Infant formulas having vitamin complexes with enhanced bioavailability

Abstract

An infant food formulation having a vitamin complex with enhanced bioavailability, including a protein; a carbohydrate; a fat; and a vitamin B complex, wherein the vitamin B complex includes a vitamer of vitamin B.sub.6, a vitamer of vitamin B.sub.9, and a vitamer of vitamin B.sub.12.

Claims

1. An infant food formulation having a vitamin complex with enhanced bioavailability, comprising: a protein; a carbohydrate; a fat; and a vitamin B complex, wherein the vitamin B complex comprises: a first vitamin, wherein the first vitamin comprises a form of vitamin B6; a second vitamin, wherein the second vitamin comprises N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt; and a third vitamin, wherein the third vitamin comprises a form of vitamin B12; wherein a weight ratio of the first vitamin to the second vitamin to the third vitamin ranges from approximately 250:75:1 to approximately 100:25:1 by weight of the total infant food formulation.

2. The infant food formulation according to claim 1, wherein the first vitamin comprises the structure of formula I or nutraceutically acceptable salts or solvates thereof: ##STR00013## wherein R.sub.1-R.sub.6, are each independently selected from the group consisting of H; OH; and an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkyl-alkenyl, alcohol, ether, ketone, carboxylic acid, acid halide, acid anhydride, ester, and/or amide group containing approximately 1 to approximately 25 carbon atom(s); wherein at least three of R.sub.1-R.sub.5 comprise OH; and wherein X.sub.1-X.sub.3 are each independently selected from the group consisting of N—R.sub.6; O; and S.

3. The infant food formulation according to claim 1, wherein the first vitamin comprises the structure of formula II or nutraceutically acceptable salts or solvates thereof: ##STR00014##

4. The infant food formulation according to claim 1, wherein the third vitamin comprises the structure of formula V or nutraceutically acceptable salts or solvates thereof: ##STR00015## wherein R.sub.1 is selected from the group consisting of H; OH; and an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkyl-alkenyl, alcohol, ether, ketone, carboxylic acid, acid halide, acid anhydride, ester, and/or amide group containing approximately 1 to approximately 25 carbon atom(s).

5. The infant food formulation according to claim 1, wherein the third vitamin comprises the structure of formula VI or nutraceutically acceptable salts or solvates thereof: ##STR00016##

6. The infant food formulation according to claim 1, wherein the first vitamin comprises [(4-formyl-5-hydroxy-6-methylpyridin-3-yl)methoxy]phosphonic acid, the second vitamin comprises N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt, and the third vitamin comprises methylcobalamin.

7. The infant food formulation according to claim 6, wherein the weight ratio of the first vitamin to the second vitamin to the third vitamin is approximately 200:55:1 by weight of the total infant food formulation.

8. The infant food formulation according to claim 1, comprising a caloric density of approximately 20 to approximately 30 kcal/fluid ounce.

9. The infant food formulation according to claim 1, wherein the protein comprises at least one of egg protein, milk protein, whey protein, whey protein concentrate, whey protein isolate, whey protein hydrolysate, casein protein, hydrolyzed protein, soy protein, rice protein, and pea protein.

10. The infant food formulation according to claim 1, wherein the carbohydrate comprises at least one of a starch, a complex carbohydrate, a sugar, a simple carbohydrate, and a fiber.

11. The infant food formulation according to claim 1, wherein the fat comprises at least one of a saturated fat, a trans fat, a monounsaturated fat, and a polyunsaturated fat.

12. The infant food formulation according to claim 1, wherein the fat comprises at least one of hexadecatrienoic acid, α-linolenic acid, stearidonic acid, eicosatrienoic acid, eicosatetraenoic acid, eicosapentaenoic acid, heneicosapentaenoic acid, docosapentaenoic acid, clupanodonic acid, docosahexaenoic acid, tetracosapentaenoic acid, and tetracosahexaenoic acid.

13. The infant food formulation according to claim 1, wherein the fat comprises at least one of linoleic acid, gamma-linolenic acid, calendic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid, tetracosatetraenoic acid, and tetracosapentaenoic acid.

14. The infant food formulation according to claim 1, further comprising an amino acid selected from the group consisting of L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamine, L-glutamic acid, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, and combinations thereof.

15. The infant food formulation according to claim 1, further comprising a vitamin/mineral selected from the group consisting of vitamin A, thiamin, riboflavin, niacin, pantothenic acid, biotin, vitamin C, choline, vitamin D, vitamin E, vitamin K, calcium, chloride, chromium, copper, fluoride, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, silicon, selenium, sodium, sulfur, tin, vanadium, zinc, and combinations thereof.

