WO2007084754A2

WO2007084754A2 - Baby food and infant formula compositions

Info

Publication number: WO2007084754A2
Application number: PCT/US2007/001629
Authority: WO
Inventors: Thomas E. Mower
Original assignee: Sakura Properties, Llc
Priority date: 2006-01-19
Filing date: 2007-01-19
Publication date: 2007-07-26
Also published as: WO2007084754A3

Abstract

A baby food composition for consumption by, and to provide nutrition to a baby, which includes partially hydrolyzed fucoidan. The fucoidan may be sulfonated. The baby food composition may be in the form of a prepared food, a drink, a hard finger food, a soft finger food, or a cereal. Also disclosed is an infant formula composition including fucoidan, a protein, and a lipid. The fucoidan may be partially hydrolyzed, and also may be sulfonated. The protein may be derived from quinoa. Also disclosed are infant formula kits to be assembled in the field. The kits may include a substantially dehydrated infant formula composition and a diluting agent. The kit may alternatively include a ready-to-consume infant formula composition and substantially dehydrated additives which may be added to the formula before consumption.

Description

BABY FOOD AND INFANT FORMULA COMPOSITIONS

BACKGROUND OF THE INVENTION

The present inyention relates generally to baby food and infant formula compositions and, more particularly, to baby food and infant formula compositions that include fucoidan. Of the stages of human development, the most important stages have been said to be those at the beginning of life. Because the early stages of life are important for the future and development of the baby, it is important that the baby receive adequate nutrition, and even nutrition that assists in the development of the baby. Physicians and dietitians typically agree that the proper diet for an infant is that provided by nature, and often the most convenient for the mother and baby, that is, human milk. Human milk typically contains all of the essential nutrients in the necessary proportions needed for proper development of the infant. Human milk may even change in composition as the infant ages. For example, the first human milk that is provided is known as colostrum, which is followed by a mature milk. Human milk contains the ω-3 fatty acid, docosahexaenoic acid (DHA). Human milk typically includes about 3 percent fats, 7.5 percent carbohydrates, 1.2 percent proteins, and 0.25 percent mineral salts. The proteins include casein and lactalbumin, in the amounts of about 0.4 and 0.8 percent of the milk, respectively.

There are many reasons or situations in which an infant is not given human milk. For example, some mothers are not capable of producing milk, or the mother has other reasons for not providing human milk for the infant, such as lack of time, fear of harm to her body and/or breasts, inconvenience, and so forth. Alternatively, the mother may not be available to the infant because of adoption, hospitalization of the mother, and so forth. Further, after a certain period of time, the child is not given human milk, and moves on to eating other foods.

As a result of babies not being fed human milk, another form of aliment must be available to the baby. One popular aliment is cow's milk. Though relatively convenient in many parts of the world, cow's milk is not the best substitute for human milk, especially for infants. Cow's milk contains about 4 percent fat, 4 percent carbohydrates, 4.3 percent protein, and 0.65 percent mineral salts. Further, the cow's milk includes about 4 percent casein and 0.3 percent lactalbumin. As such, cow's milk contains fewer carbohydrates, much more casein, and less lactalbumin than human milk. Cow's milk also lacks other nutrients needed by babies, such as DHA.

As a result, what is needed is an infant formula capable of replacing human milk, and a baby food formula capable of maintaining the nutritional benefits of human milk in the food-based diet of the baby. Some researchers have found ways to modify cow's milk, or create a food that is more akin to human milk. This research is represented in the following patents and patent applications.

An infant formula the mimics human milk is difficult to produce because of the difficulty to produce many of the components of human milk, especially the living cells that may be present in human milk, and components with unique molecular formulas that are difficult to reproduce. Further, infant formula typically must be preserved before it is consumed. The requirements for preservation of the infant formula make it difficult for the infant formula to mimic human milk.

For example, Masor discloses, in U.S. Patent No. 5,700,590, an improved enteral formula containing ribo-nucleotide equivalents (RNA, mono-, di- and triphosphate nucleotides, nucleosides and adducts such as activated sugars) at a level of at least 10 mg/ 100 Kcal (kilocalorie) of formula. More specifically, an infant formula containing at least 10 milligrams of nucleotide equivalents per 100 Kcal of formula where the nucleotide equivalents consist of RNA; mono-, di-, and triphosphate esters of adenosine, cytidine, guanosine, and uridine, and the d-ribose adducts thereof; and wherein the weight ratio of said cytidine nucleotide equivalents to said uridine nucleotide equivalents is 1.5-1 to 2.6:1 ; of said cytidine nucleotide equivalent to said adenosine nucleotide equivalents is 2:1 to 3.9:1; and of said cytidine nucleotide equivalents to said guanosine nucleotide equivalents is 1.75:1 to 2.8:1, is disclosed. The formula comprises carbohydrates, lipids, proteins, vitamins and minerals and four (4) ribo-nucleotide equivalents at specific levels and ratios. This invention also provides a dietary formula that enhances the immune system and alleviates diarrhea.

In a further example, Borschel discloses in U.S. Patent No. 5 ,02 1 ,245, a novel liquid nutritional for use as an infant formula for use in the treatment of infantile colic. The formula comprises protein, fat, carbohydrates and dietary fiber of a concentration of between 3.1 and 14.1 grams of fiber per liter of formula. Also disclosed is a method of treating infants with colic by feeding an infant the formula made in accordance with the invention. Also disclosed is a method for manufacturing the infant formula of the invention.

In yet another example, Nielsen discloses in U.S. Patent No. 1,607,844 the production of a food for infants, children, and invalids, and its principal object is to produce a food that has a nutritive value substantially equal to that of normal human milk. The production includes as its precursors: cow's milk, cereals, sweet whey, mineral salts, orange juice, and vitamins.

In another example, Theuer et al. disclose, in U.S. Patent Application Publication 2003/0207004, baby food compositions comprising about 5% to about 25% egg yolk solids and an acidulant in an acceptable, shelf-stable, baby-food preparation. The acidulant can be an acid, a cultured food substance containing lactic acid, or a fruit or vegetable component that contributes acidity to the composition of a combination thereof. Also disclosed are methods for preparing and using the compositions. The egg yolk solids can serve as delivery vehicles for nutrients such as the polyunsaturated fatty acid, DHA, if the eggs are produced by chickens fed diets high in DHA or DHA precursors.

Increasing the concentration of DHA in hen eggs is disclosed, for example, in U.S. Patent No. 5,415,879 to Oh. According to the Oh patent, chickens are fed a composition including fish oil over a period of time. Modified eggs laid by such chickens contain substantial quantities of omega-3 polyunsaturated fatty acids. The modified eggs are fed to humans with the result that serum cholesterol, serum triglycerides and blood pressure are reduced as compared to humans eating a like number of regular eggs with a subsequent decrease in heart disease. The Theuer patent application publication also discusses the benefits of egg yolks as a part of an infant's diet. Theuer discloses that egg yolks contain substantial levels of nutrients such as high quality protein with all the essential amino acids, many vitamins and minerals, and polyunsaturated fatty acids.

In another example, Theuer further discloses in U.S. Patent No. 6,051,235, baby-food compositions containing ginger which can be used in reducing gastrophageal reflux in infants. The compositions can contain a ginger puree and one or more fruits or vegetables. Also disclosed are methods of making and using the compositions. Baby foods may exist in several different forms. One need only peruse an "infants," or "baby" isle of a supermarket to see the varieties of baby foods. For infants, there are formulas available. The formulas may be purchased for example, in ready-to-use (liquid) form or in powder form that can be dissolved in water before feeding to the infant. These formulas are sold, for example, under the trademark Enfamil^®, (Mead Johnson & Company, Evansville, Indiana). These formulas are available in several varieties, such as milk-based, soy-based, hypoallergenic (for allergies to cow's milk), low iron, lactose-free, sugar-free, including DHA, and so forth. Formulas are available for stages of the infant and/or child's life. For example, also available under the trademark Enfamil^®, is a broad range of products for various ages, such as Premature LIPIL^® for premature infants, Enfamil^® for infants, NEXT STEP^® for toddlers of 9.-24 months, and Kindercal^® for children up to the age of 10.

Other than formula-type infant and baby foods are semi-solid and solid foods for infants and children. Infants typically start eating solid or semi-solid foods at about the age of 6 months. Many of the foods available for this stage are available under the trademark Gerber^® (Gerber Products Company, Freemont, Michigan). Some of the products available under the Gerber^® trademark include juices, cereals, staged foods, finger foods, and organic foods. Some of the juices available include LiquiLites^® liquid or powder (for dissolution with water) electrolytes, fruit juices, vegetable juices, and juice and yogurt blends. Some of the cereals available include rice cereals, oatmeal cereals, barley cereals, cereals with fruit, cereals made with the ingredients of formula, and mixtures of grains and fruits. Typically, the cereals are sold in a dehydrated form (flakes or powders) for rehydration prior to feeding the baby. Many of the cereals available are fortified with vitamins and/or minerals that may be necessary for the development of the baby.

Staged foods come with different ingredients, viscosity, content of solids/chunks, and so forth. For example, under the trademark of Gerber^® are available 1st Foods^®, which are purees of cooked and fortified vegetables or fruits. 2nd Foods^® include prepared cereals, fruits, vegetables, dinners (which include meats), meats, desserts, and tropical fruit desserts. These also may be fortified with vitamins and/or minerals. Further available under the Gerber^® trademark are 3rd Foods^® including prepared cereals, fruits, vegetables, dinners, desserts, and entrees. The entrees include separate sections of different food s.

Also available are "finger foods". Generally, finger foods include any food that the baby can pick up and feed himself. Some examples of finger foods are available under the trademark Gerber^®. These include fruit puffs, veggie puffs, biter biscuits, zwieback toast, veggie wagon wheels, and fruit wagon wheel. These foods are somewhat solid, and shaped such that the baby can pick them up and eat.

One goal common to most baby foods is to include nutrients that the baby needs. Some examples of such nutrients include DHA, the ω-3 fatty acid, arachidonϊc acid (ARA), vitamins, minerals such as iron, and so forth. Many baby foods are available that are supplemented with vitamins, minerals, DHA, and/or ARA. For example, baby foods sold under the trademark Beech Nut^® (Canajoharie, New York), such as First Advantage^®, contain both DHA and ARA.

Though there are many available baby foods with different nutritive advantages, consumer demand for natural-based products has been growing in recent years. Chemical synthesis is perceived as environmentally unsafe. A chemically synthesized ingredient may contain harsh chemicals. Natural products are perceived as pure and mild and superior to chemically synthesized products. Delivering a dietary benefit to babies from plant sources, however, is not trivial. To derive a real benefit from a natural source, not only should a plant or a part of the plant containing a specific active ingredient be identified, but a minimum concentration and/or a specific extract of that plant should be identified that truly delivers a dietary benefit to babies.

