Food compositions that promote neurodevelopment, and related kits, systems, and methods.

Abstract

Food compositions are provided that are designed to promote neurodevelopment in developing subjects. The food compositions of the present disclosure can provide the subject with nutrients that are required for or otherwise beneficially affect developing brain regions and their neurons during specific periods of neurodevelopment. Kits and systems related to the subject food compositions are also provided, as well as methods, such as methods for formulating the described food compositions.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to the filing date of U.S. Provisional Patent Application No. 62 / 501,602, filed May 4, 2017, pursuant to 35 U.S.C. § 119(e), and the disclosure of that application is incorporated herein by reference.

Background Art

[0002] The brain undergoes significant development during the first few years after birth. During this period, specific neural regions grow and develop within specific time frames. The vulnerability of the brain to a lack of sufficient nutrients can be more influential than its flexibility, as evidenced not only by the presence of developmental brain dysfunction in the case of deficiencies of particularly important nutrients, but also by the persistence of such dysfunctions when nutrients are supplied after the appropriate developmental period has ended. It has been demonstrated that early post - natal growth and nutrient intake affect brain growth and maturation and subsequently also affect neurodevelopment that continues into childhood and adolescence.

Summary of the Invention

[0003] A food composition is provided that is configured to promote neurodevelopment in a developing subject. The food composition of the present disclosure can make available to the subject nutrients required by or otherwise favorably affecting developing brain regions and their neurons during specific periods of neurodevelopment. Also provided are kits and systems related to the subject food composition, as well as methods such as methods of formulating the described food composition. [Invention 1001] A food composition comprising: a lutein-containing food in an amount sufficient to provide 0-150 μg of lutein; a DHA-containing food in an amount sufficient to provide 0-50 mg of docosahexaenoic acid (DHA); an iron-containing food in an amount sufficient to provide 0-10 mg of iron; a zinc-containing food in an amount sufficient to provide 0-10 mg of zinc; a copper-containing food in an amount sufficient to provide 0-0.7 mg of copper; a choline-containing food in an amount sufficient to provide 0-55 mg of choline; a vitamin A-containing food in an amount sufficient to provide 0-400 retinol equivalents (RE) of vitamin A; and 0-1 mg of vitamin B6. A food composition comprising: a food containing a sufficient amount of vitamin B6; a food containing a sufficient amount of selenium to provide 0-20 μg of selenium; a food containing a sufficient amount of iodine to provide 0-70 μg of iodine; a food containing a sufficient amount of folic acid to provide 0-50 μg of folic acid; a food containing a sufficient amount of vitamin D to provide 0-8.5 μg of vitamin D; a food containing a sufficient amount of vitamin B3 to provide 0-9 mg of vitamin B3; a food containing a sufficient amount of vitamin E to provide 0-6 mg of vitamin E; and a food containing a sufficient amount of vitamin B12 to provide 0-0.7 μg of vitamin B12. [Invention 1002] The food composition of the present invention 1001, wherein the food composition is a single serving with a total calorie content of 18 to 350 calories and contains 0 to 16 calories of protein and 0 to 117 calories of fat. [Invention 1003] The amount of the lutein-containing food is sufficient to provide 0 to 100 μg of lutein, the amount of the docosahexaenoic acid (DHA)-containing food is sufficient to provide 0 to 35 mg of DHA, the amount of the iron-containing food is sufficient to provide 0 to 9 mg of iron, the amount of the zinc-containing food is sufficient to provide 0 to 5 mg of zinc, the amount of the copper-containing food is sufficient to provide 0 to 0.6 mg of copper, the amount of the choline-containing food is sufficient to provide 0 to 50 mg of choline, the amount of the vitamin A-containing food is sufficient to provide 0 to 375 retinol equivalents (RE) of vitamin A, and the amount of the vitamin B6-containing food is sufficient to provide 0 to 0.6 mg of vitamin B6. A food composition according to the present invention 1001, wherein the amount of the selenium-containing food is sufficient to provide vitamin B6, the amount of the iodine-containing food is sufficient to provide 0 to 15 μg of selenium, the amount of the iodine-containing food is sufficient to provide 0 to 50 μg of iodine, the amount of the folic acid-containing food is sufficient to provide 0 to 35 μg of folic acid, the amount of the vitamin D-containing food is sufficient to provide 0 to 7 μg of vitamin D, the amount of the vitamin B3-containing food is sufficient to provide 0 to 6 mg of vitamin B3, the amount of the vitamin E-containing food is sufficient to provide 0 to 4 mg of vitamin E, and the amount of the vitamin B12-containing food is sufficient to provide 0 to 0.5 μg of vitamin B12. [Invention 1004] The food composition of the present invention 1003, wherein the food composition is a single serving with a total calorie content of 30 to 200, and contains 0 to 14 calories of protein and 0 to 67 calories of fat. [Invention 1005] The amount of the lutein-containing food is sufficient to provide 0 to 75 μg of lutein, the amount of the docosahexaenoic acid (DHA)-containing food is sufficient to provide 0 to 25 mg of DHA, the amount of the iron-containing food is sufficient to provide 0 to 8 mg of iron, the amount of the zinc-containing food is sufficient to provide 0 to 5 mg of zinc, the amount of the copper-containing food is sufficient to provide 0 to 0.5 mg of copper, the amount of the choline-containing food is sufficient to provide 0 to 35 mg of choline, the amount of the vitamin A-containing food is sufficient to provide 0 to 375 retinol equivalents (RE) of vitamin A, and the amount of the vitamin B6-containing food is sufficient to provide 0 to 0.6 mg of vitamin A. A food composition according to the present invention 1001, wherein the amount of the selenium-containing food is sufficient to provide vitamin B6, the amount of the iodine-containing food is sufficient to provide 0 to 15 μg of selenium, the amount of the iodine-containing food is sufficient to provide 0 to 40 μg of iodine, the amount of the folic acid-containing food is sufficient to provide 0 to 35 μg of folic acid, the amount of the vitamin D-containing food is sufficient to provide 0 to 8.5 μg of vitamin D, the amount of the vitamin B3-containing food is sufficient to provide 0 to 5 mg of vitamin B3, the amount of the vitamin E-containing food is sufficient to provide 0 to 4 mg of vitamin E, and the amount of the vitamin B12-containing food is sufficient to provide 0 to 0.5 μg of vitamin B12. [Invention 1006] The food composition of the present invention 1005, wherein the food composition is a single serving with a total calorie content of 30 to 100, and contains 0 to 14 calories of protein and 0 to 33 calories of fat. [Invention 1007] The amount of the lutein-containing food is sufficient to provide 0 to 50 μg of lutein, the amount of the docosahexaenoic acid (DHA)-containing food is sufficient to provide 0 to 20 mg of DHA, the amount of the iron-containing food is sufficient to provide 0 to 6 mg of iron, the amount of the zinc-containing food is sufficient to provide 0 to 4 mg of zinc, the amount of the copper-containing food is sufficient to provide 0 to 0.4 mg of copper, the amount of the choline-containing food is sufficient to provide 0 to 25 mg of choline, the amount of the vitamin A-containing food is sufficient to provide 0 to 375 retinol equivalents (RE) of vitamin A, and the amount of the vitamin B6-containing food is sufficient to provide 0 to 0.3 mg of vitamin A. A food composition according to the present invention 1001, wherein the amount of the selenium-containing food is sufficient to provide vitamin B6, the amount of the iodine-containing food is sufficient to provide 0 to 10 μg of selenium, the amount of the iodine-containing food is sufficient to provide 0 to 40 μg of iodine, the amount of the folic acid-containing food is sufficient to provide 0 to 25 μg of folic acid, the amount of the vitamin D-containing food is sufficient to provide 0 to 8.5 μg of vitamin D, the amount of the vitamin B3-containing food is sufficient to provide 0 to 5 mg of vitamin B3, the amount of the vitamin E-containing food is sufficient to provide 0 to 3 mg of vitamin E, and the amount of the vitamin B12-containing food is sufficient to provide 0 to 0.3 μg of vitamin B12. [Invention 1008] The food composition of the present invention 1007, wherein the food composition is a single serving with a total calorie content of 18 to 80 calories and contains 0 to 13 calories of protein and 0 to 25 calories of fat. [Invention 1009] The lutein-containing foods are selected from the group consisting of leafy vegetables, broccoli, zucchini, Brussels sprouts, peas, corn, carrots, okra, celery, oranges, tomatoes, melons, grapefruits, beets, asparagus, eggs, spinach, kiwi, grapes, zucchini, squash, and combinations thereof. The DHA-containing foods are selected from the group consisting of fish, eggs, walnuts, chia, flaxseed, seaweed, lamb, beef, game meat, poultry, and combinations thereof. The aforementioned iron-containing foods are selected from the group consisting of beef, chicken, turkey, ham, fish, veal, legumes, tofu, breakfast cereals, pumpkin seeds, sesame seeds, squash seeds, lima beans, kidney beans, chickpeas, dried apricots, baked potatoes, egg noodles, wheat germ, split peas, nuts, raisins, dried peaches, dried prunes, broccoli, raw spinach, pasta, bread, brown rice or fortified rice, and combinations thereof. The aforementioned zinc-containing foods are selected from the group consisting of oysters, beef, lamb, wheat germ, spinach, pumpkin seeds, cashews, chocolate, pork, chicken, chickpeas, fortified cereals, oatmeal, kidney beans, almonds, flaxseed, lima beans, egg yolks, peanuts, brown rice, peas, and combinations thereof. The copper-containing foods are selected from the group consisting of sunflower seeds, lentils, almonds, asparagus, seafood, kale, sesame, cashews, chickpeas, avocados, goat's milk cheese, blackberries, kiwis, grapes, mangoes, raspberries, pineapples, bosque pears, potatoes, turnips, taro, lima beans, spinach, asparagus, Swiss chard, lentils, almonds, and combinations thereof. The choline-containing foods are selected from the group consisting of liver, eggs, cauliflower, mushrooms, beet greens, shellfish, asparagus, Brussels sprouts, cooked bok choy, collard greens, broccoli, Swiss chard, spinach, chicken, turkey, tuna, salmon, beef, green peas, cabbage, green beans, summer squash, and combinations thereof. The aforementioned vitamin A-containing foods are selected from the group consisting of sweet potatoes, carrots, dark-colored leafy vegetables, squash, dried apricots, cantaloupe, red bell peppers, tuna, mango, spinach, broccoli, liver, cod oil, eggs, butter, cream, and combinations thereof. The aforementioned vitamin B6-containing foods are selected from the group consisting of sunflower seeds, pistachios, tuna, turkey, chicken, pork, beef, bananas, avocados, spinach, sweet potatoes, hazelnuts, plantains, wheat bran, oatmeal, and combinations thereof. The selenium-containing foods are selected from the group consisting of Brazil nuts, tuna, oysters, sunflower seeds, whole wheat bread, pork, beef, chicken, turkey, mushrooms, rye, eggs, cheese, mushrooms, oats, wheat, rye, brown rice, soybeans, pasta, and combinations thereof. The iodine-containing foods are selected from the group consisting of seaweed, cranberries, yogurt, white beans, strawberries, cheese, potatoes, milk, eggs, lima beans, corn, green peas, bananas, tuna, cod, shrimp, baked potatoes, milk, shrimp, prunes, yogurt, bananas, strawberries, canned corn, white bread, green beans, pineapple, rhubarb, watercress, and combinations thereof. The folic acid-containing foods are selected from the group consisting of cowpeas, lentils, dark-colored leafy vegetables, asparagus, avocados, broccoli, mangoes, citrus fruits, white bread, papaya, strawberries, raspberries, legumes, peas, lentils, okra, Brussels sprouts, sunflower seeds, flaxseed, peanuts, almonds, cauliflower, corn, beets, celery, carrots, winter squash, summer squash, and combinations thereof. The aforementioned vitamin D-containing foods are selected from the group consisting of fish oil, fatty fish, mushrooms, tofu, fortified cereals, fish roe, queso fresco, very low-fat ham, eggs, plain soy milk yogurt, beef liver, and combinations thereof. The aforementioned vitamin B3-containing foods are selected from the group consisting of fish, chicken, turkey, pork, peanuts, beef, grilled portobello mushrooms, green peas, sunflower seeds, avocado, broccoli, asparagus, green beans, tahini, bell peppers, shiitake mushrooms, enoki mushrooms, wheat, grains, barley, rye, almonds, lentils, and combinations thereof. The vitamin E-containing foods are selected from the group consisting of dark-colored leafy vegetables, almonds, sunflower seeds, avocados, shrimp, trout, olive oil, broccoli, butternut squash, kiwi, sweet potatoes, wheat germ, palm oil, hazelnuts, pine nuts, parsley, papaya, olives, pine nuts, red bell peppers, mangoes, basil, oregano, pistachios, peanut butter, red chili peppers, tomatoes, and combinations thereof, or The vitamin B12-containing foods are selected from the group consisting of shellfish, beef, chicken, liver, fish, yogurt, eggs, and combinations thereof. A food composition according to any of invention 1001 to 1008. [Invention 1010] A food composition according to any one of the invention 1001 to 1009, wherein the food composition is an infant formula or a semi-solid. [Invention 1011] A food composition according to any one of the present invention 1001 to 1010, wherein the aforementioned food composition is present in a container for one serving. [Invention 1012] A kit comprising multiple single-serving containers of the present invention 1011, sufficient to feed an infant aged 3 to 18 months for at least one day. [Invention 1013] An infant feeding system comprising two or more food compositions, each of which is Composition for the neurodevelopmental period of 3 to 6 months. Composition for the neurodevelopmental period of 7 to 9 months. Compositions for the neurodevelopmental period of 10 to 12 months, and Composition for the neurodevelopmental period of 13 to 18 months A system that provides specific nutrients for different neurodevelopmental periods, selected from a group consisting of the following. [Invention 1014] The aforementioned composition for the 3-6 month neurodevelopment period comprises a lutein-containing food in an amount sufficient to provide 0-50 μg of lutein, a DHA-containing food in an amount sufficient to provide 0-20 mg of docosahexaenoic acid (DHA), an iron-containing food in an amount sufficient to provide 0-6 mg of iron, a zinc-containing food in an amount sufficient to provide 0-4 mg of zinc, a copper-containing food in an amount sufficient to provide 0-0.4 mg of copper, a choline-containing food in an amount sufficient to provide 0-25 mg of choline, a vitamin A-containing food in an amount sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and 0-0.3 mg of vitamin A. This product contains a sufficient amount of vitamin B6-containing food to provide vitamin B6, a sufficient amount of selenium-containing food to provide 0-10 μg of selenium, a sufficient amount of iodine-containing food to provide 0-40 μg of iodine, a sufficient amount of folic acid-containing food to provide 0-25 μg of folic acid, a sufficient amount of vitamin D-containing food to provide 0-8.5 μg of vitamin D, a sufficient amount of vitamin B3-containing food to provide 0-5 mg of vitamin B3, a sufficient amount of vitamin E-containing food to provide 0-3 mg of vitamin E, and a sufficient amount of vitamin B12-containing food to provide 0-0.3 μg of vitamin B12. The aforementioned composition for the 7-9 month neurodevelopment period comprises a lutein-containing food in an amount sufficient to provide 0-75 μg of lutein, a DHA-containing food in an amount sufficient to provide 0-25 mg of docosahexaenoic acid (DHA), an iron-containing food in an amount sufficient to provide 0-8 mg of iron, a zinc-containing food in an amount sufficient to provide 0-5 mg of zinc, a copper-containing food in an amount sufficient to provide 0-0.5 mg of copper, a choline-containing food in an amount sufficient to provide 0-35 mg of choline, a vitamin A-containing food in an amount sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and 0-0.6 mg of vitamin A. This product contains a sufficient amount of vitamin B6-containing food to provide vitamin B6, a sufficient amount of selenium-containing food to provide 0-15 μg of selenium, a sufficient amount of iodine-containing food to provide 0-40 μg of iodine, a sufficient amount of folic acid-containing food to provide 0-35 μg of folic acid, a sufficient amount of vitamin D-containing food to provide 0-8.5 μg of vitamin D, a sufficient amount of vitamin B3-containing food to provide 0-5 mg of vitamin B3, a sufficient amount of vitamin E-containing food to provide 0-4 mg of vitamin E, and a sufficient amount of vitamin B12-containing food to provide 0-0.5 μg of vitamin B12. The aforementioned composition for the 10-12 month neurodevelopment period comprises a lutein-containing food in an amount sufficient to provide 0-100 μg of lutein, a DHA-containing food in an amount sufficient to provide 0-35 mg of docosahexaenoic acid (DHA), an iron-containing food in an amount sufficient to provide 0-9 mg of iron, a zinc-containing food in an amount sufficient to provide 0-5 mg of zinc, a copper-containing food in an amount sufficient to provide 0-0.6 mg of copper, a choline-containing food in an amount sufficient to provide 0-50 mg of choline, a vitamin A-containing food in an amount sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and 0-0.6 mg of vitamin A. This product contains a sufficient amount of vitamin B6-containing food to provide vitamin B6, a sufficient amount of selenium-containing food to provide 0-15 μg of selenium, a sufficient amount of iodine-containing food to provide 0-50 μg of iodine, a sufficient amount of folic acid-containing food to provide 0-35 μg of folic acid, a sufficient amount of vitamin D-containing food to provide 0-7 μg of vitamin D, a sufficient amount of vitamin B3-containing food to provide 0-6 mg of vitamin B3, a sufficient amount of vitamin E-containing food to provide 0-4 mg of vitamin E, and a sufficient amount of vitamin B12-containing food to provide 0-0.5 μg of vitamin B12. The aforementioned composition for the 13-18 month neurodevelopment period comprises a lutein-containing food in an amount sufficient to provide 0-150 μg of lutein, a DHA-containing food in an amount sufficient to provide 0-50 mg of docosahexaenoic acid (DHA), an iron-containing food in an amount sufficient to provide 0-10 mg of iron, a zinc-containing food in an amount sufficient to provide 0-10 mg of zinc, a copper-containing food in an amount sufficient to provide 0-0.7 mg of copper, a choline-containing food in an amount sufficient to provide 0-55 mg of choline, a vitamin A-containing food in an amount sufficient to provide 0-400 retinol equivalents (RE) of vitamin A, and 0-1 mg of vitamin A. This product includes a food containing a sufficient amount of vitamin B6 to provide vitamin B6, a food containing a sufficient amount of selenium to provide 0-20 μg of selenium, a food containing a sufficient amount of iodine to provide 0-70 μg of iodine, a food containing a sufficient amount of folic acid to provide 0-50 μg of folic acid, a food containing a sufficient amount of vitamin D to provide 0-7 μg of vitamin D, a food containing a sufficient amount of vitamin B3 to provide 0-9 mg of vitamin B3, a food containing a sufficient amount of vitamin E to provide 0-6 mg of vitamin E, and a food containing a sufficient amount of vitamin B12 to provide 0-0.7 μg of vitamin B12. The system of the present invention 1013. [Invention 1015] A method for formulating a single serving of infant food composition for the neurodevelopmental period, Foods containing lutein in sufficient quantities to provide 0-150 μg of lutein, foods containing DHA in sufficient quantities to provide 0-50 mg of docosahexaenoic acid (DHA), foods containing iron in sufficient quantities to provide 0-10 mg of iron, foods containing zinc in sufficient quantities to provide 0-10 mg of zinc, foods containing copper in sufficient quantities to provide 0-0.7 mg of copper, foods containing choline in sufficient quantities to provide 0-55 mg of choline, foods containing vitamin A in sufficient quantities to provide 0-400 retinol equivalents (RE) of vitamin A, and foods containing vitamin B6 in sufficient quantities to provide 0-1 mg of vitamin B6. A combination of a B6-containing food, a selenium-containing food in an amount sufficient to provide 0-20 μg of selenium, an iodine-containing food in an amount sufficient to provide 0-70 μg of iodine, a folic acid-containing food in an amount sufficient to provide 0-50 μg of folic acid, a vitamin D-containing food in an amount sufficient to provide 0-8.5 μg of vitamin D, a vitamin B3-containing food in an amount sufficient to provide 0-9 mg of vitamin B3, a vitamin E-containing food in an amount sufficient to provide 0-6 mg of vitamin E, a protein-containing food, and a vitamin B12-containing food in an amount sufficient to provide 0-0.7 μg of vitamin B12. A method comprising the above, wherein the infant food composition has a total calorie content of 350 or less. [Brief explanation of the drawing]