16. An infant food formulation having a vitamin complex with enhanced bioavailability, comprising: a protein; a carbohydrate; a fat; a vitamin B complex, wherein the vitamin B complex comprises: a first vitamin, wherein the first vitamin comprises [(4-formyl-5-hydroxy-6-methylpyridin-3-yl)methoxy]phosphonic acid; a second vitamin, wherein the second vitamin comprises N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt; and a third vitamin, wherein the third vitamin comprises methylcobalamin, wherein the weight ratio of the first vitamin to the second vitamin to the third vitamin ranges from approximately 250:75:1 to approximately 100:25:1 by weight of the total infant food formulation; and at least five amino acids selected from the group consisting of L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamine, L-glutamic acid, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, and L-valine.

17. An infant food formulation having a vitamin complex with enhanced bioavailability, consisting of: a protein; a carbohydrate; a fat; a vitamin B complex, wherein the vitamin B complex comprises: a first vitamin, wherein the first vitamin comprises [(4-formyl-5-hydroxy-6-methylpyridin-3-yl)methoxy]phosphonic acid; a second vitamin, wherein the second vitamin comprises N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt; and a third vitamin, wherein the third vitamin comprises methylcobalamin, wherein the weight ratio of the first vitamin to the second vitamin to the third vitamin ranges from approximately 250:75:1 to approximately 100:25:1 by weight of the total infant food formulation; and an amino acid; vitamins other than B vitamins; minerals; and wherein any remainder comprises adjunct agents.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) While this invention is susceptible of embodiment in many different forms, there is shown in the structural formulas and described herein in detail several specific embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. It will be understood that the structural formulas disclosed herein are intended to comprise all stereochemcial configurations regardless of graphical representations.

(2) In accordance with the present invention, infant formulas are disclosed herein that include vitamins and/or vitamin complexes having enhanced bioavailability for maximizing nutritional absorption. Without being bound by any one particular theory, it is believed that the infant formulas of the present invention facilitate enhanced bioavailability by reducing and/or eliminating multi-step biochemical conversions and/or are formulated in such a manner that relevant vitamins or their nutraceutically acceptable salts or solvates are neither compromised and/or adversely affected by other and/or adjunct ingredients. It will be understood that the infant formulas of the present invention are suitable for use in powder (e.g., non-compressed, partially compressed, compressed, etcetera), liquid concentrate, and liquid ready-to-feed forms.

(3) In a first embodiment of the present invention, the infant food formulation preferably includes a protein, a carbohydrate, a fat, and a vitamin complex having enhanced bioavailability for maximizing nutritional absorption, relative to infant food formulations having primarily synthetic vitamers. In accordance with the present invention the vitamin complex preferably includes a first vitamin, wherein the first vitamin comprises a specific vitamer of vitamin B.sub.6, a second vitamin, wherein the second vitamin comprises a specific vitamer of vitamin B.sub.9, and a third vitamin, wherein the third vitamin comprises a specific vitamer of vitamin B.sub.12.

(4) For purposes of the present disclosure, the first vitamin preferably comprises the structure of formula I or nutraceutically acceptable salts (e.g., deprotonated derivatives) or solvates thereof:

(5) ##STR00007##
wherein R.sub.1-R.sub.6, are each independently selected from the group consisting of H; OH; and an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkyl-alkenyl, alcohol, ether, ketone, carboxylic acid, acid halide, acid anhydride, ester, and/or amide group containing approximately 1 to approximately 25 carbon atom(s); wherein at least three of R.sub.1-R.sub.5 comprise OH; and wherein X.sub.1-X.sub.3 are each independently selected from the group consisting of N—R.sub.6; O; and S. In particular, the first vitamin preferably comprises the structure of formula II or nutraceutically acceptable salts or solvates thereof:

(6) ##STR00008##

(7) For purposes of reducing any potential ambiguity associated with the structure of formula II, it will be understood that this structure is a vitamer of vitamin B.sub.6 known as [(4-formyl-5-hydroxy-6-methylpyridin-3-yl)methoxy]phosphonic acid and/or pyridoxal-5′-phosphate and is commercially available from Sigma-Aldrich—among other chemical suppliers.

