Formulations for personalized treatment methods

Abstract

Disclosed herein are formulations and methods of administering the formulations to cells starved of nutrients, such as amino acids. The formulations of the invention may be substantially devoid of one or more non-essential amino acids.

Description

[Technical Field]

[0001] Related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 034,137, filed on 3 June 2020, which is incorporated herein by reference in its entirety. [Background technology]

[0002]

[0002] Current treatments for cancer or other pathological conditions may be ineffective due to patient-specific factors. Therefore, personalized methods and formulations may be developed for the treatment of various diseases, including cancer. Reference

[0003] All publications, patents, and patent applications referenced herein are invoked by reference to the same extent as each individual publication, patent, or patent application is specifically and individually referred to. [Overview of the project] [Means for solving the problem]

[0003]

[0004] In some embodiments, compositions are disclosed herein that, a) a non-essential amino acid or a salt thereof that is not part of a polypeptide, b) a first essential amino acid or a first salt and a second essential amino acid or a second salt thereof are present in equal amounts in the composition, wherein the first essential amino acid and its first salt and the second essential amino acid and its second salt thereof are not part of a polypeptide, and c) a pharmaceutically acceptable excipient are included in unit dosage forms. In some embodiments, compositions are disclosed herein that, a) an essential amino acid which is not part of a polypeptide, b) a non-essential amino acid which is not part of a polypeptide, and c) a pharmaceutically acceptable excipient are included in powder form, wherein the composition does not contain serine or glycine, and in a study of tumor volume changes in a subject, the tumor volume of a subject administered the composition is reduced by at least about 20% compared to a subject not administered the composition.

[0004]

[0005] In some embodiments, compositions are disclosed herein that, in studies of tumor volume changes in subjects, the tumor volume of subjects administered with the composition is reduced by at least about 20% compared to subjects administered with a placebo.

[0005]

[0006] In some embodiments, a composition is disclosed herein comprising, in powder form, a) an essential amino acid which is not part of a polypeptide, b) a non-essential amino acid which is not part of a polypeptide, and c) a pharmaceutically acceptable excipient, wherein the composition does not contain serine or glycine, and in a study of tumor volume changes in a subject, the tumor volume of a subject administered the composition is reduced by at least about 20% compared to a subject administered a placebo. In some embodiments, a method is disclosed herein for reducing the tumor volume of a subject, the method comprising the step of administering a therapeutically effective amount of the composition to a subject, wherein the composition lacks at least one non-essential amino acid for at least one month.

[0006]

[0007] In some embodiments, a method for treating cancer in a subject requiring treatment, wherein the subject is receiving a modified diet, the modified diet providing up to about 50% of his daily calorie intake from carbohydrates, and the method comprises the step of administering a therapeutically effective dose of a dietary product to the subject, wherein the dietary product lacks at least one non-essential amino acid. In some embodiments, a method for reducing the mean serum amino acid level of at least one non-essential amino acid in a subject requiring reduction, the method comprises the steps of a) administering a therapeutically effective dose of a dietary product lacking at least one non-essential amino acid to the subject for a first period, the subject receiving a modified diet providing at least about 1% to up to about 40% of his daily calorie intake from carbohydrates for the first period, and b) not administering the dietary product to the subject for a second period, the subject receiving a normal diet providing at least about 45% of his daily calorie intake from carbohydrates for the second period. [Brief explanation of the drawing]

[0007] [Figure 1]

[0008] A sachet containing one of the compositions disclosed herein is placed in a glass of water, and the subject is shown drinking the mixture of compositions. [Figure 2]

[0009] This provides a chart showing the serum amino acid levels in subjects before and after administration of the proline-deficient diet described in Example 17. [Figure 3]

[0010] This provides a chart showing the serum amino acid levels in subjects before and after administration of the proline-deficient diet described in Example 18. [Figure 4]

[0011] This provides a chart showing the serum amino acid levels in subjects before and after administration of the proline-deficient diet described in Example 19. [Figure 5]

[0012] The chart provided shows the serum proline levels as a percentage of the pre-meal baseline level in subjects administered the proline-deficient diet described in Examples 17 (Panel A), 18 (Panel B), and 19 (Panel C). [Figure 6]

[0013] This chart shows the serum proline levels as a percentage of the pre-meal baseline level in pancreatic cancer patients who were administered the proline-deficient diet described in Example 20. [Figure 7]

[0014] This provides a chart showing serum amino acid levels in subjects before and after administration of the serine and glycine-deficient diet described in Example 21. [Figure 8]

[0015] This provides a chart showing serum amino acid levels in subjects before and after administration of the proline, glycine, and serine-deficient diet described in Example 22. [Figure 9]

[0016] A chart is provided showing the serum levels of serine, proline, and glycine as percentages of pre-meal baseline levels in subjects administered the diet described in Example 22. [Figure 10]

[0017] Provide a chart showing the serum levels of proline, glycine, and serine in subjects administered a diet lacking serine, proline, and glycine daily (Panel A) or intermittently (Panel B) according to the protocol described in Example 23. Panel C (left) shows a chart comparing the serum amino acids as a percentage of the habitual diet in subjects administered a diet lacking serine, glycine, or proline daily for 11 days or intermittently for 11 days. Panel C (right) shows a chart comparing the serum amino acids as a percentage of the habitual diet in subjects administered a diet lacking serine, glycine, or proline daily for 16 days or intermittently for 18 days. [Figure 11]

[0018] Provide a chart showing the serum levels of amino acids in subjects after administration of a 1613 kcal / day low-protein diet lacking serine, glycine, glutamate, and cysteine as described in Example 24. [Figure 12]

[0019] Provide a chart showing the serum levels of amino acids in subjects after administration of a 1711 kcal / day low-protein, low-carbohydrate diet lacking serine, glycine, glutamate, and cysteine as described in Example 24. [Figure 13]

[0020] Provide a chart showing the serum levels of amino acids in subjects before and after administration of a 1613 kcal / day low-protein diet (Panel A) or a 1711 kcal / day low-protein, low-carbohydrate diet (Panel B) as described in Example 24. Panel C shows the average % serum levels after administration of the low-protein diet (left) and the average % serum levels after administration of the low-protein, low-carbohydrate diet (right).

Mode for Carrying Out the Invention

[0008]

[0021] This specification describes compositions and dietary products containing essential and non-essential amino acids. The compositions disclosed herein can be administered to subjects to treat diseases, such as cancer. As shown in Figure 1, the compositions disclosed herein can be provided as powder in sachets (101). The powder, taken from the sachets, can be added to, for example, water (102) to create a liquid beverage to be consumed by the subject. The subject (104) drinks the mixture (103) of the composition prepared in water.

[0009]

[0022] Removing specific amino acids or amino acid combinations from a target diet can lead to improved treatment of various diseases, including cancer. Lowering the levels of the target amino acid reduces the production of proteins, metabolites, lipids, or nucleic acids that can promote cancer growth and metastasis.

[0010]

[0023] In some embodiments, the compositions disclosed herein are pharmaceutical compositions. In some embodiments, the compositions disclosed herein are medical foods. In some embodiments, the compositions disclosed herein are food supplements. In some embodiments, the compositions disclosed herein are nutritional supplements. In some embodiments, the compositions disclosed herein are nutritional supplements. In some embodiments, the compositions disclosed herein are dietary products. In some embodiments, the compositions disclosed herein are drugs.

[0011]

[0024] In some embodiments, the compositions disclosed herein can be used in conjunction with at least one therapeutic agent, such as a drug, antibody, or enzyme. In some embodiments, the compositions disclosed herein can create a therapeutic agent that is more effective in treating a certain condition.

[0012]

[0025] In some embodiments, the compositions disclosed herein are foods formulated to be taken or administered enterally under the supervision of a physician and are intended for the specific dietary management of a disease or condition in which unique nutritional requirements based on recognized scientific principles have been established by medical evaluation.

[0013] amino acid

[0026] The compositions of the present disclosure contain at least 10 amino acids or salts thereof. In some embodiments, the compositions of the present disclosure contain 10, 11, 12, 13, 14, 15, 16, 17, 18, or 19 amino acids or salts thereof of any of these amino acids. In some embodiments, the compositions of the present disclosure contain 10 amino acids or salts thereof of any of these amino acids. In some embodiments, the compositions of the present disclosure contain 14 amino acids or salts thereof of any of these amino acids. In some embodiments, the compositions of the present disclosure contain 18 amino acids or salts thereof of any of these amino acids. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0014]

[0027] In some embodiments, the compositions of the Disclosure comprise one, two, three, four, five, six, seven, eight, or nine essential amino acids or a salt of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise seven, eight, or nine essential amino acids or a salt of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise eight essential amino acids or a salt of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise nine essential amino acids or a salt of any of these amino acids. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0015]

[0028] In some embodiments, the compositions of the Disclosure comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 non-essential amino acids or salts of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise 7, 8, 9, 10, or 11 non-essential amino acids or salts of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise 7 non-essential amino acids or salts of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise 8 non-essential amino acids or salts of any of these amino acids. In some embodiments, the compositions of the Disclosure comprise 9 non-essential amino acids or salts of any of these amino acids. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0016]

[0029] The compositions of the present disclosure may include essential amino acids or salts thereof and non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the present disclosure include 1, 2, 3, 4, 5, 6, 7, 8, or 9 essential amino acids or salts thereof of any of those amino acids and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the present disclosure include 7, 8, or 9 essential amino acids or salts thereof of any of those amino acids and 6, 7, 8, or 9 non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the present disclosure include 8 or 9 essential amino acids or salts thereof of any of those amino acids and 8 or 9 non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the present disclosure include 9 essential amino acids or salts thereof of any of those amino acids and 7 non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the present disclosure include 9 essential amino acids or salts thereof of any of those amino acids and 8 non-essential amino acids or salts thereof of any of those amino acids. In some embodiments, the compositions of the Disclosure comprise nine essential amino acids or salts of any of those amino acids and nine non-essential amino acids or salts of any of those amino acids. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0017]

[0030] In some embodiments, the compositions of the present disclosure include histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, taurine, threonine, tryptophan, valine, arginine, glutamine, alanine, aspartic acid, asparagine, glutamic acid, or proline. In some embodiments, the compositions of the present disclosure include L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-cysteine, L-phenylalanine, L-tyrosine, L-threonine, L-tryptophan, L-valine, L-arginine, L-glutamine, L-alanine, L-aspartic acid, L-asparagine, L-glutamic acid, or L-proline. Any composition of the present disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0018]

[0031] In some embodiments, the composition comprises histidine or a salt thereof, for example, L-histidine or L-histidine hydrochloride. In some embodiments, the composition of the disclosure comprises isoleucine or a salt thereof, for example, L-isoleucine, L-isoleucine methyl hydrochloride, or L-isoleucine ethyl hydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts. In some embodiments, the composition of the disclosure comprises leucine or a salt thereof, for example, L-leucine, L-leucine methyl hydrochloride, or L-leucine ethyl hydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts. In some embodiments, the composition of the disclosure comprises lysine or a salt thereof, for example, L-lysine, L-lysine hydrochloride, or L-lysine dihydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts. In some embodiments, the composition of the disclosure comprises methionine or a salt thereof, for example, L-methionine, L-methionine methyl hydrochloride, or L-methionine hydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0019]

[0032] In some embodiments, the compositions of the Disclosure comprise cysteine ​​or a salt thereof, e.g., L-cysteine, L-cysteine ​​hydrochloride, L-cysteine ​​methyl ester hydrochloride, or L-cysteine ​​ethyl ester hydrochloride. Any composition of the Disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine. In some embodiments, the compositions disclose cystine or a salt thereof, e.g., L-cystine. Salts of amino acids disclosed herein may be pharmaceutically acceptable salts. In some embodiments, the compositions of the Disclosure comprise phenylalanine or a salt thereof, e.g., L-phenylalanine, DL-phenylalanine, or L-phenylalanine methyl ester hydrochloride. In some embodiments, the compositions of the Disclosure comprise tyrosine or a salt thereof, e.g., L-tyrosine or L-tyrosine hydrochloride. In some embodiments, the compositions of the Disclosure comprise threonine or a salt thereof, e.g., L-threonine or L-threonine methyl ester hydrochloride. In some embodiments, the compositions of the Disclosure comprise L-tryptophan. In some embodiments, the compositions of the Disclosure comprise valine or a salt thereof, such as L-valine, L-valine methyl hydrochloride, or L-valine ethyl hydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0020]

[0033] In some embodiments, the compositions of the Disclosure include arginine or a salt thereof, for example, L-arginine or L-arginine hydrochloride. In some embodiments, the compositions of the Disclosure include glutamine or a salt thereof, for example, L-glutamine or L-glutamine hydrochloride. In some embodiments, the compositions of the Disclosure include alanine or a salt thereof, for example, L-alanine or β-alanine. In some embodiments, the compositions of the Disclosure include aspartic acid or a salt thereof, for example, L-aspartic acid, D-aspartic acid, potassium L- or D-aspartate salt, L- or D-aspartate hydrochloride; magnesium L- or D-aspartate salt, or calcium L- or D-aspartate salt. In some embodiments, the compositions of the Disclosure include L-asparagine. In some embodiments, the compositions of the Disclosure include glutamic acid or a salt thereof, for example, L-glutamic acid or L-glutamate hydrochloride. In some embodiments, the compositions of the present disclosure include proline or a salt thereof, such as L-proline, L-proline hydrochloride, L-proline methyl ester hydrochloride, or L-proline ethyl ester hydrochloride. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0021]

[0034] In some embodiments, the compositions of the Disclosure do not contain proline, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain serine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain glycine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain cysteine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain glutamine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain glutamic acid, its hydrate, or a salt thereof.

[0022]

[0035] In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; and (b) glycine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; and (c) proline, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; and (c) cysteine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; and (d) cysteine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; and (d) arginine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; and (d) tyrosine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) cysteine, its hydrate, or a salt thereof; and (d) arginine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) cysteine, its hydrate, or a salt thereof; and (d) tyrosine, its hydrate, or a salt thereof.

[0023]

[0036] In some embodiments, the compositions of the present disclosure do not include (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; (d) cysteine, its hydrate, or a salt thereof; and (e) arginine, its hydrate, or a salt thereof. In some embodiments, the compositions of the present disclosure do not include (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; (d) cysteine, its hydrate, or a salt thereof; and (e) tyrosine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) proline, its hydrate, or a salt thereof; (d) cysteine, its hydrate, or a salt thereof; (e) tyrosine, its hydrate, or a salt thereof; and (f) arginine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure do not contain (a) serine, its hydrate, or a salt thereof; (b) glycine, its hydrate, or a salt thereof; (c) cysteine, its hydrate, or a salt thereof; (d) glutamine, its hydrate, or a salt thereof; and (e) glutamic acid, its salt, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure further lack glutamine, its hydrate, or a salt thereof. In some embodiments, the compositions of the Disclosure further lack glutamine, its hydrate, or a salt thereof.

[0024]

[0037] In some embodiments, the composition is a) histidine or its salt approximately 2% to approximately 6% (w / w); b) isoleucine or its salt approximately 2% to approximately 6% (w / w); c) leucine or its salt approximately 6% to approximately 11% (w / w); d) lysine or its salt approximately 5% to approximately 9% (w / w); e) methionine or its salt approximately 2% to approximately 4% (w / w); f) cysteine ​​or its salt approximately 1% to approximately 3% (w / w); g) phenylalanine or its salt approximately 3% to approximately 6% (w / w); h) tyrosine or its salt approximately 1% to approximately 3% (w / w); i) threonine or its salt approximately 3% to approximately 5% (w / w); j) tryptophan or its salt approximately 1% to approximately 3% (w / w);k) valine or its salts about 5% to about 9% (w / w);l) arginine or its salts about 5% to about 9% (w / w);m) glutamine or its salts about 5% to about 11% (w / w);n) alanine or its salts about 2% to about 7% (w / w);o) aspartic acid or its salts about 6% to about 10% (w / w);p) asparagine or its salts about 3% to about 7% (w / w);q) glutamic acid or its salts about 8% to about 14% (w / w);orr) proline or its salts about 6% to about 12% (w / w) may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of these.In some embodiments, the composition is a) histidine or its salt approximately 2% to approximately 6% (w / w); b) isoleucine or its salt approximately 2% to approximately 6% (w / w); c) leucine or its salt approximately 6% to approximately 11% (w / w); d) lysine or its salt approximately 5% to approximately 9% (w / w); e) methionine or its salt approximately 2% to approximately 4% (w / w); f) cysteine ​​or its salt approximately 1% to approximately 3% (w / w); g) phenylalanine or its salt approximately 3% to approximately 6% (w / w); h) tyrosine or its salt approximately 1% to approximately 3% (w / w); i) threonine or its salt approximately 3% to approximately 5% (w / w); j) A unit dosage form may contain approximately 1% to 3% (w / w) of tryptophan or its salt; k) approximately 5% to 9% (w / w) of valine or its salt; l) approximately 5% to 9% (w / w) of arginine or its salt; m) approximately 5% to 11% (w / w) of glutamine or its salt; n) approximately 2% to 7% (w / w) of alanine or its salt; o) approximately 6% to 10% (w / w) of aspartic acid or its salt; p) approximately 3% to 7% (w / w) of asparagine or its salt; q) approximately 8% to 14% (w / w) of glutamic acid or its salt; and r) approximately 6% to 12% (w / w) of proline or its salt. Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0025]

[0038] In some embodiments, the composition of the present disclosure is a) histidine or a salt thereof in about 5% to about 9% (w / w); b) isoleucine or a salt thereof in about 5% to about 9% (w / w); c) leucine or a salt thereof in about 9% to about 15% (w / w); d) lysine or a salt thereof in about 7% to about 12% (w / w); e) methionine or a salt thereof in about 5% to about 8% (w / w); f) cysteine ​​or a salt thereof in about 4% to about 7% (w / w); g) phenylalanine or a salt thereof in about 6% to about 10% ( It may contain at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 of the following: w / w); h) tyrosine or a salt thereof about 4% to about 7% (w / w); i) threonine or a salt thereof about 6% to about 10% (w / w); j) tryptophan or a salt thereof about 4% to about 7% (w / w); k) valine or a salt thereof about 8% to about 13% (w / w); l) arginine or a salt thereof about 5% to about 9% (w / w); or m) glutamine or a salt thereof about 7% to about 11% (w / w). In some embodiments, the composition is a) histidine or its salt in about 5% to about 9% (w / w); b) isoleucine or its salt in about 5% to about 9% (w / w); c) leucine or its salt in about 9% to about 15% (w / w); d) lysine or its salt in about 7% to about 12% (w / w); e) methionine or its salt in about 5% to about 8% (w / w); f) cysteine ​​or its salt in about 4% to about 7% (w / w); g) phenylalanine or its salt A unit dosage form may contain approximately 6% to 10% (w / w) of cystine or its salt, approximately 4% to 7% (w / w) of tyrosine or its salt, approximately 6% to 10% (w / w) of threonine or its salt, approximately 4% to 7% (w / w) of tryptophan or its salt, approximately 8% to 13% (w / w) of valine or its salt, approximately 5% to 9% (w / w) of arginine or its salt, and approximately 7% to 11% (w / w) of glutamine or its salt. Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0026]

