 40% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 30% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 30% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 25% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises from about 2.5% to about 25% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises from about 5% to about 20% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises from about 5% to about 20% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 5% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 5% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 5% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 5% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 10% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 10% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 10% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 10% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 15% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 15% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 15% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 15% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 20% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 20% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 20% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 20% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 25% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 25% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 25% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 25% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 30% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 30% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 30% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 30% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 35% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 35% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 35% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 35% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 40% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 40% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 40% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 40% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 45% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 45% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 45% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 45% amino acids on a mass/mass basis. In another embodiment, an amino acid stock mixture comprises about 50% amino acids on a mass/volume basis. In another embodiment, an amino acid stock mixture comprises about 50% amino acids on a mass/mass basis. In another embodiment, an amino acid stock solution comprises about 50% amino acids on a mass/volume basis. In another embodiment, an amino acid stock solution comprises about 50% amino acids on a mass/mass basis.

In one embodiment, an amino acid stock mixture comprising 15% amino acids on a mass/volume basis has the formulation described in Table I.

TABLE I Amino Acids 15.0 g Total Nitrogen 2.37 g PH, optionally adjusted with glacial 6.0 ± 1.0 acetic acid and/or sodium hydroxide Lysine (from Lysine Acetate) 1.18 g Leucine 1.04 g Phenylalanine 1.04 g Valine 960 mg Histidine 894 mg Isoleucine 749 mg Methionine 749 mg Threonine 749 mg Tryptophan 250 mg Alanine 2.17 g Arginine 1.47 g Glycine 1.04 g Proline 894 mg Glutamic Acid 749 mg Serine 592 mg Aspartic Acid 434 mg Tyrosine 39 mg Acetate from Lysine Acetate and glacial 127 mEq acetic acid (balanced by ions from amino acids) Osmolarity (Calculated) 1357 mOsmol/L

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