(8) In one embodiment, the second vitamin preferably comprises a folate derivative and/or the structure of formula III or nutraceutically acceptable salts or solvates thereof:

(9) ##STR00009##
wherein R.sub.1-R.sub.12, are each independently selected from the group consisting of H; OH; and an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkyl-alkenyl, alcohol, ether, ketone, carboxylic acid, acid halide, acid anhydride, ester, and/or amide group containing approximately 1 to approximately 25 carbon atom(s); and wherein X.sub.1-X.sub.4 are each independently selected from the group consisting of N—R.sub.12; O; and S. In particular, the second vitamin preferably comprises the structure of formula IV or nutraceutically acceptable salts or solvates thereof:

(10) ##STR00010##

(11) For purposes of reducing any potential ambiguity associated with the structure of formula IV, it will be understood that this structure is a vitamer of vitamin B.sub.9 known as N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt and/or (6S)-5-methyltetrahydrofolate glucosamine salt and is commercially available from Sigma Aldrich and/or Parchem—among other chemical suppliers.

(12) In accordance with the present invention, the third vitamin preferably comprises the structure of formula V or nutraceutically acceptable salts or solvates thereof:

(13) ##STR00011##
wherein R.sub.1 is selected from the group consisting of H; OH; and an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkyl-alkenyl, alcohol, ether, ketone, carboxylic acid, acid halide, acid anhydride, ester, and/or amide group containing approximately 1 to approximately 25 carbon atom(s). In particular, the third vitamin preferably comprises the structure of formula V or nutraceutically acceptable salts or solvates thereof:

(14) ##STR00012##

(15) For purposes of reducing any potential ambiguity associated with the structure of formula VI, it will be understood that this structure is a vitamer of vitamin B.sub.12 known as methylcobalamin and is commercially available from Sigma-Aldrich—among other chemical suppliers.

(16) The weight ratio of the first vitamin to the second vitamin to the third vitamin preferably ranges from approximately 300:100:1 to approximately 100:20:1 by weight of the total infant food formulation, and more preferably ranges from approximately 250:75:1 to approximately 100:25:1 by weight of the total infant food formulation. In one embodiment, the weight ratio of the first vitamin to the second vitamin to the third vitamin is approximately 200:55:1 by weight of the total infant food formulation.

(17) Preferably the infant food formulations of the present invention include animal protein and/or plant protein. Suitable examples of proteins include, for example, egg protein, milk protein, whey protein, whey protein concentrate, whey protein isolate, whey protein hydrolysate, casein protein, hydrolyzed protein, soy protein, rice protein, and/or pea protein.

(18) The infant food formulations of the present invention, preferably include one or more carbohydrates, such as, but not limited to, a starch, a complex carbohydrate, a sugar, a simple carbohydrate, and/or a fiber. It will be understood that the weight ratio of the first vitamin to the second vitamin and the third vitamin to the carbohydrate preferably ranges from approximately 200,000:1 to approximately 100,000:1 by weight of the total infant food formulation, and more preferably ranges from approximately 175,000:1 to approximately 130,000:1 by weight of the total infant food formulation.

(19) In accordance with the present invention, the fat preferably comprises a saturated fat, a trans fat, a monounsaturated fat, and/or a polyunsaturated fat—especially including omega-3 and omega-6 fatty acids. Suitable examples include, but are not limited to, hexadecatrienoic acid, α-linolenic acid, stearidonic acid, eicosatrienoic acid, eicosatetraenoic acid, eicosapentaenoic acid, heneicosapentaenoic acid, docosapentaenoic acid, clupanodonic acid, docosahexaenoic acid, tetracosapentaenoic acid, tetracosahexaenoic acid, linoleic acid, gamma-linolenic acid, calendic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid, tetracosatetraenoic acid, and/or tetracosapentaenoic acid.

(20) The infant food formulations of the present invention also preferably includes one or more amino acids. Non-limiting examples of amino acids include L and D enantiomers of alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and/or valine.

(21) In one embodiment of the present invention, the infant food formulations also preferably include one or more prebiotics, such as galacto- and fructo-oligosaccharides, also known as oligogalactosyllactose, oligogalactose, oligolactose or trans galactooligosaccharides (TOS).

(22) Preferably, the infant food formulations also include one or more nucleotides (adenosine-5′-monophosphate, cytidine-5′-monophosphate, disodium guanosine-5′-monophosphate, disodium uridine-5′-monophosphate, etcetera).

(23) Preferably, the infant food formulations of the present invention include additional vitamins and minerals. Examples include vitamin A, other B vitamins, thiamin, riboflavin, niacin, pantothenic acid, biotin, vitamin C, choline, vitamin D, vitamin E, vitamin K, calcium, chloride, chromium, copper, fluoride, iodine, iron (e.g., ferrous gluconate, Ferronyl™) magnesium, manganese, molybdenum, nickel, phosphorus, potassium, silicon, selenium, sodium, sulfur, tin, vanadium, zinc, and combinations thereof.

