Alpha keto acid compositions for treating hypo-albuminemia
Provided herein are nutritional, or therapeutic, compositions and methods of use in primarily treating kidney patients suffering from low serum albumin. The compositions are divided into four formulations, comprising: 1) the magnesium salt and/or the calcium salt of the alpha keto acids of: α-leucine, α-valine, α-isoleucine, α-phenylalanine, α-hydroxy methionine; and/or α-tryptophan, and/or α-tyrosine; 2) L-lysine monoacetate, L-threonine; and/or 3) histidine, tryptophan, and tyrosine, as amino acids or base acids. The specific formulation administered depends in part upon which stage 2-5 of renal disease the patient has. The invention further comprises methods of treatment of disorders associated with low serum albumin using the composition as an over-the-counter pill. The patient's serum albumin is tested on a periodic basis and the selected composition and dose are adjusted accordingly. And the invention comprises method of making α-leucine, α-valine, α-isoleucine, a-tyrosine and α-tryptophan in a multi-step process.
1. A nutritional or therapeutic composition safe for oral consumption, comprising:
a) at least three alpha keto analogue or acid of an amino acid of, or any combination thereof:
1) a magnesium salt;
2) a calcium salt;
3) a calcium salt and a magnesium salt;
4) wherein the at least three alpha keto analogue of the amino acid comprises:
i) a α-leucine;
ii) a α-valine;
iii) a α-isoleucine;
iv) a α-phenylalanine;
v) a α-methionine or an α-hydroxy methionine;
b) a L-lysine monoacetate, and a L-threonine;
c) histidine amino acid, or a magnesium salt, or a calcium salt, or a calcium salt and a magnesium salt, of a keto analogue of a α-histidine;
d) tryptophan amino acid, or a magnesium salt, or a calcium salt, or a calcium salt and a magnesium salt, of a keto analogue of a α-tryptophan; and
e) wherein the oral composition comprises: a nitrogen load that does not exceed 3.8%; a calcium load that does not exceed 6.5%; a magnesium load that is at least 2.2%; and a sodium load that does not exceed 0.8%.
2. The nutritional or therapeutic composition of claim 1 , further comprising a tyrosine amino acid, or a magnesium salt, or a calcium salt, or a calcium salt and a magnesium salt, of a keto analogue of a α-tyrosine.
3. The nutritional or therapeutic composition of claim 1 , further comprising:
about 8 to 31% wt/wt of the alpha keto analogue of leucine;
about 5 to 21% wt/wt of the alpha keto analogue of valine;
about 3 to 16% wt/wt of the alpha keto analogue of isoleucine;
about 6 to 10% wt/wt of the alpha keto analogue of phenylalanine;
about 3 to 5 wt/wt of the alpha keto analogue of hydroxy-methionine;
about 9 to 13% wt/wt of L-lysine monoacetate;
about 5 to 8% wt/wt of L-threonine;
about 0 to 0.7% wt/wt of tyrosine or the magnesium salt of the alpha keto analogue of tyrosine; and/or about 0 to 0.4% wt/wt of tryptophan, or the alpha keto analogue of tryptophan; and/or
about 2 to 4v % wt/wt of histidine amino acid, or a calcium or magnesium salt, or non-salt of the α keto analog of histidine.
4. The nutritional or therapeutic composition of claim 1 , formulated as a tablet with an excipient comprising one or more of: microcrystalline cellulose, povidone K-30, crospovidone, and magnesium stearate.
5. The nutritional or therapeutic composition of claim 1 , comprising:
1) the magnesium salt of the keto analogue of α-leucine, α-valine, α-isoleucine-α-phenylalanine, α-methionine;
2) a free amino acid of histidine, or a calcium or magnesium keto analogue of α-histidine;
3) a magnesium salt of the alpha keto analogue of tryptophan; or a base acid of tryptophan;
4) L-lysine monoacetate;
5) L-threonine; and
6) wherein said composition is to treat kidney disease.
6. The nutritional or therapeutic composition of claim 1 , comprising:
1) the magnesium salt of the keto analogue of α-leucine, α-valine, α-isoleucine, α-tryptophan;
2) the calcium salt of the keto analogue of α-phenylalanine, α-methionine;
3) the free amino acid of histidine, or the calcium salt, or the magnesium salt, of the keto analogue of α-histidine;
4) L-lysine monoacetate;
5) L-threonine; and
6) wherein said composition is to treat kidney disease.
7. The nutritional or therapeutic composition of claim 1 , comprising:
1) the calcium salt of the keto analogue of α-leucine, α-valine, α-isoleucine, α-phenylalanine, α-hydroxy methionine;
2) the magnesium salt of the keto analogue of α-tryptophan, α-leucine, α-valine, or α-isoleucine;
3) the free amino acid of histidine, or the calcium salt, or the magnesium salt, of the keto analogue of α-histidine;
4) magnesium salt of the keto analogue of tyrosine, or tyrosine amino acid;
5) L-lysine monoacetate;
6) L-threonine; and
7) wherein said composition is to treat stage 4 kidney disease.
8. The nutritional or therapeutic composition of claim 1 , comprising:
1) the calcium salt of keto analogue of α-leucine, α-valine, α-isoleucine, α-phenylalanine, α-hydroxy methionine;
2) the magnesium salt of the keto analogue of α-tyrosine, or a tyrosine amino acid;
3) the free amino acid of histidine, or the calcium salt, or the magnesium salt, of the keto analogue of α-histidine;
4) the magnesium salt of the keto analogous of tryptophan or tryptophan amino acid;
5) L-lysine monoacetate;
6) L-threonine; and
7) wherein said composition is able to treat stage 5 kidney disease.