Accordingly, consumers demand an effective baby food composition that helps with growth, mental stimulation, proper development, assistance with the immune system, and does not upset the stomach. Further, consumers demand that the baby food composition be based on natural products to promote the beneficial effects herein described.

Fucoidan is a sulfated polysaccharide found in many sea plants and animals and is particularly concentrated in the cell walls of brown algae (Phaeophyceae). Fucoidan is a complex carbohydrate polymer composed mostly of sulfated L-fucose residues. These polysaccharides are easily extracted from the cell wall of brown algae with hot water or dilute acid and can account for more than 40% of the dry weight of isolated cell walls. O. Berteau & B. Mulloy, Sulfated Fucans, Fresh Perspectives: Structures, Functions, and Biological Properties of Sulfated Fucans and an Overview of Enzymes Active Toward This Class of Polysaccharide, 13 Glycobiology 29R-40R (2003). Fucoidan structure appears to be linked to algal species, but there is insufficient evidence to establish any systematic correspondence between structure and algal order. High amounts of α(l -3) and α(l -4) glycosidic bonds occur in fucoidans from Ascυphyllum nodosum. A disaccharide repeating unit of alternating α( 1 -3) and α( 1 -4) bonds represents the most abundant structural feature of fucoidans from both A. nodosum and Fuciis vesiculostts, which are species of seaweed. Sulfate residues are found mainly in position 4. Further heterogeneity is added by the presence of acetyl groups coupled to oxygen atoms and branches, which are present in all the plant fucoidans. Following is a representation of A. nodosum fucoidan:

Fucoidan-containing seaweeds have been eaten and used medicinally for at least 3000 years in Tonga and at least 2000 years in China. An enormous amount of research has been reported in the modern scientific literature, where more than 500 studies are referenced in a PubMed search for fucoidan. The physiological properties of fucoidans in the algae appear to be a role in cell wall organization and possibly in cross-linking of alginate and cellulose and morphogenesis of algal embryos. Fucoidans also have a wide spectrum of activity in biological systems. They have anticoagulant and antithrombotic activity, act on the inflammation and immune systems, have antiproliferative and antiadhesive effects on cells, and have been found to protect cells from viral infection. Further, fucoidan has numerous beneficial functions that heal and strengthen different systems of the body, including anti-viral, anti-inflammatory, anti-coagulant, and anti-tumor properties. A.I. Usov et a!., ^'Polysaccharides of Algae: Polysaccharide Composition of Several Brown Algae from Kamchatka. 27 Russian J. Bio. Chem. 395-399 (2001). Fucoidan has been found to build and stimulate the immune system. Research has also indicated that fucoidan reduces allergies, inhibits blood clotting, fights diabetes by controlling blood sugar, prevents ulcers, relieves stomach disorders, reduces inflammation, protects the kidneys by increasing renal blood flow, and detoxifies the body. Fucoidan also helps to reduce and prevent cardiovascular disease by lowering high cholesterol levels and activating enzymes involved in the beta- oxidation of fatty acids.

A Japanese study found that fucoidans enhanced phagocytosis, the process in which white blood cells engulf, kill, digest, and eliminate debris, viruses, and bacteria. An American study reported that fucoidans increased the number of circulating mature white blood cells. An Argentine study and a Japanese study found that fucoidans inhibited viruses, such as herpes simplex type I, from attaching to, penetrating, and replicating in host cells. A Swedish study is among the many that showed fucoidans inhibit inflammation cascades and tissue damage that may lead to allergies. Other studies, such as one in Canada, found that fucoidans block the complement activation process that is believed to play an adverse role in .chronic. degenerative diseases, such as atherosclerosis, heart attack, and Alzheimer's disease. Two American studies found that fucoidans increase and mobilize stem cells.

Researchers have also determined that fucoidan tends to combat cancer by reducing angiogenesis (blood vessel growth), inhibiting metastasis (spreading of cancer cells to other parts of the body), and promoting death of cancer cells. Certain societies that make brown seaweed part of their diet appear to have remarkably low instances of cancer. For example, the prefecture of Okinawa, where the inhabitants enjoy some of the highest life expectancies in Japan, also happens to have one of the highest per capita consumption rates of fucoidans. It is noteworthy that the cancer death rate in Okinawa is the lowest of all the prefectures in Japan.

Brown seaweed, a ready source of fucoidan, is found in abundance in various ocean areas of the world. One of the purest locations that provides some of the highest yields of fucoidan is in the clear waters surrounding the Tongan islands, where the seaweed is called limu moui. In Japan, hoku kombu {Laminaria japonicά), is said to be particularly rich in fucoidans and is similar to limu moui. The Japanese also consume at least two other types of brown seaweed— wakame and mozuku (Cladosiphon and Nemacystus).

Typically, about four percent by weight of Tongan limu moui is fucoidan. There are at least three types of fucoidan polymer molecules found in brown seaweed. U-fucoidan, having about 20 percent glucuronic acid, is particularly active in carrying out cancer cell destruction. F-fiicoidan, a polymer of mostly sulfated fucose, and G-fucoidan, which contains galactose, both tend to induce the production of HGF cells that assist in restoring and repairing damaged cells. All three types of fucoidan also tend to induce the production of agents that strengthen the immune system. The available infant formulas lack some of the essential benefits needed by infants. For example, currently available infant formulas do not sufficiently mimic human milk. Further, currently available infant formulas may include some synthesized components. Stiil further, currently available infant formulas may not assist in regenerating damaged cells and tissues, promote growth factors, are high in antioxidants, help fight free radicals, and/or slow the unwanted aging processes. What is needed are baby food and infant formula compositions that solve one or more of the problems described herein and/or one or more problems that may come to the attention of one skilled in the art upon becoming familiar with this specification. One of such problems is providing a baby food and an infant formula that assist in anti-aging, regeneration of cells and tissues such as muscles and/or bones, promoting growth factors, promoting vitality and youthfulness, strengthening the immune system, reducing allergies, inhibiting blood clotting, controlling blood sugar, preventing ulcers, reliving stomach disorders, reducing inflammation, protecting the kidneys, lowering cholesterol levels, inhibiting smooth muscle cell proliferation, activating enzymes involved in the beta-oxidation of fatty acids and/or detoxifying the body. Another problem is in providing a baby food composition that includes a natural ingredient that more closely mimic's the effects of human milk.

BRIEF SUMMARY OF THE INVENTION

The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available baby food compositions. According to one illustrative embodiment of the present invention, there is a baby food composition for consumption by, and to provide nutrition to a baby, comprising partially hydrolyzed fucoidan and a carrier. The fucoidan may be sulfonated. The baby food composition may be dehydrated. The baby food composition may further include mangosteen. The fucoidan may be derived from the group consisting of: Japanese mozuku seaweed, Japanese kombu seaweed, Tongan limu moui seaweed, and combinations thereof. The baby food composition may further include an anti-oxidant beyond any that may be present in fucoidan. The baby food composition may further include an electrolyte.

In one illustrative embodiment of the baby food composition, the carrier is a flour. The baby food composition may further include an additional baby food composition in a soft finger food form, comprising partially hydrolyzed fucoidan, fruit, sweetener, and a gelling agent. The flour may be quinoa flour.

In yet another illustrative embodiment, the carrier is a cereal. The cereal may be quinoa. The cereal may be toasted.

In still another illustrative embodiment, the carrier may be a fruit. The carrier may be a vegetable. In another illustrative embodiment, the carrier may be a juice. The baby food composition may further comprise a milk product. The baby food composition of this embodiment may be dehydrated.

In still yet another illustrative embodiment, the present invention includes a baby food composition in the form of a soft finger food, comprising partially hydrolyzed fucoidan, fruit, a gelling agent, sweetener, and quinoa flour, wherein the baby food composition is a gel.

In even another illustrative embodiment, the present invention includes a baby food composition in the form of a prepared food, comprising partially hydrolyzed fucoidan, a food base, and quinoa flour.

In another illustrative embodiment, there is provided an infant formula composition comprising fucoidan, which may be partially hydrolyzed, a protein, and a lipid. The protein may be a derivative of quinoa. The infant formula may further include an ω-3 fatty acid.

According to another illustrative embodiment, the present invention includes a concentrated infant formula composition kit that can be mixed in the field, wherein the kit includes: a concentrated infant formula composition, comprising fucoidan and a lipid; and a diluting agent. The diluting agent may include water and a mineral. The diluting agent may be water and a vitamin. The concentrated infant formula composition may be substantially dehydrated. The concentrated infant formula may be a concentrated liquid. The fucoidan may be partially hydrolyzed. The fucoidan may be sulfonated. The kit may further include a protein derived from quinoa.

According to yet another embodiment, the present invention includes an infant formula composition kit that can be mixed in the field, wherein the kit includes: an infant formula composition, comprising fucoidan and a lipid; and an additive in concentrated form. The fucoidan may be partially hydrolyzed. The fucoidan may be sulfonated. The infant formula composition may further include a protein derived from quinoa. The additive may include a protein derived from quinoa. The additive may include dietary Fiber. Reference throughout this specification to features, advantages, or similar language does not imply that all of the features and advantages that may be realized with the present invention should be or are in any single embodiment of the invention. Rather, language referring to the features and advantages is understood to mean that a specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, discussion of the features and advantages, and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment.

Furthermore, the described features, advantages, and characteristics of the invention may be combined in any suitable manner in one or more embodiments. One skilled in the relevant art will recognize that the invention can be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments of the invention.

These features and advantages of the present invention will become more fully apparent from the following description and appended ciaims, or may be learned by the practice of the invention as set forth hereinafter.

DETAILED DESCRIPTION For the purposes of promoting an understanding of the principles of the invention, specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the invention as illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the invention.

Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "one embodiment," "an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, different embodiments, or component parts of the same or different illustrated invention. Additionally, reference to the wording "an embodiment," or the like, for two or more features, elements, etc. does not mean that the features are related, dissimilar, the same, etc. The use of the term "an embodiment," or similar wording, is merely a convenient phrase to indicate optional features, which may or may not be part of the invention as claimed. i Each statement of an embodiment is to be considered independent of any other statement of an embodiment despite any use of similar or identical language characterizing each embodiment. Therefore, where one embodiment is identified as "another embodiment," the identified embodiment is independent of any other embodiments characterized by the language "another embodiment." The independent embodiments are considered to be able to be combined in whole or in part one with another as the claims and/or art may direct, either directly or indirectly, implicitly or explicitly.

Finally, the fact that the wording "an embodiment," or the like, does not appear at the beginning of every sentence in the specification, such as is the practice of some practitioners, is merely a convenience for the reader's clarity. However, it is the intention of this application to incorporate by reference the phrasing "an embodiment," and the like, at the beginning of every sentence herein where logically possible and appropriate.

In describing and claiming the present invention, the following terminology will be used in accordance with the definitions set out below.

As used herein, "comprising," "including," "containing," "is," "characterized by," and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional, unrecited elements or method steps. "Comprising" is to be interpreted as including the more restrictive terms "consisting of and "consisting essentially of."