[0039] In some embodiments, the composition is a) histidine or its salt approximately 2% to approximately 5% (w / w); b) isoleucine or its salt approximately 2% to approximately 5% (w / w); c) leucine or its salt approximately 6% to approximately 10% (w / w); d) lysine or its salt approximately 5% to approximately 8% (w / w); e) methionine or its salt approximately 2% to approximately 4% (w / w); f) cysteine ​​or its salt approximately 1% to approximately 3% (w / w); g) phenylalanine or its salt approximately 3% to approximately 5% (w / w); h) tyrosine or its salt approximately 1% to approximately 3% (w / w); i) threonine or its salt approximately 3% to approximately 5% (w / w); j) tryptophan or its salt approximately 1% to approximately It may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of the following: 3% (w / w); k) valine or its salt about 5% to about 9% (w / w); l) arginine or its salt about 5% to about 9% (w / w); m) glutamine or its salt about 7% to about 11% (w / w); n) alanine or its salt about 4% to about 7% (w / w); o) aspartic acid or its salt about 6% to about 10% (w / w); p) asparagine or its salt about 3% to about 6% (w / w); q) glutamic acid or its salt about 8% to about 14% (w / w); and r) proline or its salt about 6% to about 10% (w / w).In some embodiments, the composition is a) histidine or its salt approximately 2% to approximately 5% (w / w); b) isoleucine or its salt approximately 2% to approximately 5% (w / w); c) leucine or its salt approximately 6% to approximately 10% (w / w); d) lysine or its salt approximately 5% to approximately 8% (w / w); e) methionine or its salt approximately 2% to approximately 4% (w / w); f) cysteine ​​or its salt approximately 1% to approximately 3% (w / w); g) phenylalanine or its salt approximately 3% to approximately 5% (w / w); h) tyrosine or its salt approximately 1% to approximately 3% (w / w); i) threonine or its salt approximately 3% to approximately 5% (w / w); j) A unit dosage form may contain approximately 1% to 3% (w / w) of tryptophan or its salt; k) approximately 5% to 9% (w / w) of valine or its salt; l) approximately 5% to 9% (w / w) of arginine or its salt; m) approximately 7% to 11% (w / w) of glutamine or its salt; n) approximately 4% to 7% (w / w) of alanine or its salt; o) approximately 6% to 10% (w / w) of aspartic acid or its salt; p) approximately 3% to 6% (w / w) of asparagine or its salt; q) approximately 8% to 14% (w / w) of glutamic acid or its salt; and r) approximately 6% to 10% (w / w) of proline or its salt. Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0027]

[0040] In some embodiments, the composition of the present disclosure is a) histidine or a salt thereof in a quantity of about 5% to about 9% (w / w); b) isoleucine or a salt thereof in a quantity of about 5% to about 9% (w / w); c) leucine or a salt thereof in a quantity of about 9% to about 15% (w / w); d) lysine or a salt thereof in a quantity of about 7% to about 12% (w / w); e) methionine or a salt thereof in a quantity of about 5% to about 8% (w / w); f) cysteine ​​or a salt thereof in a quantity of about 4% to about 7% (w / w); g) phenylalanine or a salt thereof in a quantity of about 6% to about 10% (w / w);h) tyrosine or a salt thereof about 4% to about 7% (w / w);i) threonine or a salt thereof about 6% to about 10% (w / w);j) tryptophan or a salt thereof about 4% to about 7% (w / w);k) valine or a salt thereof about 8% to about 13% (w / w);l) arginine or a salt thereof about 5% to about 9% (w / w);or m) glutamine or a salt thereof about 7% to about 11% (w / w) may contain at least 2, 3, 4, 5, 6, 7, 8, 9, or 10. In some embodiments, the composition is a) histidine or its salt in about 5% to about 9% (w / w); b) isoleucine or its salt in about 5% to about 9% (w / w); c) leucine or its salt in about 9% to about 15% (w / w); d) lysine or its salt in about 7% to about 12% (w / w); e) methionine or its salt in about 5% to about 8% (w / w); f) cysteine ​​or its salt in about 4% to about 7% (w / w); g) phenylalanine or its salt A unit dosage form may contain approximately 6% to 10% (w / w) of cystine or its salt, approximately 4% to 7% (w / w) of tyrosine or its salt, approximately 6% to 10% (w / w) of threonine or its salt, approximately 4% to 7% (w / w) of tryptophan or its salt, approximately 8% to 13% (w / w) of valine or its salt, approximately 5% to 9% (w / w) of arginine or its salt, and approximately 7% to 11% (w / w) of glutamine or its salt. Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0028]

[0041] In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 3% to about 7% (w / w); b) isoleucine, its hydrate, or its salt in about 3% to about 6% (w / w); c) leucine, its hydrate, or its salt in about 7% to about 11% (w / w); d) lysine, its hydrate, or its salt in about 5% to about 9% (w / w); e) methionine, its hydrate, or its salt in about 2% to about 4% %(w / w);f) Cysteine, its hydrate, or its salt, approximately 1% to 3% (w / w);g) Phenylalanine, its hydrate, or its salt, approximately 3% to 7% (w / w);h) Tyrosine, its hydrate, or its salt, approximately 1% to 3% (w / w);i) Threonine, its hydrate, or its salt, approximately 2% to 5% (w / w);j) Tryptophan, its hydrate, or its salt, approximately 1% to 3% (w / w); k) Valine, its hydrate, or its salt, approximately 5% to 9% (w / w); l) Arginine, its hydrate, or its salt, approximately 5% to 9% (w / w); m) Glutamine, its hydrate, or its salt, approximately 7% to 11% (w / w); n) Alanine, its hydrate, or its salt, approximately 3% to 7% (w / w); o) Aspartic acid, its hydrate, or its salt, approximately 6% to 10% (w / w); p) Asparagine, It may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of the following: q) glutamic acid, its hydrate, or its salt in amounts of about 3% to about 6% (w / w); r) serine, its hydrate, or its salt in amounts of about 2% to about 5% (w / w); or s) glycine, its hydrate, or its salt in amounts of about 3% to about 7% (w / w).In some embodiments, a) histidine, its hydrate, or its salt in approximately 3% to 7% (w / w); b) isoleucine, its hydrate, or its salt in approximately 3% to 6% (w / w); c) leucine, its hydrate, or its salt in approximately 7% to 11% (w / w); d) lysine, its hydrate, or its salt in approximately 5% to 9% (w / w); e) methionine, its hydrate, or its salt in approximately 2% to 4% (w / w); f) cysteine, its hydrate, or its salt in approximately 1% to 3% (w / w); g) phenylalanine, its hydrate, or its salt in approximately 3% to 7% (w / w); h) tyrosine, its hydrate, or its salt in approximately 1% to 3% (w / w); i) threonine, its hydrate, or its salt in approximately 2% to 5% (w / w); j) tryptophan, its hydrate, or its salt in approximately 1%~approx. 3% (w / w); k) Valine, its hydrate, or its salt approx. 5%~approx. 9% (w / w); l) Arginine, its hydrate, or its salt approx. 5%~approx. 9% (w / w); m) Glutamine, its hydrate, or its salt approx. 7%~approx. 11% (w / w); n) Alanine, its hydrate, or its salt approx. 3%~approx. 7% (w / w); o) Aspartic acid, its hydrate, or its salt approx. 6%~ Compositions containing approximately 10% (w / w) of p) asparagine, its hydrate, or its salt in a unit dosage form are disclosed herein. q) glutamic acid, its hydrate, or its salt in a unit dosage form is approximately 3% to 6% (w / w). r) serine, its hydrate, or its salt in a unit dosage form is approximately 2% to 5% (w / w). s) glycine, its hydrate, or its salt in a unit dosage form is approximately 3% to 7% (w / w). Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0029]

[0042] In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 3% to about 7% (w / w); b) isoleucine, its hydrate, or its salt in about 4% to about 8% (w / w); c) leucine, its hydrate, or its salt in about 9% to about 13% (w / w); d) lysine, its hydrate, or its salt in about 8% to about 12% (w / w); e) methionine, its hydrate, or its salt in about 1% to about 4% (w / w); f) cysteine, its hydrate, or its salt in about 1% to about 4% (w / w); g) phenylalanine, its hydrate, or its salt in about 5% to about 9% (w / w); h) tyrosine, its hydrate, or its salt in about 1% to about 5% (w / w); i) threonine, its hydrate, or its salt in about 4% to about 8% (w / w); j) tri It may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of the following: putophane, its hydrate, or its salt, about 1% to about 4% (w / w); k) valine, its hydrate, or its salt, about 5% to about 10% (w / w); l) arginine, its hydrate, or its salt, about 1% to about 10% (w / w); m) glutamine, its hydrate, or its salt, about 1% to about 5% (w / w); n) alanine, its hydrate, or its salt, about 4% to about 8% (w / w); o) aspartic acid, its hydrate, acid, or its salt, about 4% to about 12% (w / w); p) asparagine, its hydrate, or its salt, about 4% to about 8% (w / w); or q) glutamic acid, its hydrate, or its salt, about 5% to about 15% (w / w).In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 3% to about 7% (w / w); b) isoleucine, its hydrate, or its salt in about 4% to about 8% (w / w); c) leucine, its hydrate, or its salt in about 9% to about 13% (w / w); d) lysine, its hydrate, or its salt in about 8% to about 12% (w / w); e) methionine, its hydrate, or its salt in about 1% to about 4% (w / w); f) cysteine, its hydrate, or its salt in about 1% to about 4% (w / w); g) phenylalanine, its hydrate, or its salt in about 5% to about 9% (w / w); h) tyrosine, its hydrate, or its salt in about 1% to about 5% (w / w); i) threonine, its hydrate, or its The unit dosage form may contain approximately 4% to 8% (w / w) of salt; j) tryptophan, its hydrate, or its salt; k) valine, its hydrate, or its salt; l) arginine, its hydrate, or its salt; m) glutamine, its hydrate, or its salt; n) alanine, its hydrate, or its salt; o) aspartic acid, its hydrate, its acid, or its salt; p) asparagine, its hydrate, or its salt; and q) glutamic acid, its hydrate, or its salt; and approximately 5% to 15% (w / w) of glutamic acid. Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0030]

[0043] In some embodiments, the composition is a) histidine, its hydrate, or its salt at about 4% to about 6% (w / w); b) isoleucine, its hydrate, or its salt at about 5% to about 7% (w / w); c) leucine, its hydrate, or its salt at about 9% to about 12% (w / w); d) lysine, its hydrate, or its salt at about 8% to about 12% (w / w); e) methionine, its hydrate, or its salt at about 1% to about 4% (w / w); f) cysteine, its hydrate, or its salt at about 1% to about 3% (w / w); g) phenylalanine, its hydrate, or its salt at about 6% to about 8% (w / w); h) tyrosine, its hydrate, or its salt at about 1% to about 4% (w / w); i) threonine, its hydrate, or its salt at about 4% to about 7% (w / w); j) th) It may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of the following: k) Liptophan, its hydrate, or its salt, about 1% to about 3% (w / w); k) Valine, its hydrate, or its salt, about 4% to about 9% (w / w); l) Arginine, its hydrate, or its salt, about 7% to about 11% (w / w); m) Glutamine, its hydrate, or its salt, about 2% to about 4% (w / w); n) Alanine, its hydrate, or its salt, about 4% to about 7% (w / w); o) Aspartic acid, its hydrate, or its salt, about 8% to about 11% (w / w); p) Asparagine, its hydrate, or its salt, about 4% to about 7% (w / w); or q) Glutamic acid, its hydrate, or its salt, about 4% to about 8% (w / w).In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 4% to about 6% (w / w); b) isoleucine, its hydrate, or its salt in about 5% to about 7% (w / w); c) leucine, its hydrate, or its salt in about 9% to about 12% (w / w); d) lysine, its hydrate, or its salt in about 8% to about 12% (w / w); e) methionine, its hydrate, or its salt in about 1% to about 4% (w / w); f) cysteine, its hydrate, or its salt in about 1% to about 3% (w / w); g) phenylalanine, its hydrate, or its salt in about 6% to about 8% (w / w); h) tyrosine, its hydrate, or its salt in about 1% to about 4% (w / w); i) threonine, its hydrate, or its salt The unit dosage form may contain approximately 4% to 7% (w / w) of the salt of (i) (j) tryptophan, its hydrate, or its salt, approximately 1% to 3% (w / w) of (k) valine, its hydrate, or its salt, approximately 4% to 9% (w / w) of (l) arginine, its hydrate, or its salt, approximately 7% to 11% (w / w) of (m) glutamine, its hydrate, or its salt, approximately 2% to 4% (w / w) of (n) alanine, its hydrate, or its salt, approximately 4% to 7% (w / w) of (o) aspartic acid, its hydrate, or its salt, approximately 8% to 11% (w / w) of (p) asparagine, its hydrate, or its salt, approximately 4% to 7% (w / w) of (p) and (q) glutamic acid, its hydrate, or its salt, approximately 4% to 8% (w / w). Any composition of this disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0031]

[0044] In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 4% to about 6% (w / w); b) isoleucine, its hydrate, or its salt in about 5% to about 7% (w / w); c) leucine, its hydrate, or its salt in about 11% to about 13% (w / w); d) lysine, its hydrate, or its salt in about 8% to about 10% (w / w); e) methionine, its hydrate, or its salt in about 2% to about 4% (w / w); f) phenylalanine, its hydrate, or its salt in about 6% to about 8% (w / w); g) tyrosine, its hydrate, or its salt in about 1% to about 3% (w / w); h) threonine, its hydrate, or its salt in about 3% to about 5% (w / w); i) It may contain at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 of the following: tryptophan, its hydrate, or its salt in about 1% to about 3% (w / w); j) valine, its hydrate, or its salt in about 8% to about 10% (w / w); k) arginine, its hydrate, or its salt in about 7% to about 9% (w / w); l) alanine, its hydrate, or its salt in about 3% to about 5% (w / w); m) aspartic acid, its hydrate, or its salt in about 4% to about 6% (w / w); n) asparagine, its hydrate, or its salt in about 4% to about 7% (w / w); or o) proline, its hydrate, or its salt in about 14% to about 17% (w / w).In some embodiments, the composition is a) histidine, its hydrate, or its salt in about 4% to about 6% (w / w); b) isoleucine, its hydrate, or its salt in about 5% to about 7% (w / w); c) leucine, its hydrate, or its salt in about 11% to about 13% (w / w); d) lysine, its hydrate, or its salt in about 8% to about 10% (w / w); e) methionine, its hydrate, or its salt in about 2% to about 4% (w / w); f) phenylalanine, its hydrate, or its salt in about 6% to about 8% (w / w); g) tyrosine, its hydrate, or its salt in about 1% to about 3% (w / w); h) threonine, its hydrate, or The unit dosage form may contain approximately 3% to 5% (w / w) of the salt of the present invention; i) approximately 1% to 3% (w / w) of tryptophan, its hydrate, or its salt; j) approximately 8% to 10% (w / w) of valine, its hydrate, or its salt; k) approximately 7% to 9% (w / w) of arginine, its hydrate, or its salt; l) approximately 3% to 5% (w / w) of alanine, its hydrate, or its salt; m) approximately 4% to 6% (w / w) of aspartic acid, its hydrate, or its salt; n) approximately 4% to 7% (w / w) of asparagine, its hydrate, or its salt; and o) approximately 14% to 17% (w / w) of proline, its hydrate, or its salt. Any composition of the present disclosure may contain cysteine ​​instead of cystine, or cystine instead of cysteine.

[0032] Pharmaceutically acceptable salts

[0045] Any molecular component (e.g., an amino acid) of the pharmaceutical compositions described herein can be provided as a pharmaceutically acceptable salt. Pharmaceutically acceptable salts include, for example, acid addition salts and base addition salts. The acid added to the compound to form an acid addition salt may be an organic or inorganic acid. The base added to the compound to form a base addition salt may be an organic or inorganic base. In some embodiments, the pharmaceutically acceptable salt is a metal salt.

[0033]

[0046] Metal salts are obtained from the addition of an inorganic base to the compounds of this disclosure. The inorganic base consists of a metal cation paired with a basic counterion, such as a hydroxide ion, carbonate ion, bicarbonate ion, or phosphate ion. The metal may be an alkali metal, alkaline earth metal, transition metal, or typical metal. In some embodiments, the metal is lithium, sodium, potassium, cesium, cerium, magnesium, manganese, iron, calcium, strontium, cobalt, titanium, aluminum, copper, cadmium, or zinc.

[0034]

[0047] In some embodiments, the metal salt is a lithium salt, sodium salt, potassium salt, cesium salt, cerium salt, magnesium salt, manganese salt, iron salt, calcium salt, strontium salt, cobalt salt, titanium salt, aluminum salt, copper salt, cadmium salt, or zinc salt.

[0035]

[0048] Ammonium salts may result from the addition of ammonia or an organic amine to the compounds of the present disclosure. In some embodiments, the organic amine is triethylamine, diisopropylamine, ethanolamine, diethanolamine, triethanolamine, morpholine, N-methylmorpholine, piperidine, N-methylpiperidine, N-ethylpiperidine, dibenzylamine, piperazine, pyridine, pyrazole, imidazole, or pyrazine.

[0036]

[0049] In some embodiments, the ammonium salt is triethylamine salt, trimethylamine salt, diisopropylamine salt, ethanolamine salt, diethanolamine salt, triethanolamine salt, morpholine salt, N-methylmorpholine salt, piperidine salt, N-methylpiperidine salt, N-ethylpiperidine salt, dibenzylamine salt, piperazine salt, pyridine salt, pyrazole salt, pyridazine salt, pyrimidine salt, imidazole salt, or pyrazine salt.

[0037]

[0050] Acid addition salts may result from the addition of an acid to the compounds of the present disclosure. In some embodiments, the acid is organic. In some embodiments, the acid is inorganic. In some embodiments, the acid is hydrochloric acid, hydrobromic acid, hydroiodic acid, nitric acid, nitrite, sulfuric acid, sulfurous acid, phosphoric acid, isonicotinic acid, lactic acid, salicylic acid, tartaric acid, ascorbic acid, gentisic acid, gluconic acid, glucuronic acid, sugar acid, formic acid, benzoic acid, glutamic acid, pantothenic acid, acetic acid, propionic acid, butyric acid, fumaric acid, succinic acid, methanesulfonic acid, ethanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, citric acid, oxalic acid, or maleic acid.

[0038]

[0051] In some embodiments, the salt is hydrochloride, hydrobromide, hydroiodide, nitrate, nitrite, sulfate, sulfite, phosphate, isonicotinate, lactate, salicylate, tartrate, ascorbate, gentisinate, gluconate, glucuronate, sugarate, formate, benzoate, glutamate, pantothenate, acetate, propionate, butyrate, fumarate, succinate, methanesulfonate, ethanesulfonate, benzenesulfonate, p-toluenesulfonate, citrate, oxalate, or maleate.

[0039] vitamin

[0052] The compositions of the present disclosure may contain one or more essential vitamins. In some embodiments, the compositions of the present disclosure may contain vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, and vitamin B. In some embodiments, the compositions of the present disclosure may contain thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), folic acid (vitamin B9), or cobalamin (vitamin B12). In some embodiments, the compositions of the present disclosure may contain fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, or vitamin K. In some embodiments, the compositions of the present disclosure may contain water-soluble vitamins such as vitamin C and vitamin B. In some embodiments, the compositions of the present disclosure may include water-soluble vitamins, such as vitamin B, including thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), folic acid (vitamin B9), or cobalamin (vitamin B12).

[0040]

[0053] In some embodiments, the compositions of the Disclosure may include vitamin A, vitamin B, vitamin C, vitamin D, and vitamin E. In some embodiments, the compositions of the Disclosure may include vitamin A, vitamin C, vitamin D, vitamin E, thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), folic acid (vitamin B9), and cobalamin (vitamin B12).

[0041]

[0054] The compositions of this disclosure may contain the recommended dietary allowances of vitamins for adult males. In some embodiments, the compositions of this disclosure contain the recommended dietary allowances of vitamins for adult males: vitamin A, 900 μg; vitamin C, 90 mg; vitamin D, 15 μg; vitamin E, 15 mg; vitamin K, 120 μg; thiamine, 1.2 mg; riboflavin, 1.3 mg; niacin, 16 mg; pantothenic acid, 5 mg; pyridoxine, 1.3 mg; biotin, 30 μg; folic acid, 400 μg; and choline, 550 mg. The compositions of this disclosure may also contain the recommended dietary allowances of vitamins for adult females. In some embodiments, the compositions of the present disclosure contain the recommended nutritional requirements for vitamins in adult males: vitamin A, 700 μg; vitamin C, 75 mg; vitamin D, 15 μg; vitamin E, 15 mg; vitamin K, 90 μg; thiamine, 1.1 mg; riboflavin, 1.1 mg; niacin, 14 mg; pantothenic acid, 5 mg; pyridoxine, 1.3 mg; biotin, 30 μg; folic acid, 400 μg; and choline, 425 mg.