(24) In a preferred embodiment of the present invention, the infant food formulations further comprise adjunct agents including, but not limited to, preservatives, anti-microbial agents, oral hygiene additives, medicaments, herbal additives, additional anti-oxidants, emulsifying agents, buffers, sweeteners, lactoferrin and related derivatives, scents, colorants, flavorants, viscosity modifiers, thickening agents, stabilizers, and/or a solvents (e.g., water, milk, etcetera) to dissolve any solutes.

(25) Non-limiting examples of additional adjunct and non-adjunct agents may comprise, for example, Aequival® 2′FL, 2′FL HMO (2′-Fucosyllactose), phospholipids & MFGM (Lacprodan® MFGM-10), osteopontin (Lacprodan® OPN-10), alpha-lactabumin (Lacprodan® ALPHA-10, Lacprodan® ALPHA-20), casein glycomacropeptide (Lacprodan® CGMP-10), hydrolysates (Lacprodan® DI-3070, Lacprodan® DI-3071, Lacprodan® DI-2021, Peptigen® IF-3087, Peptigen® IF-3090, Peptigen® IF-3080, HYDRO.365, Lacprodan® HYDRO.clear, Lacprodan® HYDRO.milk, Lacprodan® HYDRO.power), milk minerals (Capolac® MM-0525), whey protein concentrate (Lacprodan® DI-7017, Lacprodan® DI-8090, Lacprodan® DI-8790, Lacprodan® DI-8702, Lacprodan® SP-8011), whey protein isolate (Lacprodan® DI-9212, Lacprodan® DI-9213, Lacprodan® DI-9224, Lacprodan® SP-9225), phospholipids (Lacprodan® Phospholipids), milk phospholipids (Lacprodan® PL-20), and/or phenylketonuria (PKU) (Lacprodan® CGMP-20).

(26) Provided below is a non-limiting example of an infant formula in accordance with the present invention. The vitamins and minerals to be included are as follows and are specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container: Vitamin A (250-750 IU), Vitamin D (40-100 IU), Vitamin E (minimum 0.7 IU), Vitamin K (minimum 4 mcg), Thiamine-Vitamin B1 (minimum 40 mcg), Riboflavin-Vitamin B2 (minimum 60 mcg), Pyridoxal-5-phosphate-Vitamin B6 (minimum 35 mcg), Methylcobalamin-Vitamin B12 (minimum 0.15 mcg), Niacin (minimum 250 mcg), Folate (minimum 4 mcg), Pantothenic acid (minimum 300 mcg), Biotin (required for non-milk-based formula only, minimum 1.5 mcg), Vitamin C (minimum 8 mg), Choline (required for non-milk-based formula only, minimum 7 mg), Inositol (required for non-milk-based formula only, minimum 4 mg), Calcium (minimum 60 mg), Phosphorus (minimum 30 mg), Magnesium (minimum 6 mg), Iron (0.15-3.0 mg), Zinc (minimum 0.5 mg), Manganese (minimum 5 mcg), Copper (minimum 60 mcg), Iodine (5-75 mcg), Selenium (2-7 mcg), Sodium (20-60 mg), Potassium (80-200 mg), Chloride (55-150 mg). The infant formula compositions may also further comprise suitable types of lipid, carbohydrates, and protein as will be recognized by those skilled in the art. The amount of lipid or fat can vary from about 3 to about 7 g/100 kcal. The amount of protein can vary from about 1 to about 5 g/100 kcal. The amount of carbohydrate can vary from about 8 to about 12 g/100 kcal.

(27) Provided below are non-limiting examples of infant food formulations. Ingredients are provided per 100 kcal.