[0004] This invention is best understood by reading the following detailed description in conjunction with the accompanying drawings. As is customary, it should be emphasized that various features in the drawings are not to scale. Rather, the dimensions of these features have been arbitrarily enlarged or reduced for clarity. These drawings include the following figures.

[0005] [Figure 1] This shows the development of specific brain regions in children aged 3 to 18 months. [Figure 2] Figure 1 shows the nutrients required for the relevant brain regions at each developmental age, corresponding to the development of specific brain regions from 3 months to 18 months of age. [Figure 3] Table 1 is provided. [Modes for carrying out the invention]

[0006] Detailed explanation Food compositions are provided that are configured to promote neurodevelopment in developing subjects. The food compositions of this disclosure can make available to a subject nutrients that are required by or otherwise beneficial to developing brain regions and their neurons during a specific period of neurodevelopment. Kits and systems related to the subject food compositions, as well as methods such as methods for formulating the described food compositions, are also provided.

[0007] Before describing the methods and compositions of the present invention, it should be understood that the present invention is not limited to the specific methods or compositions described, and therefore may naturally differ. Furthermore, since the scope of the present invention is limited only by the appended claims, it should also be understood that the terms used herein are intended solely to describe specific embodiments and are not intended to limit them.

[0008] When a range of values ​​is presented, it is understood that, unless explicitly indicated otherwise in the context, each intermediate value between the upper and lower limits of that range, up to one-tenth of the lower limit, is also specifically disclosed. Each smaller range between any stated value or intermediate value in a stated range and any other stated value or intermediate value in that range is included herein. The upper and lower limits of these smaller ranges may independently be included in or excluded from that range, and each range in which either limit value is included, neither limit value is included, or both limit values ​​are included in the invention, insofar as any explicitly excluded limit value lies within the stated range. If a stated range includes one or both limit values, a range excluding either or both of those included limit values ​​is also included in the invention.

[0009] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the invention pertains. Any methods and materials similar to or equivalent to those described herein may be used in carrying out or testing the invention, but some possible and preferred methods and materials are listed below. All publications described herein are incorporated herein by reference to disclose and explain the relevant methods and / or materials from which such publications are cited. It should be understood that this disclosure takes precedence over any disclosure of the incorporated publications to the extent that such a conflict arises.

[0010] As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has distinct components and features that can be readily separated from or combined with features of any of several other embodiments without departing from the scope or spirit of the invention. Any method described may be performed in the order of events described or in any other logically possible order.

[0011] When used herein and in the appended claims, it should be noted that, unless explicitly indicated otherwise in the context, the singular forms “a,” “an,” and “the” also include plural referents. For example, a reference to “a cell” includes multiple such cells, and a reference to “the peptide” includes one or more peptides and their equivalents known to those skilled in the art, such as polypeptides.

[0012] The publications discussed herein are provided only for disclosures prior to the filing date of this application. Nothing in this specification should be construed as an acknowledgment that the present invention has no prior rights to such disclosures by prior art. Furthermore, the publication dates provided may differ from the actual publication dates, which may need to be verified on a case-by-case basis.

[0013] Compositions and methods As summarized above, this disclosure provides food compositions configured to promote neurodevelopment in developing subjects, and methods for producing such food compositions. The food compositions of this disclosure can make available to subjects the nutrients required during specific neurodevelopmental periods. The food compositions of this disclosure can, for example, have a beneficial effect on the development of specific brain regions and their neurons, including brain regions that grow / develop during specific neurodevelopmental periods.