[0042]

[0055] The compositions of this disclosure may contain about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100% of the recommended dietary requirement for any of the vitamins in adult men or women. In some embodiments, the compositions of this disclosure may contain about 20%, about 30%, about 40%, about 50%, or about 60% of the recommended dietary requirement for any of the vitamins in adult men or women. In some embodiments, the compositions of this disclosure may contain about 30% of the recommended dietary requirement for any of the vitamins in adult men or women. In some embodiments, the compositions of this disclosure may contain about 50% of the recommended dietary requirement for any of the vitamins in adult men or women.

[0043] mineral

[0056] The compositions of the present disclosure may contain one or more minerals or elements. In some embodiments, the compositions of the present disclosure may contain calcium, chromium, copper, fluoride, iodide, iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, potassium, sodium, or chloride.

[0044]

[0057] The compositions of this disclosure may contain the recommended daily allowance of an element or mineral for adult males. In some embodiments, the compositions of this disclosure contain the recommended daily allowance of an element or mineral for adult males: calcium, 1000 mg; chromium, 35 μg; copper, 900 μg; fluoride, 4 mg; iodide, 150 μg; iron, 8 mg; magnesium, 400 mg; manganese, 2.3 mg; molybdenum, 45 μg; phosphorus, 700 mg; selenium, 55 μg; zinc, 11 mg; potassium, 3400 mg; sodium, 1500 mg; or chloride, 2.3 g. The compositions of this disclosure may also contain the recommended daily allowance of an element or mineral for adult females. In some embodiments, the compositions of the present disclosure contain the recommended daily intake of an element or mineral for adult women: calcium, 1000 mg; chromium, 25 μg; copper, 900 μg; fluoride, 3 mg; iodide, 150 μg; iron, 18 mg; magnesium, 310 mg; manganese, 1.8 mg; molybdenum, 45 μg; phosphorus, 700 mg; selenium, 55 μg; zinc, 8 mg; potassium, 2600 mg; sodium, 1500 mg; or chloride, 2.3 g.

[0045]

[0058] The compositions of this disclosure may contain about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100% of the recommended dietary requirement for any element or mineral in an adult male or female. In some embodiments, the compositions of this disclosure may contain about 20%, about 30%, about 40%, about 50%, or about 60% of the recommended dietary requirement for any element or mineral in an adult male or female. In some embodiments, the compositions of this disclosure may contain about 30% of the recommended dietary requirement for any element or mineral in an adult male or female. In some embodiments, the compositions of this disclosure may contain about 50% of the recommended dietary requirement for any element or mineral in an adult male or female.

[0046] Lipids

[0059] The compositions of the present disclosure may contain fats. In some embodiments, the pharmaceutical compositions of the present disclosure may contain saturated fats, trans fats, polyunsaturated fats, or monounsaturated fats. In some embodiments, the compositions of the present disclosure may contain saturated fats, trans fats, polyunsaturated fats, and monounsaturated fats.

[0047]

[0060] In some embodiments, the compositions of the Disclosure may contain about 1 g, about 2 g, about 3 g, about 4 g, about 5 g, about 6 g, about 7 g, about 8 g, about 9 g, or about 10 g of the total fat content. In some embodiments, the compositions of the Disclosure may contain about 5 g of the total fat content.

[0048]

[0061] In some embodiments, the compositions of the Disclosure contain cholesterol. In some embodiments, the compositions of the Disclosure contain about 100 mg / serving of cholesterol. In some embodiments, the compositions of the Disclosure contain about 50 mg / serving of cholesterol.

[0049] carbohydrates

[0062] In some embodiments, the compositions of the Disclosure include carbohydrates such as sugars, starches, or complex carbohydrates. In some embodiments, the compositions of the Disclosure include sugars such as corn syrup, fructose, galactose, glucose, high-fructose corn syrup, lactose, maltose, or sucrose. In some embodiments, the compositions of the Disclosure include sugar alcohols. In some embodiments, the compositions of the Disclosure include starch. In some embodiments, the compositions of the Disclosure include indigestible starches such as oats, rice, legumes, raw potato starch, green bananas, or Hi-Maize® flour.

[0050]

[0063] In some embodiments, the compositions of the Disclosure include complex carbohydrates such as fiber. In some embodiments, the compositions of the Disclosure include soluble fiber. In some embodiments, the compositions of the Disclosure include soluble fiber obtained from food sources such as oatmeal, flaxseed, barley, dried peas, apples, or carrots. In some embodiments, the compositions of the Disclosure include insoluble fiber. In some embodiments, the compositions of the Disclosure include insoluble fiber obtained from food sources such as seeds, nuts, dark green leafy vegetables, or wheat bran. In some embodiments, the compositions of the Disclosure include fiber such as inulin, methylcellulose, psyllium, or wheat dextrin.

[0051] Pharmaceutical excipients

[0064] The compositions of the present disclosure may include at least one pharmaceutical excipient, such as an anti-adhesion agent, binder, coating, colorant, disintegrant, flavoring agent, preservative, adsorbent, sweetener, or vehicle. In some embodiments, the compositions of the present disclosure include a colorant and a flavoring agent. In some embodiments, the compositions of the present disclosure include a colorant, a flavoring agent, and a sweetener. In some embodiments, the compositions of the present disclosure include a flavoring agent, a sweetener, and a preservative.

[0052] A. Anti-adhesion agent

[0065] The compositions of the present disclosure may contain an anti-adhesion agent. In some embodiments, the compositions of the present disclosure may contain an anti-adhesion agent such as magnesium stearate.

[0053] B. Binder

[0066] The compositions of the present disclosure may include at least one binder to hold the compositions together. In some embodiments, the compositions of the present disclosure may include binders such as sugars, proteins, or synthetic polymers. In some embodiments, the compositions of the present disclosure may include disaccharides (e.g., sucrose or lactose), polysaccharides or polysaccharide derivatives (e.g., starch, cellulose, modified cellulose, cellulose ethers), or sugar alcohols (e.g., xylitol, sorbitol, or mannitol). In some embodiments, the compositions of the present disclosure may include protein binders such as gelatin. In some embodiments, the compositions of the present disclosure may include synthetic polymer binders such as polyvinylpyrrolidone (PVP) or polyethylene glycol (PEG).

[0054] C. Preservative

[0067] The compositions of this disclosure may contain at least one preservative. In some embodiments, the compositions of this disclosure may contain an antioxidant or an antimicrobial agent. Antioxidants delay or prevent the deterioration of the composition by oxidation mechanisms. Antimicrobial agents inhibit the growth of spoilage or pathogenic microorganisms in the composition.

[0055]

[0068] In some embodiments, antioxidants are added to the composition to delay or prevent auto-oxidation or enzymatic oxidation of unsaturated fatty acids. In some embodiments, the compositions of the Disclosure comprise at least one of ascorbic acid, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), citric acid, sulfite, tertiary butylhydroquinone (TBHQ), or tocopherol. In some embodiments, the compositions of the Disclosure comprise ascorbic acid. In some embodiments, the compositions of the Disclosure comprise BHT. In some embodiments, the compositions of the Disclosure comprise citric acid.

[0056]

[0069] In some embodiments, the compositions of the Disclosure contain approximately 100 mg / kg, approximately 200 mg / kg, approximately 300 mg / kg, approximately 400 mg / kg, approximately 500 mg / kg, approximately 600 mg / kg, approximately 700 mg / kg, approximately 800 mg / kg, approximately 900 mg / kg, or approximately 11,000 mg / kg of antioxidants. In some embodiments, the compositions of the Disclosure contain up to approximately 100 mg / kg, up to approximately 200 mg / kg, up to approximately 300 mg / kg, up to approximately 400 mg / kg, up to approximately 500 mg / kg, up to approximately 600 mg / kg, up to approximately 700 mg / kg, up to approximately 800 mg / kg, up to approximately 900 mg / kg, or up to approximately 1,000 mg / kg of antioxidants.

[0057]

[0070] In some embodiments, an antimicrobial agent is added to the composition to delay or prevent the growth of putrefactive or pathogenic microorganisms in the composition. In some embodiments, the compositions of the present disclosure include at least one of acetic acid, benzoic acid, natamycin, nisin, nitrates, nitrites, propionic acid, sorbic acid, sulfites, or sulfur dioxide.

[0058]

[0071] In some embodiments, the compositions of the Disclosure contain an antimicrobial agent in amounts of approximately 100 mg / kg, approximately 200 mg / kg, approximately 300 mg / kg, approximately 400 mg / kg, approximately 500 mg / kg, approximately 600 mg / kg, approximately 700 mg / kg, approximately 800 mg / kg, approximately 900 mg / kg, or approximately 1000 mg / kg. In some embodiments, the compositions of the Disclosure contain an antimicrobial agent in amounts of up to approximately 100 mg / kg, up to approximately 200 mg / kg, up to approximately 300 mg / kg, up to approximately 400 mg / kg, up to approximately 500 mg / kg, up to approximately 600 mg / kg, up to approximately 700 mg / kg, up to approximately 800 mg / kg, up to approximately 900 mg / kg, or up to approximately 1000 mg / kg.

[0059] D. Colorants

[0072] The compositions of the present disclosure may include at least one colorant. In some embodiments, the compositions of the present disclosure may include a natural colorant or a synthetic colorant.

[0060]

[0073] In some embodiments, the compositions of the Disclosure include natural colorants. In some embodiments, the compositions of the Disclosure include anthocyanins. In some embodiments, the compositions of the Disclosure include anthocyanins such as pelargonidin-3-glucoside obtained from strawberries (Fragaria species) or malvidin-3-glucoside obtained from grapes (Vitis species). In some embodiments, the compositions of the Disclosure include betacyanins. In some embodiments, the compositions of the Disclosure include betacyanins such as betanin obtained from beet roots (Beta vulgaris). In some embodiments, the compositions of the Disclosure include carotenoids. In some embodiments, the compositions of the Disclosure include carotenoids, for example, bixin obtained from annatto (Bixa Orellana); crocin obtained from saffron (Crocus sativus); capsanthin obtained from paprika (Capsicum annuum); beta-carotene obtained from ginseng (Daucus carota); or canthaxanthin obtained from mushroom (Cantharellus cinnabarinus). In some embodiments, the compositions of the Disclosure include phenols. In some embodiments, the compositions of the Disclosure include phenols such as curcumin obtained from turmeric (Cuycuma longa).

[0061]

[0074] In some embodiments, the compositions of the Disclosure include synthetic colorants. In some embodiments, the compositions of the Disclosure include Allura Red AC, Brilliant Blue FCF, Erythrosine, Fast Green FCF, Indigo Carmine, Sunset Yellow FCF, or Tartrazine. In some embodiments, the compositions of the Disclosure include FD&C Red 40, FD&C Blue 1, FD&C Red 3, FD&C Green 3, FD&C Blue 2, FD&C Yellow 6, or FD&C Yellow 5. In some embodiments, the compositions of the Disclosure include E133, E127, E132, E110, or E102.

[0062] E. Flavoring agents

[0075] The compositions of the present disclosure may contain at least one flavoring agent. In some embodiments, the compositions of the present disclosure may contain a natural flavoring substance, a natural equivalent flavoring substance, or an artificial flavoring substance. In some embodiments, the compositions of the present disclosure may contain a natural flavoring substance such as a spice, fruit juice, or vegetable juice. In some embodiments, the compositions of the present disclosure may contain a natural equivalent flavoring substance such as vanillin.

[0063]

[0076] In some embodiments, the compositions of the present disclosure may contain artificial flavoring substances such as allylpyrazine, methoxypyrazine, 2-iso-butyl-3-methoxypyrazine, acetyl-L-pyrazine, 2-acetoxypyrazine, aldehydes, alcohols, esters, ketones, pyrazines, phenols, or terpenoids.

[0064] F. Sweeteners

[0077] The compositions of the present disclosure may contain at least one sweetener. In some embodiments, the compositions of the present disclosure may contain sucrose, glucose, fructose, corn syrup, high-fructose corn syrup, or a sugar alcohol. In some embodiments, the compositions of the present disclosure may contain a sugar alcohol such as sorbitol, mannitol, or xylitol. In some embodiments, the compositions of the present disclosure may contain fructose.

[0065]

[0078] In some embodiments, the compositions of the disclosure include synthetic sweeteners. In some embodiments, the compositions of the disclosure include saccharin, cyclamate, aspartame, or acesulfame K. In some embodiments, the compositions of the disclosure include aspartame.

[0066]

[0079] In some embodiments, the compositions of the present disclosure may contain a sweetener in amounts of about 0.5 g / serving, about 1 g / serving, about 1.5 g / serving, about 2 g / serving, about 2.5 g / serving, about 3 g / serving, about 3.5 g / serving, about 4 g / serving, about 4.5 g / serving, about 5 g / serving, about 5.5 g / serving, about 6 g / serving, about 6.5 g / serving, about 7 g / serving, about 7.5 g / serving, about 8 g / serving, about 8.5 g / serving, about 9 g / serving, about 9.5 g / serving, or about 10 g / serving. In some embodiments, the compositions of the present disclosure may contain about 1 g / serving of sweetener. In some embodiments, the compositions of the present disclosure may contain about 2.5 g / serving of sweetener. In some embodiments, the compositions of the present disclosure may contain about 5 g / serving of sweetener.

[0067] G. Processing Agent

[0080] The compositions of the present disclosure may include at least one processing additive. In some embodiments, the compositions of the present disclosure may include anticaking agents, bleaching agents, chelating agents, clarifying agents, conditioning agents, emulsifiers, humectants, pH regulators, stabilizers, or thickeners. In some embodiments, the compositions of the present disclosure may include anticaking agents such as sodium aluminosilicate, chelating agents such as ethylenediaminetetraacetic acid (EDTA), conditioning agents such as potassium bromate, or pH regulators such as citric acid or lactic acid. In some embodiments, the compositions of the present disclosure may include humectants such as glycerol, or stabilizers and thickeners, such as pectin, gelatin, carrageenan, or guar gum.

[0068] formulation

[0081] The compositions of the present invention may, for example, be in immediate-release or controlled-release formulations. Immediate-release formulations can be formulated so that the compound acts rapidly. Non-limiting examples of immediate-release formulations include readily soluble formulations. Controlled-release formulations may be pharmaceutical formulations that are adapted so that the release rate and release profile of the activator match physiological and time-course therapeutic requirements, or formulated to result in the release of the activator at a programmed rate. Non-limiting examples of controlled-release formulations include granules, delayed-release granules, hydrogels (e.g., synthetic or naturally occurring), other gelling agents (e.g., gel-forming dietary fiber), matrix-based formulations (e.g., formulations comprising a polymer material in which at least one active ingredient is dispersed), granules in a matrix, polymer mixtures, and granular masses.

[0069]

[0082] In some embodiments, the controlled-release formulation is a delayed-release form. The delayed-release form can be formulated to delay the action of the compound for an extended period. For example, the delayed-release form can be formulated to delay the release of an effective dose of one or more compounds for about 4 hours, about 8 hours, about 12 hours, about 16 hours, or about 24 hours.

[0070]

[0083] Controlled-release formulations may be sustained-release formulations. Sustained-release formulations can be formulated, for example, to prolong the action of a compound over an extended period. Sustained-release formulations can be formulated to provide an effective dose of any compound described herein (e.g., to provide a physiologically effective blood profile) over a period of about 4 hours, about 8 hours, about 12 hours, about 16 hours, or about 24 hours.

[0071]

[0084] Non-limiting examples of pharmaceutically acceptable excipients can be found, for example, in Remington: The Science and Practice of Pharmacy, 19th edition (Easton, Pa.: Mack Publishing Company, 1995); Hoover, John E., Remington's Pharmaceutical Sciences, Mack Publishing Co., Easton, Pennsylvania, 1975; Liberman, HA and Lachman, L., eds., Pharmaceutical Dosage Forms, Marcel Decker, New York, NY, 1980; and Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th edition (Lippincott Williams & Wilkins, 1999).

[0072] taking

[0085] The compositions described herein can be administered to supplement a meal consumed by an individual. The compositions described herein can be administered as a meal replacement. The compositions described herein can be administered immediately before or immediately after a meal. The compositions described herein can be administered within approximately 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours before or after a meal.

[0073]

[0086] The compositions described herein can be in unit dosage forms suitable for single-dose administration of precise dosages. In unit dosage forms, the formulation is divided into unit doses containing an appropriate amount of the composition. In some embodiments, the unit dose may be in the form of a package containing discrete doses of the formulation. In some embodiments, the formulations of the Disclosure may be supplied as unit dosage forms in single-dose pouches. In some embodiments, the formulations of the Disclosure may be supplied in a single-dose, non-re-sealable container. In some embodiments, the formulations of the Disclosure may be supplied in a re-sealable container, and the subject may obtain a single dose of the formulation using a spoon or scoop designed to dispense a single dose. In some embodiments, the formulations of the Disclosure may be supplied in a re-sealable container, and the subject may obtain a single dose of the formulation using a spoon or scoop designed to dispense half a dose (i.e., two scoops to dispense a single dose).

[0074]

[0087] The compositions described herein can exist as single doses in the range of approximately 1g to 2g, 2g to 3g, 3g to 4g, 4g to 5g, 5g to 6g, 6g to 7g, 7g to 8g, 8g to 9g, 9g to 10g, 10g to 11g, 11g to 12g, 12g to 13g, 13g to 14g, 14g to 15g, 15g to 16g, 16g to 17g, 17g to 18g, 18g to 19g, 19g to 20g, 20g to 21g, 21g to 22g, 22g to 23g, 23g to 24g, or 24g to 25g.

[0075]

[0088] The compositions described herein may exist as a single dose in amounts of approximately 1 g, 2 g, 3 g, 4 g, 5 g, 6 g, 7 g, 8 g, 9 g, 10 g, 11 g, 12 g, 13 g, 14 g, 15 g, 16 g, 17 g, 18 g, 19 g, 20 g, 21 g, 22 g, 23 g, 24 g, or 25 g. In some embodiments, the compositions described herein may exist as a single dose in amounts of approximately 10 g, 12 g, 15 g, 20 g, or 24 g.

[0076]

[0089] In some embodiments, the composition described herein exists as a unit dose in an amount of about 12 g. In some embodiments, the composition described herein exists as a unit dose in a pouch in an amount of about 12 g. In some embodiments, the composition described herein exists as a unit dose in an amount of about 15 g. In some embodiments, the composition described herein exists as a unit dose in a pouch in an amount of about 15 g. In some embodiments, the composition described herein exists as a unit dose in an amount of about 24 g. In some embodiments, the composition described herein exists as a unit dose in a pouch in an amount of about 24 g.

[0077]

[0090] In some embodiments, the dose of the composition of the Disclosure may be expressed as the amount of drug divided by the mass of the subject, for example, the number of grams of drug per kilogram of body weight of the subject. In some embodiments, the therapeutically effective dose of the composition of the Disclosure may be about 0.1 g / kg / day to about 0.2 g / kg / day, about 0.2 g / kg / day to about 0.3 g / kg / day, about 0.3 g / kg / day to about 0.4 g / kg / day, about 0.4 g / kg / day to about 0.5 g / kg / day, about 0.5 g / kg / day to about 0.6 g / kg / day, about 0.6 g / kg / day to about 0.7 g / kg / day, or about 0.7 g The therapeutic dose is approximately 0.8 g / kg / day to 0.8 g / kg / day, approximately 0.8 g / kg / day to 0.9 g / kg / day, approximately 0.9 g / kg / day to 10 g / kg / day, approximately 10 g / kg / day to 11 g / kg / day, approximately 11 g / kg / day to 12 g / kg / day, approximately 12 g / kg / day to 13 g / kg / day, approximately 13 g / kg / day to 14 g / kg / day, or approximately 14 g / kg / day to 15 g / kg / day. In some embodiments, the therapeutic dose of the composition of the Disclosure is approximately 0.4 g / kg / day to 0.5 g / kg / day. In some embodiments, the therapeutic dose of the composition of the Disclosure is approximately 0.6 g / kg / day to 0.7 g / kg / day. In some embodiments, the therapeutic dose of the composition of the Disclosure is approximately 0.8 g / kg / day to 0.9 g / kg / day.