As used herein, "partially hydrolyzed fucoidan" means fucoidan that has been hydrolyzed into smaller polymers and oligomers, but not so thoroughly hydrolyzed as to result in complete hydrolysis to substantially primarily monosaccharides.

As used herein, "baby" means an infant, toddler, or child. Unless the terms "infant," "toddler," or "child" are used, then all three are assumed, and contained within the term "baby".

As used herein, "ORAC means "oxygen radical absorbance capacity."

As used herein, "high ORAC value" or similar terms means an ORAC value of at least about 400 per 100 grams of fruit or vegetable. For example, blueberries have an ORAC value of about 2,400 per 100 grams, and the following fruits have ORAC values as shown in parentheses per 100 grams: blackberries (2,036), cranberries (1 ,750), strawberries (1 ,540), raspberries (1 ,220), plums (949), oranges (750), red grapes (739) cherries (670), kiwi fruit (602), and white grapes (446). Other fruits known to have a high ORAC value include black grapes, mangosteen, noni, aronia, wolfberry, and acai, and the like. Further, nutraceutical ingredients known to have high ORAC values include proanthocyanidins, such as from extracts of grape seed and bark of white pine of southern Europe (e.g., pycnogenol, U.S. Patent No. 4,698,360), and curcuminoids. Oligomeric proanthocyanidins (OPC) are illustrative.

As used herein, "Brix" is a scale for measuring the sugar content of grapes, wine, and the like. Each degree of Brix is equivalent to one gram of sugar per 100 ml of liquid. Thus, an I S degree Brix sugar solution contains 18% by weight of sugar. Brix also describes the percent of suspended solids in a liquid. Thus, 95 Brix, for example, denotes a liquid that contains 95% by weight of suspended solids. Brix is measured with an optical device called a refractometer. The Brix system of measurement is named for A.F.W. Brix, a I 9th century German inventor.

As used herein, "pasteurization" means a process named after scientist Louis Pasteur to destroy harmful bacteria that may be present without substantially affecting flavor and food value. For example, one pasteurization process includes heating every particle of milk is heated to not lower than 62.8⁰C (i.e., 145°F) for not less than 30 minutes and promptly cooling the milk. Currently, the most common method of pasteurization in the United States is High Temperature Short Time (HTST) pasteurization, which uses metal plates and hot water to raise temperatures to 71.7⁰C (i.e., 161⁰F) for not less than 15 seconds, followed by rapid cooling. Ultra Pasteurization (UP) is a process similar to HTST pasteurization, but using higher temperatures and longer times. UP pasteurization results in a product with longer shelf life but still requiring refrigeration of milk, but not of acidified foods or nutritional supplements (pH < 4.6). Another method, Ultra High Temperature (UHT) pasteurization, raises the temperature to over 93.3°C (i.e., 200⁰F) for a few seconds, followed by rapid cooling. A UHT-pasteurized product that is packaged aseptically results in a "shelf stable" product that does not require refrigeration until it is opened.

As used herein, "sterilizing" and similar terms means, with respect to nutritional supplements having a pH less than 4.6 and a water activity greater than 0.85, pasteurizing the nutritional supplement and storing at room temperature. With respect to nutritional supplements having a pH greater than 4.6 and a water activity greater than 0.85, "sterilizing¹' and similar terms mean applying heat such that the nutritional supplement is rendered free of microorganisms capable of reproducing in the nutritional supplement under normal non-refrigerated conditions of storage and distribution.

As used herein, "aseptic processing and packaging" and similar terms mean the filling of a sterilized cooled product into pre-sterilized containers, followed by aseptic hermetic sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms. As used herein, "hermetically sealed container" and similar terms mean a container that is designed and intended to be secure against the entry of microorganisms and thereby to maintain the sterility of its contents after processing.

The present invention is drawn toward baby food compositions, which include fucoidan and a carrier such as, for example, baby food cereals, prepared foods, dehydrated foods, drinks, finger foods, and so forth. The baby food compositions may be produced by any method known in the art. Fucoidan

The present invention advances prior art baby food compositions by providing a baby food composition formulated with fucoidan from seaweed, such as limu moui, kombu, or mozuku. The addition of fucoidan to the baby food composition of the present invention serves to provide significant advantages not found in prior art baby food compositions. The fucoi dan-enhanced baby food compositions of the present invention provide many beneficial functions, including simulating human milk, providing for regeneration of cells and tissues; promoting youthfulness; reducing inflammation and the like. In addition, the fucoidan-enhanced baby food compositions of the present invention minimize the unwanted visible signs of both biological and environmental aging. That is, the present dietary supplements slow the unwanted aging process, assist in regenerating damaged cells and tissues, and promote growth factors in the body.

Fucoidan js high in antioxidants that help to fight free radical damage to the body that may lead to cancer. These antioxidants help to fight free radical damage caused by the sun and other changing environmental conditions and elements.

Brown seaweed, a source of fucoidan, grows in many oceans, including off the coasts of Japan and Okinawa, Russian coastal waters, Tonga, and other places. An excellent source of fucoidan is the limu moui sea plant growing in the waters of the Tongan islands. This brown seaweed contains many vitamins, minerals, and other beneficial substances and is particularly rich in fucoidan.

Typically, the brown seaweed grows in long angel hair stems with numerous leaves. The fucoidan ingredient is found in natural compositions on the cell walls of the seaweed, providing a slippery sticky texture that protects the cell walls from the sunlight.

In one embodiment, a kombu-type or mozuku-type seaweed is harvested from the coastal waters of the Tongan islands. These seaweeds can be manually harvested , including stems and leaves, by divers and cleaned to remove extraneous materials. The seaweed is then usually frozen in large containers and shipped to a processing plant. In processing, the heavy outer fibers must first be broken down to provide access to the fucoidan component. If frozen, the seaweed material is first thawed, but if not frozen, then the seaweed material is placed in a mixing vat and shredded, while being hydrolyzed with acids and water. The material may optionally be sulfonated with sulfuric acid to help in breaking down the heavy cell fibers. The mixture is also buffered with citric acid and thoroughly blended to maintain suspension. The material may also be heated at atmospheric or greater than atmospheric pressure while mixing. The resulting puree is tested and maintained at a pH of about 2 to 4 so as to remain acidic, enhancing preservative and stability characteristics.

The puree may be used in preparing baby food and infant formula compositions. Alternately, the' mixture may be refrozen in small containers for later processing. In another example, the puree may be dehydrated. The dehydration may be performed by any means known in the art of food processing, such as vacuum drying, spray drying, heating, freeze drying, and so forth. Dehydrated fucoidan may be in any form known in the art, such as, for example, in the form of a powder, flakes, pellets, and so forth!

According to an illustrative embodiment, the present invention provides a baby food composition formulated with fucoidan compositions from seaweed, such as the limu moui seaweed plant, the Japanese mozuku seaweed, or Japanese kombu seaweed, or mixtures thereof. In another embodiment, the fucoidan may be partially hydrolyzed fucoidan. In yet another embodiment, the fucoidan may be sulfonated. In still another embodiment, the fucoidan compositions are present in selected embodiments in the amount of at least about 0.05 weight percent, or at least about 3 weight percent, or at least about 5 weight percent; and less than about 99 weight percent, or less than about 80 weight percent, or less than about 50 weight percent of the total weight of the baby food composition. According to another illustrative embodiment, the present invention provides an infant formula composition formulated with fucoidan compositions from seaweed, such as the limu moui seaweed plant, the Japanese mozuku seaweed, or Japanese kombu seaweed, or mixtures thereof. In another embodiment, the fucoidan may be partially hydrolyzed fucoidan. In yet another embodiment, the fucoidan may be sulfonated. In still another embodiment, the fucoidan compositions are present in selected embodiments in the amount of at least about 0.05 weight percent, or at least about 3 weight percent, or at least about 5 weight percent; and less than about 100 weight percent, or less than about 80 weight percent, or less than about 50 weight percent of the total weight of the infant formula composition.

In a further embodiment, the partially hydrolyzed fucoidan may be derived from Tongan limu moui, Japanese hoku kombu (Laminariajaponicay, wakame, or mozuku (Cladosipkon and Nemacystus). In still a further embodiment, the partially hydrolyzed fucoidan may be sulfonated. Baby Food Cereals

In one embodiment, the baby food composition includes fucoidan and a carrier, wherein the carrier is a cereal. Generally cereals include the edible seeds of grasses. Baby food cereals; however, include an edible composition in which the edible seeds of grasses have been prepared for consumption by a baby. Cereals include, for example, wheat, rice, maize, millets, sorghums, rye, triticale, oats, barley, teff, wild rice, spelt, quinoa, buckwheat, amaranth, cockscomb, and so forth. Cereals are typically a source of starch (this is how the food energy is stored in cereals), protein, amino acids, dietary fiber, essential fatty acids, and other nutrients.

In one embodiment, the cereal includes quinoa. Quinoa is the seed of a leafy plant that is related to spinach. Quinoa grows best in poor soil and in high altitudes. The ancient Incas cultivated and ate quinoa for many years. Quinoa is native of the Andes mountains, and is now cultivated in the higher elevations of the Rocky Mountains. Quinoa provides many nutrients needed not only by babies, but by all humans.

Interestingly, quinoa includes the amino acid lysine, which most other grains and cereals lack. This makes the proteins of quinoa more complete, and more akin to the proteins of milk. Quinoa has more iron than many other cereals and grains. Quinoa is also an excellent source of potassium, riboflavin, vitamin B6, niacin, thiamin, magnesium, zinc, copper, and manganese.

According to one embodiment, the baby food cereal of the present invention may include a cereal, and fucoidan. Further, the baby food cereal may include additives, nutrients, flavorings, coloring, and so forth. Some of the flavorings may include natural flavorings such as fruits, fruit juices, vegetables, vegetable juices, and so forth. In one embodiment, the baby food cereal of the present invention includes only natural ingredients, such as partially hydrolyzed fucoidan, a cereal, fruits, fruit juices, vegetables, vegetable juices, nutrients, and so forth.

Typically cereals must be processed in some manner before being consumed by a baby. As described in U.S. Patent No. 5,631,032 the starches present in cereals may be modified to be better digested by the baby. In one embodiment, the modification process alters the structure of the links between amylase and amylopectin by mixing the cereal with water, heating to temperature of at least 100⁰C, cooling the mixture, adding enzymes for treatment of hydrolysis for the whole mixture or a part thereof, and drying the mixture. The enzymes may be deactivated.

In an alternative embodiment, the cereal may be toasted. This embodiment may be used together with, or alternatively to the modification process described above. Toasting may be carried out at the temperature of from about 120-150⁰C for 15-90 minutes. The toasting and/or modification of starches may be performed before or after the addition of fucoidan. The fucoidan may be in slurry or dehydrated form. Additional process steps may include inactivating the enzymes, re-heating, addition of chemical reagents, pH adjustments, addition of additional components such as vitamins, minerals,, edulcorants, fats, sweeteners, milk, water, fruits, vegetables, or other nutrients, forming into flakes, pellets, powder, dehydrating, spray-drying, and so forth.