[0014] The subject food composition may be formulated for administration to mammalian subjects, including, for example, humans. The subject food composition may be formulated for administration to human infants.

[0015] The subject food composition may be formulated for administration to human infants during the development of one or more brain regions, for example, during the peak neurodevelopment period of a particular brain region. Brain regions targeted include, but are not limited to, the amygdala, angular gyrus, Broca's region, calcaneal spur region, caudate nucleus (right), cerebellar region, cingulate gyrus region, posterior cingulate gyrus region, cuneiform region (right), DLPFC region, lower frontal region, central frontal region, upper frontal region, fusiform region, hippocampus, insula region, lingual region, lower occipital region, central occipital region, upper occipital region, olfactory region, orbitomedial region, globus pallidus region, paracentral lobule (right), parahippocampal gyrus (right), lower parietal region, upper parietal region (right), precuneus region, primary auditory (Heschel) region, putamen region, rectus region, Roland's region, SMA region, lower temporal region, central temporal region, upper temporal region, temporal pole region, Wernicke's region, etc.

[0016] Figure 1 provides a diagram showing the developmental timeframes for specific brain regions by age. The subject food composition may promote the development of specific brain regions and their neurons by providing nutrients required by those brain regions during their developmental period. The subject food composition may promote the development of specific brain regions and their neurons by providing nutrients that enhance the development of those brain regions during their developmental period. As used herein, “promote development” and “enhance development” generally mean any beneficial effect on the development of a brain region, including the prevention of stunting, the prevention of abnormal development, and the promotion of growth.

[0017] In some cases, the food composition of the subject may promote balanced growth or development. Balanced growth and / or development may mean balanced growth and / or development of the infant's brain and / or cognitive function. This may mean the physical development of the brain, including neurotransmitter activity, as well as the size / shape of the brain or surrounding areas of the head and / or specific brain regions. This may also mean any brain function or brain behavior observed in or later in the infant's life, such as mood, appetite, sleep, memory, learning, and certain social behaviors. It may also mean preventing or reducing the risk of the infant developing various neurological disorders and / or mental illnesses of the central nervous system later in life. Any convenient measure of the physical, chemical, and / or physiological properties of the brain of a particular subject can be assessed, for example, through the use of standardized measurements and tests.

[0018] In addition to being administered to infants during specific neurodevelopmental periods and / or developmental stages of specific brain regions, the subject food compositions are specifically formulated for such administrations, for example, containing or not containing specific nutrients tailored to the needs of specific brain regions and their neurons that develop during that period. For example, Figure 2 provides a list of nutrients for each month superimposed on the age-based developmental timeframes provided in Figure 1. As can be seen in Figure 2, the subject food compositions can be tailored to administration periods of various lengths, including periods of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 12 months, and / or any combination thereof.

[0019] As summarized above, the food composition is, for example, 0-18 months, 1-18 months, 2-18 months, 3-18 months, 4-18 months, 5-18 months, 6-18 months, 7-18 months, 8-18 months, 9-18 months, 10-18 months, 11-18 months, 12-18 months, 13-18 months, 14-18 months, 15-18 months, 16-18 months, 17-18 months, 3-17 months, 3-16 months, 3-15 months, 3-14 months, 3-13 months, 3-12 months, 3-11 months, 3-10 months It may be formulated to be administered to infants over a specific period or over a specific time frame based on the age of the infant, including, but not limited to, months, 3-9 months, 3-8 months, 3-7 months, 3-6 months, 3-5 months, 3-4 months, 3-6 months, 7-9 months, 10-12 months, 13-18 months, 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, etc.

[0020] The age of an infant may be determined by any convenient means, including but not limited to, age after birth or gestational age. In some cases, a particular formulation may be configured for administration to premature or low-birth-weight infants. In some cases, the formulation may be limited to a composition for full-term (40 weeks or more of gestation) or near-full-term (e.g., 38 weeks or more of gestation) infants.

[0021] The compositions of this disclosure include food compositions. Food compositions are nutrient-rich substances that are eaten, drunk, or otherwise ingested into the body for purposes such as sustaining life, providing energy, and promoting growth. The food compositions of the subject matter will vary considerably and will typically include mixtures of two or more different food components, including three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, eleven or more, twelve or more, thirteen or more, fourteen or more, fifteen or more, and so on.

[0022] As used herein, the term “food ingredient” means a nutritious substance of plant or animal origin, whether natural or non-artificial. Food ingredients used in the manufacture of the food compositions of this disclosure may be raw or processed. “Food processing” means that a raw material or food product is transformed into a different form of food or food by physical or chemical means. Food processing may include freezing, drying, freeze-drying, dicing, slicing, mincing, softening, liquefying, emulsifying, cooking (boiling, broiling, frying, grilling, steaming, roasting, etc.), pickling, salting, pasteurization, fermentation, mixing, pureeing, etc. “Raw” means a food product that has not undergone one or more of such processing steps. In some cases, certain food ingredients used in the compositions of this disclosure may be raw before being added to the subject composition. In some cases, certain food ingredients used in the compositions of this disclosure may be processed, for example, by cooking, before being added to the subject composition.

[0023] The subject food composition may contain one or more of the following: lutein-containing components, DHA-containing components, iron-containing components, zinc-containing components, copper-containing components, choline-containing components, vitamin A-containing components, vitamin B6-containing components, selenium-containing components, iodine-containing components, folic acid-containing components, vitamin D-containing components, vitamin B3-containing components, vitamin E-containing components, and vitamin B12-containing components.

[0024] The food compositions of this disclosure may contain one or more lutein-containing food ingredients. In some cases, the lutein-containing food ingredients may be one or more of the following, or derived therefrom: leafy vegetables, broccoli, zucchini, Brussels sprouts, peas, corn, carrots, okra, celery, oranges, tomatoes, melons, grapefruits, beets, asparagus, eggs, spinach, kiwi, grapes, zucchini, squash, etc. In some cases, the composition may contain, but is not limited to, 0-150 μg of lutein, 1-150 μg of lutein, 0-100 μg of lutein, 1-100 μg of lutein, 0-75 μg of lutein, 1-75 μg of lutein, 0-50 μg of lutein, 1-50 μg of lutein, 10-150 μg of lutein, 25-150 μg of lutein, 10-100 μg of lutein, 25-100 μg of lutein, 10-75 μg of lutein, 25-75 μg of lutein, 10-50 μg of lutein, 25-50 μg of lutein, etc., as the composition contains one or more lutein-containing food ingredients in a certain amount so as to contain 0-150 μg of lutein.

[0025] The food compositions of this disclosure may contain one or more docosahexaenoic acid (DHA)-containing food components. In some cases, the DHA-containing food components may be one or more of the following, or may be derived from fish, eggs, walnuts, chia, flaxseed, seaweed, lamb, beef, game meat, poultry, etc. In some cases, the composition may contain, but is not limited to, 0-50 mg of DHA, 1-50 mg of DHA, 0-35 mg of DHA, 1-35 mg of DHA, 0-25 mg of DHA, 1-25 mg of DHA, 0-20 mg of DHA, 1-20 mg of DHA, 5-50 mg of DHA, 10-50 mg of DHA, 5-35 mg of DHA, 10-35 mg of DHA, 5-25 mg of DHA, 10-25 mg of DHA, 5-20 mg of DHA, 10-20 mg of DHA, etc., by containing one or more DHA-containing food components in a certain amount so that it contains 0-50 mg of DHA.

[0026] The food compositions of this disclosure may contain one or more iron-containing food ingredients. In some cases, the iron-containing food ingredients may be one or more of the following, or derived therefrom: beef, chicken, turkey, ham, fish, veal, legumes, tofu, breakfast cereals, pumpkin seeds, sesame seeds, squash seeds, lima beans, kidney beans, chickpeas, dried apricots, baked potatoes, egg noodles, wheat germ, split peas, nuts, raisins, dried peaches, dried prunes, broccoli, raw spinach, pasta, bread, brown rice or fortified rice, etc. In some cases, the composition may contain, but is not limited to, 0-10 mg of iron, 1-10 mg of iron, 0-9 mg of iron, 1-9 mg of iron, 0-8 mg of iron, 1-8 mg of iron, 0-6 mg of iron, 1-6 mg of iron, 2-10 mg of iron, 3-10 mg of iron, 2-9 mg of iron, 3-9 mg of iron, 2-8 mg of iron, 3-8 mg of iron, 2-6 mg of iron, 3-6 mg of iron, etc., by containing one or more iron-containing food ingredients in a certain amount so as to contain 0-10 mg of iron.

[0027] The food compositions of this disclosure may contain one or more zinc-containing food ingredients. In some cases, the zinc-containing food ingredients may be one or more of the following, or derived therefrom: oysters, beef, lamb, wheat germ, spinach, pumpkin seeds, cashews, chocolate, pork, chicken, chickpeas, fortified cereals, oatmeal, kidney beans, almonds, flaxseed, lima beans, egg yolks, peanuts, brown rice, peas, etc. In some cases, the composition may contain one or more zinc-containing food ingredients in a certain amount such that it contains, for example, 0-10 mg of zinc, 1-10 mg of zinc, 0-5 mg of zinc, 1-5 mg of zinc, 0-4 mg of zinc, 1-4 mg of zinc, 2-10 mg of zinc, 3-10 mg of zinc, 2-5 mg of zinc, 3-5 mg of zinc, 2-4 mg of zinc, 3-4 mg of zinc, etc.

[0028] The food compositions of this disclosure may contain one or more copper-containing food ingredients. In some cases, the copper-containing food ingredients may be one or more of the following, or derived therefrom: sunflower seeds, lentils, almonds, asparagus, seafood, kale, sesame, cashews, chickpeas, avocados, goat's milk cheese, blackberries, kiwis, grapes, mangoes, raspberries, pineapples, bosque pears, potatoes, turnips, taro, lima beans, spinach, asparagus, Swiss chard, lentils, almonds, etc. In some cases, the composition may contain, but is not limited to, 0-0.7 mg of copper, such as 0-0.7 mg of copper, 0.1-0.7 mg of copper, 0-0.6 mg of copper, 0.1-0.6 mg of copper, 0-0.5 mg of copper, 0.1-0.5 mg of copper, 0-0.4 mg of copper, 0.1-0.4 mg of copper, 0.2-0.7 mg of copper, 0.3-0.7 mg of copper, 0.2-0.6 mg of copper, 0.3-0.6 mg of copper, 0.2-0.5 mg of copper, 0.3-0.5 mg of copper, 0.2-0.4 mg of copper, 0.3-0.4 mg of copper, etc., as the composition contains one or more copper-containing food ingredients in a certain amount so as to contain 0-0.7 mg of copper.

[0029] The food compositions of this disclosure may contain one or more choline-containing food ingredients. In some cases, the choline-containing food ingredients may be one or more of the following, or derived therefrom: liver, eggs, cauliflower, mushrooms, beet leaves, shellfish, asparagus, Brussels sprouts, cooked bok choy, collard leaves, broccoli, Swiss chard, spinach, chicken, turkey, tuna, salmon, beef, green peas, cabbage, green beans, summer squash, etc. In some cases, the composition may contain, but is not limited to, 0-55 mg of choline, 1-55 mg of choline, 0-50 mg of choline, 1-50 mg of choline, 0-35 mg of choline, 1-35 mg of choline, 0-25 mg of choline, 1-25 mg of choline, 5-55 mg of choline, 10-55 mg of choline, 10-50 mg of choline, 5-35 mg of choline, 10-35 mg of choline, 5-25 mg of choline, 10-25 mg of choline, etc., as the composition contains one or more choline-containing food ingredients in a certain amount so as to contain 0-55 mg of choline.

[0030] The food compositions of this disclosure may contain one or more vitamin A-containing food components. In some cases, the vitamin A-containing food component may be one or more vitamin A-containing foods selected from the group consisting of sweet potatoes, carrots, dark leafy vegetables, squash, dried apricots, cantaloupe, red bell peppers, tuna, mangoes, spinach, broccoli, liver, cod oil, eggs, butter, cream, etc., or may be derived from there. In some cases, the composition may contain one or more vitamin A-containing food components in a certain amount so as to contain, for example, 0 to 400 retinol equivalents (RE) of vitamin A, 1 to 400 RE of vitamin A, 0 to 375 RE of vitamin A, 1 to 375 RE of vitamin A, 100 to 400 RE of vitamin A, 200 to 400 RE of vitamin A, 100 to 375 RE of vitamin A, 200 to 375 RE of vitamin A, etc., but not limited to these.