[0078]

[0091] The compositions described herein can be provided to an object to achieve a certain amount of protein per unit body weight of the object. In some embodiments, the compositions described herein can be provided to an object to achieve a range of about 0.2 g protein / kg to about 0.4 g protein / kg, about 0.4 g protein / kg to about 0.6 g protein / kg, about 0.6 g protein / kg to about 0.8 g protein / kg, or about 0.8 g protein / kg to about 1 g protein / kg per kg of the object's body weight. In some embodiments, the compositions described herein can be provided to an object to achieve a range of about 0.6 g protein / kg to about 0.8 g protein / kg per kg of the object's body weight.

[0079]

[0092] The compositions described herein can be provided to a subject as one or more doses per day. In some embodiments, one, two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve doses of the compositions described herein are provided to a subject per day. In some embodiments, three doses of the compositions described herein are provided to a subject per day. In some embodiments, six doses of the compositions described herein are provided to a subject per day. In some embodiments, nine doses of the compositions described herein are provided to a subject per day.

[0080] Method of administration

[0093] The compositions of the present disclosure can be administered to a subject in the form of a liquid beverage. In some embodiments, the beverage is prepared for the subject by dissolving one or more sachets of the compositions of the present disclosure in a substantially nutrient-free liquid. In some embodiments, the beverage is prepared for the subject by dissolving one or more sachets of the compositions of the present disclosure in water. In some embodiments, the beverage is prepared for the subject by dissolving one or more sachets of the compositions of the present disclosure in juice. In some embodiments, the beverage is prepared for the subject by dissolving one or more sachets of the compositions of the present disclosure in an electrolyte beverage.

[0081]

[0094] In some embodiments, a beverage is prepared for the subject by dissolving one or more sachets of the composition of the present disclosure in water, and a flavoring agent is added to the mixture. In some embodiments, at least one drop of flavoring agent, such as Mio Liquid Water Enhancer, is added to the aqueous mixture of the pharmaceutical composition of the present disclosure. In some embodiments, a flavoring agent powder, such as Squash Stix, is added. TM A water enhancer is added to the aqueous mixture of the composition of this disclosure.

[0082]

[0095] In some embodiments, a beverage is prepared for the subject by dissolving one or more sachets of the composition of the present disclosure in water, and a nutritional gel or a ready-made nutritional beverage is added to the mixture. In some embodiments, a nutritional gel, such as Vitaflo gel, is used. TM The following is added to the aqueous mixture of the composition of the present disclosure. In some embodiments, a ready-made nutritional supplement beverage, such as Vitaflo cooler TM The aqueous mixture of the composition of this disclosure is added to it.

[0083]

[0096] In some embodiments, the composition is prepared as a ready-made beverage in a bottle or carton.

[0097] The compositions of the present disclosure can be administered to a subject, and the administration may be accompanied by a food-based diet that is low in or substantially lacking in at least one amino acid. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in one amino acid. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in serine. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in glycine. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in two amino acids or salts thereof. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in serine and glycine. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in three amino acids or salts thereof. In some embodiments, the administration of the compositions of the present disclosure is accompanied by a food-based diet that is low in or substantially lacking in four amino acids or salts thereof. The amino acid salts disclosed herein may be pharmaceutically acceptable salts.

[0084]

[0098] Compositions of the present disclosure lacking amino acids may be administered with a diet containing amino acids in amounts up to approximately 500 mg / day, approximately 450 mg / day, approximately 400 mg / day, approximately 350 mg / day, approximately 300 mg / day, approximately 250 mg / day, approximately 200 mg / day, approximately 150 mg / day, or approximately 100 mg / day. In some embodiments, compositions of the present disclosure lacking amino acids may be administered with a diet containing amino acids in amounts up to approximately 450 mg / day. In some embodiments, compositions of the present disclosure lacking amino acids may be administered with a diet containing amino acids in amounts up to approximately 400 mg / day. In some embodiments, compositions of the present disclosure lacking amino acids may be administered with a diet containing amino acids in amounts up to approximately 350 mg / day. In some embodiments, compositions of the present disclosure lacking amino acids may be administered with a diet containing amino acids in amounts up to approximately 250 mg / day. In some embodiments, compositions lacking proline may be administered with a diet containing proline in amounts up to approximately 450 mg / day. In some embodiments, the proline-deficient composition is administered with a diet containing up to approximately 350 mg / day of proline. In some embodiments, the proline-deficient composition is administered with a diet containing up to approximately 250 mg / day of proline.

[0085]

[0099] Compositions of the Disclosure lacking the first and second amino acids may be administered with a diet containing up to about 500 mg / day, up to about 450 mg / day, up to about 400 mg / day, up to about 350 mg / day, up to about 300 mg / day, up to about 250 mg / day, up to about 200 mg / day, up to about 150 mg / day, or up to about 100 mg / day of the first amino acid and up to about 500 mg / day, up to about 450 mg / day, up to about 400 mg / day, up to about 350 mg / day, up to about 300 mg / day, up to about 250 mg / day, up to about 200 mg / day, up to about 150 mg / day, or up to about 100 mg / day of the second amino acid. In some embodiments, compositions of the Disclosure lacking the first and second amino acids may be administered with a diet containing up to about 450 mg / day of the first amino acid and up to about 300 mg / day of the second amino acid. In some embodiments, compositions of the Disclosure lacking the first and second amino acids can be administered with a diet containing up to about 450 mg / day of the first amino acid and up to about 250 mg / day of the second amino acid. In some embodiments, compositions of the Disclosure lacking the first and second amino acids can be administered with a diet containing up to about 350 mg / day of the first amino acid and up to about 250 mg / day of the second amino acid. In some embodiments, compositions of the Disclosure lacking the first and second amino acids can be administered with a diet containing up to about 400 mg / day of the first amino acid and up to about 250 mg / day of the second amino acid.

[0086]

[0100] The compositions of the present disclosure can be administered to subjects on a diet. In some embodiments, the compositions of the present disclosure are administered to a subject who follows a low-protein diet. In some embodiments, the compositions of the present disclosure are administered to a subject who follows a low-carbohydrate diet. In some embodiments, the compositions of the present disclosure are administered to a subject who follows a high-fat, low-carbohydrate diet (e.g., a ketogenic diet). In some embodiments, the compositions of the present disclosure are administered to a subject who follows a vegetarian diet. In some embodiments, the compositions of the present disclosure are administered to a subject who follows a vegan diet.

[0087]

[0101] In some embodiments, the compositions of the Disclosure are administered to subjects consuming a low-protein diet that is also low in at least one non-essential amino acid. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a low-protein diet that is also low in serine and glycine. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a low-protein diet of less than approximately 2 g / day, approximately 1.75 g / day, approximately 1.5 g / day, approximately 1.25 g / day, approximately 1 g / day, approximately 0.75 g / day, or approximately 0.5 g / day of serine or glycine. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a low-protein diet of less than approximately 50 mg / day, approximately 450 mg / day, approximately 400 mg / day, approximately 350 mg / day, approximately 300 mg / day, approximately 250 mg / day, approximately 200 mg / day, approximately 150 mg / day, approximately 100 mg / day, or approximately 50 mg / day of serine or glycine.

[0088]

[0102] In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-glucose natural food diet.

[0103] In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein diet. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 15 g of protein / day, up to approximately 14 g of protein / day, up to approximately 13 g of protein / day, up to approximately 12 g of protein / day, up to approximately 11 g of protein / day, up to approximately 10 g of protein / day, up to approximately 9 g of protein / day, up to approximately 8 g of protein / day, up to approximately 7 g of protein / day, up to approximately 6 g of protein / day, or up to approximately 5 g of protein / day. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 12 g of protein / day. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 11 g of protein / day. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 10 g of protein / day. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 9 g of protein per day. In some embodiments, the compositions of the present disclosure are administered to subjects consuming a low-protein natural food diet containing up to approximately 8 g of protein per day.

[0089]

[0104] In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% of their daily calorie intake comes from carbohydrates. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 50% of their daily calorie intake comes from carbohydrates. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 25% of their daily calorie intake comes from carbohydrates. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 15% of their daily calorie intake comes from carbohydrates. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 9% of their daily calorie intake comes from carbohydrates.

[0090]

[0105] In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 10%, 9%, 8%, 7%, 6%, 5%, 4.5%, 4%, 3.5%, 3%, 2.5%, 2%, 1.5%, or 1% of their daily calorie intake is derived from protein. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 3% of their daily calorie intake is derived from protein. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 2.5% of their daily calorie intake is derived from protein. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 2% of their daily calorie intake is derived from protein. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which up to approximately 1.5% of their daily calorie intake is derived from protein.

[0091]

[0106] In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which at least about 95%, at least about 90%, at least about 85%, at least about 80%, at least about 75%, at least about 70%, at least about 65%, at least about 60%, at least about 55%, at least about 50%, at least about 45%, at least about 40%, at least about 35%, or at least about 30% of their daily calorie intake comes from lipids. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which at least about 45% of their daily calorie intake comes from lipids. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which at least about 60% of their daily calorie intake comes from lipids. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which at least about 80% of their daily calorie intake comes from lipids. In some embodiments, the compositions of the Disclosure are administered to subjects consuming a diet in which at least about 90% of their daily calorie intake comes from lipids.

[0092]

[0107] The compositions of the present disclosure can be administered to subjects receiving at least one nutritional supplement. In some embodiments, the compositions of the present disclosure are administered to subjects together with an energy supplement. In some embodiments, the compositions of the present disclosure are administered to subjects together with an energy supplement, such as caffeine, guarana, Asian ginseng, vitamin B12, or coenzyme Q10. In some embodiments, the compositions of the present disclosure are administered to subjects together with an energy supplement, such as caffeine, tyrosine, pyrroloquinoline quinone (PQQ), theanine, coenzyme Q10, acetyl-L-carnitine (ALCAR), alpha-lipoic acid (ALA), citicoline, creatine, citrulline, beetroot powder, ashwagandha, or Rhodiola rosea. In some embodiments, the compositions of the present disclosure are administered to subjects together with coenzyme Q10.

[0093]

[0108] In some embodiments, the compositions of the Disclosure are administered to a subject together with micronutrient supplements. In some embodiments, the compositions of the Disclosure are administered to a subject together with multivitamins. In some embodiments, the compositions of the Disclosure are administered to a subject together with vitamin supplements, such as vitamin C or vitamin supplements. In some embodiments, the compositions of the Disclosure are administered to a subject together with mineral supplements, such as iron or zinc supplements.

[0094]

[0109] In some embodiments, the compositions of the present disclosure are administered to subjects together with energy supplements and micronutrient supplements. In some embodiments, the compositions of the present disclosure are administered to subjects together with coenzyme Q10 and multivitamins. In some embodiments, the compositions of the present disclosure are administered to subjects together with coenzyme Q10 and mineral supplements.

[0095]

[0110] In some embodiments, the compositions of the present disclosure are administered to subjects as nutritionally complete products. In some embodiments, the compositions are administered as complete food shakes or powders. In some embodiments, the compositions are administered via enteral feeding tubes.

[0096]

[0111] Multiple therapeutic agents can be administered in any order or simultaneously. In some embodiments, the composition of the present invention is administered before or after treatment with another therapeutic agent. When administered simultaneously, multiple therapeutic agents can be provided in a single, integrated form or in multiple forms, for example, as multiple separate pills. The drugs can be packaged together or separately in a single package or multiple packages. One or all therapeutic agents can be administered in multiple doses. When not administered simultaneously, the timing between multiple doses can vary by as much as one month.

[0097]

[0112] The therapeutic agents described herein can be administered before, during, or after the onset of a disease or condition, and the timing of administration of compositions containing the therapeutic agents can vary. For example, a composition can be used as a preventive agent and can be administered sequentially to a subject prone to a condition or disease in order to reduce the likelihood of the disease or condition developing. A composition can be administered to a subject during or as soon as possible after the onset of symptoms.

[0098]

[0113] The compositions disclosed herein can be administered as quickly as possible after the onset of a disease or condition is detected or suspected, for a duration required to treat the disease. In some embodiments, the duration required to treat the disease is about 12 hours, about 24 hours, about 36 hours, or about 48 hours. In some embodiments, the duration required to treat the disease is about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 11 days, about 12 days, about 13 days, about 14 days, or about 15 days. In some embodiments, the duration required to treat the disease is about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, about 5 weeks, about 6 weeks, about 7 weeks, about 8 weeks, about 9 weeks, about 10 weeks, about 11 weeks, about 12 weeks, about 13 weeks, about 14 weeks, about 15 weeks, about 16 weeks, about 17 weeks, about 18 weeks, about 19 weeks, or about 20 weeks. In some embodiments, the length of time required to treat the disease is approximately 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, or 24 months.

[0099]

[0114] In some embodiments, the length of time over which the compound can be administered is approximately 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 2 months, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 3 months, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 4 months, 17 weeks, 18 weeks, 19 weeks, 20 weeks, 5 months, and approximately The duration can be 21 weeks, approximately 22 weeks, approximately 23 weeks, approximately 24 weeks, approximately 6 months, approximately 7 months, approximately 8 months, approximately 9 months, approximately 10 months, approximately 1 year, approximately 13 months, approximately 14 months, approximately 15 months, approximately 16 months, approximately 17 months, approximately 18 months, approximately 19 months, approximately 20 months, approximately 21 months, approximately 22 months, approximately 23 months, approximately 2 years, approximately 2.5 years, approximately 3 years, approximately 3.5 years, approximately 4 years, approximately 4.5 years, approximately 5 years, approximately 6 years, approximately 7 years, approximately 8 years, approximately 9 years, or approximately 10 years. The length of treatment can vary for each individual.

[0100]

[0115] The compositions of the present disclosure can be administered continuously. In some embodiments, the compositions of the present disclosure can be administered continuously for about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, about 1 month, about 5 weeks, about 6 weeks, about 7 weeks, about 8 weeks, about 2 months, about 9 weeks, about 10 weeks, about 11 weeks, about 12 weeks, about 3 months, about 13 weeks, about 14 weeks, about 15 weeks, about 16 weeks, about 4 months, about 17 weeks, about 18 weeks, about 19 weeks, about 20 weeks, about 5 weeks, about 21 weeks, about It can be administered for 22 weeks, approximately 23 weeks, approximately 24 weeks, approximately 6 months, approximately 7 months, approximately 8 months, approximately 9 months, approximately 10 months, approximately 1 year, approximately 13 months, approximately 14 months, approximately 15 months, approximately 16 months, approximately 17 months, approximately 18 months, approximately 19 months, approximately 20 months, approximately 21 months, approximately 22 months, approximately 23 months, approximately 2 years, approximately 2.5 years, approximately 3 years, approximately 3.5 years, approximately 4 years, approximately 4.5 years, approximately 5 years, approximately 6 years, approximately 7 years, approximately 8 years, approximately 9 years, or approximately 10 years. The length of treatment can be varied for each individual patient.

[0101]

[0116] In some embodiments, the compositions of the present disclosure can be administered in the early stages of the disease. In some embodiments, the compositions of the present disclosure can be administered in the later stages of the disease. In some embodiments, the compositions of the present disclosure can be administered during the pre-symptomatic stage of the disease. In some embodiments, the compositions of the present disclosure can be administered during the symptomatic stage of the disease. In some embodiments, the compositions of the present disclosure can be administered during the severe stage of the disease.

[0102]

[0117] The compositions of the present disclosure can be administered intermittently. In some embodiments, the compositions of the present disclosure can be administered with a modified diet for a first number of days, and a normal / habitual diet (i.e., the subject's typical diet before administration of the composition) can be administered for a second number of days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the compositions of the present disclosure can be administered with a modified diet for one day, and a normal / habitual diet for one day, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the compositions of the present disclosure can be administered with a modified diet for one day, and a normal / habitual diet for two days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the compositions of the present disclosure can be administered with a modified diet for one day, and a normal / habitual diet for three days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered daily with a modified diet and a normal / habitual diet for four days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered daily with a modified diet and a normal / habitual diet for five days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered daily with a modified diet and a normal / habitual diet for six days, and the cycle of composition / modified diet and normal / habitual diet can be repeated.

[0103]

[0118] In some embodiments, the composition of the present disclosure can be administered with a modified diet for two days, and a normal / habitual diet (i.e., the subject's typical diet before administration of the composition) for one day, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for two days, and a normal / habitual diet for two days, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for two days, and a normal / habitual diet for three days, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for two days, and a normal / habitual diet for four days, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for two days, and a normal / habitual diet for five days, and the composition / modified diet and normal / habitual diet cycle can be repeated.

[0104]

[0119] In some embodiments, the composition of the present disclosure can be administered with a modified diet for 3 days and a normal / habitual diet (i.e., a typical diet of the subject before administration of the composition) for 1 day, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 3 days and a normal / habitual diet for 2 days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 3 days and a normal / habitual diet for 3 days, and the cycle of composition / modified diet and normal / habitual diet can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 3 days and a normal / habitual diet for 4 days, and the cycle of composition / modified diet and normal / habitual diet can be repeated.

[0105]

[0120] In some embodiments, the composition of the present disclosure can be administered with a modified diet for 4 days, and a normal / habitual diet (i.e., the subject's typical diet before administration of the composition) can be administered for 1 day, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 4 days, and a normal / habitual diet can be administered for 2 days, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 4 days, and a normal / habitual diet can be administered for 3 days, and the composition / modified diet and normal / habitual diet cycle can be repeated.

[0106]

[0121] In some embodiments, the composition of the present disclosure can be administered with a modified diet for 5 days, and a normal / habitual diet (i.e., the subject's typical diet before administration of the composition) can be administered for 1 day, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 5 days, and a normal / habitual diet can be administered for 2 days, and the composition / modified diet and normal / habitual diet cycle can be repeated. In some embodiments, the composition of the present disclosure can be administered with a modified diet for 6 days, and a normal / habitual diet can be administered for 1 day, and the composition / modified diet and normal / habitual diet cycle can be repeated.

[0107]

[0122] In some embodiments, the composition of the present disclosure may be administered with a modified diet for a first number of days, and a normal / habitual diet (i.e., a typical diet of the subject prior to administration of the composition) may be administered for a second number of days, and the cycle of composition / modified diet and normal / habitual diet may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times. In some embodiments, the composition of the present disclosure may be administered with a modified diet for a first number of days, and a normal / habitual diet may be administered for a second number of days, and the cycle of composition / modified diet and normal / habitual diet may be repeated 5 times.

[0108]

[0123] In some embodiments, the compositions of the present disclosure may be administered with a modified diet for a first number of days, and a normal / habitual diet (i.e., the subject's typical diet prior to administration of the composition) may be administered for a second number of days, with the composition / modified diet and normal / habitual diet cycles being approximately 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 2 months, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 3 months, 13 months. It can be repeated for weeks, approximately 14 weeks, 15 weeks, 16 weeks, 4 months, 17 weeks, 18 weeks, 19 weeks, 20 weeks, 5 months, 21 weeks, 22 weeks, 23 weeks, 24 weeks, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 1 year, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5 years, 5 years, 6 years, 7 years, 8 years, 9 years, or 10 years. The length of treatment can be varied for each individual.

[0109]

[0124] The compositions of the present disclosure may be administered one, two, three, four, five, six, seven, or eight times a day over a 24-hour period. In some embodiments, the compositions of the present disclosure may be administered once a day. In some embodiments, the compositions of the present disclosure may be administered twice a day. In some embodiments, the compositions of the present disclosure may be administered three times a day. In some embodiments, the compositions of the present disclosure may be administered four times a day. In some embodiments, the compositions of the present disclosure may be administered five times a day. In some embodiments, the compositions of the present disclosure may be administered six times a day.

[0110]

[0125] The compositions described herein may be in unit dosage forms suitable for single-dose administration of precise dosages. In unit dosage forms, the formulation is divided into unit doses containing appropriate amounts of one or more compounds. Unit doses may be in the form of packages containing discrete doses of the formulation. Aqueous suspension compositions may be packaged in single-dose, non-resealable containers. Resealable containers for multiple doses may be used, for example, with or without preservatives.