Example 1

(28) TABLE-US-00001 Ingredient Name Amount Source Nonfat milk .1-10 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, lactose, glucose syrup solids, sugar) 1-50 g Grain Millers, Marroquin Organic Fat (e.g., high oleic sunflower oil, high oleic safflower oil, soy oil, MCT oil, 0.1-200 g Connoils coconut oil, palm oil or palm olein) Soy or Sunflower lecithin 5-500 mg American Lecithin Whey protein concentrate .1-50 g Grain Millers Mixed tocopherol concentrate or natural mixed tocopherols 1-500 ppm Organic Technologies Calcium (e.g., calcium carbonate, calcium citrate malate, calcium citrate, 10-500 mg Parchem/Albion calcium phosphate, calcium ascorbate, calcium chloride, calcium hydroxide, calcium bisglycinate chelate, Calci-K ®, calcium potassium phosphate citrate) Copper (e.g., cupric sulfate, copper citrate, copper gluconate, copper 5-200 mcg Parchem/Albion bisglycinate chelate) Iron (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate, Ferronyl ™ .5-5.0 mg Parchem/Ashland/ carbonyl iron, Ferrochel ®, ferrous bisglycinate chelate, ferric trisglycinate Albion chelate, ferric glycinate) Magnesium (e.g., magnesium oxide, magnesium gluconate, magnesium 1-50 mg Parchem/Albion citrate, magnesium chloride, dimagnesium malate, magnesium glycinate, magnesium phosphate, magnesium bisglycinate chelate) Manganese (e.g., manganese sulfate, manganese citrate, manganese 1-50 mcg Parchem/Albion gluconate, manganese bisglycinate chelate) Potassium iodide 5-500 mcg Parchem Potassium (e.g., potassium bicarbonate, potassium chloride, potassium 1-450 mg Parchem/Albion phosphate, potassium hydroxide, potassium citrate, potassium glycinate complex) Selenium (e.g., sodium selenite, l-selenomethionine, sodium selenate, 1-50 mcg Parchem/Albion selenium glycinate complex) Zinc (e.g., zinc sulfate, zinc picolinate, zinc gluconate, zinc citrate, zinc .5-50 mg Parchem/Albion acetate, zinc bisglycinate chelate) Vitamin C (e.g., ascorbic acid, sodium ascorbate, calcium ascorbate 1-500 mg Parchem Sodium (e.g., sodium chloride, sodium citrate) 2-200 mg Parchem Choline (e.g., choline chloride, choline bitartrate, choline citrate) 1-200 mg Parchem Biotin .5-20 mcg Parchem Inositol 1-100 mg Parchem Taurine 1-100 mg Parchem (6S)-5-methyltetrahydrofolate glucosamine salt 1-100 mcg Parchem/ Sigma-Aldrich Methylcobalamin 0.10-5.0 mcg Parchem Pyridoxal-5-Phosphate 5-350 mcg Parchem Riboflavin (e.g., Riboflavin, Riboflavin - 5 - Phosphate) 5-500 mcg Parchem Thiamine (e.g., thiamine hydrochloride, thiamine mononitrate) 1-100 mcg Parchem Calcium pantothenate 100-700 mcg Parchem Niacinamide 25-1,000 mcg Parchem Vitamin A (e.g., beta carotene, Vitamin A Palmitate) 25-1,000 IU Parchem Cholecalciferol 25-1,000 IU Parchem Vitamin E (e.g., dl-alpha tocopheryl acetate, d-alpha tocopherol acetate, d- 0.1-20 IU Parchem alpha tocopherol succinate) Vitamin K (e.g., Phytonadione, Phylloquinone) 1-20 mcg Parchem

Example 2

(29) TABLE-US-00002 Ingredient Name Amount Source Nonfat milk .1-10 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, lactose, glucose syrup solids, sugar) 1-50 g Grain Millers, Marroquin Organic Fat (e.g., high oleic sunflower oil, high oleic safflower oil, soy oil, MCT oil, 0.1-200 g Connoils coconut oil, palm oil or palm olein) Soy or Sunflower lecithin 5-500 mg American Lecithin Whey protein concentrate .1-50 g Grain Millers Mixed tocopherol concentrate or natural mixed tocopherols 1-500 ppm Organic Technologies Calcium (e.g., calcium carbonate, calcium citrate malate, calcium citrate, 10-500 mg Parchem/Albion calcium phosphate, calcium ascorbate, calcium chloride, calcium hydroxide, calcium bisglycinate chelate, Calci-K ®, calcium potassium phosphate citrate) Copper (e.g., cupric sulfate, copper citrate, copper gluconate, copper 5-200 mcg Parchem/Albion bisglycinate chelate) Iron (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate, Ferronyl ™ .5-5.0 mg Parchem/Ashland/ carbonyl iron, Ferrochel ®, ferrous bisglycinate chelate, ferric trisglycinate Albion chelate, ferric glycinate) Magnesium (e.g., magnesium oxide, magnesium gluconate, magnesium 1-50 mg Parchem/Albion citrate, magnesium chloride, dimagnesium malate, magnesium glycinate, magnesium phosphate, magnesium bisglycinate chelate) Manganese (e.g., manganese sulfate, manganese citrate, manganese 1-50 mcg Parchem/Albion gluconate, manganese bisglycinate chelate) Potassium iodide 5-500 mcg Parchem Vitamin C (e.g., ascorbic acid, sodium ascorbate, calcium ascorbate 1-500 mg Parchem Sodium (e.g., sodium chloride, sodium citrate) 2-200 mg Parchem Choline (e.g., choline chloride, choline bitartrate, choline citrate) 1-200 mg Parchem Taurine 1-100 mg Parchem (6S)-5-methyltetrahydrofolate glucosamine salt 1-100 mcg Parchem/Sigma- Aldrich Methylcobalamin 0.10-5.0 mcg Parchem Pyridoxal-5-Phosphate 5-350 mcg Parchem Calcium pantothenate 100-700 mcg Parchem Niacinamide 25-1,000 mcg Parchem Vitamin A (e.g., beta carotene, Vitamin A Palmitate) 25-1,000 IU Parchem Cholecalciferol 25-1,000 IU Parchem Vitamin E (e.g., dl-alpha tocopheryl acetate, d-alpha tocopherol acetate, d- 0.1-20 IU Parchem alpha tocopherol succinate) Vitamin K (e.g., Phytonadione, Phylloquinone) 1-20 mcg Parchem