[0031] The food compositions of this disclosure may contain one or more vitamin B6-containing food ingredients. In some cases, the vitamin B6-containing food ingredients may be one or more of the following, or derived therefrom: sunflower seeds, pistachios, tuna, turkey, chicken, pork, beef, bananas, avocados, spinach, sweet potatoes, hazelnuts, plantains, wheat bran, oatmeal, etc. In some cases, the composition may contain, but is not limited to, 0-1 mg of vitamin B6, 0.1-1 mg of vitamin B6, 0-0.6 mg of vitamin B6, 0.1-0.6 mg of vitamin B6, 0-0.3 mg of vitamin B6, 0.1-0.3 mg of vitamin B6, 0.2-1 mg of vitamin B6, 0.3-1 mg of vitamin B6, 0.2-0.6 mg of vitamin B6, 0.3-0.6 mg of vitamin B6, 0.2-0.3 mg of vitamin B6, etc., as the composition contains one or more vitamin B6-containing food ingredients in a certain amount so as to contain 0-1 mg of vitamin B6.

[0032] The food compositions of this disclosure may contain one or more selenium-containing food components. In some cases, the selenium-containing food component may be one or more selenium-containing foods selected from the group consisting of Brazil nuts, tuna, oysters, sunflower seeds, whole wheat bread, pork, beef, chicken, turkey, mushrooms, rye, eggs, cheese, oats, wheat, rye, brown rice, soybeans, pasta, etc., or may be derived from there. In some cases, the composition may contain, but is not limited to, 0-20 μg of selenium, 1-20 μg of selenium, 0-15 μg of selenium, 1-15 μg of selenium, 0-10 μg of selenium, 1-10 μg of selenium, 2-20 μg of selenium, 5-20 μg of selenium, 2-15 μg of selenium, 5-15 μg of selenium, 2-10 μg of selenium, 5-10 μg of selenium, etc., so that the composition contains one or more selenium-containing food components in a certain amount so that it contains 0-20 μg of selenium.

[0033] The food compositions of this disclosure may contain one or more iodine-containing food ingredients. In some cases, the iodine-containing food ingredients may be one or more of the following, or derived therefrom: seaweed, cranberries, yogurt, white beans, strawberries, cheese, potatoes, milk, eggs, lima beans, corn, green peas, bananas, tuna, cod, shrimp, baked potatoes, milk, shrimp, prunes, yogurt, bananas, strawberries, canned corn, white bread, green beans, pineapple, rhubarb, watercress, etc. In some cases, the composition may contain, but is not limited to, 10-70 μg of iodine, 20-70 μg of iodine, 10-50 μg of iodine, 20-50 μg of iodine, 10-40 μg of iodine, 20-40 μg of iodine, etc., and may contain, but is not limited to, 0-70 μg of iodine, 1-70 μg of iodine, 0-50 μg of iodine, 1-50 μg of iodine, 0-40 μg of iodine, 1-40 μg of iodine, 10-70 μg of iodine, etc., or contain 0-70 μg of iodine. The composition contains one or more iodine-containing food ingredients in a certain amount.

[0034] The food compositions of this disclosure may contain one or more folic acid-containing food ingredients. In some cases, the folic acid-containing food ingredients may be one or more of the following, or derived therefrom: cowpeas, lentils, dark leafy vegetables, asparagus, avocados, broccoli, mangoes, citrus fruits, white bread, papayas, strawberries, raspberries, legumes, peas, lentils, okra, Brussels sprouts, sunflower seeds, flaxseed, peanuts, almonds, cauliflower, corn, beets, celery, carrots, winter squash, summer squash, etc. In some cases, the composition may contain, but is not limited to, 0-50 μg of folic acid, 1-50 μg of folic acid, 0-35 μg of folic acid, 1-5 μg of folic acid, 0-25 μg of folic acid, 1-25 μg of folic acid, 10-50 μg of folic acid, 15-50 μg of folic acid, 10-35 μg of folic acid, 15-5 μg of folic acid, 10-25 μg of folic acid, 15-25 μg of folic acid, etc., as the composition contains one or more folic acid-containing food ingredients in a certain amount so as to contain 0-50 μg of folic acid.

[0035] The food compositions of this disclosure may contain one or more vitamin D-containing food ingredients. In some cases, the vitamin D-containing food ingredients may be one or more of the following, or derived therefrom: fish oil, fatty fish, mushrooms, tofu, fortified cereals, fish roe, queso fresco, very low-fat ham, eggs, plain soy milk yogurt, beef liver, etc. In some cases, the composition may contain one or more amounts of one or more vitamin D-containing food ingredients so that it contains, for example, 0-8.5 μg of vitamin D, 1-8.5 μg of vitamin D, 0-7 μg of vitamin D, 1-7 μg of vitamin D, 3-8.5 μg of vitamin D, 5-8.5 μg of vitamin D, 3-7 μg of vitamin D, 5-7 μg of vitamin D, etc., but is not limited to these, totaling 0-8.5 μg of vitamin D.

[0036] The food compositions of this disclosure may contain one or more vitamin B3-containing food ingredients. In some cases, the vitamin B3-containing food ingredients may be one or more of the following, or derived therefrom: fish, chicken, turkey, pork, peanuts, beef, grilled portobello mushrooms, green peas, sunflower seeds, avocado, broccoli, asparagus, green beans, tahini, bell peppers, shiitake mushrooms, enoki mushrooms, wheat, grains, barley, rye, almonds, lentils, etc. In some cases, the composition may contain, but is not limited to, 0-9 mg of vitamin B3, 1-9 mg of vitamin B3, 0-6 mg of vitamin B3, 1-6 mg of vitamin B3, 0-5 mg of vitamin B3, 1-5 mg of vitamin B3, 3-9 mg of vitamin B3, 4-9 mg of vitamin B3, 3-6 mg of vitamin B3, 4-6 mg of vitamin B3, 3-5 mg of vitamin B3, 4-5 mg of vitamin B3, etc., as the composition contains one or more vitamin B3-containing food ingredients in a certain amount so as to contain 0-9 mg of vitamin B3.

[0037] The food compositions of this disclosure may contain one or more vitamin E-containing food ingredients. In some cases, the vitamin E-containing food ingredients may be one or more of the following, or derived therefrom: dark leafy vegetables, almonds, sunflower seeds, avocados, shrimp, trout, olive oil, broccoli, butternut squash, kiwi, sweet potatoes, wheat germ, palm oil, hazelnuts, pine nuts, parsley, papaya, olives, pine nuts, red peppers, mangoes, basil, oregano, pistachios, peanut butter, red chili peppers, tomatoes, etc. In some cases, the composition may contain, but is not limited to, 0-6 mg of vitamin E, 1-6 mg of vitamin E, 0-4 mg of vitamin E, 1-4 mg of vitamin E, 0-3 mg of vitamin E, 1-3 mg of vitamin E, 2-6 mg of vitamin E, 3-6 mg of vitamin E, 2-4 mg of vitamin E, 3-4 mg of vitamin E, 2-3 mg of vitamin E, etc., as the composition contains one or more vitamin E-containing food ingredients in a certain amount so as to contain 0-6 mg of vitamin E.

[0038] The food compositions of this disclosure may contain one or more vitamin B12-containing food ingredients. In some cases, the vitamin B12-containing food ingredients may be one or more of the following, or may be derived from them: shellfish, beef, chicken, liver, fish, yogurt, eggs, etc. In some cases, the composition may contain, but is not limited to, 0-0.7 μg of vitamin B12, 0.1-0.7 μg of vitamin B12, 0-0.5 μg of vitamin B12, 0.1-0.5 μg of vitamin B12, 0-0.3 μg of vitamin B12, 0.1-0.3 μg of vitamin B12, 0.2-0.7 μg of vitamin B12, 0.3-0.7 μg of vitamin B12, 0.2-0.5 μg of vitamin B12, 0.3-0.5 μg of vitamin B12, or 0.2-0.3 μg of vitamin B12, as the composition contains one or more vitamin B12-containing food ingredients in a certain amount so that it contains 0-0.7 μg of vitamin B12.

[0039] In some cases, a food composition may not contain one or more of the nutrients listed above. For example, in some cases, a food composition may not contain one or more of the following: lutein-containing components, DHA-containing components, iron-containing components, zinc-containing components, copper-containing components, choline-containing components, vitamin A-containing components, vitamin B6-containing components, selenium-containing components, iodine-containing components, folic acid-containing components, vitamin D-containing components, vitamin B3-containing components, vitamin E-containing components, and vitamin B12-containing components.

[0040] In some cases, food compositions formulated for administration during a specific age in infant development may contain only the nutrients listed above, along with the corresponding developmental ages in Tables 1 and 2. For ease of understanding, the nutrients specified individually for each age may, in some cases, be combined to produce compositions suitable for multiple ages, for example, compositions suitable for administration over two months or more.

[0041] The food compositions of this disclosure may contain one or more protein-containing food ingredients. In some cases, the protein-containing food ingredients may be one or more of the following, or derived therefrom: Greek yogurt, cottage cheese, Swiss cheese, eggs, milk, whey protein, beef, eggs, almonds, chicken breast, turkey breast, oats, broccoli, quinoa, whey protein, lentils, Ezekiel bread, pumpkin seeds, Brussels sprouts, peanuts, flax, Hubbard squash, peas, falafel, passion fruit, avocado, oatmeal, hummus, green beans, pistachios, black rice, chickpeas, pasta, etc. In some cases, the composition may contain, but is not limited to, 0-16 calories of protein, 1-16 calories of protein, 0-14 calories of protein, 1-14 calories of protein, 0-13 calories of protein, 1-13 calories of protein, 5-16 calories of protein, 10-16 calories of protein, 5-14 calories of protein, 10-14 calories of protein, 5-13 calories of protein, 10-13 calories of protein, etc., by containing a certain amount of one or more protein-containing food components to contain 0-16 calories of protein.

[0042] In some cases, the composition may contain, but is not limited to, fats of 0-117 calories, fats of 1-117 calories, fats of 0-67 calories, fats of 1-67 calories, fats of 0-33 calories, fats of 1-33 calories, fats of 0-25 calories, fats of 1-25 calories, fats of 10-117 calories, fats of 20-117 calories, fats of 10-67 calories, fats of 20-67 calories, fats of 10-33 calories, fats of 20-33 calories, fats of 10-25 calories, fats of 20-25 calories, etc., by containing one or more fat-containing food components in a certain amount so as to contain fats of 0-117 calories.

[0043] In some cases, the composition contains one or more fat-containing food components in a certain amount so that it contains, for example, carbohydrates / sugars of 0-350 calories, carbohydrates / sugars of 1-350 calories, carbohydrates / sugars of 0-200 calories, carbohydrates / sugars of 1-200 calories, carbohydrates / sugars of 0-100 calories, carbohydrates / sugars of 1-100 calories, carbohydrates / sugars of 0-80 calories, carbohydrates / sugars of 1-80 calories, carbohydrates / sugars of 10-350 calories, carbohydrates / sugars of 50-350 calories, carbohydrates / sugars of 10-200 calories, carbohydrates / sugars of 50-200 calories, carbohydrates / sugars of 10-100 calories, carbohydrates / sugars of 50-100 calories, carbohydrates / sugars of 10-80 calories, carbohydrates / sugars of 50-80 calories, etc., but is not limited to these.

[0044] In some cases, the food compositions of this disclosure may or may not contain one or more food additives. Non-limiting examples of food additives include added sugars, texturing agents, stabilizers, moisture regulators, emulsifiers, preservatives and / or antioxidants, flavorings, seasonings (e.g., salt), colorants, clouding agents, milk solids, gums, fiber-containing components, and combinations thereof.