[0111]

[0126] In some embodiments, the composition is administered to the subject throughout the day. In some embodiments, the composition is administered to the subject with meals. In some embodiments, the composition is administered to the subject with snacks. In some embodiments, the composition is administered to the subject without meals. In some embodiments, the composition is administered to the subject at equal intervals throughout the day. In some embodiments, the first dose is administered before breakfast, the second dose with breakfast, the third dose with lunch, the fourth and fifth doses with dinner, and the sixth dose before bedtime.

[0112]

[0127] The compositions provided by the present invention can be administered in conjunction with other treatments, such as chemotherapy, radiation, surgery, anti-inflammatory drugs, immunotherapy, biologics, and selected vitamins. Other agents can be administered before, after, or concurrently with the pharmaceutical composition. Methods of using the compositions disclosed herein.

[0113]

[0128] This disclosure provides methods for treating subjects. The compositions disclosed herein can be used to treat any disease. In some embodiments, the compositions disclosed herein are used to treat cancer in subjects requiring treatment of cancer. By altering the diet and nutrition of a subject, desired health benefits may be produced, which may be effective in treating the disease.

[0114]

[0129] Based on a specific disease and / or patient needs, this disclosure provides methods for generalized treatment recommendations for a subject, as well as methods for subject-specific treatment recommendations. A treatment method may include one of the following steps: determining the levels of nutrients in the subject; detecting the presence or absence of a disease in the subject based on the determination; and recommending at least one generalized or subject-specific treatment for the subject to improve the symptoms of the disease.

[0115]

[0130] In some embodiments, the compositions disclosed herein can be used to manage a disease or condition through dietary intervention. In some embodiments, the compositions disclosed herein can be used as part of a treatment plan for a particular disease or condition.

[0116]

[0131] In some embodiments, the subject has cancer. Cancer is caused by the uncontrolled proliferation of tumor cells, leading to invasion into adjacent and distant tissues and ultimately death. Cancer cells are often underpinned by genetic or epigenetic abnormalities that affect both the coding and regulatory regions of the genome. These genetic abnormalities in cancer cells can alter the structure, dynamics, and expression levels of proteins, resulting in changes in the cellular metabolism of cancer cells. Due to changes in the cell cycle, cancer cells can proliferate at a much faster rate than normal cells. Increased metabolic rate and proliferation mean that cancer tissue has much higher nutritional demands compared to normal tissue.

[0117]

[0132] Cancer cells are nutritionally resistant and have much higher nutrient requirements compared to normal cells. As an adaptation to meet these increased nutrient needs, cancer cells can upregulate glucose and amino acid transporters on their cell membranes to obtain more nutrients from the circulation. Cancer cells can also enhance glycolysis and glutaminolysis to rewire metabolic pathways and maintain faster ATP production or energy supply. Glucose and amino acids are essential nutrients in cancer cells. Some cancer cell types and tumor tissues are known to be nutritionally resistant to specific amino acids. The nutritional requirements of cancer for various amino acids may make this type of cancer vulnerable to amino acid starvation treatment.

[0118]

[0133] When mammalian cells experience amino acid starvation, they undergo a homeostatic response to the lack of amino acids. Amino acid deficiency can trigger common amino acid regulatory pathways, which involve shifting the cell's resources and energy to the expression of membrane transporters, growth hormones, and metabolic enzymes for amino acid homeostasis. Upregulation of membrane transporters promotes amino acid uptake, and upregulation of metabolic enzymes promotes amino acid synthesis. Cells can also regenerate non-essential amino acids through autophagy by reusing proteins and organelles. Through common amino acid regulatory pathways and autophagy, cells attempt to maintain amino acid homeostasis. Tumor tissues can also overcome amino acid starvation by enhancing angiogenesis to obtain a greater supply of nutrients.

[0119]

[0134] If homeostasis cannot be achieved due to severe amino acid starvation, cancer cells may inhibit protein synthesis, suppress proliferation, or undergo programmed cell death. The cell death mechanisms in amino acid starvation may include caspase-dependent apoptosis, autophagy, or ferroptosis. Amino acid transporters, metabolic enzymes, autophagy-related proteins, and amino acid starvation can be used to control cancer growth.

[0120]

[0135] The methods disclosed herein can monitor nutrient consumption by a subject. Nutrient consumption can be measured by taking a biological sample from the subject. Biological samples may be, for example, whole blood, serum, plasma, mucous membrane, saliva, cheek swab, urine, feces, cells, tissue, body fluids, sweat, breath, lymph, CNS fluid, and lesion exudate. Combinations of biological samples can be used in conjunction with the methods disclosed herein.

[0121]

[0136] The composition methods of this disclosure can slow the growth of cancer cell lines or kill cancer cells. Non-limiting examples of cancers that can be treated with the compounds of this disclosure include acute lymphoblastic leukemia, acute myeloid leukemia, adrenocortical carcinoma, AIDS-related cancers, AIDS-related lymphomas, anal cancer, appendiceal cancer, astrocytoma, basal cell carcinoma, cholangiocarcinoma, bladder cancer, bone cancer, brain tumors such as cerebellar astrocytoma, cerebral astrocytoma / gliomas, ependymoma, medulloblastoma, supratentorial primordial neuroectodermal tumors, visual pathway and hypothalamic gliomas, breast cancer, bronchial adenoma, Burkitt lymphoma, cancers of unknown primary origin, central nervous system lymphomas, cerebellar astrocytoma, cervical cancer, childhood cancers, and chronic cancers. Lymphocytic leukemia, chronic myeloid leukemia, chronic myeloproliferative disorders, colon cancer, cutaneous T-cell lymphoma, fibrinogenic round cell tumor, endometrial cancer, ependymoma, esophageal cancer, Ewing's sarcoma, germ cell tumor, gallbladder cancer, stomach cancer, gastrointestinal carcinoid tumor, gastrointestinal stromal tumor, glioma, hairy cell leukemia, head and neck cancer, heart cancer, hepatocellular carcinoma (liver) cancer, Hodgkin's lymphoma, hypopharyngeal cancer, intraocular melanoma, islet cell carcinoma, Kaposi's sarcoma, kidney cancer, laryngeal cancer, lip and oral cancer, liposarcoma, liver cancer, lung cancer including non-small cell and small cell lung cancer, lymphoma, Leukemia, macroglobulinemia, malignant fibrous histiocytoma / osteosarcoma, medulloblastoma, melanoma, mesothelioma, metastatic squamous cell carcinoma of unknown primary origin, oral cancer, multiple endocrine neoplasia syndrome, myelodysplastic syndrome, myeloid leukemia, nasal cavity cancer and paranasal sinus cancer, nasopharyngeal cancer, neuroblastoma, non-Hodgkin lymphoma, non-small cell lung cancer, oral cancer, oropharyngeal cancer, osteosarcoma / malignant fibrous histiocytoma, ovarian cancer, ovarian epithelial carcinoma, ovarian germ cell tumor, pancreatic cancer, islet cell carcinoma, paranasal sinus and nasal cavity cancer, parathyroid cancer, penile cancer, pharyngeal cancer, pheochromocytoma, pineal astrocytoma, pineal This includes somatic germ cell tumors, pituitary adenomas, pleuroblastomas, plasma cell tumors, primary central nervous system lymphomas, prostate cancer, rectal cancer, renal cell carcinoma, renal pelvis and ureteral transitional cell carcinoma, retinoblastoma, rhabdomyosarcoma, salivary gland cancer, sarcomas, skin cancer, Merkel cell carcinoma of the skin, small intestine cancer, soft tissue sarcoma, squamous cell carcinoma, gastric cancer, T-cell lymphoma, pharyngeal cancer, thymoma, thymic carcinoma, thyroid cancer, gestational trophoblastoma, cancer of unknown primary site, urethral cancer, uterine sarcoma, vaginal cancer, vulvar cancer, Waldenström macroglobulinemia, and Wilms' tumor.

[0122]

[0137] In some embodiments, the methods of the Disclosure can be used to treat breast cancer. In some embodiments, the methods of the Disclosure can be used to treat colorectal cancer. In some embodiments, the methods of the Disclosure can be used to treat pancreatic cancer.

[0123] Treatment effect.

[0138] In some embodiments, the Disclosure provides compositions comprising, a) essential amino acids, the essential amino acid not being part of a polypeptide; b) non-essential amino acids, the non-essential amino acid not being part of a polypeptide; and c) pharmaceutically acceptable excipients, in powder form. In some embodiments, the compositions are free of serine, glycine, and cysteine. In some embodiments, the compositions are free of serine, glycine, and glutamic acid, glutamine, and cystine. In some embodiments, the compositions are free of proline. In some embodiments, the compositions are free of serine and glycine.

[0124]

[0139] The serum amino acid level of at least one amino acid can be regulated by administration of the composition. In some embodiments, the serum amino acid level of an amino acid can be reduced by administering an amino acid-deficient composition. In some embodiments, the serum amino acid level of an amino acid can be reduced by about 10% to about 20%, about 20% to about 30%, about 30% to about 40%, about 40% to about 50%, about 50% to about 60%, about 60% to about 70%, about 70% to about 80%, and about 80% to about 90% by administering an amino acid-deficient composition. In some embodiments, the serum amino acid level of an amino acid can be reduced by about 10% to about 20% by administering an amino acid-deficient composition. In some embodiments, the serum amino acid level of an amino acid can be reduced by about 20% to about 30% by administering an amino acid-deficient composition. In some embodiments, administering an amino acid-deficient composition can reduce the serum amino acid level of an amino acid by about 5%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, or about 95%. In some embodiments, administering an amino acid-deficient composition can reduce the serum amino acid level of an amino acid by about 10%. In some embodiments, administering an amino acid-deficient composition can reduce the serum amino acid level of an amino acid by about 20%. In some embodiments, administering an amino acid-deficient composition can reduce the serum amino acid level of an amino acid by about 30%.

[0125]

[0140] Administration of a composition lacking a first amino acid can reduce serum amino acids of at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 amino acids. In some embodiments, administration of a composition lacking a first amino acid can reduce serum amino acids of at least the first and second amino acids. In some embodiments, administration of a composition lacking a first amino acid can reduce serum amino acids of at least the first, second, and third amino acids. In some embodiments, administration of a composition lacking a first amino acid can reduce serum amino acids of at least the first, second, third, and fourth amino acids. In some embodiments, administration of a composition lacking a first amino acid can reduce serum amino acids of at least the first, second, third, fourth, and fifth amino acids.

[0126]

[0141] By administering a composition of the Disclosure lacking an amino acid, serum amino acid levels of the amino acid can be altered over a long period of time. In some embodiments, by administering a composition of the Disclosure lacking an amino acid, serum amino acid levels of the amino acid can be reduced over a long period of time. In some embodiments, by administering a composition of the Disclosure lacking an amino acid, serum amino acid levels of the amino acid can be reduced for at least about 4 hours, at least about 8 hours, at least about 12 hours, at least about 16 hours, at least about 20 hours, at least about 24 hours, at least about 2 days, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 7 days, at least about 8 days, at least about 9 days, at least about 10 days, at least about 11 days, at least about 12 days, at least about 13 days, at least about 14 days, at least about 3 weeks, at least about 4 weeks, at least about 5 weeks, at least about 6 weeks, at least about 7 weeks, at least about 8 weeks, at least about 9 weeks, at least about 10 weeks, at least about 11 weeks, or at least about 12 weeks. In some embodiments, administration of a composition of the present disclosure lacking an amino acid can reduce serum amino acid levels of the amino acid for at least about 4 hours and at least about 2 days. In some embodiments, administration of a composition of the present disclosure lacking an amino acid can reduce serum amino acid levels of the amino acid for at least about 4 hours and at least about 4 days. In some embodiments, administration of a composition of the present disclosure lacking an amino acid can reduce serum amino acid levels of the amino acid for at least about 4 hours and at least about 2 weeks. In some embodiments, administration of a composition of the present disclosure lacking an amino acid can reduce serum amino acid levels of the amino acid for at least about 4 hours and at least about 4 weeks.

[0127]

[0142] The compositions of the present disclosure can reduce cell proliferation in subjects. In some embodiments, administration of the compositions of the present disclosure can reduce cell proliferation in subjects by about 5% to about 10%, about 10% to about 15%, about 15% to about 20%, about 20% to about 25%, about 25% to about 30%, about 35% to about 40%, about 40% to about 45%, about 45% to about 50%, about 50% to about 75%, about 75% to about 100%, about 100% to about 125%, about 125% to about 150%, about 150% to about 175%, or about 175% to about 200% compared to subjects that have not been administered the dietary composition. In some embodiments, the compositions of the present disclosure can reduce cell proliferation in subjects undergoing cancer therapy compared to subjects undergoing cancer therapy but not receiving the compositions of the present disclosure. In some embodiments, administration of the composition of the Disclosure can reduce cell proliferation in a subject by about 20% to about 25% compared to a subject that has not been administered the dietary composition. In some embodiments, administration of the composition of the Disclosure can reduce cell proliferation in a subject by about 50% to about 75% compared to a subject that has not been administered the dietary composition.

[0128]

[0143] In some embodiments, administration of the compositions of the Disclosure can reduce cell proliferation in subjects by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 75%, about 100%, about 125%, about 150%, about 175%, or about 200% compared to subjects that have not been administered the dietary composition. In some embodiments, the compositions of the Disclosure can reduce cell proliferation in subjects undergoing cancer therapy compared to subjects undergoing cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can reduce cell proliferation in subjects by about 20% compared to subjects that have not been administered the dietary composition. In some embodiments, administration of the compositions of the Disclosure can reduce cell proliferation in subjects by about 30% compared to subjects that have not been administered the dietary composition. In some embodiments, administration of the compositions of the Disclosure can reduce cell proliferation in subjects by about 50% compared to subjects that have not been administered the dietary composition. In some embodiments, administration of the composition of the present disclosure can reduce cell proliferation in a subject by approximately 70% compared to a subject that has not been administered the dietary composition.

[0129]

[0144] In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 5% to about 10%, about 10% to about 15%, about 15% to about 20%, about 20% to about 25%, about 25% to about 30%, about 35% to about 40%, about 40% to about 45%, about 45% to about 50%, about 50% to about 75%, about 75% to about 100%, about 100% to about 125%, about 125% to about 150%, about 150% to about 175%, or about 175% to about 200%. In some embodiments, the compositions of the Disclosure can reduce the tumor volume in a subject receiving cancer therapy compared to a subject receiving cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 20% to about 25%. In some embodiments, administration of the compositions of this disclosure can reduce the tumor volume in a subject by about 45% to about 50%.

[0130]

[0145] In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 75%, about 100%, about 125%, about 150%, about 175%, or about 200%. In some embodiments, the compositions of the Disclosure can reduce the tumor volume in a subject receiving cancer therapy compared to a subject receiving cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 20%. In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 30%. In some embodiments, administration of the compositions of the Disclosure can reduce the tumor volume in a subject by about 50%.

[0131]

[0146] Administration of the compositions of the Disclosure can increase the overall survival of subjects. In some embodiments, administration of the compositions of the Disclosure can increase the overall survival of subjects by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95%. In some embodiments, the compositions of the Disclosure can increase the overall survival of subjects receiving cancer therapy compared to subjects receiving cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can increase the overall survival of subjects by at least about 10%. In some embodiments, administration of the compositions of the Disclosure can increase the overall survival of subjects by at least about 20%. In some embodiments, administration of the compositions of this disclosure can increase the overall survival of subjects by at least about 30%.

[0132]

[0147] Administration of the compositions of the Disclosure can increase the progression-free survival of subjects. In some embodiments, administration of the compositions of the Disclosure can increase the progression-free survival of subjects by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95%. In some embodiments, the compositions of the Disclosure can increase the progression-free survival of subjects receiving cancer therapy compared to subjects receiving cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can increase the progression-free survival of subjects by at least about 10%. In some embodiments, administration of the compositions of the Disclosure can increase the progression-free survival of subjects by at least about 20%. In some embodiments, administration of the compositions of this disclosure can increase the progression-free survival of subjects by at least about 30%.

[0133]

[0148] The percentage of cancer cell death can be increased by administering the compositions of the Disclosure. In some embodiments, the percentage of cancer cell death can be increased by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95% by administering the compositions of the Disclosure. In some embodiments, the compositions of the Disclosure can increase the percentage of cancer cell death in subjects receiving cancer therapy compared to subjects receiving cancer therapy but not receiving the compositions of the Disclosure. In some embodiments, the percentage of cancer cell death can be increased by at least about 10% by administering the compositions of the Disclosure. In some embodiments, administration of the compositions of the Disclosure can increase the percentage of cancer cell death by at least about 20%. In some embodiments, administration of the compositions of the Disclosure can increase the percentage of cancer cell death by at least about 30%.

[0134]

[0149] By administering the compositions of the Disclosure, the sensitivity of a subject to cancer treatment can be increased. In some embodiments, by administering the compositions of the Disclosure, the sensitivity of a subject to cancer treatment can be increased by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95%. In some embodiments, by administering the compositions of the Disclosure, the sensitivity of a subject to cancer treatment can be increased by at least about 10%. In some embodiments, by administering the compositions of the Disclosure, the sensitivity of a subject to cancer treatment can be increased by at least about 20%. In some embodiments, by administering the compositions of the Disclosure, the sensitivity of a subject to cancer treatment can be increased by at least about 30%.

[0135]

[0150] The treatment response rate of a therapeutic agent can be increased by administering the compositions of the present disclosure. In some embodiments, the treatment response rate of a therapeutic agent can be increased by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95%. In some embodiments, the treatment response rate of a therapeutic agent can be increased by at least about 10% by administering the compositions of the present disclosure. In some embodiments, the treatment response rate of a therapeutic agent can be increased by at least about 20% by administering the compositions of the present disclosure. In some embodiments, the treatment response rate of a therapeutic agent can be increased by at least about 30% by administering the compositions of the present disclosure.

[0136]

[0151] Administering the compositions of the Disclosure together with a therapeutic agent can enhance the efficacy of the therapeutic agent in a subject compared to a subject treated with the compositions of the Disclosure alone. In some embodiments, administering the compositions of the Disclosure together with a therapeutic agent can enhance the efficacy of the therapeutic agent in a subject by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95% compared to a subject treated with the compositions of the Disclosure alone. In some embodiments, administering the compositions of the Disclosure together with a therapeutic agent can enhance the efficacy of the therapeutic agent in a subject by at least about 10% compared to a subject treated with the compositions of the Disclosure alone. In some embodiments, administering the composition of the Disclosure together with a therapeutic agent can increase the efficacy of the therapeutic agent in a subject by at least about 20% compared to a subject treated with the composition of the Disclosure alone. In some embodiments, administering the composition of the Disclosure together with a therapeutic agent can increase the efficacy of the therapeutic agent in a subject by at least about 30% compared to a subject treated with the composition of the Disclosure alone.

[0137]

[0152] By administering the compositions of the present disclosure to a subject together with a therapeutic agent, the same results can be achieved by reducing the dose of the therapeutic agent compared to a subject treated with the therapeutic agent alone. In some embodiments, by administering the compositions of the present disclosure to a subject together with a therapeutic agent, the required dose of the therapeutic agent can be reduced by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95% compared to a subject treated with the therapeutic agent alone, and the same results can be achieved. In some embodiments, by administering the compositions of the present disclosure to a subject together with a therapeutic agent, the required dose of the therapeutic agent can be reduced by at least about 10% compared to a subject treated with the therapeutic agent alone, and the same results can be achieved. In some embodiments, administering the composition of the Disclosure to a subject together with a therapeutic agent can achieve the same results with a reduction in the required dose of the therapeutic agent by at least about 20% compared to a subject treated with the therapeutic agent alone. In some embodiments, administering the composition of the Disclosure to a subject together with a therapeutic agent can achieve the same results with a reduction in the required dose of the therapeutic agent by at least about 30% compared to a subject treated with the therapeutic agent alone.