The cereal, fucoidan, and additional components may be mixed. Once the components are mixed, the baby food cereal may be consumed, packaged for consumption, or dehydrated. The dehydration may be performed by spray drying, vacuum drying, heating, freeze drying, or any other method of dehydration. The dehydrated baby food cereal may be in the form of peflets, flakes, or powder. The dehydrated baby food cereal may then be consumed, packaged, or reconstituted with a liquid such as milk, water, fruit juice, vegetable juice, and so forth. In one embodiment, the dehydrated baby food cereal is packaged, and later reconstituted by the consumer, whereby it may be consumed. The reconstitution may be by adding liquid.

The additional components may be added to the baby food cereal at any suitable point, and in any suitable form. The additional components may be in a dehydrated form, such as powdered banana, powdered apple, vitamins, minerals and so forth. The dehydrated additional components may be added to the hydrated baby food composition, which may then be dehydrated. Alternatively, the dehydrated additional components may be added to the dehydrated baby food composition, followed by mixing. In another embodiment, the additional components may be in a hydrated form, such as banana, apple, fruit, vegetables, liquid vitamins, liquid minerals, and so forth. The hydrated additional components may be added to the hydrated baby food composition, which may then be dehydrated. Alternatively, the hydrated additional components may be added to the dehydrated baby food composition as the composition is reconstituted.

Dehydrated baby food cereals have several advantages. For example, they may weigh less than the hydrated baby food cereal. Thus, the dehydrated baby food cereal costs less to ship. Further, dehydrated baby food cereal may require less volume for the same nutritional value than hydrated baby food cereal. Dehydrated baby food cereal may have a longer shelf life due to its lack of water, which is needed by many of the microbes that cause the spoilage of food. Further, the consumer may use any number of liquids to reconstitute the dehydrated baby food cereal, and the consumer may reconstitute the dehydrated baby food cereal with a liquid of the consumer's choosing, resulting in an edible composition at a desired temperature.

Hydrated baby food cereals also have advantages. One of which is convenience. A hydrated baby food cereal is ready to eat as it is, and consumers often desire a product that is ready to use when it is purchased. Further, if the baby food cereal is pasteurized and sealed, it may have a substantially long shelf life without substantial risk of spoilage. Thus both hydrated and dehydrated baby food cereal compositions are within the scope of the present invention.

The baby food composition in the form of a cereal includes at least about 0.1 weight percent, or at least about 1 weight percent, or at least about 5 weight percent, and less than about 99 weight percent, or less than about 90 weight percent, or less than about 80 weight percent fucoidan. The balance of the composition may include the carrier and the additional components, if the additional components are added. Drink

According to one embodiment of the present invention is a baby food composition in the form of a drink. The baby food composition according to this embodiment may include a carrier, and fucoidan, wherein the carrier is a juice. The juice may be a fruit juice or a vegetable juice. The juice may be prepared by any means known in the art of processing foods. In one embodiment, the juice is one from a fruit with a high ORAC value such as the juice of blackberries, cranberries, strawberries, raspberries, plums, oranges, red grapes, cherries, kiwi fruit, white grapes, black grapes, mangosteen, noni, aronia, wolfberry, acai, and the like.

In one embodiment, the baby food drink includes a milk product. The milk product may be, for example, a yogurt, milk, butter, cream, buttermilk, cheese, and so forth. According to one particular embodiment, the milk product is yogurt. The baby food juice with yogurt may be in the form of a smoothie or shake, that is, it is more viscous than typical fruit juice.

The baby food composition in the form of a drink may include any of the additional components listed below under the appropriate heading. Additionally, baby food juice may include added electrolytes. Electrolytes may help to regulate bodily fluid levels, and may be necessary for proper functioning of the heart, muscles, and other organs. The electrolytes may include any edible salt, acid, or base. Some examples of electrolytes may include salts, acids, or bases of sodium, calcium, chlorine, magnesium, potassium, chloride, bicarbonate, and so forth.

The baby food composition in the form of a drink may be dehydrated for later reconstitution. The baby food composition may be dehydrated by any means known in the art, such as spray drying, vacuum drying, heating, freeze drying, and so forth. In one embodiment, the baby food composition is separately dehydrated (that is, some components are separately dehydrated) before the components are mixed. For example, the partially hydrolyzed fucoidan slurry may be dehydrated, and added to a dehydrated fruit or vegetable. Dehydrated fruits and vegetables are commercially available in powder form, for example, from lndo World Trading Corporation (Badarpur, New Delhi, India), and include banana powder, papaya powder, tomato powder, pineapple fruit juice powder, orange juice powder, mango juice powder, grape fruit juice powder, ginger powder, and the like. Additional components may also be added to the dehydrated partially hydrolyzed fucoidan and dehydrated fruit or vegetable. For example, powdered electrolytes, vitamins, minerals, sweeteners, and the like may be added. The powder mixture may then be consumed or rehydrated by the addition of a liquid such as water, milk, fruit juice, and so forth and may then be consumed.

The baby food composition in the form of a . drink includes at least about 0.1 weight percent, or at least about 1 weight percent, or at least about 5 weight percent, and less than about 99 weight percent, or less than about 90 weight percent, or less than about 80 weight percent fucoidan. The balance of the composition may include the carrier and the additional components, if the additional components are added. Prepared Foods

Prepared foods may include those commonly available in readily edible format. Prepared foods typically are available in a slurry or paste form, and sold in single-serving containers. The prepared food of the present invention includes fucoidan and a carrier, wherein the carrier may be a food base.

The food base may be any that is edible by babies. Some examples of food bases may include applesauce, bananas, peaches, pears, prunes, carrots, green beans, peas, squashes, potatoes, sweet potatoes, berries, cherries, grapes, apricots, broccoli, oranges, pineapples, plums, spinach, corn, soy, chicken, noodles, rice, turkey, cheese, macaroni, beef, lamb, ham, veal, and so forth. The food base may be any food or combination of foods prepared in such a manner that it may be consumed by a baby. To be prepared in such a manner, the food may undergo any of the following exemplary processes, or others known in the art of food processing: cooking, roasting, broiling, grilling, boiling, blanching, stewing poaching, sautόing, frying, parboiling, steaming, caramelizing, glazing, braising, pan roasting, toasting, reducing, rendering, scalding, blending, pureeing, pressing, sieving, emulsifying, grinding, grating, crushing, juicing, whipping, kneading, rolling, basting, mashing, cutting, mincing, tenderizing, softening, thinning, thickening, pasteurizing, homogenizing, separating, chopping, cleaving, slicing, and so forth. The food base may include a flour. The flour may be the flour of a grain, cereal, or nut, such as, for example, red wheat, white wheat, semolina, spelt, rye, barley, oat, rice, maize, millets, sorghums, triticale, tefF, wild rice, quinoa, buckwheat, amaranth, cockscomb, and so forth. In one embodiment, the flour includes flour of quinoa. The food base may include a food with a high e value such as, for example, blackberries, cranberries, strawberries, raspberries, plums, oranges, red grapes, cherries, kiwi fruit, white grapes, black grapes, mangosteen, noni, aronia, wolfberry, acai, and the like. The prepared food may also include any of the additional components listed herein.

The prepared food may be dehydrated. The step of dehydrating may be performed by any dehydrating technique known in the art of processing foods. Dehydration may be done, for example, by spray drying, vacuum drying, freeze drying, heating, and so forth. In one particular embodiment, the components of the prepared food may be dehydrated prior to mixing the separate components. For example, dehydrated potatoes and dehydrated fucoidan may be mixed to form a dehydrated prepared baby food composition. For use, this baby food composition may be reconstituted by the addition of a liquid such as water, milk, vegetable juice, fruit juice, gravy, base, stock, and so forth.

The ba&y food composition in the form of a prepared food includes at least about 0.1 weight percent, or at least about 1 weight percent, or at least about 5 weight percent, and less than about 99 weight percent, or less than about 90 weight percent, or less than about 80 weight percent fucoidan. The balance of the composition may include the carrier and the additional components, if the additional components are added.

Finger Foods

According to yet another embodiment, the baby food composition of the present invention may be in the form of a finger food. The finger food includes fucoidan. The finger food may include a carrier such as a cereal, a grain, soy, a nut flour, and the like. The finger food of the present invention may be in any form that a baby can handle and place in her mouth. The finger food may be hard or soft, large or bite-sized. One of the purposes of a finger food is to help the baby with teething. Hard finger foods may be better suited to assist the tooth in breaking out of the gums. Another purpose of finger food is to help the baby learn to chew food. A soft or a tough finger food may be best suited to this end. Accordingly, the present invention is drawn toward both hard and soft finger foods.

In one embodiment, the finger food is of a hard form. In this embodiment, the finger food includes fucoidan, and a carrier. The carrier may include flour. The flour may be of any grain capable of making a flour. Some representative grains may include, for example, red wheat, white wheat, semolina, spelt, rye, barley, oat, rice, maize, millets, sorghums, triticale, teff, wild rice, quinoa, buckwheat, amaranth, cockscomb, and so forth. The grain may be ground until it is in the form of a flour. The grain may be whole, bleached, or separated. The finger food may also contain any of the additional components described herein. The finger food may also include a sweetener. The finger food may include a nutraceutical having a high ORAC value such as, for example, blackberries, cranberries, strawberries, raspberries, plums, oranges, red grapes, cherries, kiwi fruit, white grapes, black grapes, mangosteen, noni, aronia, wolfberry, acai, and the like. In one particular embodiment, the flour includes the flour of quinoa. The finger food in hard form may be prepared by combining a liquid, the flour, the fucoidan, and the alternative ingredients, together with a leavening agent. The finger food may include a fat such as butter, oil, shortening, lard, and the like. The leavening agent may include a chemical or a biological leavening agent. Some examples of chemical leavening agents include baking powder, baking soda, and so forth. Some examples of biological leavening agents include yeasts, bacteria, and so forth. The relative amounts of each of the components to make a hard finger food could be calculated by one skilled in the art to make a dough. The dough may then be cooked to form a hard finger food using a technique such as baking, frying, boiling, broiling, grilling, and so forth, for a time and at a temperature that may be easily found by one skilled in the art. A soft finger food may be in the form of, for example, a dehydrated fruit food product. The soft finger food includes fucoidan and a carrier. The soft finger food may include fruits and/or fruit juices as the carrier. The soft finger food may further include a nutraceutical with a high ORAC value such as, for example, blackberries, cranberries, strawberries, raspberries, plums, oranges, red grapes, cherries, kiwi fruit, white grapes, b]ack grapes, mangosteen, noni, aronia, wolfberry, acai, and the like. The soft finger food may include any of the optional components as described herein. The soft finger food may include sweeteners. The soft finger food may include thickeners such as gluten, starch, or the like. The soft finger food may include a gelling agent.