Example 3

(30) TABLE-US-00003 Ingredient Name Amount Source Nonfat milk .1-10 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, lactose, glucose syrup solids, sugar) 1-50 g Grain Millers, Marroquin Organic Fat (e.g., high oleic sunflower oil, high oleic safflower oil, soy oil, MCT oil, 0.1-200 g Connoils coconut oil, palm oil or palm olein) Soy or Sunflower lecithin 5-500 mg American Lecithin Whey protein concentrate .1-50 g Grain Millers Mixed tocopherol concentrate or natural mixed tocopherols 1-500 ppm Organic Technologies Calcium (e.g., calcium carbonate, calcium citrate malate, calcium citrate, 10-500 mg Parchem/Albion calcium phosphate, calcium ascorbate, calcium chloride, calcium hydroxide, calcium bisglycinate chelate, Calci-K ®, calcium potassium phosphate citrate) Copper (e.g., cupric sulfate, copper citrate, copper gluconate, copper 5-200 mcg Parchem/Albion bisglycinate chelate) Iron (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate, Ferronyl ™ .5-5.0 mg Parchem/Ashland/ carbonyl iron, Ferrochel ®, ferrous bisglycinate chelate, ferric trisglycinate Albion chelate, ferric glycinate) Magnesium (e.g., magnesium oxide, magnesium gluconate, magnesium 1-50 mg Parchem/Albion citrate, magnesium chloride, dimagnesium malate, magnesium glycinate, magnesium phosphate, magnesium bisglycinate chelate) Manganese (e.g., manganese sulfate, manganese citrate, manganese 1-50 mcg Parchem/Albion gluconate, manganese bisglycinate chelate) Potassium iodide 5-500 mcg Parchem Potassium (e.g., potassium bicarbonate, potassium chloride, potassium 1-450 mg Parchem/Albion phosphate, potassium hydroxide, potassium citrate, potassium glycinate complex) Selenium (e.g., sodium selenite, l-selenomethionine, sodium selenate, 1-50 mcg Parchem/Albion selenium glycinate complex) Zinc (e.g., zinc sulfate, zinc picolinate, zinc gluconate, zinc citrate, zinc .5-50 mg Parchem/Albion acetate, zinc bisglycinate chelate) Vitamin C (e.g., ascorbic acid, sodium ascorbate, calcium ascorbate 1-500 mg Parchem Sodium (e.g., sodium chloride, sodium citrate) 2-200 mg Parchem Choline (e.g., choline chloride, choline bitartrate, choline citrate) 1-200 mg Parchem Biotin .5-20 mcg Parchem Inositol 1-100 mg Parchem Taurine 1-100 mg Parchem (6S)-5-methyltetrahydrofolate glucosamine salt 1-100 mcg Parchem/Sigma- Aldrich Methylcobalamin 0.10-5.0 mcg Parchem Pyridoxal-5-Phosphate 5-350 mcg Parchem