[0138]

[0153] By administering the compositions of this disclosure to a subject together with a therapeutic agent, adverse events associated with the additional treatment can be reduced compared to a subject treated with the additional treatment alone. In some embodiments, by administering the compositions of this disclosure to a subject together with a therapeutic agent, adverse events associated with the additional treatment can be reduced by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, or at least about 95% compared to a subject treated with the additional treatment alone. In some embodiments, by administering the compositions of this disclosure to a subject together with a therapeutic agent, adverse events associated with the additional treatment can be reduced by at least about 10% compared to a subject treated with the additional treatment alone. In some embodiments, administering the compositions of the disclosure together with a therapeutic agent to a subject can reduce adverse events associated with the additional treatment by at least about 20% compared to a subject treated with the additional treatment alone. In some embodiments, administering the compositions of the disclosure together with a therapeutic agent to a subject can reduce adverse events associated with the additional treatment by at least about 30% compared to a subject treated with the additional treatment alone.

[0139] kit

[0154] The compositions of the present invention can be packaged as a kit. In some embodiments, the kit includes instructions for use regarding the administration / use of the composition. Written materials may be, for example, labels. Written materials may indicate the conditions and methods of administration. The instructions for use provide best guidance to the subject and supervising physician for achieving optimal clinical outcomes from the administration of the treatment. Written materials may be labels. In some embodiments, the labels may be approved by a regulatory body, for example, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other regulatory bodies.

[0140] App-based guidance based on the composition of the disclosure

[0155] The compositions of the present invention can be administered while the subject is being coached in a coaching application. In some embodiments, the composition is in the form of a sachet. In some embodiments, the composition is in the form of a shake. In some embodiments, the composition contains all of the subject's daily protein requirements. In some embodiments, the composition is supplemented with other nutritional requirements.

[0141]

[0156] In some embodiments, the coaching application can instruct the subject by telling them to consume precise amounts of the composition. In some embodiments, the coaching application can instruct the subject on the food intake categories and the amounts of each food. In some embodiments, the coaching application can provide a dietary plan to eliminate macronutrient categories (e.g., protein) so that the composition can provide the subject with the macronutrients they need.

[0142]

[0157] The coaching application may include educational materials. In some embodiments, the coaching application may include educational pamphlets, meal diaries, biomarker feedback, or coaching by a nutritionist or healthcare professional. [Examples]

[0143] Example 1: Amino acid preparation

[0158] Prepare an amino acid formulation lacking seven non-essential amino acids. Table 1 shows the components of Formulation A, which contains histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, cysteine, tyrosine, glutamine, and arginine. Table 1 also shows the amount (mg) of each amino acid contained in a sachet containing approximately 12 g of Formulation.

[0144] [Table 1]

[0145]

[0159] Table 2 shows the amounts of each amino acid administered to subjects receiving 0.6 g / kg / day and 0.8 g / kg / day of protein. The amounts of amino acids are supplied in mg / kg / day.

[0146] [Table 2]

[0147]

[0160] Table 3 shows the amount of protein and the number of sachets containing Formulation A administered to patients receiving 0.8 g / kg / day of protein supplementation.

[0148] [Table 3]

[0149]

[0161] Table 4 shows the amount of protein and the number of sachets containing Formulation A administered to patients receiving 0.6 g / kg / day of protein supplementation.

[0150] [Table 4]

[0151] Example 2: An amino acid preparation lacking a single amino acid.

[0162] Prepare formulations lacking one amino acid. Tables 5-10 show formulations lacking tyrosine, arginine, glutamic acid, glutamine, aspartic acid, or alanine.

[0152] [Table 5]

[0153] [Table 6]

[0154] [Table 7]

[0155] [Table 8]

[0156] [Table 9]

[0157] [Table 10]

[0158]

[0163] Table 11 shows formulations supplemented with potassium and magnesium but lacking asparagine. Table 12 shows formulations supplemented with taurine and glucose but lacking proline.

[0159] [Table 11]

[0160] [Table 12-1]

[0161] [Table 12-2]

[0162] Example 3: An amino acid preparation lacking two or more amino acids.

[0164] Preparations lacking two amino acids are prepared. Table 13 shows preparations lacking serine and glycine.

[0163] [Table 13]

[0164] Example 4: Formulation lacking three amino acids

[0165] Preparations lacking three amino acids are prepared. Tables 14-17 show preparations lacking asparagine, glutamine, glutamic acid, or proline.

[0165] [Table 14]

[0166] [Table 15]

[0167] [Table 16]

[0168]

[0166] Potassium and magnesium supplements lacking serine, glycine, and proline were prepared. The contents of each preparation are shown in Tables 17 to 22. Table 17 shows potassium and magnesium supplements lacking proline, serine, and glycine. Table 18 shows potassium and magnesium supplements lacking proline, serine, and glycine. Table 19 shows potassium and magnesium supplements lacking proline, serine, and glycine. Table 20 shows potassium and magnesium supplements lacking proline, serine, and glycine. Table 21 shows preparations lacking cysteine, serine, and glycine. Table 22 shows potassium and magnesium supplements lacking serine, glycine, and cysteine.

[0169] [Table 17-1]

[0170] [Table 17-2]

[0171] [Table 18-1]

[0172] [Table 18-2]

[0173] [Table 19-1]

[0174] [Table 19-2]

[0175] [Table 20-1]

[0176] [Table 20-2]

[0177] [Table 21]

[0178] [Table 22-1]

[0179] [Table 22-2]

[0180] Example 5: Amino acid preparation lacking at least four amino acids

[0167] Prepare formulations lacking four amino acids. Table 23 shows formulations lacking glutamine, glutamic acid, serine, and glycine. Table 24 shows formulations lacking cysteine, proline, serine, and glycine.

[0181] [Table 23]

[0182] [Table 24]

[0183] Example 6: Amino acid preparation lacking five amino acids

[0168] Prepare formulations lacking five amino acids. Tables 25 to 27 show formulations lacking cysteine, glutamine, glutamic acid, serine, glycine, proline, or tyrosine.

[0184] [Table 25]

[0185] [Table 26]

[0186] [Table 27]

[0187] Example 7: Amino acid preparation lacking six amino acids

[0169] Prepare formulations lacking six amino acids. Tables 28 and 29 show formulations lacking cysteine, glutamine, glutamic acid, proline, serine, glycine, and tyrosine.

[0188] [Table 28]

[0189] [Table 29]

[0190] Example 8: Amino acid preparation lacking 7 amino acids

[0170] Prepare formulations lacking seven amino acids. Tables 30 and 31 show formulations lacking alanine, aspartic acid, asparagine, glutamic acid, proline, serine, glycine, or tyrosine.

[0191] [Table 30]

[0192] [Table 31]

[0193] Example 9: An amino acid preparation lacking 8 amino acids.

[0171] Prepare formulations lacking eight amino acids. Table 32 shows formulations lacking cysteine, tyrosine, arginine, asparagine, glutamic acid, proline, serine, and glycine.

[0194] [Table 32]

[0195] Example 10: An amino acid preparation lacking 9 amino acids.

[0172] Prepare formulations lacking nine amino acids. Tables 33 and 34 show formulations lacking cysteine, tyrosine, glutamine, arginine, asparagine, glutamic acid, proline, serine, glycine, and tyrosine.

[0196] [Table 33]

[0197] [Table 34]

[0198] Example 11: An amino acid preparation lacking 10 amino acids.

[0173] Prepare formulations lacking 10 amino acids. Tables 35-38 show formulations lacking cysteine, tyrosine, glutamine, arginine, alanine, aspartic acid, arginine, glutamic acid, proline, serine, or glycine. Formulations lacking 10 amino acids contain one non-essential amino acid.

[0199] [Table 35]

[0200] [Table 36]

[0201] [Table 37]

[0202] [Table 38]

[0203] Example 12: An amino acid preparation lacking 11 amino acids.

[0174] Prepare formulations lacking 11 amino acids. Table 39 shows formulations lacking cysteine, tyrosine, glutamine, arginine, alanine, aspartic acid, asparagine, glutamic acid, proline, serine, and glycine. Formulations lacking 11 amino acids do not contain non-essential amino acids.

[0204] [Table 39]

[0205] Example 13: A nutritionally complete formulation. A nutritionally complete formulation is prepared in cartons containing 237 mL of the formulation. Table 40 shows the components of the nutritionally complete formulation.

[0206]

Table 40-1

[0207]

Table 40-2

[0208]

Table 40-3

[0209] Example 14: Administration of the compositions disclosed herein.

[0176] Assign a target daily protein intake of 0.8 g / kg / day or 48 g / day to a 60 kg subject having cancer. Prescribe 4 sachets (each 12 g) per day containing Formulation A to the subject. The subject mixes the sachets in a cup of water and adds a drop of a flavoring agent such as a concentrated fruit flavor beverage if necessary. The subject drinks the mixture of the composition. FIG. 1 shows adding the composition contained in the sachet (101) to a cup of water (102), and the subject (104) drinks the mixture of the composition prepared in the water (103).

[0210]

[0177] Monitor the subject's consumption of other foods and beverages throughout the day. Prescribe a detailed diet to the subject to closely manage the daily protein intake. The diet consists of ready-to-eat meals and snacks low in protein and low in amino acids excluded from the composition. The amino acid levels of the subject are measured in biological samples obtained from the subject using an analytical method including liquid chromatography or liquid chromatography-mass spectrometry.

[0211] Example 15: Treatment of conditions.

[0178] A subject with a disease, such as cancer, visits a medical professional for treatment. The medical professional prescribes formulation B. Formulation B is prescribed as several sachets. The subject mixes the sachets in a glass of water and adds flavoring drops, such as MiO flavoring drops, if necessary. The subject drinks the mixture of the composition. Figure 1 shows the composition contained in a sachet (101) being added to a glass of water (102), and the subject (104) drinking the mixture of the composition prepared in the water (103). A sample is taken from the subject to monitor the subject's nutrient and amino acid levels. Based on the sample, the amounts of different formulations or formulation B disclosed herein are adjusted.

[0212] Example 16: A study to evaluate the compositions disclosed herein for treating diseases in a subject.

[0179] A study is conducted to evaluate the effects of the compositions disclosed herein when treating a condition in subjects. Twenty patients with cancer participate in a double-blind, placebo-controlled, randomized study. The experimental group includes 10 subjects who are given the formulations in Table 6 as sachets. The parameters observed are nutrient and amino acid levels in the subjects before and after administration of the formulations. The control group includes 10 subjects who are given sachets of powdered placebo. The placebo is administered at the same time as the experimental group takes the formulations in Table 6. The parameters observed are nutrient and amino acid levels in the subjects before and after administration of the placebo. After treatment, subjects in the experimental group show a reduction in tumor cell proliferation or tumor cell volume compared to the control group.

[0213] Example 17: Study of amino acid levels in healthy subjects administered with an amino acid preparation lacking proline.

[0180] Three healthy human subjects aged 18–60 years with a body mass index (BMI) between 18–30 and who regularly consumed a Western diet were given their regular diet (i.e., a diet typical of the subjects before administration of the composition) for one day to establish baseline levels of serum amino acids. A Western diet may consist of a daily calorie intake of approximately 50% from carbohydrates, 15% from protein, and 35% from fat.

[0214]

[0181] Participants meeting the following criteria were not permitted to participate in the study: (i) those with a clinically relevant medical history or the presence of a disease (i.e., respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc.); (ii) those with a history of disease or illness, or those using drugs that specifically alter proline; (iii) those who have fainted or nauseated upon seeing a needle, blood, or during blood donation; (iv) those who have been ill in the past or have recently been ill, such as those who have recently experienced a gastrointestinal disorder including fever and / or vomiting and / or diarrhea; (v) those who do not wish to follow, or are unlikely to adhere to, a diet low in protein and lacking in meat and dairy products (milk, cheese) during the course of the study; (vi) those who habitually consume diets that restrict food groups (e.g., carbohydrates, as in a ketogenic diet) or specific ingredients (e.g., gluten); (vii) those with a known food allergy to dairy products, wheat, nuts, or sucralose; (vii) those who, at the time of recruitment, were using tobacco or nicotine in any form. (ix) Subjects who used the product; (e.g., daily intake > 4 tall coffees, > 5 teas, or > 8 soft drinks); (x) Subjects who did not wish to discontinue consuming coffee with milk during the study (subjects who did not wish to discontinue consuming coffee without milk (with / without sugar or sucralose) or coffee with coconut milk (without other forms of creamer) were permitted); (xi) Subjects who consumed alcohol during the study (xii) Participants who did not wish to discontinue; (xiii) Participants who normally exercise for >2 hours per day or engage in very vigorous, energetic, or otherwise extreme exercise; (xiv) Participants who did not wish to adjust their exercise habits to 1) less than 60 minutes per day on each day of study participation, and 2) exercise only after afternoon post-meal blood sampling (i.e., not exercise before lunch); (xiv) Participants who did not speak fluent English (due to a shortage of available translators during the COVID-19 pandemic); and (xv) Participants who had participated in a clinical trial / experimental study in the past 14 days.

[0215]

[0182] Next, each subject was given a low-protein whole-food diet of 1613 kcal / day for 5 days. The diet consisted of 9 g of protein / day and approximately 350 mg of proline / day. 50%, 2%, and 48% of the daily calorie intake came from carbohydrates, protein, and fat, respectively. Over the 5 days, the diet was administered in combination with doses of supplemental amino acid preparations in sachet form. Each sachet contained the components listed in Table 41. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 g of nutritional supplements per kilogram of body weight per day. The sachets and diet were consumed at typical times of the day (breakfast between 07:00 and 08:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Plain water (with or without calorie sweeteners) was available free of charge. Blood samples were collected from each subject two hours after lunch each day, and their amino acid content was analyzed using LC-MS.

[0216]

[0183] Figure 2 shows the mean serum amino acid levels of the subjects measured during consumption of their habitual diet (i.e., the subjects' typical diet before administration of the composition) and after the start of the experimental diet (HD = habitual diet, ED = experimental diet). Figure 5, panel A shows the serum levels of proline as a percentage of the baseline level of the habitual diet over 5 days (* = p < 0.05 ANOVA).

[0217] [Table 41]

[0218] Example 18: Study of amino acid levels in healthy subjects administered with an amino acid preparation lacking proline. Four healthy human subjects recruited according to the criteria outlined in Example 17 were allowed to consume their habitual diet (i.e., the diet typical of the subjects prior to administration of the composition) for two days to establish baseline levels of serum amino acids. Next, each subject was given a low-protein whole-food diet of 1613 kcal / day for five days. The diet consisted of 9 g of protein / day and approximately 350 mg of proline / day. 50%, 2%, and 48% of the daily calorie amount were derived from carbohydrates, protein, and fat, respectively. Over the five days, the diet was administered in combination with doses of the auxiliary amino acid preparation in sachet form. Each sachet contained the ingredients listed in Table 42. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 grams of nutritional supplements per kilogram of body weight per day. The sachets and diet were consumed during the typical time periods of the day (breakfast between 07:00 - 08:00, lunch between 12:00 - 13:00, dinner between 18:00 - 19:00). Plain water (with or without non-calorie sweeteners) could be consumed freely. Blood samples were collected from each subject two hours after lunch every day, and the amino acid content was analyzed by LC-MS.

[0219]

[0185] Figure 3 shows the mean serum amino acid levels of the subjects measured during consumption of their habitual diet (i.e., the typical diet of the subjects prior to administration of the composition) and after initiation of the experimental diet (HD = habitual diet, ED = experimental diet). Figure 5, Panel B shows the serum levels of proline as a percentage of the baseline levels of the habitual diet over five days (* = p<0.05 ANOVA).

[0220]

Table 42

[0221] Example 19: Study of amino acid levels in healthy subjects administered a taurine-supplemented amino acid preparation lacking proline.

[0186] Four healthy human subjects recruited according to the criteria outlined in Example 17 were given a routine diet (i.e., a diet typical of the subjects before administration of the composition) for two days to establish baseline levels of serum amino acids. Then, each subject was given a low-protein whole-food diet of 1613 kcal / day for 21 days. The diet consisted of 9 g of protein / day and approximately 350 mg of proline / day. 50%, 2%, and 48% of the daily calorie intake came from carbohydrates, protein, and fat, respectively. Over the 21 days, the diet was administered in combination with doses of the supplemental amino acid preparation in sachet form. Each sachet contained the components listed in Table 43. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 grams of the supplement per kilogram of body weight per day. Sachets and meals were consumed at typical times of the day (breakfast between 7:00 and 8:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Plain water (with or without calorie sweeteners) was available for unrestricted consumption. Blood samples were collected from each subject two hours after lunch each day, and amino acid content was analyzed by LC-MS.

[0222]

[0187] Figure 4 shows the mean serum amino acid levels of the subjects measured during consumption of their habitual diet (i.e., the subjects' typical diet before administration of the composition) and after the start of the experimental diet (HD = habitual diet, ED = experimental diet). Figure 5, panel C shows serum proline levels as a percentage of the baseline level of the habitual diet over 21 days (* = p < 0.05 ANOVA).

[0223] [Table 43]

[0224] Example 20: Study of amino acid levels in pancreatic cancer patients administered a taurine-supplemented amino acid preparation lacking proline.

[0188] Baseline serum proline levels were determined in four human subjects diagnosed with pancreatic cancer. Each subject was then given a low-protein whole-food diet of 1613 kcal / day for four weeks. The diet consisted of 9 g of protein / day and approximately 350 mg of proline / day. 50%, 2%, and 48% of the daily calorie intake came from carbohydrates, protein, and fat, respectively. Over the four weeks, the diet was administered in combination with a dose of supplemental amino acid preparations in sachet form. Each sachet contained the components listed in Table 44. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 g of the nutritional supplement per kilogram of body weight per day. The sachets and diet were consumed at typical times of the day (breakfast between 07:00 and 08:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Participants were free to consume plain water (with or without calorie-free sweeteners). Blood samples were collected from each participant two hours after lunch each day, and serum proline content was analyzed by LC-MS.

[0225]

[0189] Figure 6 shows the mean serum proline levels of subjects over 4 weeks as a percentage of baseline (BL) levels measured during habitual diet consumption (*=p<0.05 ANOVA).

[0226] [Table 44]

[0227] Example 21: Study of amino acid levels in healthy subjects administered an amino acid preparation lacking serine and glycine.

[0190] Healthy human subjects recruited according to the criteria outlined in Example 17 were given a habitual diet (i.e., a diet typical of the subjects before administration of the composition) for one day to establish baseline levels of serum amino acids. The subjects were then given a low-protein and low-carbohydrate diet of 1711 kcal / day for 5 days. The diet consisted of 10 g / day of protein, approximately 420 mg / day of proline, approximately 410 mg / day of serine, and approximately 230 mg / day of glycine. 9%, 2%, and 89% of the daily calorie intake came from carbohydrates, protein, and fat, respectively. Over the 5 days, the diet was administered in combination with doses of the supplemental amino acid preparation in sachet form. Each sachet contained the components listed in Table 45. The subjects consumed a total of 0.8 grams of the supplement per kilogram of body weight per day, divided into multiple sachets throughout the day. Blood samples were collected from each subject 2 hours after lunch each day, and serum amino acid content was analyzed by LC-MS.

[0228]

[0191] Figure 7 shows the mean serum amino acid levels of the subjects measured during consumption of their habitual diet and after the start of the experimental diet (HD = habitual diet, ED = experimental diet).

[0229] [Table 45]

[0230] Example 22: Study of amino acid levels in healthy subjects administered with taurine-supplemented amino acid preparations lacking serine, glycine, and proline.

[0192] Three healthy human subjects recruited according to the criteria outlined in Example 17 were given a habitual diet (i.e., a diet typical of the subjects before administration of the composition) for two days to establish baseline levels of serum amino acids. The subjects were then given a low-protein and low-carbohydrate diet of 1711 kcal / day for 16–18 days. The diet consisted of 10 g / day of protein, approximately 420 mg / day of proline, approximately 410 mg / day of serine, and approximately 230 mg / day of glycine. 9%, 2%, and 89% of the daily calorie intake came from carbohydrates, protein, and fat, respectively. Over the 16–18 days, the diet was administered in combination with doses of a supplemental amino acid preparation in sachet form. Each sachet contained the components listed in Table 46. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 grams of the supplement per kilogram of body weight per day. Sachets and meals were consumed at typical times of the day (breakfast between 7:00 and 8:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Plain water (with or without calorie sweeteners) was available for unrestricted consumption. Blood samples were collected from each subject two hours after lunch each day, and serum amino acid content was analyzed by LC-MS.