The gelling agent may be formulated to form a gel upon cooling, heating, curing, drying, or so forth. The type and amount of gelling agent in the soft finger food may be calculated such that the resultant soft finger food may be handled by a baby without the gel breaking, but soft enough to be chewed by a baby with or without teeth. This calculation is within the ability of one skilled in the art. The amount of gelling agent may be at least about 0.01 weight percent, or from about 5 weight percent, and less than about 15 weight percent, or less than about 10 weight percent. Some examples of gels that gel upon cooling include carrageenan, gelatin, gellan gum, agar, alginates, and so forth, which may be used singly or in combination. Examples of alginates include alkali metal alginates such as sodium alginate, alkaline earth metal alginates such as calcium alginate, and so forth. Some general gelling agents include carbohydrate gel forming polymers, such as pectin, gel forming starches, alginates, agar, and so forth.

An emulsifier such as glyceryl monostearate may be present in the soft finger food to maintain product softness over time. The emulsifier may be present in an amount of from about 0.01 to about 3 weight percent. Other emulsifiers could also be used such as glycerol esters, diacetyl tartaric acids, esters of monoglycerides, mono and di-glycerides, polyglycerol esters, polysorbate, propylene glycol esters, rice extract esters, sodium stearoyl-2-lactylate, sorbitaπ esters, sugar esters, acetylated monoglycerides, lecithin, or combinations thereof.

The soft finger food may include a humectant such as glycerin for moisture retention in an amount of from about 0.01 to about 2 weight percent. Other examples of hurnectants that could be used include sorbitol solution, a mixture of glycerin and sorbitol, fructose, propylene glycol, or combinations thereof.

A glazing agent such as carnauba wax and beeswax may also be present in the soft finger food in an amount of from about 0.01 to about 2 weight percent, or from about 0.01 to about 0.5 weight percent.

The soft finger food may include a bulking agent configured to add bulk. The bulking agent may be a dextrin, maltodextrin, starch, a modified starch, a flour, or other bulking agent known in the art. In one embodiment, the bulking agent is a flour of a grain or cereal such as, for example, red wheat, white wheat, semolina, spelt, rye, barley, oat, rice, maize, millets, sorghums, triticale, teff, wild rice, quinoa, buckwheat, amaranth, cockscomb, and so forth. In one particular embodiment, the flour is a flour of quinoa. The amount of bulking agent to be provided should be sufficient to provide the desired bulk, but less than enough to sufficiently diminish the desired flavor of the finger food. The bulking agent may be present in the amount of at least about 0.01 weight percent, or at least about 3 weight percent; and less than about 2 5 weight percent, or less than about 10 weight percent.

The soft finger food may be prepared by partially dehydrating the components of the soft finger food. The components may be mixed in a hydrated form, shaped into the desired shape (which may include a shape, a sheet, a stick, or any desired shape), and partially dehydrated using a method that does not substantially disturb the shape. U.S. Patent Application Publication No. 2005/0191405 to Okos describes methods for forming, shaping and gelling food products.

In one embodiment, the soft finger food may be dehydrated by vacuum drying, freeze drying, heating, simple evaporation, and like techniques until the desired state of dehydration is reached. In one embodiment, a product akin to fruit leather is made using the above technique. In yet another embodiment, a nibs of the soft finger food are prepared using the above technique. Jn still another embodiment, sticks of the soft finger food are prepared by making a sheet form of the soft finger food, followed by tightly rolling the sheet into a stick form. The soft finger food may be consumed in this form. In one embodiment, the soft finger food is formed using a gelling agent. In this embodiment, the soft finger food may be prepared without drying finger food using the above techniques, but the soft finger food may simply cure, or set up over time.

In one embodiment, hard fingeτ food includes pieces, such as nubs of the soft finger food prepared according to the above techniques. This finger food may help with teething due to the presence of the hard phase, as well as the chewing due to the presence of the soft phase of the finger food. The baby food composition in the form of a finger food includes at least about 0.1 weight percent, or at least about 1 weight percent, or at least about 5 weight percent, and less than about 99 weight percent, or less than about 90 weight percent, or less than about 80 weight percent fucoidan. The balance of the composition may include the carrier and the additional components, if the additional components are added. Protein The infant formula of the present invention may include at least about 0.01 weight percent, or at least about 5 weight percent, and less than about 20 weight percent, or less than about 16 weight percent protein. Protein is an important building block of growing babies, and an important nutrient for life. Generally, proteins are high-molecular-weight organic compounds consisting of amino acids joined by peptide bonds. Amino acids have both a carboxyl group and an amino group. A peptide bond is a bond between the carboxyl group of one molecule and the amino group of another molecule. In food, proteins serve as the source of amino acids. Twenty amino acids make up DNA, are called standard amino acids, and include alanine, cysteine, aspartic acid, glutamic acid, phenylalanine, glycine, histidine, isoleucine, lysine, leucine, methionine, asparagine, proline, glutamine, arginϊne, serine, threonine, valine, tryptophan, and tyrosine. Protein sources that contain any or all of the standard amino acids may be used in the infant formula of the present invention. Some protein sources include, for example, animal sources such as milks, meats, hooves, fish, and so forth; plant sources such as grains, cereals, soy, and so forth; synthesized; and so forth.

Cow's milk may be a protein source for the infant formula of the present invention. U.S. Patent No. 1 ,607,844 to Nielsen teaches a method of including proteins from cow's milk for an infant formula. Further, the Nielsen patent discloses isolating the protein lactalbumin from sweet whey, and including this protein in the infant formula such that the balance of proteins more closely mimics that of human milk.

Some specific sources of protein that may be included in the infant formulas of the present invention may include, for example, soy protein (in the form of soybean meal, or soybean hulls, for example), isolated soy protein, whey protein, grain proteins (such as red wheat, white wheat, semolina, spelt, rye, barley, oat, rice, maize, millets, sorghums, triticale, teff, wild rice, quinoa, buckwheat, amaranth, cockscomb, and so forth), sodium caseinate, calcium caseinate, casein hydrolysate, whole milk, skim milk, buttermilk, condensed milk, evaporated milk, milk solids non-fat, pea proteins, hemp proteins, bean proteins, lupin proteins, rice protein, cottonseed meal, wheat middlings, com byproducts, microbial protein (such as, for example, torula yeast, brewer's yeast, and so forth), meat meal, poultry meal, egg proteins, blood meal, feather meal, fish meal, and so forth.

On particularly good source of protein includes quinoa. The benefits of quinoa, described above, make quinoa and derivatives thereof a good source of nutrients for the infant formula of the present invention. In one embodiment, the protein includes quinoa or a derivative thereof. The quinoa may be a quinoa flour, quinoa meal, and the like.

In another embodiment, the protein is a derivative of soy. Soy is another good source of proteins that are usable by infants. One particularly good source of protein from soy is soy protein isolate. Soy protein isolate is a product of defatted soy beans, which have had almost all of the other components of the soy bean removed. Most of the carbohydrates are also removed, resulting in a substantially taste-free substance. Soy protein isolate typically include at least about 90 weight percent protein. Soy protein isolate is commercially available in powder form from The Solae Company, St. Louis, Missouri.

In yet another embodiment, the protein is a protein derived from milk. Milk derivatives include milk, milk powder, cheeses, yogurts, creams, butters, and the like. The milk may be any mammalian milk such as, for example, human milk, bovine milk, horses milk, goat milk, and the like. The protein may be a whole protein and/or a protein hydrolysate. Protein hydrolysates may be formed by hydrolyzing a material that includes a milk protein. Lipid

The infant formula of the present invention may include at least about 0.01 weight percent, or at least about 5 weight percent, and less than about 50 weight percent, or less than about 25 weight percent of a lipid. Lipids are typically somewhat water insoluble or non-polar compounds of biological origin. Lipids include waxes, fatty acids, fatty-acid derived phospholipids, sphϊngolipids, glycolipids and terpenoids, such as retinoids and steroids.

The lipid may be derived from oleic oil, oleo oil, coconut oil, babassu oil, a seed oil such as soybean oil, corn oil, peanut oil, sunflower seed oil, safflόwer oil, cottonseed oil, milk fats, egg fats, and so forth, and/or derivatives thereof. The lipid may be chosen from any of the edible fats and/or fatty acids known. Several lipids are discussed in patents and patent applications. One example is U.S. PatenfNo. 6,863,918 to Bindels. The lipids of this patent include all fatty acid triglycerides known for use in food products. Fatty acid triglycerides generally comprise a glyceride molecule to which are attached, by means of ester bonds, three fatty acid residues, which may be the same or different, and which are generally chosen from saturated and unsaturated fatty acids containing 6 to 26 carbon atoms, including but not limited to Iinoleic acid, a-linolenic acid, oleic acid, palmitic acid (C 16) and/or stearic acid (CI S).

The lipids described in U.S. Patent No. 4,670,285 to Clandinin may be used in the infant formulas of the present invention. The lipids according to the Clandinin patent also may include certain fatty acids. These fatty acids include C20 and C22 ω-6 fatty acids and C20 and C22 ω-3 fatty acids. The fatty acids may be derivatives of egg yolk lipids blended with coconut oil and/or soybean oil. The fatty acids may be derivatives of red blood cell membranes. Alternatively, the fatty acids may be from fish or marine oils, such as, for example, oils from tilapia, menhaden, herring, caplin, and mixtures thereof. To more closely mimic human milk, the fatty acids may be blended with oils such as, for example, coconut oil, soybean oil, cocoa oil, palm oil, oleo oil, sunflower oil, and mixtures thereof. Carbohydrate

The infant formulas of the present invention may include a carbohydrate. Generally, carbohydrates are compounds that consist of monosaccharide sugars. Carbohydrates have varying chain lengths. The general formula for carbohydrates is C_1n(H₂O)_n. In living organisms, carbohydrates are important sources of energy. Carbohydrates may be classified by the number of sugar unit into monosaccharides (glucose, for example), disaccharides (saccharose, for example), oligosaccharides, and polysaccharides (starch, glycogen, and cellulose, for example).

The carbohydrates of the present invention may include any that are used in the food industry. Some examples of the carbohydrates that may be used in the infant formulas of the present invention may include: glucose, glucose polymers, dextrose, maltose, maltodextrin, maltotriose, lactose, galactose, sucrose, sucanat, arabinose, ribose, xylose, fructose, levulose, psicose, sorbose, tagose, and sorbitol, and combinations thereof. The carbohydrates may be added as a component of another additive, such as, for example, refined sugar, brown sugar, molasses, corn syrup, maple syrup, fruit juices, fruit syrups, and other commercially available carbohydrates. The carbohydrates may come from the fucoidan. The infant formulas of the present invention may include at least about 5 weight percent, or at least about 8 weight percent, and less than about 15 weight percent, or less than about ] 1 weight percent total carbohydrates.