[0045] In some cases, the food compositions of this disclosure may or may not contain added sugars. If present, added sugars may be included in the composition to impart bulk and / or sweetness, and / or to assist in moisture management. Various sugars may be used. In some cases, sucrose may be the main sugar. In some cases, monosaccharides may be included, for example, to help prevent crystallization of sucrose during storage. In some cases, the subject composition may be substantially free of added sugars and / or other sweeteners.

[0046] Suitable sweeteners, when used, include, but are not limited to, sucrose, glucose, dextrose, maltose, dextrin, invert sugar, fructose, levose, galactose, lactose, corn syrup, corn syrup solids, saccharin, brown sugar, fruit juice, tagatose, honey, molasses, and mixtures thereof. In some cases, unsweetened sweeteners may or may not be used. For example, sugar alcohols such as sorbitol, mannitol, xylitol, erythritol, hydrolyzed hydrogenated starch, maltitol, and mixtures thereof are suitable for use in the compositions of the present invention. In some cases, sugar substitutes may or may not be used. Examples of suitable sugar substitutes, when used, include high-intensity artificial sweeteners such as sucralose, aspartame, N-substituted APM derivatives such as neotame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizinates, dihydrochalcone, thaumatin, monellin, and mixtures thereof.

[0047] In some cases, the food compositions of this disclosure may or may not contain texturing agents. If used, various texturing components may be included in the composition to obtain a desired mouthfeel. For example, in some cases, vegetable shortening may be used to impart a smooth, plastic texture. In some cases, dried egg white may be used as a suitable texture-imparting component.

[0048] In some cases, the food compositions of this disclosure may or may not contain stabilizers. Stabilizers such as starch and hydrophilic colloids (such as gum) may be included in certain compositions to function as gelling agents and / or water binders. Uncooked processed starches, such as those derived from waxy maize or tapioca, are sometimes suitable for use. Non-limiting examples of hydrophilic colloids that can be used may be selected from the group consisting of guar gum, locust bean gum, cellulose ethers (such as methylcellulose), carrageenan, propylene glycol alginate, and the like.

[0049] In some cases, the food compositions of this disclosure may or may not contain one or more starches. When used, useful starches may include, for example, modified tapioca starch, modified rice starch, modified corn starch, potato starch, specialty starches, and mixtures thereof. Non-limiting examples include modified tapioca starches such as FRIGEX HV®, FRIGEX®, and TEXTRA®, available from National Starch and Chemical Company (Bridgewater, NJ), as well as other specialty starches such as the PURITY® brand, CLEARJEL®, and NOVATION® series (e.g., NOVATION® 3300 and NOVATION® 3600) (all available from National Starch and Chemical Company (Bridgewater, NJ)).

[0050] In some cases, starch is substantially hydrated during processing. The hydration process depends on several factors, including time, temperature, shear conditions, water content, the presence of additives or other dissolved components, and the type of starch used.

[0051] In some cases, the food compositions of this disclosure may or may not contain moisture modifiers. If used, a variety of useful moisture modifiers can be available. Non-limiting examples include glycerin or other low molecular weight polyhydric alcohols that may be used in the composition to bind moisture and thus control or maintain the moisture content of the composition at a desired level. Other humectants, such as carbohydrate-based humectants, may be used in some cases, for example, instead of or in addition to one or more polyhydric alcohols.

[0052] In some cases, the food compositions of this disclosure may or may not contain emulsifiers. Non-limiting examples of suitable emulsifiers include fatty acid lactic acid esters, ethoxylated monoglycerides and diglycerides, polyglycerol esters and diacetyl tartrate esters, and mixtures thereof. Exemplary emulsifiers that may be used in the compositions of the present invention include, but are not limited to, sorbitan monostearate, mono- and / or diglyceride polyoxyethylene sorbitan fatty acid esters, such as polysorbate 60 (polyoxyethylene (20) sorbitan monostearate), and sodium stearoyl-2-lactate. Suitable emulsifiers also include, for example, mono- and di-glycerides (e.g., mono- and di-glycerides alone, mono- and di-glycerides and propylene glycol, mono- and di-glycerides and citric acid, glyceryl lactoesters of fatty acids, etc.), distilled monoglycerides (e.g., monoglycerides alone, monoglycerides containing ascorbic acid, monoglycerides containing mixed tocopherols and ascorbic acid, monoglycerides containing ascorbic acid and citric acid, monoglycerides containing citric acid and ascorbic acid and complete Other examples include, but are not limited to, hydrogenated soybean oil, ethoxylated monoglycerides (e.g., ethoxylated mono- and di-glycerides, mixed tocopherols and / or ethoxylated mono- and di-glycerides with or without citric acid), propylene glycol monoesters (PGMEs) (e.g., propylene glycol mono- and di-esters of fats and fatty acids), lactylates (e.g., sodium stearoyl lactylate (SSL), calcium stearoyl lactylate (CSL), combinations of SSL and CSL, oleyl lactylic oleate and tocopherols (OLA), etc.), non-GMO emulsifiers (e.g., any non-GMO type of any of the above emulsifiers, etc.), hydrated emulsifiers, bead-shaped fats (e.g., hydrogenated cottonseed oil, etc.), etc.

[0053] In some cases, the food compositions of this disclosure may or may not contain preservatives. For example, in some cases, the compositions of this disclosure may be “preservative-free.” In some cases, useful preservatives and / or antioxidants may be used. Where used, various preservatives, e.g., potassium sorbate, and antioxidants, e.g., propyl gallate, may be included in the compositions of this disclosure. Antioxidants and preservatives can typically inhibit oxidation that leads to rancidity. Useful antioxidants and preservatives may also include mixed tocopherols, citric acid, ascorbic acid, TBHQ, BHT, BHA, propyl gallate, etc.

[0054] In some cases, the food compositions of this disclosure may or may not contain fiber-containing components. If used, suitable fiber-containing components may include, but are not limited to, cellulose, polydextrose, raftilose, raftilin, fructooligosaccharides (NutraFlora®), palatinose oligosaccharides, guar gum hydrolysate (Sun Fiber®), dextrin and maltodextrin (Nutriose® brand supplied by Roquette), indigestible dextrin (Fibersol®), insulin, or mixtures thereof.

[0055] In some cases, the subject food composition may be formulated to contain a specific amount of total nutrients (i.e., a certain amount of total calories). For example, the subject food composition may be formulated as a single serving containing a target amount of total calories and / or a target range of total calories. The total amount of calories that can be formulated to contain the subject food composition is, for example, less than 1000, less than 900, less than 800, less than 750, less than 700, less than 650, less than 600, less than 550, less than 500, less than 450, less than 400, less than 350, less than 300, less than 250, less than 225, less than 200, less than 175, less than 150, less than 125, less than 100, less than 90, less than 80, more than 500, more than 450, more than 400, more than 350, more than 300, more than 250, more than 225, more than 200, more than 175, more than 150, more than 125, more than 100, more than 90, more than 80, 1 It may fluctuate within any range greater than zero and greater than or equal to 1000, including but not limited to 0-1000, 20-1000, 30-1000, 30-800, 30-600, 30-400, 30-350, 30-300, 30-250, 30-200, 30-150, 30-100, 30-50, 10-20, 10-30, 10-40, 10-50, 10-60, 10-70, 10-80, 10-90, 10-100, 18-20, 18-30, 18-40, 18-50, 18-60, 18-70, 18-80, 18-90, 18-100, etc.

[0056] In some cases, the subject food composition may be formulated as a single serving, and such a serving may contain the calorie content or a portion of the recommended daily intake for infants of the age group the food composition is intended for. For example, the food composition may contain, but is not limited to, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, etc., up to 100% of the recommended daily calorie intake. In some cases, the food composition may contain several easily divisible portions of the recommended daily calorie intake for infants of the age group intended for, such as 50%, 33%, 25%, etc., so that the daily meals of infants may consist of several food compositions of some convenient proportion. In some cases, the composition may be formulated considering the total daily intake of infants. The recommended daily intake for infants and young children is 150 mL / kg / day.

[0057] In some cases, the food composition may be formulated as single-serving containers sized for one or more meals per day, including, for example, a size for one meal per day, a size for two meals per day (two single-serving containers), a size for three meals per day (three single-serving containers), a size for four meals per day (four single-serving containers), and so on. Any convenient form of single-serving container may be used, including, but not limited to, pouches, bottles, tubes, packs, etc.

[0058] The subject composition may be formulated in various ways, for example, the food composition may be formulated as an infant formula (e.g., liquid infant formula, powdered infant formula), a liquid beverage, a puree, a semi-solid, etc., but is not limited to these.

[0059] The compositions of this disclosure may be formulated in a variety of ways, including, for example, by combining the subject components described above into the composition. Such methods may include processing the composition through one or more food processing steps, including but not limited to one or more of the food processing steps described herein, such as freezing, drying, freeze-drying, dicing, slicing, mincing, softening, liquefying, emulsifying, cooking (boiling, broiling, frying, grilling, steaming, roasting, etc.), pickling, salting, pasteurization, fermentation, mixing, and pureeing. Producing the title food composition may further include packaging the composition into suitable containers, such as bulk containers or single-serving containers (e.g., pouches, bottles, tubes, packs, etc.).

[0060] Various suitable containers can be used. Examples of suitable containers include, but are not limited to, those having a flexible body, such as sachets, pouches, and bottles, and those having a rigid or semi-rigid body, such as hard bottles, cartons, and boxes.

[0061] As will be readily apparent to those skilled in the art, the pouch used in the composition of the present invention may be any suitable pouch, including, for example, a spouted pouch. Generally, a pouch is a multi-layer laminate consisting of a printable outer layer and a barrier inner layer. Examples of suitable pouch types include shaped pouches, standing pouches, retort pouches, box pouches, slider pouches, zipper pouches, etc., and the above-mentioned pouches with or without a spout. Pouches may be obtained from a variety of suppliers, including, but not limited to, manufacturers such as Glenroy, Inc. (Menomonee Falls, Wis.) or ProAmpac (Cincinnati, Ohio).

[0062] In some embodiments, the container used to contain the compositions of the present disclosure may be a single-use pouch or a multi-use pouch, also referred to in the art as a sachet. The sachet may also be in the form of a shaped, standing, retort, box, slider, or zipper sachet.

[0063] The flexible body of the container used may be made from any of a variety of suitable materials. In some embodiments, the flexible body is formed from polymers or plastics used for packaging consumer products. These include, but are not limited to, polycarbonate (PC), polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), and polyvinyl chloride (PVC), as well as combinations thereof. In the case of retort pouches or sachets, the inner layer may be formed from a thin metal foil. In some embodiments, the flexible body may be formed by co-extruding the inner and outer layers.

[0064] In some embodiments, the polymer or plastic used to form a flexible body can be made of biodegradable or soluble polymers. Biodegradable polymers are a special type of polymer that decomposes after its intended purpose, producing natural by-products such as gases (CO2, N2), water, biomass, and inorganic salts. Biodegradable polymers are found naturally and are also produced artificially, and consist mainly of ester, amide, and ether functional groups. Possible biodegradable polymers include, but are not limited to, polyhydroxyalkanoates (PHAs), e.g., poly-3-hydroxybutyrate (PHB), hydroxyvalerate (PHV), and polyhydroxyhexanoate (PHH); polylactic acid (PLA); polybutylene succinate (PBS), polycaprolactone (PCL), and polyanhydride (PAH). Possible soluble polymers include, but are not limited to, polyvinyl alcohol (PVOH); most starch derivatives; and cellulose ethers, e.g., cellulose acetate and nitrocellulose and their derivatives (celluloid).

[0065] In some cases, rigid, i.e., inflexible or substantially inflexible containers may be used to contain the compositions of the present disclosure. Non-limiting examples of suitable inflexible or substantially inflexible containers include vials, tubes, jars, bottles, flasks, jugs, carboys, and the like. Such containers may be constructed from a variety of materials, including, but not limited to, rigid or semi-rigid polymers or plastics, biodegradable or soluble polymers, glass, and metals (e.g., stainless steel, aluminum, etc.).