Example 4

(31) TABLE-US-00004 Ingredient Name Amount Source Nonfat milk .5-4 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, lactose, glucose syrup solids, sugar) 1-25 g Grain Millers, Marroquin Organic Fat (e.g., high oleic sunflower oil, high oleic safflower oil, soy oil, MCT oil, 0.5-20 g Connoils coconut oil, palm oil or palm olein) Soy or Sunflower lecithin 50-300 mg American Lecithin Whey protein concentrate .5-4 g Grain Millers Mixed tocopherol concentrate or natural mixed tocopherols 1-300 ppm Organic Technologies Calcium (e.g., calcium carbonate, calcium citrate malate, calcium citrate, 60-100 mg Parchem/Albion calcium phosphate, calcium ascorbate, calcium chloride, calcium hydroxide, calcium bisglycinate chelate, Calci-K ®, calcium potassium phosphate citrate) Copper (e.g., cupric sulfate, copper citrate, copper gluconate, copper 60-90 mcg Parchem/Albion bisglycinate chelate) Iron (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate, Ferronyl ™ .5-3.0 mg Parchem/Ashland/ carbonyl iron, Ferrochel ®, ferrous bisglycinate chelate, ferric trisglycinate Albion chelate, ferric glycinate) Magnesium (e.g., magnesium oxide, magnesium gluconate, magnesium 6-40 mg Parchem/Albion citrate, magnesium chloride, dimagnesium malate, magnesium glycinate, magnesium phosphate, magnesium bisglycinate chelate) Manganese (e.g., manganese sulfate, manganese citrate, manganese 5-25 mcg Parchem/Albion gluconate, manganese bisglycinate chelate) Potassium iodide 15-30 mcg Parchem Potassium (e.g., potassium bicarbonate, potassium chloride, potassium 8-300 mg Parchem/Albion phosphate, potassium hydroxide, potassium citrate, potassium glycinate complex) Selenium (e.g., sodium selenite, l-selenomethionine, sodium selenate, 2-7 mcg Parchem/Albion selenium glycinate complex) Zinc (e.g., zinc sulfate, zinc picolinate, zinc gluconate, zinc citrate, zinc .5-2 mg Parchem/Albion acetate, zinc bisglycinate chelate) Vitamin C (e.g., ascorbic acid, sodium ascorbate, calcium ascorbate 10-20 mg Parchem Sodium (e.g., sodium chloride, sodium citrate) 20-60 mg Parchem Choline (e.g., choline chloride, choline bitartrate, choline citrate) 5-35 mg Parchem Biotin 1.5-6 mcg Parchem Inositol 4-8 mg Parchem Taurine 5-12 mg Parchem (6S)-5-methyltetrahydrofolate glucosamine salt 4-30 mcg Parchem/Sigma- Aldrich Methylcobalamin 0.15-0.7 mcg Parchem Pyridoxal-5- Phosphate 35-80 mcg Parchem Riboflavin (e.g., Riboflavin, Riboflavin -5 - Phosphate) 60-175 mcg Parchem Thiamine (e.g., thiamine hydrochloride, thiamine mononitrate) 40-100 mcg Parchem Calcium pantothenate 300-500 mcg Parchem Niacinamide 250-1100 mcg Parchem Vitamin A (e.g., beta carotene, Vitamin A Palmitate) 250-500 IU Parchem Cholecalciferol 40-100 IU Parchem Vitamin E (e.g., dl-alpha tocopheryl acetate, d-alpha tocopherol acetate, d- 0.7-5 IU Parchem alpha tocopherol succinate) Vitamin K (e.g., Phytonadione, Phylloquinone) 4-10 mcg Parchem

Example 5

(32) TABLE-US-00005 Ingredient Name Amount Source Nonfat milk 2-4 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, lactose, glucose syrup solids, sugar) 5-25 g Grain Millers, Marroquin Organic Fat (e.g., high oleic sunflower oil, high oleic safflower oil, soy oil, MCT oil, 5-20 g Connoils coconut oil, palm oil or palm olein) Soy or Sunflower lecithin 50-100 mg American Lecithin Whey protein concentrate 1-4 g Grain Millers Mixed tocopherol concentrate or natural mixed tocopherols 1-100 ppm Organic Technologies Calcium (e.g., calcium carbonate, calcium citrate malate, calcium citrate, 50-100 mg Parchem/Albion calcium phosphate, calcium ascorbate, calcium chloride, calcium hydroxide, calcium bisglycinate chelate, Calci-K ®, calcium potassium phosphate citrate) Copper (e.g., cupric sulfate, copper citrate, copper gluconate, copper 50-100 mcg Parchem/Albion bisglycinate chelate) Iron (e.g., ferrous sulfate, ferrous fumarate, ferrous gluconate, Ferronyl ™ 1-2.0 mg Parchem/Ashland/ carbonyl iron, Ferrochel ®, ferrous bisglycinate chelate, ferric trisglycinate Albion chelate, ferric glycinate) Magnesium (e.g., magnesium oxide, magnesium gluconate, magnesium 10-25 mg Parchem/Albion citrate, magnesium chloride, dimagnesium malate, magnesium glycinate, magnesium phosphate, magnesium bisglycinate chelate) Manganese (e.g., manganese sulfate, manganese citrate, manganese 10-25 mcg Parchem/Albion gluconate, manganese bisglycinate chelate) Potassium iodide 15-30 mcg Parchem Potassium (e.g., potassium bicarbonate, potassium chloride, potassium 10-50 mg Parchem/Albion phosphate, potassium hydroxide, potassium citrate, potassium glycinate complex) Selenium (e.g., sodium selenite, l-selenomethionine, sodium selenate, 5-10 mcg Parchem/Albion selenium glycinate complex) Zinc (e.g., zinc sulfate, zinc picolinate, zinc gluconate, zinc citrate, zinc 1-5 mg Parchem/Albion acetate, zinc bisglycinate chelate) Vitamin C (e.g., ascorbic acid, sodium ascorbate, calcium ascorbate 10-20 mg Parchem Sodium (e.g., sodium chloride, sodium citrate) 20-50 mg Parchem Choline (e.g., choline chloride, choline bitartrate, choline citrate) 10-30 mg Parchem Biotin 1-5 mcg Parchem Inositol 1-5 mg Parchem Taurine 5-10 mg Parchem (6S)-5-methyltetrahydrofolate glucosamine salt 5-25 mcg Parchem/Sigma- Aldrich Methylcobalamin 0.15-0.5 mcg Parchem Pyridoxal-5-Phosphate 5-50 mcg Parchem Riboflavin (e.g., Riboflavin, Riboflavin - 5 - Phosphate) 25-75 mcg Parchem Thiamine (e.g., thiamine hydrochloride, thiamine mononitrate) 20-80 mcg Parchem Calcium pantothenate 50-100 mcg Parchem Niacinamide 25-500 mcg Parchem Vitamin A (e.g., beta carotene, Vitamin A Palmitate) 50-300 IU Parchem Cholecalciferol 20-75 IU Parchem Vitamin E (e.g., dl-alpha tocopheryl acetate, d-alpha tocopherol acetate, d- 0.5-2 IU Parchem alpha tocopherol succinate) Vitamin K (e.g., Phytonadione, Phylloquinone) 2-5 mcg Parchem