[0231]

[0193] Figure 8 shows the mean serum amino acid levels of the subjects measured during consumption of their habitual diet (i.e., the subjects' typical diet before administration of the composition) and after the start of the experimental diet (HD = habitual diet, ED = experimental diet). Figure 9 shows the serum proline levels as a percentage of the habitual diet baseline during consumption of the experimental diet (* = p < 0.05 ANOVA, BL = baseline (habitual diet); Avg = mean).

[0232] [Table 46]

[0233] Example 23: Study of amino acid levels in healthy subjects administered with a taurine-supplemented amino acid preparation lacking serine, glycine, and proline.

[0194] Two groups, each consisting of one healthy human subject recruited according to the criteria outlined in Example 17, were given a habitual diet (i.e., a diet typical of the subject before administration of the composition) for two days to establish baseline levels of serum amino acids. Next, the first group was given a low-protein and low-carbohydrate diet of 1711 kcal / day daily for 16 days. The second group followed the same dietary regimen, except that they were instructed to consume a habitual diet instead of the experimental diet on days 7 and 14 of the 16 days. In each group, the experimental diet consisted of 10 g / day of protein, approximately 420 mg / day of proline, approximately 410 mg / day of serine, and approximately 230 mg / day of glycine. 9%, 2%, and 89% of the daily calorie intake came from carbohydrates, protein, and fat, respectively.

[0234]

[0195] For 16 days, subjects were administered an experimental diet in combination with a dose of supplemental amino acid preparations in sachet form, except on days when they were instructed to consume their regular diet. Each sachet contained the components listed in Table 46 of Example 22. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 grams of nutritional supplements per kilogram of body weight per day. Sachets and meals were consumed at typical times of the day (breakfast between 07:00 and 08:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Plain water (with or without calorie sweeteners) was available for unrestricted consumption. Blood samples were collected from each subject two hours after lunch each day, and serum amino acid content was analyzed by LC-MS.

[0235]

[0196] The mean serum amino acid levels of the subjects, measured during the consumption of the subjects' habitual diet (i.e., the subjects' typical diet before administration of the composition) and after the start of the experimental diet, are shown in Panel A of Figure 10 for the first group that consumed a constant daily diet, and in Panel B for the second group that consumed a diet intermittently (HD = habitual diet; ED = experimental diet). Figure 10, Panel C shows the serum levels of serine, glycine, and proline as percentages of baseline levels of the habitual diet over 21 days in both the constant and intermittent groups.

[0236] Example 24: Study of amino acid levels in healthy subjects administered with taurine-supplemented amino acid preparations lacking serine, glycine, glutamate, glutamine, and cysteine.

[0197] Two groups of healthy human subjects, each consisting of two subjects recruited according to the criteria outlined in Example 17, were given a habitual diet (i.e., a diet typical of the subjects before administration of the composition) for two days to establish baseline levels of serum amino acids.

[0237]

[0198] In Group 1, subjects were then given a low-protein whole-food diet of 1613 kcal / day for 4 days. The diet consisted of 9 g of protein / day and approximately 350 mg of proline / day. 50%, 2%, and 48% of the daily calorie intake came from carbohydrates, protein, and fat, respectively.

[0238]

[0199] In Group 2, subjects were then given a low-protein and low-carbohydrate diet of 1711 kcal / day for 4 days. The Group 2 diet consisted of 10 g of protein / day, approximately 420 mg of proline / day, approximately 410 mg of serine / day, and approximately 230 mg of glycine / day. 9%, 2%, and 89% of the daily calorie intake came from carbohydrates, protein, and fat, respectively.

[0239]

[0200] In each group, meals were administered in combination with a dose of supplemental amino acid preparations in sachet form over a period of 4 days. Each sachet contained the components listed in Table 47. The number of sachets administered to each subject was adjusted so that each subject consumed a total of 0.8 grams of nutritional supplements per kilogram of body weight per day. The sachets and meals were consumed at typical times of the day (breakfast between 07:00 and 08:00, lunch between 12:00 and 13:00, and dinner between 18:00 and 19:00). Plain water (with or without calorie sweeteners) was available for unrestricted consumption. Blood samples were collected from each subject 2 hours after lunch each day, and serum amino acid content was analyzed by LC-MS.

[0240]

[0201] Mean serum amino acid levels measured during the consumption of the habitual diet and after the start of the experimental diet are shown in Figure 11 for the 1613 kcal / day low-protein whole food group and in Figure 12 for the 1711 kcal / day low-protein and low-carbohydrate group (HD = habitual diet, ED = experimental diet). Figure 13 provides a chart showing serum levels of serine and glycine in subjects before and after administration of the 1613 kcal / day low-protein diet (Panel A) or the 1711 kcal / day low-protein, low-carbohydrate diet (Panel B) (HD = habitual diet; ED = experimental diet; *P = 0.00019, t-test (two-tailed, paired)). Panel C shows the mean % serum levels after administration of the low-protein diet (left) and the mean % serum levels after administration of the low-protein, low-carbohydrate diet (right).

[0241] [Table 47]

[0242] Embodiment

[0202] The following non-limiting embodiments provide examples of the present invention, but do not limit the scope of the present invention.

[0243]

[0203] Embodiment 1. A composition comprising, a) a non-essential amino acid or a salt thereof that is not part of a polypeptide, b) a first essential amino acid or a first salt thereof and a second essential amino acid or a second salt thereof, present in equal amounts in the composition, wherein the first essential amino acid or a first salt thereof and the second essential amino acid or a second salt thereof are not part of a polypeptide, and c) a pharmaceutically acceptable excipient, all in the form of a unit dosage form.

[0244]

[0204] Embodiment 2. The composition of Embodiment 1, wherein the first essential amino acid or its first salt is histidine, and the second essential amino acid or its second salt is isoleucine.

[0205] Embodiment 3. The composition of Embodiment 1 or 2, wherein the equivalent amount is about 2% to about 6% (w / w).

[0245]

[0206] Embodiment 4. The composition of Embodiment 1, wherein the equivalent amount is approximately 5.5% to approximately 8.3% (w / w).

[0207] Embodiment 5. The composition of Embodiment 1, wherein the salt of the non-essential amino acid is a pharmaceutically acceptable salt, the first salt is a pharmaceutically acceptable salt, and the second salt is a pharmaceutically acceptable salt.

[0246]

[0208] Embodiment 6. A composition comprising, a) an essential amino acid which is not part of a polypeptide, b) a non-essential amino acid which is not part of a polypeptide, and c) a pharmaceutically acceptable excipient in powder form, wherein the composition does not contain serine or glycine, and in a study of tumor volume changes in a subject, the tumor volume of a subject administered with the composition is reduced by at least about 20% compared to a subject not administered with the composition.

[0247]

[0209] Embodiment 7. A composition comprising, in the form of a unit dosage form, a) a non-essential amino acid or a salt thereof that is not part of a polypeptide, b) a first essential amino acid or a first salt thereof and a second essential amino acid or a second salt thereof, present in equal amounts in the composition, wherein the first essential amino acid or a first salt thereof and the second essential amino acid or a second salt thereof are not part of a polypeptide, and c) a pharmaceutically acceptable excipient, wherein, in a study of tumor volume changes in a subject, the tumor volume of a subject administered with the composition is reduced by at least about 20% compared to a subject administered with a placebo.

[0248]

[0210] Embodiment 8. A composition comprising, a) an essential amino acid which is not part of a polypeptide, b) a non-essential amino acid which is not part of a polypeptide, and c) a pharmaceutically acceptable excipient in powder form, wherein the composition does not contain serine or glycine, and in a study of tumor volume changes in a subject, the tumor volume of a subject administered the composition is reduced by at least about 20% compared to a subject administered a placebo.

[0249]

[0211] Embodiment 9. Any one of the compositions from Embodiments 1 to 8, wherein the composition lacks at least one non-essential amino acid.

[0212] Embodiment 10. A composition which is any one of Embodiments 1 to 9, wherein the composition lacks at least serine.

[0250]

[0213] Embodiment 11. A composition which is any one of Embodiments 1 to 10, wherein the composition lacks at least glycine.

[0214] Embodiment 12. A composition which is any one of Embodiments 1 to 11, wherein the composition lacks at least proline.

[0251]

[0215] Embodiment 13. A composition according to any one of Embodiments 1 to 12, wherein the composition lacks at least cysteine.

[0216] Embodiment 14. A composition which is any one of Embodiments 1 to 13, wherein the composition lacks at least tyrosine.

[0252]

[0217] Embodiment 15. A composition which is any one of Embodiments 1 to 14, wherein the composition lacks at least arginine.

[0218] Embodiment 16. Any one of Embodiments 1 to 15, wherein the composition is a pharmaceutical composition.

[0253]

[0219] Embodiment 17. A composition according to any one of Embodiments 1 to 16, wherein the unit dosage form has a weight of about 12 g.

[0220] Embodiment 18. Any one of the compositions from Embodiments 1 to 17, wherein the composition is in powder form.

[0254]

[0221] Embodiment 19. Any one of Embodiments 1 to 18, further comprising a preservative.

[0222] Embodiment 20. Any one of Embodiments 1 to 19, further comprising a pharmaceutically acceptable excipient.

[0255]

[0223] Embodiment 21. Any one of Embodiments 1 to 20, further comprising a flavoring agent.

[0224] Embodiment 22. Any one of the compositions from Embodiments 1 to 21, wherein the composition further comprises about 0.05% to about 2% (w / w) of taurine, its hydrate, or a salt thereof.

[0256]

[0225] Embodiment 23. The composition contains about 1% to about 4% (w / w) Mg 2+ A composition comprising any one of embodiments 1 to 22, further comprising a source.

[0226] Embodiment 24. Mg 2+ The composition of Embodiment 23, wherein the source comprises magnesium citrate, magnesium fumarate, magnesium acetate, magnesium aspartate, magnesium threonate, magnesium glycinate, magnesium chloride, magnesium sulfate, magnesium oxide, or magnesium maleate, magnesium orotate, or hydrates thereof.

[0257]

[0227] Embodiment 25. Mg 2+ The composition of Embodiment 23, wherein the source is magnesium citrate.

[0228] Embodiment 26. Mg 2+ The composition of Embodiment 23, wherein the source is magnesium aspartate, and the aspartic acid, its hydrate, or its salt is the free acid of aspartic acid.

[0258]

[0229] Embodiment 27. The composition further comprises about 2% to about 5% of K + The composition according to any one of Embodiments 1 to 26.

[0230] Embodiment 28. K + The composition of Embodiment 27, wherein the source includes potassium citrate, potassium phosphate, potassium chloride, potassium sulfate, potassium gluconate, potassium hydrogen carbonate, potassium aspartate, potassium acetate, and potassium orotate.

[0259]

[0231] Embodiment 29. K + The composition of Embodiment 27, wherein the source is potassium chloride.

[0232] Embodiment 30. K + The composition of Embodiment 27, wherein the source is potassium aspartate, and the aspartic acid, its hydrate, or its hydrate is the free base of aspartic acid.

[0260]

[0233] Embodiment 31. In the study of the change in the tumor volume of a subject, the tumor volume of the subject administered with the composition is reduced by at least about 20% compared to the subject not administered with the composition. The composition according to any one of Embodiments 1 to 30.

[0261]

[0234] Embodiment 32. The composition of Embodiment 31, wherein the tumor volume is measured by caliper measurement.

[0235] Embodiment 33. A method for reducing the tumor volume of a subject, the method comprising the step of administering a therapeutically effective amount of the composition to the subject, and the composition lacks at least one non-essential amino acid for at least one month.

[0262]

[0236] Embodiment 34. The method of Embodiment 33, wherein the subject is receiving a modified diet, the modified diet providing at least about 50% of the daily calorie intake from lipids.

[0237] Embodiment 35. A method for treating a subject in need of treatment for cancer, wherein the subject is receiving a modified diet, the modified diet providing up to approximately 50% of the daily calorie intake from carbohydrates, and the method comprises the step of administering a therapeutically effective amount of a dietary product to the subject, the dietary product lacking at least one non-essential amino acid.

[0263]

[0238] Embodiment 36. The method of Embodiment 35, wherein the cancer is pancreatic cancer.

[0239] Embodiment 37. The method of Embodiment 35, wherein the cancer is colorectal cancer.

[0240] Embodiment 38. The method of Embodiment 35, wherein the cancer is breast cancer.

[0264]

[0241] Embodiment 39. A method for reducing the mean serum amino acid level of at least one non-essential amino acid in a subject requiring a reduction, the method comprising: a) administering a therapeutically effective amount of a dietary product lacking at least one non-essential amino acid to a subject for a first period, wherein the subject is receiving a modified diet during the first period, during which at least about 1% to a maximum of about 40% of his daily calorie intake comes from carbohydrates; and b) not administering the dietary product to a subject for a second period, during which the subject is receiving a normal diet during the second period, during which at least about 45% of his daily calorie intake comes from carbohydrates.

[0265]

[0242] Embodiment 40. The method of Embodiment 39, wherein the first period is approximately 5 days.

[0243] Embodiment 41. The method of Embodiment 39, wherein the second period is approximately one day.

[0244] Embodiment 42. The method of Embodiment 39, wherein the second period is approximately 2 days.

[0266]

[0245] Embodiment 43. The method of Embodiment 39, further comprising the step of repeating steps a) and b).

[0246] Embodiment 44. The method of Embodiment 43, wherein steps a) and b) are repeated for at least about one week.

[0267]

[0247] Embodiment 45. The method of Embodiment 43, wherein steps a) and b) are repeated for at least about one month.

[0248] Embodiment 46. Any one of Embodiments 39 to 45, wherein the mean serum amino acid level is reduced by at least about 30%.

[0268]

[0249] Embodiment 47. Any one of Embodiments 39 to 34, wherein the mean serum amino acid level is reduced by at least about 50%.

[0250] Embodiment 48. Any one of Embodiments 39 to 47, wherein the reduced mean serum amino acid level persists for a second period.

[0269]

[0251] Embodiment 49. Any one of Embodiments 35 to 48, wherein the modified diet provides at least about 50% of the daily calorie intake from lipids.

[0252] Embodiment 50. Any one of Embodiments 35 to 48, wherein the modified diet provides at least about 80% of the daily calorie intake from lipids.

[0270]

[0253] Embodiment 51. Any one of Embodiments 35 to 50, wherein the modified diet provides up to approximately 30% of the daily calorie intake from carbohydrates.

[0254] Embodiment 52. Any one of Embodiments 35 to 50, wherein the modified diet provides up to approximately 15% of the daily calorie intake from carbohydrates.

[0271]

[0255] Embodiment 53. Any one of Embodiments 35 to 52, wherein the modified diet provides up to approximately 10 g of protein per day.

[0256] Embodiment 54. Any one of Embodiments 35 to 52, wherein the modified diet provides up to approximately 9 g of protein per day.

[0272]

[0257] Embodiment 55. Any one of Embodiments 35 to 54, wherein the modified diet provides at least one non-essential amino acid up to approximately 500 mg / day.

[0258] Embodiment 56. Any one of Embodiments 35 to 55, wherein the modified diet provides up to approximately 500 mg / day of serine.

[0273]

[0259] Embodiment 57. Any one of Embodiments 35 to 55, wherein the modified diet provides up to approximately 500 mg / day of glycine.

[0260] Embodiment 58. Any one of Embodiments 33 to 57, wherein administration is by oral administration.

[0274]

[0261] Embodiment 59. Any one of Embodiments 33 to 58, wherein the dietary therapy product is administered three times a day.

[0262] Embodiment 60. Any one of Embodiments 33 to 59, wherein the dietary therapy product is administered four times a day.

[0275]

[0263] Embodiment 61. Any one of Embodiments 33 to 60, wherein the therapeutically effective dose of the dietary therapy product is approximately 0.5 g / kg / day to approximately 1 g / kg / day.

[0264] Embodiment 62. The method of Embodiment 61, wherein the therapeutically effective dose of the dietary therapy product is approximately 0.8 g / kg / day.

[0276]

[0265] Embodiment 63. The dietary therapy product contains approximately 2% to approximately 5% K + Any one of embodiments 33 to 62, further including a source.

[0266] Embodiment 64.K + The method of Embodiment 63, wherein the source is potassium chloride.

[0277]

[0267] Embodiment 65.K +The method of Embodiment 63, wherein the source is potassium aspartate, and aspartic acid, its hydrate, or its hydrate is the free base of aspartic acid.

[0268] Embodiment 66. Dietary therapy product contains approximately 1% to approximately 4% (w / w) Mg 2+ Any one of embodiments 33 to 65, further including a source.

[0278]

[0269] Embodiment 67. Mg 2+ The method of embodiment 66, wherein the source is magnesium citrate.

[0270] Embodiment 68. Mg 2+ The method of Embodiment 66, wherein the source is magnesium aspartate, and aspartic acid, its hydrate, or its salt is the free acid of aspartic acid.

[0279]

[0271] Embodiment 69. Any one of Embodiments 33 to 68, wherein the dietary product further comprises about 0.05% to about 2% (w / w) of taurine, its hydrate, or a salt thereof.

[0272] Embodiment 70. Any one of Embodiments 33 to 69, wherein the dietary product further contains glucose.

[0280]

[0273] Embodiment 71. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is proline.

[0274] Embodiment 72. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is serine.

[0281]

[0275] Embodiment 73. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is glycine.

[0276] Embodiment 74. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is glutamate.

[0282]

[0277] Embodiment 75. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is glutamine.

[0278] Embodiment 76. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is cysteine.

[0283]

[0279] Embodiment 77. Any one of Embodiments 33 to 70, wherein at least one non-essential amino acid is asparagine.

[0280] Embodiment 78. Any one of Embodiments 33 to 70 wherein the dietary product does not contain serine or glycine.

[0284]

[0281] Embodiment 79. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, or proline.

[0282] Embodiment 80. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, or cysteine.

[0285]

[0283] Embodiment 81. Any one of Embodiments 33 to 70 wherein the dietary product does not contain serine, glycine, proline, or cysteine.

[0284] Embodiment 82. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, proline, or tyrosine.

[0286]

[0285] Embodiment 83. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, proline, or arginine.

[0286] Embodiment 84. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, proline, cysteine, or tyrosine.

[0287]

[0287] Embodiment 85. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, proline, cysteine, or arginine.

[0288] Embodiment 86. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, proline, cysteine, tyrosine, or arginine.

[0288]

[0289] Embodiment 87. Any one of Embodiments 33 to 70, wherein the dietary product does not contain serine, glycine, glutamate, glutamine, or cysteine.

[0290] Embodiment 88. Any one of Embodiments 33 to 87, further comprising the step of administering a therapeutic agent.

[0289]

[0291] Embodiment 89. The method of Embodiment 88, wherein the therapeutic agent is chemotherapy.

[0292] Embodiment 90. The method of Embodiment 88, wherein the therapeutic agent is radiotherapy.

[0293] Embodiment 91. The method of Embodiment 88, wherein the therapeutic agent is immunotherapy.

[0290]

[0294] Embodiment 100. a) Approximately 2% to approximately 6% (w / w) histidine or a salt thereof, b) Approximately 2% to approximately 6% (w / w) isoleucine or a salt thereof, c) Approximately 6% to approximately 11% (w / w) leucine or a salt thereof, d) Approximately 5% to approximately 9% (w / w) lysine or a salt thereof, e) Approximately 2% to approximately 4% (w / w) methionine or a salt thereof, f) Approximately 1% to approximately 3% (w / w) cysteine ​​or a salt thereof, g) Approximately 3% to approximately 6% (w / w) phenylalanine or a salt thereof, h) Approximately 1% to approximately 3% (w / w) tyrosine or a salt thereof, i) Approximately 3% to approximately 5% (w / w) threonine or a salt thereof, j) Approximately 1% A composition comprising, in unit dosage form, approximately 3% (w / w) tryptophan or a salt thereof, k) approximately 5% to approximately 9% (w / w) valine or a salt thereof, l) approximately 5% to approximately 9% (w / w) arginine or a salt thereof, m) approximately 5% to approximately 11% (w / w) glutamine or a salt thereof, n) approximately 2% to approximately 7% (w / w) alanine or a salt thereof, o) approximately 6% to approximately 10% (w / w) aspartic acid or a salt thereof, p) approximately 3% to approximately 7% (w / w) asparagine or a salt thereof, q) approximately 8% to approximately 14% (w / w) glutamic acid or a salt thereof, and r) approximately 6% to approximately 12% (w / w) proline or a salt thereof.