[0066] In some cases, a container for containing the composition of the present disclosure may include a suitable spout through which the composition (e.g., configured as a liquid or semi-solid) can be introduced into and / or removed from the container. The spout may be connected to the body of the container by various means. A spout suitable for use in the container of the present invention may be made from any suitable material. Non-limiting examples of such materials include polymers or plastics used in packaging consumer products. These include, but are not limited to, high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polycarbonate (PC), polyethylene terephthalate (PET), and polyvinyl chloride (PVC). In some embodiments, the spout may be formed from a metal or a biodegradable or soluble polymer as considered above.

[0067] In some cases, a container for holding a composition of the present disclosure may be specifically configured to be handled and / or operated by an infant, toddler, and / or child. Various methods may be used to configure a container of the subject for an infant, toddler, and / or child. For example, in some cases, the container may be sized for an infant, toddler, and / or child-sized hand or grip (for example, the container may have a diameter sized to fit an infant, toddler, and / or child-sized hand or grip). In some cases, the container of the subject may include one or more handles sized for an infant, toddler, and / or child-sized hand or grip. A useful handle configuration, for example, includes two handles symmetrically or asymmetrically on the container, for example, on opposite sides of the container, so that they can be grasped by both hands of an infant, toddler, and / or child.

[0068] In some cases, the container or its spout used may be configured to prevent leakage, for example, to prevent leakage when handled by infants, toddlers, and / or children. Any of the various methods used to make the container or its opening and / or spout “leak-resistant” and / or “leak-proof” may be employed.

[0069] The methods of this disclosure may include methods for administering the food compositions described herein to infants and / or systems of the food compositions described below. The food compositions and / or components of the system may be administered according to a schedule. Such methods may promote healthy neurodevelopment in infants and / or enhance the overall neurodevelopment of the infant's brain or the neurodevelopment of specific areas of the infant's brain, such as those described herein.

[0070] Kits and Systems As summarized above, this disclosure also provides kits and systems related to the subject food composition, as well as kits and systems for use in the subject method.

[0071] A kit is provided that contains multiple single-unit food compositions of a subject, including, for example, a kit of a subject that contains multiple single-serving containers, each containing a food composition. When a kit of a subject contains multiple single units, the food compositions contained within each individual unit may be the same or different. For example, in some cases, all individual units of a kit may be formulated to be administered during the same developmental period. In some cases, two or more individual units of a kit may be formulated to be administered during different developmental periods.

[0072] In some cases, the subject kit contains enough units to feed an infant over a specified period of time, such as one day, more than one day, two days, three days, four days, five days, six days, one week, two weeks, three weeks, four weeks, one month, etc., but not limited to these.

[0073] Furthermore, an infant feeding system comprising two or more food compositions as described above is also provided. The two or more food compositions of the subject system typically include food compositions intended for infants to eat during at least two different neurodevelopmental periods. Such periods may vary as described above, for example, and may include periods of one month, two months, three months, etc., or ranges of months including, for example, months 3-6, months 7-9, months 10-12, months 13-18, etc.

[0074] In some cases, the subject system may include two or more food compositions, each providing specific nutrients for different neurodevelopmental stages. In some cases, the subject system may include three or more food compositions, each providing specific nutrients for different neurodevelopmental stages. In some cases, the subject system may include four or more food compositions, each providing specific nutrients for different neurodevelopmental stages.

[0075] Different food compositions, or multi-unit kits thereof, for specific developmental stages of the subject system may be provided to the user at the same time or at different times. For example, in some cases, the user may receive from the food composition provider different food compositions formulated for at least two different developmental stages. In some cases, the user may receive from the food composition provider only one type of food composition formulated for only one developmental stage at a time. For example, in some cases, the food composition for each specific developmental stage may be provided to the user only one at a time, for example, to prevent the user from administering the food composition during a stage that is not properly suited to the user. Such provision may be managed by any convenient means, including, for example, through a subscription service (for example, coordinating food delivery with the age of the infant or young child to whom the food composition is intended, as provided by the user). Delivery of the food composition, including when a subscription service is used, may be managed through any convenient means or market, including, for example, a physically existing store, mail order, online, etc.

[0076] In addition to the components described above, the subject kit and system may further include instructions for carrying out the subject method (in a particular embodiment). These instructions may be present in the subject kit or provided in various forms with the subject system, one or more of which may be present in the kit or provided with the subject system. One possible form of these instructions is as information printed on a suitable medium or substrate, for example, one or more sheets of paper with the information printed on them, such as in an accompanying document, inserted into the package of the kit or cell line(s). Yet another form of these instructions is a computer-readable medium, such as a diskette, compact disc (CD), flash drive, etc., on which the information is stored. Yet another possible form of these instructions is a website address, which can be used to access the information from a remote site via the internet. [Examples]

[0077] The following examples are provided to those skilled in the art to provide a complete disclosure and explanation of the manufacturing method and use of the present invention, and are not intended to limit the scope of what the inventors consider to be their invention, nor to indicate that the following experiments are all or only experiments in which such experiments are performed. While efforts have been made to ensure accuracy with respect to the figures used (e.g., quantity, temperature, etc.), some experimental error and deviation should be taken into consideration. Unless otherwise indicated, parts are parts by weight, molecular weight is the weight-average molecular weight, temperature is in degrees Celsius, and pressure is the pressure in or near the atmosphere. Standard abbreviations may be used, such as room temperature (RT), base pair (bp), kilobase (kb), picoliters (pl), seconds (s or sec), minutes (m or min), hours (h or hr), days (d), weeks (wk or wks), nanoliters (nl), microliters (ul), milliliters (ml), liters (L), nanograms (ng), micrograms (ug), milligrams (mg), grams (g) in the context of mass, kilograms (kg), equivalence of gravity (g) in the context of centrifugation, nanomoles (nM), micromoles (uM), millimoles (mM), moles (M), amino acids (aa), kilobases (kb), base pairs (bp), nucleotides (nt), intramuscular (im), intraperitoneal (ip), subcutaneous (sc), etc.

[0078] Example 1: Formulation of food compositions for four neurodevelopmental stages from 3 months to 18 months of age. Food-based nutritional pouches are formulated for the following developmental periods, from 3 to 18 months of age: (1) 3–6 months, (2) 7–9 months, (3) 10–12 months, and (4) 13–18 months. Specific nutritional formulations are designed for each period based on the nutritional requirements of specific brain regions and their neurons that experience rapid growth and development during that time.

[0079] Table 2 provides nutrient pouch formulations for each period. The nutrient amounts provided represent the target maximum values ​​for each nutrient in the final composition, although these amounts may range, for example, from zero to the indicated maximum values.

[0080] (Table 2) TIFF0007872122000001.tif87146

[0081] The formulations for each period consist of target maximum total calorie values ​​of 80, 100, 200, and 350, respectively. However, the total calorie values ​​for each period may be in the range of, for example, 18-80, 30-100, 30-200, and 30-350, respectively. In the provided examples, the subject formulation in each pouch may further contain protein content corresponding to 0-13 cal, 0-14 cal, 0-14 cal, and 0-16 cal, respectively. The subject formulation in each pouch may further contain fat content corresponding to 0-25 cal, 0-33 cal, 0-67 cal, and 0-117 cal, respectively. The subject formulation in each pouch may further contain carbohydrate / sugar content corresponding to 0-80 cal, 0-100 cal, 0-200 cal, and 0-350 cal, respectively.