Example 6

(33) TABLE-US-00006 Ingredient Name Amount Source Nonfat milk .5-4 g Marroquin Organic Carbohydrates (e.g., corn syrup solids, 1-25 g Grain Millers, lactose, glucose syrup solids, sugar) Marroquin Organic Fat (e.g., high oleic sunflower oil, high 0.5-20 g Connoils oleic safflower oil, soy oil, MCT oil, coconut oil, palm oil or palm olein) Whey protein concentrate .5-4 g Grain Millers (6S)-5-methyltetrahydrofolate 4-30 mcg Parchem/ glucosamine salt Sigma-Aldrich Methylcobalamin 0.15-0.7 mcg Parchem Pyridoxal-5-Phosphate 35-80 mcg Parchem

Example 7

(34) TABLE-US-00007 Ingredient Name Amount Source Carbohydrates (e.g., corn syrup solids, 5-20 g Grain Millers, lactose, glucose syrup solids, sugar) Marroquin Organic Fat (e.g., high oleic sunflower oil, high 0.5-10 g Connoils oleic safflower oil, soy oil, MCT oil, coconut oil, palm oil or palm olein) Whey protein concentrate .5-5 g Grain Millers (6S)-5-methyltetrahydrofolate 4-25 mcg Parchem/Sigma- glucosamine salt Aldrich Methylcobalamin 0.15-0.5 mcg Parchem Pyridoxal-5-Phosphate 40-60 mcg Parchem

(35) It will be further understood that any reference to compounds disclosed herein includes salts and/or solvates of the same.

(36) The infant formulas of the present invention are intended for infants up to 12 months of age, but could also include variations that are called toddler and “follow up” formulas and are labeled as such. Another variation could include a formula for premature, early term, and preterm infants (e.g., an early term infant is a baby born before 39 weeks of gestational age (GA); a preterm infant is defined as a baby born before 37 weeks of GA; very preterm, infant born at less than 32 weeks of pregnancy; and extremely preterm, infant born less than 28 weeks of pregnancy). Formulas of the present invention for premature babies can range in caloric density (e.g., 20 cal/oz, 22 cal/oz, 24 cal/oz, 26 cal/oz, 28 cal/oz and 30 cal/oz).

(37) The food formulations of the present invention may also include human milk fortifiers in liquid concentrate and/or powder form (e.g., 5 ml packets (liquid or powder) that are mixed in with breastmilk to give it a boost of nutrients when the babies require a little more).

(38) In accordance with the present invention, a premature formula may be amino-acid based so long as it comprises the vitamin B complex of the present invention.

(39) The foregoing description merely explains and illustrates the invention and the invention is not limited thereto except insofar as the appended claims are so limited, as those skilled in the art who have the disclosure before them will be able to make modifications without departing from the scope of the invention.