[0291]

[0295] Embodiment 102. a) Approximately 5% to 9% (w / w) histidine or a salt thereof, b) Approximately 5% to 9% (w / w) isoleucine or a salt thereof, c) Approximately 9% to 15% (w / w) leucine or a salt thereof, d) Approximately 7% to 12% (w / w) lysine or a salt thereof, e) Approximately 5% to 8% (w / w) methionine or a salt thereof, f) Approximately 4% to 7% (w / w) cysteine ​​or a salt thereof, g) Approximately 6% to 10% (w / w) phenyl A composition comprising, in unit dosage form, alanine or a salt thereof, h) approximately 4% to approximately 7% (w / w) of tyrosine or a salt thereof, i) approximately 6% to approximately 10% (w / w) of threonine or a salt thereof, j) approximately 4% to approximately 7% (w / w) of tryptophan or a salt thereof, k) approximately 8% to approximately 13% (w / w) of valine or a salt thereof, l) approximately 5% to approximately 9% (w / w) of arginine or a salt thereof, and m) approximately 7% to approximately 11% (w / w) of glutamine or a salt thereof.

[0292]

[0296] Embodiment 103. a) Approximately 2% to approximately 5% (w / w) histidine or a salt thereof, b) Approximately 2% to approximately 5% (w / w) isoleucine or a salt thereof, c) Approximately 6% to approximately 10% (w / w) leucine or a salt thereof, d) Approximately 5% to approximately 8% (w / w) lysine or a salt thereof, e) Approximately 2% to approximately 4% (w / w) methionine or a salt thereof, f) Approximately 1% to approximately 3% (w / w) cysteine ​​or a salt thereof, g) Approximately 3% to approximately 5% (w / w) phenylalanine or a salt thereof, h) Approximately 1% to approximately 3% (w / w) tyrosine or a salt thereof, i) Approximately 3% to approximately 5% (w / w) threonine or a salt thereof, j) Approximately 1% to approximately 3% (w / w) tryptophan or a salt thereof, k) Approximately 5% to approximately 9% (w / w A composition comprising, in the form of a unit dosage form, ) valine or a salt thereof, l) about 5% to about 9% (w / w) arginine or a salt thereof, m) about 7% to about 11% (w / w) glutamine or a salt thereof, n) about 4% to about 7% (w / w) alanine or a salt thereof, o) about 6% to about 10% (w / w) aspartic acid or a salt thereof, p) about 3% to about 6% (w / w) asparagine or a salt thereof, q) about 8% to about 14% (w / w) glutamic acid or a salt thereof, and r) about 6% to about 10% (w / w) proline or a salt thereof, wherein, in a study of tumor volume changes in a subject, the tumor volume of a subject administered with the composition is reduced by at least about 20% compared to a subject administered with a placebo.

[0293]

[0297] Embodiment 104. The composition of Embodiment 101 or 103, wherein salts of histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, glutamine, alanine, aspartic acid, asparagine, glutamic acid, and proline are pharmaceutically acceptable salts.

[0294]

[0298] Embodiment 105. a) Approximately 5% to approximately 9% (w / w) histidine or a salt thereof, b) Approximately 5% to approximately 9% (w / w) isoleucine or a salt thereof, c) Approximately 9% to approximately 15% (w / w) leucine or a salt thereof, d) Approximately 7% to approximately 12% (w / w) lysine or a salt thereof, e) Approximately 5% to approximately 8% (w / w) methionine or a salt thereof, f) Approximately 4% to approximately 7% (w / w) cysteine ​​or a salt thereof, g) Approximately 6% to approximately 10% (w / w) phenylalanine or a salt thereof, h) Approximately 4% to approximately 7% (w / w) tyrosine or a salt thereof, i) Approximately 6% to approximately 1 A composition comprising, in the form of a unit dosage form, 0% (w / w) threonine or a salt thereof, j) about 4% to about 7% (w / w) tryptophan or a salt thereof, k) about 8% to about 13% (w / w) valine or a salt thereof, l) about 5% to about 9% (w / w) arginine or a salt thereof, and m) about 7% to about 11% (w / w) glutamine or a salt thereof, wherein a comparative study is conducted, and the comparative study includes the step of administering the composition to a first subject and a placebo to a second subject, the tumor volume of the first subject is reduced compared to the tumor volume of the second subject.

[0295]

[0299] Embodiment 106. The composition of Embodiment 102 or 105, wherein the salts of histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, and glutamine are pharmaceutically acceptable salts.

[0296]

[0300] Embodiment 107. a) Approximately 3% to approximately 7% (w / w) of histidine, its hydrate, or a salt thereof, b) Approximately 3% to approximately 6% (w / w) of isoleucine, its hydrate, or a salt thereof, c) Approximately 7% to approximately 11% (w / w) of leucine, its hydrate, or a salt thereof, d) Approximately 5% to approximately 9% (w / w) of lysine, its hydrate, or a salt thereof, e) Approximately 2% to approximately 4% (w / w) of methionine, its hydrate or a salt thereof, f) about 1% to about 3% (w / w) cysteine, its hydrate, or a salt thereof, g) about 3% to about 7% (w / w) phenylalanine, its hydrate, or a salt thereof, h) about 1% to about 3% (w / w) tyrosine, its hydrate, or a salt thereof, i) about 2% to about 5% (w / w) threonine, its hydrate, or a salt thereof, j) about 1% to about 3% (w / w) tryptophan k) valine, its hydrate, or its salt, and l) 5% to 9% (w / w) valine, its hydrate, or its salt, and m) 7% to 11% (w / w) glutamine, its hydrate, or its salt, and n) 3% to 7% (w / w) alanine, its hydrate, or its salt, and o) 6% to 10% (w / w) asparagus A composition comprising, in the form of a unit dosage form, ginic acid, its hydrate, or a salt thereof; p) approximately 3% to approximately 6% (w / w) of asparagine, its hydrate, or a salt thereof; q) approximately 8% to approximately 14% (w / w) of glutamic acid, its hydrate, or a salt thereof; r) approximately 2% to approximately 5% (w / w) of serine, its hydrate, or a salt thereof; and s) approximately 3% to approximately 7% (w / w) of glycine, its hydrate, or a salt thereof.

[0297]

[0301] Embodiment 108. The composition of Embodiment 107, wherein salts of histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, glutamine, alanine, aspartic acid, asparagine, glutamic acid, serine, and glycine are pharmaceutically acceptable salts.

[0298]

[0302] Embodiment 109. a) Approximately 3% to approximately 7% (w / w) histidine, its hydrate, or a salt thereof, b) Approximately 4% to approximately 8% (w / w) isoleucine, its hydrate, or a salt thereof, c) Approximately 9% to approximately 13% (w / w) leucine, its hydrate, or a salt thereof, d) Approximately 8% to approximately 12% (w / w) lysine, its hydrate, or a salt thereof, e) Approximately 1% to approximately 4% (w / w) methionine, its hydrate, or its salt, f) about 1% to about 4% (w / w) cysteine, its hydrate, or its salt, g) about 5% to about 9% (w / w) phenylalanine, its hydrate, or its salt, h) about 1% to about 5% (w / w) tyrosine, its hydrate, or its salt, i) about 4% to about 8% (w / w) threonine, its water j) a dihydrate or salt thereof, and k) approximately 1% to 4% (w / w) tryptophan, its hydrate or salt thereof, and l) approximately 1% to 10% (w / w) valine, its hydrate or salt thereof, and m) approximately 1% to 5% (w / w) glutamine, its hydrate or salt thereof, and n) approximately 4 A composition comprising, in unit dosage form, approximately 8% (w / w) alanine, its hydrate, or a salt thereof; o) approximately 4% to 12% (w / w) aspartic acid, its hydrate, acid, or a salt thereof; p) approximately 4% to 8% (w / w) asparagine, its hydrate, or a salt thereof; and q) approximately 5% to 15% (w / w) glutamic acid, its hydrate, or a salt thereof.

[0299]

[0303] Embodiment 110. a) Approximately 4% to 6% (w / w) histidine, its hydrate, or a salt thereof, b) Approximately 5% to 7% (w / w) isoleucine, its hydrate, or a salt thereof, c) Approximately 9% to 12% (w / w) leucine, its hydrate, or a salt thereof, d) Approximately 8% to 12% (w / w) lysine, its hydrate, or a salt thereof, e) Approximately 1% to 4% f) % (w / w) methionine, its hydrate, or its salt, g) approximately 1% to 3% (w / w) cysteine, its hydrate, or its salt, h) approximately 6% to 8% (w / w) phenylalanine, its hydrate, or its salt, i) approximately 1% to 4% (w / w) tyrosine, its hydrate, or its salt, i) approximately 4% to 7% (w / w) threonine, A composition comprising, in the form of a unit dosage form, the hydrate or salt thereof of, j) about 1% to about 3% (w / w) of tryptophan, its hydrate or salt thereof, k) about 4% to about 9% (w / w) of valine, its hydrate or salt thereof, l) about 7% to about 11% (w / w) of arginine, its hydrate or salt thereof, m) about 2% to about 4% (w / w) of glutamine, its hydrate or salt thereof, n) about 4% to about 7% (w / w) of alanine, its hydrate or salt thereof, o) about 8% to about 11% (w / w) of aspartic acid, its hydrate or salt thereof, p) about 4% to about 7% (w / w) of asparagine, its hydrate or salt thereof, and q) about 4% to about 8% (w / w) of glutamic acid, its hydrate or salt thereof.

[0300]

[0304] Embodiment 111. The composition of Embodiment 109 or 110, wherein histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, glutamine, alanine, aspartic acid, asparagine, and a salt of glutamic acid are pharmaceutically acceptable salts.

[0301]

[0305] Embodiment 112. a) Approximately 4% to approximately 6% (w / w) histidine, its hydrate, or a salt thereof, b) Approximately 5% to approximately 7% (w / w) isoleucine, its hydrate, or a salt thereof, c) Approximately 11% to approximately 13% (w / w) leucine, its hydrate, or a salt thereof, d) Approximately 8% to approximately 10% (w / w) lysine, its hydrate, or a salt thereof, e) Approximately 2% to approximately 4% (w / w) methionine, its hydrate, or a salt thereof, f) Approximately 6% to approximately 8% (w / w) phenylalanine, its hydrate, or a salt thereof, g) Approximately 1% to approximately 3% (w / w) tyrosine, its hydrate, or a salt thereof, h) Approximately 3% to approximately 5% (w / w) threonine, A composition comprising the hydrate or salt thereof, and i) about 1% to about 3% (w / w) of tryptophan, its hydrate or salt thereof, j) about 8% to about 10% (w / w) of valine, its hydrate or salt thereof, k) about 7% to about 9% (w / w) of arginine, its hydrate or salt thereof, l) about 3% to about 5% (w / w) of alanine, its hydrate or salt thereof, m) about 4% to about 6% (w / w) of aspartic acid, its hydrate or salt thereof, n) about 4% to about 7% (w / w) of asparagine, its hydrate or salt thereof, and o) about 14% to about 17% (w / w) of proline, its hydrate or salt thereof, all in the form of a unit dosage form.

[0302]

[0306] Embodiment 113. The composition of Embodiment 112, wherein the salts of histidine, isoleucine, leucine, lysine, methionine, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, alanine, aspartic acid, asparagine, and proline are pharmaceutically acceptable salts.

[0303]

[0307] Embodiment 114. a) Approximately 3% to approximately 5% (w / w) histidine, its hydrate, or a salt thereof, b) Approximately 5% to approximately 7% (w / w) isoleucine, its hydrate, or a salt thereof, c) Approximately 10% to approximately 12% (w / w) leucine, its hydrate, or a salt thereof, d) Approximately 9% to approximately 11% (w / w) lysine, its hydrate, or a salt thereof, e) Approximately 2% to approximately f) 4% (w / w) methionine, its hydrate, or its salt, g) approximately 9% to 11% (w / w) proline, its hydrate, or its salt, h) approximately 6% to 8% (w / w) phenylalanine, its hydrate, or its salt, i) approximately 1% to 4% (w / w) tyrosine, its hydrate, or its salt, i) approximately 5% to 7% (w / w) threonine, A composition comprising the following in unit dosage form: j) about 1% to about 3% (w / w) of tryptophan, its hydrate, or its salt; k) about 5% to about 7% (w / w) of valine, its hydrate, or its salt; l) about 1% to about 3% (w / w) of arginine, its hydrate, or its salt; m) about 2% to about 4% (w / w) of glutamine, its hydrate, or its salt; n) about 5% to about 7% (w / w) of alanine, its hydrate, or its salt; o) about 4% to about 12% (w / w) of aspartic acid, its hydrate, or its salt; p) about 5% to about 7% (w / w) of asparagine, its hydrate, or its salt; and q) about 4% to about 12% (w / w) of glutamic acid, its hydrate, or its salt.

[0304]

[0308] Embodiment 115. The composition of Embodiment 114, wherein histidine, isoleucine, leucine, lysine, methionine, proline, phenylalanine, tyrosine, threonine, tryptophan, valine, arginine, glutamine, alanine, aspartic acid, asparagine, and salts of glutamic acid are pharmaceutically acceptable salts.

[0305]

[0309] Embodiment 116. Any one of Embodiments 100 to 115, wherein the composition is a pharmaceutical composition.

[0310] Embodiment 117. Any one of the compositions from Embodiments 100 to 115, wherein the composition is a medical food.

[0306]

[0311] Embodiment 118. Any one of the compositions from Embodiments 100 to 115, wherein the composition is a nutritional supplement.

[0312] Embodiment 119. A composition according to any one of Embodiments 100 to 118, wherein the unit dosage form has a weight of approximately 12 g.

[0307]

[0313] Embodiment 120. Any one of the compositions from Embodiments 100 to 119, wherein the composition is in powder form.

[0314] Embodiment 121. Any one of the compositions of Embodiments 100 to 120, further comprising a preservative.

[0308]

[0315] Embodiment 122. Any one of the compositions from Embodiments 100 to 121, further comprising a pharmaceutically acceptable excipient.

[0316] Embodiment 123. Any one of the compositions from Embodiments 100 to 122, further comprising a flavoring agent.

[0309]

[0317] Embodiment 124. Any one of the compositions from Embodiments 100 to 123, further comprising about 0.05% to about 2% (w / w) of taurine, its hydrate, or a salt thereof.

[0318] Embodiment 125. The composition contains about 1% to about 4% (w / w) Mg 2+ A composition of any one of embodiments 100 to 124, further comprising a source.

[0310]

[0319] Embodiment 126. Mg 2+ The composition of Embodiment 125, wherein the source comprises magnesium citrate, magnesium fumarate, magnesium acetate, magnesium aspartate, magnesium threonate, magnesium glycinate, magnesium chloride, magnesium sulfate, magnesium oxide, or magnesium maleate, magnesium orotate, or hydrates thereof.

[0311]

[0320] Embodiment 127. Mg 2+ The composition of Embodiment 125, wherein the source is magnesium citrate.

[0321] Embodiment 128. Mg 2+ The composition of Embodiment 125, wherein the source is magnesium aspartate, and the free acid of aspartic acid is aspartic acid, its hydrate, or a salt thereof.

[0312]

[0322] Embodiment 129. The composition contains about 2% to about 5% (w / w) of K + A composition of any one of embodiments 100 to 128, further comprising a source.

[0323] Embodiment 130.K + The composition of Embodiment 129, wherein the source comprises potassium citrate, potassium phosphate, potassium chloride, potassium sulfate, potassium gluconate, potassium bicarbonate, potassium aspartate, potassium acetate, and potassium orotate.

[0313]

[0324] Embodiment 131.K + The composition of Embodiment 129, wherein the source is potassium chloride.

[0325] Embodiment 132.K + The composition of Embodiment 129, wherein the source is potassium aspartate, and aspartic acid, its hydrate, or its hydrate is the free base of aspartic acid.

[0314]

[0326] Embodiment 133. A composition according to any one of Embodiments 100 to 132, wherein histidine, its hydrate, or a salt thereof is histidine hydrochloride.

[0327] Embodiment 134. A composition according to any one of Embodiments 100 to 132, wherein lysine, its hydrate, or a salt thereof is lysine hydrochloride.

[0315]

[0328] Embodiment 135. A composition according to any one of Embodiments 100 to 134, wherein lysine, its hydrate, or a salt thereof is lysine monohydrate.

[0329] Embodiment 136. A composition according to any one of Embodiments 100-111 or 116-135, wherein cysteine, its hydrate, or a salt thereof is cysteine ​​hydrochloride.

[0316]

[0330] Embodiment 137. A composition according to any one of Embodiments 100 or 116-136, wherein asparagine, its hydrate, or a salt thereof is asparagine hydrate.

[0331] Embodiment 138. A composition according to any one of Embodiments 100-104 or 107-137, wherein glutamic acid, its hydrate, or a salt thereof is glutamic acid arginine, and arginine is the free base of arginine.

Claims

1. A composition for use in treating a patient having cancer, comprising: a) about 4% to about 8% (w / w) of glutamic acid in the total composition, or a salt thereof, which is not a part of a polypeptide; b) a first essential amino acid or salt thereof comprising about 3% to about 7% (w / w) histidine based on the total composition and a second essential amino acid or salt thereof comprising about 2% to about 6% (w / w) isoleucine based on the total composition, the first essential amino acid or salt thereof and the second essential amino acid or salt thereof being not part of a polypeptide; c) a pharma- ceutically acceptable excipient; in unit dosage form, A composition lacking at least two non-essential amino acids, including serine and its salts and glycine and its salts.

2. The composition described in claim 1, further comprising a third essential amino acid or salt thereof, wherein the third essential amino acid or salt thereof is present in the composition in an amount different from the first essential amino acid or salt thereof and the second essential amino acid or salt thereof.

3. The composition of claim 1, further lacking proline and salts thereof.

4. The composition of claim 1, further lacking cysteine ​​and salts thereof.

5. The composition described in claim 1, wherein the unit dosage form has a weight of approximately 12 g.

6. The composition of claim 1 in powder form.

7. The composition of claim 1, further comprising about 2% to about 5% of a K + source based on the total composition.

8. The composition described in claim 7, wherein the K + source includes potassium citrate, potassium phosphate, potassium chloride, potassium sulfate, potassium gluconate, potassium bicarbonate, potassium aspartate, potassium acetate, potassium orotate, potassium bromate, potassium benzoate, potassium hydroxide, potassium iodide, or hydrates thereof.

9. The composition of claim 1, further comprising about 1% to about 4% (w / w) of a Mg 2+ source relative to the total composition.

10. The composition of claim 9, wherein the Mg2+ source comprises magnesium citrate, magnesium fumarate, magnesium acetate, magnesium aspartate, magnesium threonate, magnesium glycinate, magnesium chloride, magnesium sulfate, magnesium oxide, or magnesium maleate, magnesium orotate, magnesium gluconate, magnesium stearate, magnesium carbonate, or hydrates thereof.

11. The composition of claim 1, further comprising about 0.05% to about 2% (w / w) of taurine, its hydrate, or its salt based on the total composition.

12. The composition of claim 1, further lacking glutamine and salts thereof.

13. The composition of claim 1, further lacking glutamine and salts thereof and cysteine ​​and salts thereof.

14. The composition of claim 1, wherein the excipient comprises a flavoring agent.

15. The composition of claim 1, wherein the excipient comprises a sweetener.

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