[0082] Notwithstanding the attached claims, this disclosure is also defined by the following clauses: 1. A food composition comprising: a lutein-containing food in an amount sufficient to provide 0-150 μg of lutein; a DHA-containing food in an amount sufficient to provide 0-50 mg of docosahexaenoic acid (DHA); an iron-containing food in an amount sufficient to provide 0-10 mg of iron; a zinc-containing food in an amount sufficient to provide 0-10 mg of zinc; a copper-containing food in an amount sufficient to provide 0-0.7 mg of copper; a choline-containing food in an amount sufficient to provide 0-55 mg of choline; a vitamin A-containing food in an amount sufficient to provide 0-400 retinol equivalents (RE) of vitamin A; and 0-1 mg of vitamin B6. A food composition comprising: a food containing a sufficient amount of vitamin B6; a food containing a sufficient amount of selenium to provide 0-20 μg of selenium; a food containing a sufficient amount of iodine to provide 0-70 μg of iodine; a food containing a sufficient amount of folic acid to provide 0-50 μg of folic acid; a food containing a sufficient amount of vitamin D to provide 0-8.5 μg of vitamin D; a food containing a sufficient amount of vitamin B3 to provide 0-9 mg of vitamin B3; a food containing a sufficient amount of vitamin E to provide 0-6 mg of vitamin E; and a food containing a sufficient amount of vitamin B12 to provide 0-0.7 μg of vitamin B12. 2. The food composition described in Clause 1, wherein the food composition is a single serving containing 18 to 350 total calories. 3. The food composition described in Clause 2, wherein the food composition is a single serving containing 30 to 350 total calories. 4. A food composition according to any one of clauses 1 to 3, wherein the food composition contains 0 to 16 calories of protein. 5. A food composition according to any one of the clauses 1 to 4, wherein the food composition contains 0 to 117 calories of fat. 6. The amount of lutein-containing food is sufficient to provide 0-100 μg of lutein, the amount of docosahexaenoic acid (DHA)-containing food is sufficient to provide 0-35 mg of DHA, the amount of iron-containing food is sufficient to provide 0-9 mg of iron, the amount of zinc-containing food is sufficient to provide 0-5 mg of zinc, the amount of copper-containing food is sufficient to provide 0-0.6 mg of copper, the amount of choline-containing food is sufficient to provide 0-50 mg of choline, the amount of vitamin A-containing food is sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and the amount of vitamin B6-containing food is sufficient to provide 0-0.6 mg of vitamin A. The food composition according to Clause 1, which is sufficient to provide B6, the amount of selenium-containing food is sufficient to provide 0-15 μg of selenium, the amount of iodine-containing food is sufficient to provide 0-50 μg of iodine, the amount of folic acid-containing food is sufficient to provide 0-35 μg of folic acid, the amount of vitamin D-containing food is sufficient to provide 0-7 μg of vitamin D, the amount of vitamin B3-containing food is sufficient to provide 0-6 mg of vitamin B3, the amount of vitamin E-containing food is sufficient to provide 0-4 mg of vitamin E, and the amount of vitamin B12-containing food is sufficient to provide 0-0.5 μg of vitamin B12. 7. The food composition described in Clause 6, wherein the food composition is a single serving containing 30 to 200 total calories. 8. The food composition according to clause 6 or 7, wherein the food composition contains 0 to 14 calories of protein. 9. A food composition according to any one of clauses 6 to 8, wherein the food composition contains 0 to 67 calories of fat. 10. The amount of lutein-containing food is sufficient to provide 0-75 μg of lutein, the amount of docosahexaenoic acid (DHA)-containing food is sufficient to provide 0-25 mg of DHA, the amount of iron-containing food is sufficient to provide 0-8 mg of iron, the amount of zinc-containing food is sufficient to provide 0-5 mg of zinc, the amount of copper-containing food is sufficient to provide 0-0.5 mg of copper, the amount of choline-containing food is sufficient to provide 0-35 mg of choline, the amount of vitamin A-containing food is sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and the amount of vitamin B6-containing food is sufficient to provide 0-0.6 mg of vitamin B6. The food composition according to Clause 1, which is sufficient to provide 6, the amount of selenium-containing food is sufficient to provide 0 to 15 μg of selenium, the amount of iodine-containing food is sufficient to provide 0 to 40 μg of iodine, the amount of folic acid-containing food is sufficient to provide 0 to 35 μg of folic acid, the amount of vitamin D-containing food is sufficient to provide 0 to 8.5 μg of vitamin D, the amount of vitamin B3-containing food is sufficient to provide 0 to 5 mg of vitamin B3, the amount of vitamin E-containing food is sufficient to provide 0 to 4 mg of vitamin E, and the amount of vitamin B12-containing food is sufficient to provide 0 to 0.5 μg of vitamin B12. 11. The food composition according to Clause 10, wherein the food composition is a single serving containing 30 to 100 total calories. 12. The food composition according to clause 10 or 11, wherein the food composition contains 0 to 14 calories of protein. 13. A food composition according to any one of clauses 10 to 12, wherein the food composition contains 0 to 33 calories of fat. 14. The amount of lutein-containing food is sufficient to provide 0-50 μg of lutein, the amount of docosahexaenoic acid (DHA)-containing food is sufficient to provide 0-20 mg of DHA, the amount of iron-containing food is sufficient to provide 0-6 mg of iron, the amount of zinc-containing food is sufficient to provide 0-4 mg of zinc, the amount of copper-containing food is sufficient to provide 0-0.4 mg of copper, the amount of choline-containing food is sufficient to provide 0-25 mg of choline, the amount of vitamin A-containing food is sufficient to provide 0-375 retinol equivalents (RE) of vitamin A, and the amount of vitamin B6-containing food is sufficient to provide 0-0.3 mg of vitamin B6. The food composition according to Clause 1, which is sufficient to provide 6, the amount of selenium-containing food is sufficient to provide 0 to 10 μg of selenium, the amount of iodine-containing food is sufficient to provide 0 to 40 μg of iodine, the amount of folic acid-containing food is sufficient to provide 0 to 25 μg of folic acid, the amount of vitamin D-containing food is sufficient to provide 0 to 8.5 μg of vitamin D, the amount of vitamin B3-containing food is sufficient to provide 0 to 5 mg of vitamin B3, the amount of vitamin E-containing food is sufficient to provide 0 to 3 mg of vitamin E, and the amount of vitamin B12-containing food is sufficient to provide 0 to 0.3 μg of vitamin B12. 15. The food composition according to Clause 14, wherein the food composition is a single serving containing 18 to 80 total calories. 16. The food composition according to clause 14 or 15, wherein the food composition contains 0 to 13 calories of protein. 17. A food composition according to any one of the clauses 14 to 16, wherein the food composition contains 0 to 25 calories of fat. 18. A food composition according to any one of the clauses 1 to 17, wherein the lutein-containing food is selected from the group consisting of leafy vegetables, broccoli, zucchini, Brussels sprouts, peas, corn, carrots, okra, celery, oranges, tomatoes, melons, grapefruits, beets, asparagus, eggs, spinach, kiwi, grapes, zucchini, squash, and combinations thereof. 19. A food composition according to any one of the clauses 1 to 18, wherein the DHA-containing food is selected from the group consisting of fish, eggs, walnuts, chia, flaxseed, seaweed, lamb, beef, game meat, poultry, and combinations thereof. 20. A food composition according to any one of the clauses 1 to 19, wherein the iron-containing food is selected from the group consisting of beef, chicken, turkey, ham, fish, veal, legumes, tofu, breakfast cereal, pumpkin seeds, sesame seeds, squash seeds, lima beans, kidney beans, chickpeas, dried apricots, baked potatoes, egg noodles, wheat germ, split peas, nuts, raisins, dried peaches, dried prunes, broccoli, raw spinach, pasta, bread, brown rice or fortified rice, and combinations thereof. 21. A food composition according to any one of clauses 1 to 20, wherein the zinc-containing food is selected from the group consisting of oysters, beef, lamb, wheat germ, spinach, pumpkin seeds, cashews, chocolate, pork, chicken, chickpeas, fortified cereals, oatmeal, kidney beans, almonds, flaxseed, lima beans, egg yolks, peanuts, brown rice, peas, and combinations thereof. 22. A food composition according to any one of Clauses 1 to 21, wherein the copper-containing food is selected from the group consisting of sunflower seeds, lentils, almonds, asparagus, seafood, kale, sesame, cashews, chickpeas, avocado, goat's milk cheese, blackberries, kiwi, grapes, mango, raspberries, pineapple, bosque pear, potato, turnip, taro, lima, spinach, asparagus, Swiss chard, lentils, almonds, and combinations thereof. 23. A food composition according to any one of clauses 1 to 22, wherein the choline-containing food is selected from the group consisting of liver, eggs, cauliflower, mushrooms, beet leaves, shellfish, asparagus, Brussels sprouts, cooked bok choy, collard leaves, broccoli, Swiss chard, spinach, chicken, turkey, tuna, salmon, beef, green peas, cabbage, green beans, summer squash, and combinations thereof. 24. A food composition according to any one of clauses 1 to 23, wherein the vitamin A-containing food is selected from the group consisting of sweet potatoes, carrots, dark leafy vegetables, squash, dried apricots, cantaloupe, red bell peppers, tuna, mango, spinach, broccoli, liver, cod oil, eggs, butter, cream, and combinations thereof. 25. A food composition according to any one of clauses 1 to 24, wherein the vitamin B6-containing food is selected from the group consisting of sunflower seeds, pistachios, tuna, turkey, chicken, pork, beef, bananas, avocados, spinach, sweet potatoes, hazelnuts, plantains, wheat bran, oatmeal, and combinations thereof. 26. A food composition according to any one of clauses 1 to 25, wherein the selenium-containing food is selected from the group consisting of Brazil nuts, tuna, oysters, sunflower seeds, whole wheat bread, pork, beef, chicken, turkey, mushrooms, rye, eggs, cheese, mushrooms, oats, wheat, rye, brown rice, soybeans, pasta, and combinations thereof. 27. A food composition according to any one of clauses 1 to 26, wherein the iodine-containing food is selected from the group consisting of seaweed, cranberries, yogurt, white beans, strawberries, cheese, potatoes, milk, eggs, lima beans, corn, green peas, bananas, tuna, cod, shrimp, baked potatoes, milk, shrimp, prunes, yogurt, bananas, strawberries, canned corn, white bread, green beans, pineapple, rhubarb, watercress, and combinations thereof. 28. A food composition according to any one of Clauses 1 to 27, wherein the folic acid-containing food is selected from the group consisting of cowpeas, lentils, dark leafy vegetables, asparagus, avocados, broccoli, mangoes, citrus fruits, white bread, papaya, strawberries, raspberries, legumes, peas, lentils, okra, Brussels sprouts, sunflower seeds, flaxseed, peanuts, almonds, cauliflower, corn, beets, celery, carrots, winter squash, summer squash, and combinations thereof. 29. A food composition according to any one of Clauses 1 to 28, wherein the vitamin D-containing food is selected from the group consisting of fish oil, fatty fish, mushrooms, tofu, fortified cereals, fish roe, queso fresco, very low-fat ham, eggs, plain soy milk yogurt, beef liver, and combinations thereof. 30. A food composition according to any one of clauses 1 to 29, wherein the vitamin B3-containing food is selected from the group consisting of fish, chicken, turkey, pork, peanuts, beef, grilled portobello mushrooms, green peas, sunflower seeds, avocado, broccoli, asparagus, green beans, tahini, bell peppers, shiitake mushrooms, enoki mushrooms, wheat, grains, barley, rye, almonds, lentils, and combinations thereof. 31. A food composition according to any one of clauses 1 to 30, wherein the vitamin E-containing food is selected from the group consisting of dark-colored leafy vegetables, almonds, sunflower seeds, avocado, shrimp, trout, olive oil, broccoli, butternut squash, kiwi, sweet potato, wheat germ, palm oil, hazelnuts, pine nuts, parsley, papaya, olives, pine nuts, red bell peppers, mango, basil, oregano, mango, pistachios, peanut butter, red chili peppers, tomatoes, and combinations thereof. 32. A food composition according to any one of the clauses 1 to 31, wherein the food containing vitamin B12 is selected from the group consisting of shellfish, beef, chicken, liver, fish, yogurt, eggs, and combinations thereof. 33. A food composition according to any one of Clauses 1 to 32, wherein the food composition comprises a protein-containing food selected from the group consisting of Greek yogurt, cottage cheese, Swiss cheese, eggs, milk, whey protein, beef, eggs, almonds, chicken breast, turkey breast, oats, broccoli, quinoa, whey protein, lentils, Ezekiel bread, pumpkin seeds, Brussels sprouts, peanuts, flax, Hubbard squash, peas, falafel, passion fruit, avocado, oatmeal, hummus, green beans, pistachios, black rice, chickpeas, pasta, and combinations thereof. 34. A food composition according to any one of clauses 1 to 33, wherein the food composition is an infant formula. 35. The food composition according to Clause 34, wherein the infant formula is a liquid infant formula. 36. The food composition according to Clause 34, wherein the formula for infants is a dry powder formula. 37. A food composition according to any one of clauses 1 to 33, wherein the food composition is a puree. 38. A food composition according to any one of the provisions 1 to 33, wherein the food composition is a semi-solid. 39. A food composition according to any one of clauses 1 to 38, wherein the food composition is present in a single-serving container. 40.1 The food composition according to Clause 39, wherein the container for one serving is a pouch. 41. A kit containing multiple single-serving containers as described in Clause 39, sufficient to feed an infant between 3 and 18 months of age for at least one day. 42. The kit as described in Clause 41, which includes multiple single-serving containers sufficient to feed an infant aged 3 to 18 months for at least one week. 43. An infant feeding system comprising two or more food compositions, each providing specific nutrients for different neurodevelopmental stages. 44. Two or more food compositions, Composition for the neurodevelopmental period of 3 to 6 months. Composition for the neurodevelopmental period of 7 to 9 months. Compositions for the neurodevelopmental period of 10 to 12 months, and Composition for the neurodevelopmental period of 13 to 18 months A system as described in Clause 43, selected from the group consisting of the following: 45. A composition for the neurodevelopmental period of 3 to 6 months provides a sufficient amount of lutein-containing food to provide 0 to 50 μg of lutein, a sufficient amount of DHA-containing food to provide 0 to 20 mg of docosahexaenoic acid (DHA), a sufficient amount of iron-containing food to provide 0 to 6 mg of iron, a sufficient amount of zinc-containing food to provide 0 to 4 mg of zinc, a sufficient amount of copper-containing food to provide 0 to 0.4 mg of copper, a sufficient amount of choline-containing food to provide 0 to 25 mg of choline, a sufficient amount of vitamin A-containing food to provide 0 to 375 retinol equivalents (RE) of vitamin A, and 0 to 0.3 mg of vitamin B6. The system according to Clause 44, comprising a food containing a sufficient amount of vitamin B6, a food containing a sufficient amount of selenium to provide 0-10 μg of selenium, a food containing iodine to provide 0-40 μg of iodine, a food containing folic acid to provide 0-25 μg of folic acid, a food containing vitamin D to provide 0-8.5 μg of vitamin D, a food containing vitamin B3 to provide 0-5 mg of vitamin B3, a food containing vitamin E to provide 0-3 mg of vitamin E, and a food containing vitamin B12 to provide 0-0.3 μg of vitamin B12. A composition for the neurodevelopmental period of 46.7 to 9 months provides: a lutein-containing food in an amount sufficient to provide 0-75 μg of lutein; a DHA-containing food in an amount sufficient to provide 0-25 mg of docosahexaenoic acid (DHA); an iron-containing food in an amount sufficient to provide 0-8 mg of iron; a zinc-containing food in an amount sufficient to provide 0-5 mg of zinc; a copper-containing food in an amount sufficient to provide 0-0.5 mg of copper; a choline-containing food in an amount sufficient to provide 0-35 mg of choline; a vitamin A-containing food in an amount sufficient to provide 0-375 retinol equivalents (RE) of vitamin A; and 0-0.6 mg of vitamin B6. The system according to Clause 44, comprising a food containing vitamin B6 in sufficient quantities to provide 0-15 μg of selenium, a food containing iodine in sufficient quantities to provide 0-40 μg of iodine, a food containing folic acid in sufficient quantities to provide 0-35 μg of folic acid, a food containing vitamin D in sufficient quantities to provide 0-8.5 μg of vitamin D, a food containing vitamin B3 in sufficient quantities to provide 0-5 mg of vitamin B3, a food containing vitamin E in sufficient quantities to provide 0-4 mg of vitamin E, and a food containing vitamin B12 in sufficient quantities to provide 0-0.5 μg of vitamin B12. 47. A composition for the neurodevelopmental period of 10 to 12 months contains a sufficient amount of lutein-containing food to provide 0 to 100 μg of lutein, a sufficient amount of DHA-containing food to provide 0 to 35 mg of docosahexaenoic acid (DHA), a sufficient amount of iron-containing food to provide 0 to 9 mg of iron, a sufficient amount of zinc-containing food to provide 0 to 5 mg of zinc, a sufficient amount of copper-containing food to provide 0 to 0.6 mg of copper, a sufficient amount of choline-containing food to provide 0 to 50 mg of choline, a sufficient amount of vitamin A-containing food to provide 0 to 375 retinol equivalents (RE) of vitamin A, and 0 to 0.6 mg of vitamin B6. The system according to Clause 44, comprising a food containing vitamin B6 in sufficient quantities to provide, a food containing selenium in sufficient quantities to provide 0-15 μg of selenium, a food containing iodine in sufficient quantities to provide 0-50 μg of iodine, a food containing folic acid in sufficient quantities to provide 0-35 μg of folic acid, a food containing vitamin D in sufficient quantities to provide 0-7 μg of vitamin D, a food containing vitamin B3 in sufficient quantities to provide 0-6 mg of vitamin B3, a food containing vitamin E in sufficient quantities to provide 0-4 mg of vitamin E, and a food containing vitamin B12 in sufficient quantities to provide 0-0.5 μg of vitamin B12. 48. A composition for the neurodevelopmental period of 13 to 18 months contains a sufficient amount of lutein-containing food to provide 0 to 150 μg of lutein, a sufficient amount of DHA-containing food to provide 0 to 50 mg of docosahexaenoic acid (DHA), a sufficient amount of iron-containing food to provide 0 to 10 mg of iron, a sufficient amount of zinc-containing food to provide 0 to 10 mg of zinc, a sufficient amount of copper-containing food to provide 0 to 0.7 mg of copper, a sufficient amount of choline-containing food to provide 0 to 55 mg of choline, a sufficient amount of vitamin A-containing food to provide 0 to 400 retinol equivalents (RE) of vitamin A, and 0 to 1 mg of vitamin B6. The system according to Clause 44, comprising a food containing vitamin B6 in sufficient quantities to provide, a food containing selenium in sufficient quantities to provide 0-20 μg of selenium, a food containing iodine in sufficient quantities to provide 0-70 μg of iodine, a food containing folic acid in sufficient quantities to provide 0-50 μg of folic acid, a food containing vitamin D in sufficient quantities to provide 0-7 μg of vitamin D, a food containing vitamin B3 in sufficient quantities to provide 0-9 mg of vitamin B3, a food containing vitamin E in sufficient quantities to provide 0-6 mg of vitamin E, and a food containing vitamin B12 in sufficient quantities to provide 0-0.7 μg of vitamin B12. 49. The system according to any one of the clauses 43 to 48, wherein the system comprises three or more food compositions, each providing a specific nutrient for different neurodevelopmental periods. 50. The system according to Clause 49, wherein the system comprises four food compositions, each providing specific nutrients for different neurodevelopmental periods. 51. A method for formulating a single serving of infant food composition for the neurodevelopmental period, comprising: a lutein-containing food in an amount sufficient to provide 0-150 μg of lutein; a DHA-containing food in an amount sufficient to provide 0-50 mg of docosahexaenoic acid (DHA); an iron-containing food in an amount sufficient to provide 0-10 mg of iron; a zinc-containing food in an amount sufficient to provide 0-10 mg of zinc; a copper-containing food in an amount sufficient to provide 0-0.7 mg of copper; a choline-containing food in an amount sufficient to provide 0-55 mg of choline; a vitamin A-containing food in an amount sufficient to provide 0-400 retinol equivalents (RE) of vitamin A; and a vitamin B6-containing food in an amount sufficient to provide 0-1 mg of vitamin B6. A method for creating an infant food composition comprising combining a vitamin B6-containing food, a selenium-containing food in an amount sufficient to provide 0-20 μg of selenium, an iodine-containing food in an amount sufficient to provide 0-70 μg of iodine, a folic acid-containing food in an amount sufficient to provide 0-50 μg of folic acid, a vitamin D-containing food in an amount sufficient to provide 0-8.5 μg of vitamin D, a vitamin B3-containing food in an amount sufficient to provide 0-9 mg of vitamin B3, a vitamin E-containing food and protein-containing food in an amount sufficient to provide 0-6 mg of vitamin E, and a vitamin B12-containing food in an amount sufficient to provide 0-0.7 μg of vitamin B12, wherein the total calories of the infant food composition are 350 or less.

