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Nutritive compositions and methods of using same

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20120277170 patent thumbnailZoom

Nutritive compositions and methods of using same


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.
Related Terms: Malnutrition Parenteral Nutrition

Browse recent Pentec Health, Inc. patents - Boothwyn, PA, US
Inventor: Eileen Moore
USPTO Applicaton #: #20120277170 - Class: 514 23 (USPTO) - 11/01/12 - Class 514 
Drug, Bio-affecting And Body Treating Compositions > Designated Organic Active Ingredient Containing (doai) >Carbohydrate (i.e., Saccharide Radical Containing) Doai

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The Patent Description & Claims data below is from USPTO Patent Application 20120277170, Nutritive compositions and methods of using same.

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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

OF THE INVENTION

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.

BRIEF DESCRIPTION OF THE FIGURES

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.



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stats Patent Info
Application #
US 20120277170 A1
Publish Date
11/01/2012
Document #
13541604
File Date
07/03/2012
USPTO Class
514 23
Other USPTO Classes
514400
International Class
/
Drawings
44


Malnutrition
Parenteral Nutrition


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