Fiber, also dietary fiber, is a carbohydrate. Fibers are within the class of polysaccharides, and are generally carbohydrates that cannot be digested. Fiber is present in most plants that are eaten for food, such as fruits, vegetables, grains, and legumes. The consumption of fiber in daily diet has been shown to increase various aspects of health, including: reducing the risk of heart disease, reducing the risk of type 2 diabetes, reducing the risk of diverticular disease, and reducing constipation. Though infants typically do not start to ingest fiber as part of their diet, U.S. Patent No. 5,021,245 to Borschel illustrates an infant formula which includes fiber, and discloses a method for treating colicky infants by feeding them formula with fiber. The fiber concentration of the infant formula of the Borschel patent may be from about 3.5 to about 14 grams of fiber per liter of formula. In one particular embodiment, the infant formula is directed for an infant of at least 6 months of age. Infants at such an age may need fiber, or may be able to have fiber as a part of their regular diet. The infant formula of this embodiment includes fiber in the amount of from about 0.2 to about 2 weight percent.

The total carbohydrates of the infant formulas of the present infant formula may include the fiber. In one embodiment, the fucoidan contains carbohydrates and fiber. In one embodiment, additional carbohydrates and/or fiber are included in the formula. The sources of fiber may include any fiber source known in the food arts. In one particular embodiment, the fiber includes a soy polysaccharide. Additional Components

In addition to the other components of the various embodiments of the present invention, there are several other components that may be included in the baby or infant foods. There may be other natural components added to the baby food composition. These natural components may include, for example, mangosteen, honey, aloe, sage, clove, ginger, rhubarb, sesame, chamomile, propolis, thyme, lavender, flower or blossom oils, olive oil, palm oil, coconut oil, beeswax, and so forth. One particularly beneficial natural ingredient is a derivative of the mangosteen plant. According to one embodiment, the present invention includes from about 0.01 to about 10 weight percent of a derivative of the mangosteen plant.

The mangosteen plant (Garcinia mangostana L.) is a tropical fruit-bearing plant named after the French explorer Laurent Garcin. Many of the benefits of the mangosteen plant and its derivatives are described in U.S. Patent No. No. 6,730,333. Over the years, the mangosteen plant has been used in a number of different ways. The timber is used for cabinets, building materials, fencing and furniture. The pericarp, containing pectin, tannins, resins and a yellow latex, is used in tanning and dyeing leather black. The fruit pulp is mostly used as a dessert, but can also be canned or made into preserves. However, when removing t- he fruit pulp from the rind, care must be taken to prevent the tannins and resins of the cut pericarp from contacting the fruit pulp. The mangosteen rind, leaves, and bark have also been used as ingredients in folk medicine In areas where the plant grows indigenously. The thick mangosteen rind is used for treating catarrh, cystitis, diarrhea, dysentery, eczema, fever, intestinal ailments, itch, and skin ailments. The mangosteen leaves arc used by some natives in teas and other decoctions for diarrhea, dysentery, fever, and thrush. It is also known that concoctions of mangosteen bark can be used for genitourinary afflictions and stomatosis.

Some of the medicinal properties of the Garcinia mangostana L. plant have been the subject of pharmacological and clinical studies. These studies have isolated chemical constituents in the mangosteen leaves, wood, pericarp and seed aril, which were found to contain the following biologically active compounds, among others: l,6-dihydroxy-3-methoxy-2-(3-methyl-2-butenyl) xanthone, l,5,8-trihydroxy-3- methoxy-2-(3- τnethyl-2-butenyl) xanthone, maclurin, 1 ,3,6,7-tetrahydroxy xanthone, 1,3,6,7-tetrahydroxy xanthone-O-β-D-glucoside, chrysanthemin, cyaniding-3- O-β-D-sophoroside, S-deoxygartanin, 1,5- dihydroxy-2-isopentenyl-3- methoxy xanthone, l,7-dihydroxy-2-isopentenyl-3-methoxy xanthone, 5,9- dihydroxy-8-methoxy-2,2-dimethyl-7-(3-methylbut-2-enyI)2(H), 6(H)-pyrano- (3,2,6)-xanthen-6-one, fructose, garcinoπe A,B,C, D and E, gartanin, glucose, cis-hex-3-enyl acetate, 3-isomangostin, 3- ϊsomangostin hydrate, 1-isomangostin, 1 -isomangostin hydrate, kolanone, mangostin, β-mangostin, a- mangostin, mangostin-3,6-di-O-gIucoside, normangostin, sucrose, tannins, BR-xanthone-A, BR-xanthone-B, calabaxanthoπe demethylcalabaxanthone^-Cγ.γ-dimethylallyO-l .T-dihydroxy-S- methoxyxanthone, 2,8-bis- (γ,γ~dimethylallyl)-l ,3,7- trihydroxyxanthone, 1, 3,5.8-tetrahydroxy-2,4-diprenylxanthone, and mangostanol. Many of these chemical constituents are xanthomes, which are biologically active compounds that are receiving increasing interest in pharmacological studies for a variety of health benefits.

The infant formula composition may include a viscosity improving component. Viscosity improving components are commonly known it the food arts, and any of these may be included in the infant formulas of the present invention. The viscosity improving components may include those based on carbohydrates such as starches, starch derivatives and the like. Some particular viscosity improving components may include, for example, pregelatinized starches such as prege\atinized potato starch. The amount of viscosity improving components that may be used depends on the other components present in the formula such that the infant formula is from about 20 to about 100 cps as measured in a Brookfield viscometer at 30 rpm. Viscosity improving compositions and the appropriate amounts thereof are described, for example, in U.S. Patent No. 6,863,918 to Bindels, as well as in EP 0 846 422 to Martinez.

The use of a viscosity improving component may -provide several advantages, including, but not limited to prevention or reduction of regurgitation and/or excessive aerophagia (burps). The baby food and infant formula compositions may also include nutraceutical components having a high ORAC value. Free radicals are very reactive and highly destructive compounds in the body. Antioxidants that can be used in dietary supplements include β-carotene, vitamin E, vitamin C, //-acetyl cysteine, α-lipoic acid, selenium, and the like. Antioxidants having a high ORAC value are particularly desirable. Illustratively, nutraceutical antioxidants of high ORAC value that can be used in the present invention include concentrates of grape (red, black, or white), blueberry, acai fruit, raspberry, blackberry, strawberry, plum, orange, cherry, kiwi fruit, currant, elderberry, black currant, cranberry, mangosteen, noni, aronia, wolfberry, and mixtures thereof. Other high ORAC nutraceutical ingredients include proanthocyanidins, such as oligomeric proanthocyanidins, curcumfnoids, and the like.

The baby food and infant formula compositions may also include minerals such as, for example, iron, chloride, iodine, magnesium, zinc, selenium, copper, calcium, manganese, silicon, molybdenum, vanadium, sulfur, boron, nickel, tin, phosphorous, chromium, potassium, silver, gold, and so forth. Minerals serve a wide variety of essential physiological functions ranging from structural components of body tissues to essential components of many enzymes and other biological important molecules. Minerals are classified as micronutrients or trace elements on the basis of the amount present in the body. The seven micronutrients (calcium, potassium, sodium, magnesium, phosphorus, sulfur, and chloride) are present in the body in quantities of more than five grains. Trace elements, which include boron, copper, iron, manganese, selenium, and zinc are found in the body in quantities of less than five grams.

Calcium is the mineral element believed to be most deficient in the diet in the United States. Calcium intakes in excess of 300 mg per day are difficult to achieve in the absence of milk and dairy products in the diet. This is far below the recommended dietary allowance (RDA) for calcium (1000 mg per day for adults and children ages one to ten, 1200 mg per day for adolescents and pregnant and lactating women, which equates to about four glasses of milk per day). In fact, it has been reported that the mean daily calcium intake for females over age 12 does not exceed 85 percent of the RDA. In addition, during the years of.peak bone mass development (18 to 30), more than 66 percent of all U.S. women fail to consume the recommended amounts of calcium on any given day. After age 35, this percentage increases to over 75 percent.

Although the general public is not fully aware of the consequences of inadequate mineral intake over prolonged periods of time, there is considerable scientific evidence that low calcium intake is one of several contributing factors leading to osteoporosis. In addition, the dietary ratio of calcium to phosphorous (Ca:P) relates directly to bone health. A Ca to P ratio of 1 :1 to 2:1 is recommended to enhance bone marrowization in humans. ^' Such ratios are difficult to achieve absent an adequate dietary supply of milk and dairy products, or an adequate supply of calcium and other minerals for the lactose- intolerant segment of the population. , Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Deficits are accompanied by a variety of structural and functional disturbances. The average 70-kg adult has about 2000 rnEq of magnesium in his body. About 50% of this magnesium is found in bone, 45% exists as an intracellular cation, and 5% is in the extracellular fluid. About 30% of the magnesium in the skeleton represents an exchangeable pool present either within the hydration shell or on the crystal surface. Mobilization of the cation from this pool in bone is fairly rapid in children, but not in adults. The larger fraction of magnesium in bone is apparently an integral part of bone crystal.

The average adult in the United States ingests about 20 to 40 mEq of magnesium per day in an ordinary diet, and of this about one third is absorbed from the gastrointestinal tract. The evidence suggests that the bulk of the absorption occurs in the upper small bowel. Absorption is by means of an active process apparently closely related to the transport system for calcium. Ingestion of low amounts of magnesium results in increased absorption of calcium and vice versa.

Magnesium is a cofactor of all enzymes involved in phosphate transfer reactions that utilize adenosine triphosphate (ATP) and other nucleotide triphosphates as substrates. Various phosphatases and pyrophosphatases also represent enzymes from an enormous list that are influenced by this metallic ion.

Magnesium plays a vital role in the reversible association of intracellular particles and in the binding of macromolecules to subcellular organelles. For example, the binding of messenger RNA (mRNA) to ribosomes is magnesium dependent, as is the functional integrity of ribosomal subunits. Certain of the effects of magnesium on the nervous system are similar to those of calcium. An increased concentration of magnesium in the extracellular fluid causes depression of the central nervous system (CNS).