[0083] The above is merely illustrative of the principles of the present invention. Those skilled in the art will understand that various configurations embodying the principles of the present invention and falling within the spirit and scope of the invention can be devised, even if not explicitly described or shown herein. Furthermore, all examples and conditional terms described herein are primarily intended to assist the reader in understanding the principles of the present invention and the concepts to which the inventors contribute to the development of the art, and should be interpreted as not being limited to such specifically described examples and conditions. Moreover, all descriptions herein describing the principles, aspects, and embodiments of the present invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents of the present invention. In addition, such equivalents are intended to include both currently known equivalents and those to be developed in the future, i.e., any elements to be developed that perform the same function regardless of structure. Therefore, the scope of the present invention is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the present invention are embodied in the appended claims.

Claims

1. A food composition for infants and toddlers that does not contain milk solids and is semi-solid or puree, containing nutrients for the neurodevelopmental period of 3 to 18 months of age, wherein the nutrients are included as a food or nutrient in the following foods: (i) Foods containing iodine as a nutrient in an amount sufficient to provide 10 to 50 μg of iodine, comprising at least one food selected from the group consisting of seaweed, cranberries, white beans, strawberries, potatoes, eggs, lima beans, corn, green peas, bananas, tuna, cod, shrimp, prunes, green beans, pineapple, rhubarb, watercress, and combinations thereof. (ii) A food containing vitamin D as a nutrient in an amount sufficient to provide 1 to 8.5 μg of vitamin D, comprising at least one food selected from the group consisting of fish oil, fatty fish, mushrooms, tofu, fish roe, very low-fat ham, eggs, plain soy milk yogurt, beef liver, and combinations thereof. (iii) Foods containing choline as a nutrient in an amount sufficient to provide 1 to 55 mg of choline, comprising at least one food selected from the group consisting of liver, eggs, cauliflower, mushrooms, beet greens, shellfish, asparagus, Brussels sprouts, cooked bok choy, collard greens, broccoli, Swiss chard, spinach, chicken, turkey, tuna, salmon, beef, green peas, cabbage, green beans, summer squash, and combinations thereof, (iv) Foods containing iron as a nutrient in an amount sufficient to provide 2 to 6 mg of iron, including at least one food selected from the group consisting of beef, chicken, turkey, ham, fish, veal, legumes, tofu, pumpkin seeds, sesame seeds, squash seeds, lima beans, kidney beans, chickpeas, dried apricots, baked potatoes, egg noodles, wheat germ, split peas, nuts, raisins, dried peaches, dried prunes, broccoli, raw spinach, brown rice, fortified rice, and combinations thereof. (v) Foods containing vitamin B3 as a nutrient in an amount sufficient to provide 1 to 5 mg of vitamin B3, comprising at least one food selected from the group consisting of fish, chicken, turkey, pork, peanuts, beef, grilled portobello mushrooms, green peas, sunflower seeds, avocado, broccoli, asparagus, green beans, tahini, bell peppers, shiitake mushrooms, enoki mushrooms, wheat, grains, barley, rye, almonds, lentils, and combinations thereof. (vi) A food containing vitamin B6 as a nutrient in an amount sufficient to provide 0.1 to 1 mg of vitamin B6, comprising at least one food selected from the group consisting of sunflower seeds, pistachios, tuna, turkey, chicken, pork, beef, bananas, avocados, spinach, sweet potatoes, hazelnuts, plantains, wheat bran, oatmeal, and combinations thereof. (vii) A food containing vitamin B12 as a nutrient in an amount sufficient to provide 0.1 to 0.5 μg of vitamin B12, comprising at least one food selected from the group consisting of shellfish, beef, chicken, liver, fish, eggs, and combinations thereof. (viii) Foods containing vitamin E as a nutrient in an amount sufficient to provide 1 to 6 mg of vitamin E, comprising at least one food selected from the group consisting of dark-colored leafy vegetables, almonds, sunflower seeds, avocados, shrimp, trout, olive oil, broccoli, butternut squash, kiwi, sweet potato, wheat germ, palm oil, hazelnuts, pine nuts, parsley, papaya, olives, pine nuts, red bell peppers, mangoes, basil, oregano, pistachios, peanut butter, red chili peppers, tomatoes, and combinations thereof. (ix) Foods containing selenium as a nutrient in an amount sufficient to provide 2 to 10 μg of selenium, comprising at least one food selected from the group consisting of Brazil nuts, tuna, oysters, sunflower seeds, whole wheat bread, pork, beef, chicken, turkey, mushrooms, rye, eggs, oats, wheat, brown rice, soybeans, pasta, and combinations thereof. (x) Foods containing zinc as a nutrient in an amount sufficient to provide 1 to 10 mg of zinc, comprising at least one food selected from the group consisting of oysters, beef, lamb, wheat germ, spinach, pumpkin seeds, cashews, chocolate, pork, chicken, chickpeas, oatmeal, kidney beans, almonds, flaxseed, lima beans, egg yolks, peanuts, brown rice, peas, and combinations thereof. (xi) Foods containing docosahexaenoic acid (DHA) in an amount sufficient to provide 1 to 50 mg of DHA, comprising at least one food selected from the group consisting of fish, eggs, walnuts, chia, flaxseed, seaweed, lamb, beef, game meat, poultry, meat, and combinations thereof. (xii) Foods containing lutein as a nutrient in an amount sufficient to provide 10 to 150 μg of lutein, comprising at least one food selected from the group consisting of leafy green vegetables, broccoli, zucchini, Brussels sprouts, peas, corn, carrots, okra, celery, oranges, tomatoes, melons, grapefruits, beets, asparagus, eggs, spinach, kiwi, grapes, squash, and combinations thereof. and (xiii) Protein.

2. (i) Foods containing iodine as a nutrient in an amount sufficient to provide 20-40 μg of iodine. (ii) Foods containing vitamin D as a nutrient in an amount sufficient to provide 5-7 μg of vitamin D, (iii) Foods containing choline as a nutrient in an amount sufficient to provide 10-25 mg of choline, (iv) Foods containing iron as a nutrient in an amount sufficient to provide 3-6 mg of iron. (v) Foods containing vitamin B3 as a nutrient in an amount sufficient to provide 1-5 mg of vitamin B3. (vi) Foods containing vitamin B6 as a nutrient in an amount sufficient to provide 0.1 to 0.3 mg of vitamin B6. (vii) Foods containing vitamin B12 as a nutrient in an amount sufficient to provide 0.2 to 0.5 μg of vitamin B12. (viii) Foods containing vitamin E as a nutrient in an amount sufficient to provide 2-3 mg of vitamin E, (ix) Foods containing selenium as a nutrient in an amount sufficient to provide 5-10 μg of selenium. (x) Foods containing zinc as a nutrient in an amount sufficient to provide 1-4 mg of zinc. (xi) Foods containing the nutrient docosahexaenoic acid (DHA) in an amount sufficient to provide 10-35 mg of DHA. (xii) Foods containing lutein as a nutrient in an amount sufficient to provide 10-150 μg of lutein. and (xiii) Protein The infant food composition according to claim 1, comprising:

3. 1-50 μg of folic acid, Vitamin A in amounts of 1 to 400 retinol equivalents (RE), and 0.1–0.7 mg of copper The infant food composition according to claim 1, further comprising:

4. The infant food composition according to claim 1, wherein the infant food composition is present in a single-serving container such that one serving contains a total of 0 to 250 calories, and of the total calories, 1 to 16 calories are derived from protein.

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