Hypomagnesemia causes increased CNS irritability, disorientation, and convulsions. Magnesium also has a direct depressant effect on skeletal muscle. Abnormally low concentrations of magnesium in the extracellular fluid result in increased acetylcholine release and increased muscle excitability that can produce tetany. Boron is required by the body in trace amounts for proper metabolism of calcium, magnesium, and phosphorus. Boron helps brain function, healthy bones, and can increase alertness. Boron is also useful for people who want to build muscle. Boron is known to help prevent postmenopausal osteoporosis. Further, a relationship has been shown between a lack of boron in the diet and the chances of developing arthritis. R.E. Newnham, 46 journal of Applied Nutrition (1994). Chromium is an important trace element wherein the lack of sufficient chromium in the diet leads to impairment of glucose utilization, however, disturbances in protein and lipid metabolism have also been observed. Impaired glucose utilization occurs in many middle-aged and elderly human beings. In experimental studies, significant numbers of such persons have shown improvement in their glucose utilization after treatment with chromium. Chromium is transported by transferrin in the plasma and competes with iron for binding sites. Chromium as a dietary supplement may produce benefits due to its enhancement of glucose utilization and its possible facilitating the binding of insulin to insulin receptors, which increases its effects on carbohydrate and lipid metabolism. Chromium as a supplement may produce benefits in atherosclerosis, diabetes, rheumatism, and weight control. Copper is another important trace element in the diet. The most common defect observed in copper-deficient animals is anemia. Other abnormalities include growth depression, skeletal defects, demyelination and degeneration of the nervous system, ataxia, defects in pigmentation and structure of hair or wool, reproductive failure and cardiovascular lesions, including dissecting aneurisms. Several copper- containing metalloproteins have been isolated, including tyrosinase, ascorbic acid oxidase, laccase, cytochrome oxidase, uricase, monoamine oxidase, δ-aminolevulinic acid hydrydase, and dopamine-β- hydroxylase. Copper functions in the absorption and utilization of iron, electron transport, connective tissue metabolism, phospholipid formation, purine metabolism, and development of the nervous system. Ferroxidase I (ceruloplasmin), a copper-containing enzyme, effects the oxidation of Fe(H) to Fe(III), a required step for mobilization of stored iron. A copper-containing enzyme is thought to be responsible for the oxidative deamination of the epsilon amino group of lysine to produce desmosine and isodesmosine, the cross-links of elastin. In copper-deficient animals the arterial elastin is weaker and dissecting aneurisms may occur.

Iodine is important for the production of thyroid hormones, which regulate cellular oxidation. The iodine-deficiency disease is goiter. In iodine-deficient young, growth is depressed and sexual development is delayed, the skin and hair are typically rough, and the hair becomes thin. Cretinism, feeble-mindedness, and deaf-mutism occur in a severe deficiency. There is reproductive failure in females and decreased fertility in males that lack sufficient iodine in the diet.

Iron is an essential component of several important metalloproteins. These include hemoglobin, myoglobin, and many oxidation-reduction enzymes. In iron deficiency, there may be reduced concentrations of some of the iron-containing enzymes, such as cytochrome c in liver, kidney, and skeletal muscle, and succinic dehydrogenase in the kidney and heart.

Manganese plays a role in the synthesis of GAGs, collagen, and glycoproteins, which are important constituents of cartilage and bone. Manganese is required for enzyme activity of glycosyltransferases. This family of enzymes is responsible for linking sugars together into GAGs, adding sugars to other glycoproteins, adding sulfate to aminosugars, converting sugars to other modified sugars, and adding sugars to lipids. These functions are manifested as GAG synthesis (hyaluronic acid, chondroitin sulfate, karatan sulfate, heparin sulfate, and dermatin sulfate, among others), collagen synthesis, and function of many other glycoproteins and glycolipids. GAGs and collagen are chief structural elements for all connective tissues. Their synthesis is essential for proper maintenance and repair of connective tissues. Manganese deficiencies in humans and animals lead to abnormal bone growth, swollen and enlarged joints, and slipped tendons. In humans, manganese deficiencies are associated with bone loss, arthritis, and impaired glucose utilization. Levels of all GAGs are decreased in connective tissues during manganese deficiencies, with chondroitin sulfates being most depleted. Manganese-deficient organisms quickly normalize GAG and collagen synthesis when manganese is provided.

Manganese is also required for activity of manganese superoxide dismutase (MnSOD), which is present only in mitochondria. Manganese deficiency decreases the activity of MnSOD and may lead to mitochondrial dysfunction, manifested as decreased cellular functions. Manganese is required for the conversion of mevalonic acid to squalene. Pyruvate carboxylase is a manganese metalloenzyme, repressible by insulin, important in the citric acid cycle for the oxidation of carbohydrates, lipids, and proteins, as well as in the synthesis of glucose and lipids.

Molybdenum is an essential mineral found in highest concentrations in the liver, kidneys, skin, and bones. This mineral is required by the body to properly metabolize nitrogen. It is also a vital component of the enzyme xanthine oxidase, which is required to convert purines to uric acid, a norma! byproduct of metabolism. Molybdenum also supports the body's storage of iron and other cellular functions such as growth. A deficiency of molybdenum is associated with mouth and gum disorders and cancer. A diet high in refined and processed foods can lead to a deficiency of molybdenum, resulting in anemia, loss of appetite and weight, and stunted growth in animals. While these deficiencies have not been observed directly in humans, it is known that a molybdenum deficiency can lead to impotence in older males. Selenium is an essential trace element that functions as a component of en∑ymes involved in protection against antioxidants and thyroid hormone metabolism. In several intra- and extra-cellular glutathione peroxidases and iodothyronine 5'-deiodtnases, selenium is located at the active centers as the selenoamino acid, selenocysteine (SeCYS). At least two other proteins of unknown function also contain SeCYS. Although SeCYS is an important dietary form, it is not directly incorporated into these specific selenium-proteins; instead, a co-translational process yields tRNA-bound SeCYS. In contrast, selenium as seleno-methionine is incorporated non-specifically into many proteins, as it competes with methionine in general protein synthesis. Therefore, tissues often contain both specific, as well as the nonspecific, selenium- containing proteins when both SeCYS and selenomethionine are consumed, as found in many foods. Selenium is a major antioxidant nutrient and is involved in protecting cell membranes and preventing free radical generation, thereby decreasing the risk of cancer and disease of the heart and blood vessels. Medical surveys show that increased selenium intake decreases the risk of breast, colon, lung and prostate cancer. Selenium also preserves tissue elasticity; slows down the aging and hardening of tissues through oxidation; and helps in the treatment and prevention of dandruff. Recent research has shown antitumorigenic effects of high levels of selenium in the diets of several animal models. Vanadium is an essential nutrient beneficial for thyroid hormone metabolism. The daily requirement necessary to prevent a deficiency is about 10 to 20 micrograms a day. Vanadium deficiency can lead to slow growth, defective bones, and altered lipid metabolism. Vanadium exerts an insulin-like effect in some respects, and there has been a considerable amount of research on vanadium and diabetes. In insulin dependent diabetics, vanadium has been found to reduce the amount of insulin required to manage the disease, and in non-insulin dependent diabetics, vanadium has been known to control the condition altogether. Research has shown that supplementation, with vanadium leads to an increase in glucose transport into cells, which suggests that vanadium supplementation of the diet improves glucose metabolism and may aid in preventing diabetes.

Zinc is known to occur in many important metalloenzymes. These include carbonic anhydrase, carboxypeptidases A and B, alcohol dehydrogenase, glutamic dehydrogenase, D-glyceraldehyde-3-phosphate dehydrogenase, lactic dehydrogenase, maiic dehydrogenase, alkaline phosphatase, and aldolase. Impaired synthesis of nucleic acids and proteins has been observed in zinc deficiency. There is also evidence that zinc may be involved in the secretion of insulin and in the function of the hormone.

According to the present invention, minerals can be provided as inorganic compounds, such as chlorides, sulfates, and the like. In addition, some minerals can be provided in more bioavailable forms, such as amino acfd chelates, which are well known in the art. U.S. Patent No. 5,292,538. Examples of minerals that can be provided as amino acid chelates include calcium, magnesium, manganese, zinc, iron, boron, copper, molybdenum, and chromium. Still further, minerals can be provided as deep sea minerals. The baby food and infant formula compositions may also include vitamins such as, for example, vitamin A (retinol), vitamin Bl (thiamine), vitamin B2 (riboflavin, also known as vitamin G), vitamin B3 (niacin, also known as vitamin P), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin, also known as vitamin H), vitamin B9 (folic acid, also known as vitamin M), vitamin Bl 2 (cyanocobalamin), vitamin C (ascorbic acid), vitamin Dl (lamisterol), vitamin D2 (ergocalciferol), vitamin D3 (calciferol), vitamin D4 (dihydrotachysterol), vitamin D5 (7-dehydrositosterol), vitamin E (tocopherol), vitamin K (naphthoquinone), and so forth.

The baby food composition may also include other nutrients such as, for example, dietary fiber; ω-3 fatty acids; proteins; amino acids; fats; cholesterols; sugars; polysaccharides; choline; lycopene; lutein; zeaxanthin; beta-carotene; sweeteners such as momordica fruit, corn syrup, sucrose, dextrose, fructose, crystalline fructose, lactose, malt syrup, malt syrup solids, rice syrup solids, rice syrup, sorghum syrup, invert sugar, refiners syrup, corn syrup, corn syrup solids, maltose, high fructose corn syrup, honey, molasses, sugar alcohols, maltodextrin, and so forth; plant extracts such as green tea extract, grape seed extract, and so forth. The infant formula composition may also include other nutrients and additives such as, for example, ω-3 fatty acids (such as DHA, ARA, and so forth); ω-6 fatty acids; proteins; amino acids including but not limited to tryptophan and methionine; fats, cholesterols; sugars; polysaccharides; choline; lycopene; lutein; zeaxanthin; potassium citrate; calcium carbonate; ascorbic acid; potassium chloride; choline bitartrate; magnesium chloride; choline chloride; ferrous sulfate; ascorbyl palmitate; taurine; m-inositol; d-alpha- tocopheryl acetate; L-carnitine; mixed tocopherols; sodium chloride; zinc sulfate; niacinamide; calcium pantothenate; cupric sulfate; vitamin A palmitate; thiamine chloride hydrochloride; riboflavin; pyridoxine hydrochloride; manganese sulfate; phylloquinone; biotin; sodium selenate; cyanocobalamin; adenosine 5¹- monophosphate, cytidine 5'-monophosphate, disodium guanosine S'-monophosphate, disodium uridine 5'- monophosphate; beta-carotene; sweeteners such as momordica fruit, corn syrup, sucrose, dextrose, fructose, crystalline fructose, lactose, malt syrup, malt syrup solids, rice syrup solids, rice syrup, sorghum syrup, invert sugar, refiners syrup, corn syrup, corn syrup solids, maltose, high fructose corn syrup, honey, molasses, sugar alcohols, maltodextrin, and so forth; plant extracts such as green tea extract, grape seed extract, and so forth. The baby food and infant formula compositions may also include flavonoids. The flavonoids may include those from the groups of flavonols, fiavones, flavonones, flavon-3-ols, isoflavones. and anthocyanidins. Some non-limiting examples of edible flavonoids may include, for example, quercetin, rutin, hesperidin, naringin, tangeritin, proanthocyanidins, epicatechin, myricetin, quercetin, kaempferol, iuteolin, apigenin. and the like.

The baby food and infant formula compositions may also include anti-oxidants or oxidant scavengers in addition to those that may be present in the fucoidan. Free radicals are products of oxidative deterioration of such substances as polyunsaturated fat. Antioxidants convert free radicals into a less reactive and nonharmftil chemical form. Some examples of anti-oxidants include bioflavonoids, amino acids, silymarin, curcumin, all-trans beta-carotene, cis beta-carotenes, all-trans alpha-carotene, cis alpha- carotenes, all-trans lycopene, cis lycopenes, all-trans gamma-carotene, cis gamma-carotenes, zeta-carotene, phytofluene, phytoene, vitamin C and vitamin E and the like.

The infant formula composition may include an emulsifier. Any emulsifiers capable of being used in the art of foods may be used. Emulsifiers may be needed when additives in the infant formula composition do not dissolve in the infant formula. For example, some lipids may not dissolve in a water-based infant ^■ formula. With an emulsifier present, these non-soluble components may be substantially evenly disbursed throughout the infant formula instead of collecting at a common location within the infant formula.

The baby food and infant formula compositions may also include other nutraceutical component having a high ORAC value. Such nutraceutical components may include, for example, concentrates of black grapes, red grapes, white grapes, blueberry, acai fruit, raspberry, blackberry, strawberry, plum, orange, cherry, kiwi fruit, currant, elderberry, black currant, cranberry, mangosteen, noni, aronia, wolfberry, proanthocyanidins (such as from grape seed extract), curcuminoids, or mixtures thereof. Forms

The infant formulas of the present invention may be in any form capable of consumption, or capable of dissolving, combining, or diluting for consumption. Typically, infant formulas are available in three forms. In one form, the infant formula is available to the consumer in a ready-to-consumε form. In this ready-to-consume form, the infant formula may be packaged in a bottle with a standard threaded top shaped to receive a standard bottle nipple. The ready-to-consume forms are the most convenient for consumers, and if used within a time period before the formula degrades, are sure to have the correct concentration for the infant. Ready-to-consume forms, however, typically have a shorter shelf life than other forms, create more waste, and are more costly to transport.

The infant formula of the present invention may be in a ready-to-consume form. It may be packaged according to the disclosure below. It may be packaged in containers suitable for infant formula compositions, such as, for example, single-use containers, bulk containers, and so forth. Another form in which infant formulas are often sold is a concentrated form. The concentrated forms include both a liquid concentrated form, and a substantially dehydrated concentrated form. Both forms require that a diluting agent be added to the concentrate before it is ready to consume. The liquid concentrate has the advantage that less diluting agent need be added for consumption, and complete dissolution of the concentrate in the diluting agent is more probable than with the substantially dehydrated •form. The liquid concentrate, however, is more expensive to transport, creates more waste, and typically has a shorter shelf life than the substantially dehydrated form, however.

The infant formula of the present invention may. be in a liquid concentrate form. The liquid concentrate may be made by any method known in the food arts of making a liquid concentrate. In one embodiment, a- ready-to-con sume form of infant formula is concentrated by removal of some of the water. Removal of some of the water may be by any means known in the art, such as evaporation, vaccum evaporation, high temperature evaporation, ultra high temperature evaporation, and the like. Alternatively, separate components of the infant formula may be added in higher concentrations than in the ready-to-use form. Many of the components of the infant formula of the present invention exist in a substantially dehydrated, powder, concentrated, or slurry form that need diluting before consumption. By mixing the various components without diluting, a concentrate may be formed. Sufficient diluting agent may be added to the concentrate such that the soluble components of the infant formula sufficiently dissolve in the diluting agent.

Dehydrated infant formulas are also typically available. Dehydrated infant formulas may be made by dehydrating methods known in the food arts. Some examples of dehydrating methods include vacuum drying, freeze drying, spray drying, and the like. Dehydrated infant formulas may be in the form of a powder, grains, flakes, pellets, or the like. Dehydrated infant formulas have the advantage of being lighter, less expensive and easier to ship, typically have a longer shelf life, create less waste, and typically have a longer period between the time they are opened and the time they spoil or degrade. Unlike the ready-to- consume and liquid concentrate, which must be used within a certain amount of time after they are opened, the dehydrated infant formulas typically may last longer after being opened. This gives rise to the particular advantage of then being available in a bulk form with many servings. The disadvantages of the dehydrated form include inconvenience in measurement and mixing, difficulty in mixing, as simple addition of a diluting agent to the formula often does not result in a solution without mechanical agitation, heating, or other methods of increasing solubility.

The infant formula of the present invention may be provided in a substantially dehydrated form, in one embodiment, the substantially dehydrated form may be produced by dehydrating a ready-to-consume form of the infant formula. Tn another embodiment, the substantially dehydrated form may be produced by dehydrating a concentrated form of the infant formula. In yet another embodiment, the components, or combinations of the components of the infant formula may be substantially dehydrated piecewise (unless they are already in a substantially dehydrated state), and the substantially dehydrated components then combined and mixed. The components and/or combinations of components may be substantially dehydrated by any means known in the art, such as those listed herein.

The infant formulas of the present invention may include combinations of the forms typically available for infant formulas. Separate components of the infant formula composition may be sold in a ready-to consume liquid, and other components may be sold in a concentrated form. For example, the fucoidan and lipids may be in a ready-to-coπsume form, and other additives may be in a substantially dehydrated form. The consumer may add the substantially dehydrated additives to the ready-to-consume portion if desired before consumption. This embodiment may be especially advantageous when the consumer desires to include only specific additives in the infant formula, such as fiber, preservatives, and the like.

Concentrates may be diluted with any diluting agent known in the art of foods. The diluting agent may include, for example, water, milk, fruit juice, vegetable juice, fruit extracts, vegetable extracts, and the iike. Fruit and vegetable extracts may include, for example, a fruit or vegetable stock which may be made by cooking a fruit and/or vegetable in water, and then removing the fruit and/or vegetable from the liquid. Further, the diluting agent may be a fortified diluting agent. In one embodiment, the diluting agent is a vitamin and/or mineral fortified water. Infant Formula Composition Kit Also disclosed is an infant formula composition kit for mixing by the consumer. Consumers demand that products be safe and convenient. As the forms of infant formulas may include advantages and disadvantages as to their convenience, safety, and so forth, the kits of the present invention may be designed to provide the most advantageous combination of parts to maximize safety and convenience for the consumer, as well as save expense in shipping for the manufacturer. The kits of the present invention may include an infant formula concentrate and a diluting agent.

The infant formula concentrate may be any as described above. The infant formula concentrate may be dehydrated. The level of dehydration may be such that substantially all of the water is removed, or such that only a portion of the water is removed. The diluting agent may be any described above. In one embodiment, the infant formula concentrate is a substantially dehydrated concentrate, with substantially all of the water removed. In one embodiment the diluting agent is water. The water may be fortified with vitamins and/or minerals as described herein. Further, the diluting agent may include any of the components that may be most difficultto dehydrate, such as lipids and/or proteins, for example. The diluting agent may also include an emulsifier so that the lipids may dissolve in a polar diluting agent. Also, the diluting agent may include components that may degrade during the steps of dehydration. The water and/or formula concentrate may be packaged according to any of the embodiments illustrated below, or any other packaging method known in the art.

According to another embodiment, the kit may include an infant formula composition in a ready-to- drink form according to any of the embodiments described above, and additives in a concentrated form. The additives may include any that are described hereinabove, and may be also included in the ready-to-drink infant formula composition. The additives may be in a substantially dehydrated form. The additives may include fiber. In one embodiment, the ready-to-drink infant formula composition includes fucoidan, a lipid and a protein. The additives may include substantially dehydrated vitamins, minerals, proteins, carbohydrates, fiber, w-3 fatty acids, and so forth. The additives may be mixed or separate. For example, the kit may include the ready-to-drink form of the infant formula composition, and the additives include substantially dehydrated vitamins, packaged separately from the substantially dehydrated fiber, packaged separately from the substantially dehydrated carbohydrates, packaged separately from the w-3 fatty acids, and so forth. These embodiments have the particular advantage in that the consumer may better decide which additives are to be included in the infant formula for consumption by the infant. In use, the additives may be added to the infant formula composition in ready-to-drink form before consumption by the infant. Packaging

Liquid or hydrated baby food compositions, such as hydrated baby food cereals, juice, hydrated prepared foods, and the like, and liquid or hydrated infant formula compositions may be packaged before use and/or consumption. These baby food and infant formula compositions may be packaged in jars, bottles, cans, or the like. These baby food and infant formula compositions and/or the packaging may be sterilized so as to increase the probable shelf life of the baby food composition, and/or decrease the probability that the food will spoil before it is consumed. The process of sterilization follows the mixing of the several components of the baby food or infant formula composition. Once all components are mixed in hydrated or rehydrated form, the mixture is sterilized by pasteurization or other heating techniques. Although pasteurization (at least 87.8°C or 190°F) effectively eliminates pathogenic microorganisms, sterilization at higher temperatures may be needed to eliminate all microorganisms.

In achieving the necessary sterilization, two different sterilization processes are typically used. Using the HTST (high temperature short time) process, the mixture may be raised to about 85°C (185°F) for about 20-30 seconds. Alternately, the ultra-high temperature (UHT) process involves raising the temperature of the mixture to about 140.6°C (285°F) for about 4-6 seconds. In either process, immediately after the heating step, the temperature is rapidly lowered to at least ambient temperatures of about 21.1-26.7°C (70- 80⁰F). Alternately, the mixture may be chilled down to about 4.4°C (40⁰F).

Heating of the mixture may be accomplished by direct or indirect heating. For example, the mixture may be heated by direct contact with steam or indirectly by a selected type of heat exchanger. The sterilized blend may then be poured into containers, using a hot-fill or cold-fill method. In the hot-fill process, the product is first heated to temperatures for pasteurization, HTST, or UHT. Then it is poured into containers at elevated temperatures to kill any microorganisms inside the container. The use of preservatives, such as sodium benzoate and potassium sorbate may be used. The pH is usually maintained below 4.4, possibly using acids such as lemon juice or vinegar. After filling, the baby food composition and baby food composition may be cooled slowly by a water mist. Filling of containers may be done by aseptic processing and packaging methods, which are welϊ known in the art.

In the cold-fill process, after pasteurization or sterilization temperatures are reached, the product is immediately cooled to about room temperature prior to packaging, using aseptic processing and packaging techniques. Immediate cooling allows less vitamin degradation and variations in flavor that may be found in the hot-fill process. Thus, in cold-fill processing the flavor may be cleaner and fresher. Preservatives may be included to control the growth of yeast, molds, and bacteria.

The cold-fill process is compatible with use of high-density polyethylene (HDPE) or polyethylene terephthalate (PET) packaging, so as to not compromise the integrity of the package structure. The containers may be capable of holding only a single serving of the baby food composition. It is understood that the above-described embodiments are oniy illustrative of the application of the principles of the present invention. The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiment is to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. Thus, while the present invention has been fully described above with particularity and detail in connection with what is presently deemed to be the most practical embodiment of the invention, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use may be made, without departing from the principles and concepts of the invention as set forth in the claims.

Claims

CLAIMS The subject matter claimed is:

I . A baby food composition for consumption by, and to provide nutrition to a baby, comprising partially hydrolyzed fucoidan and a carrier. 2. The baby food composition of claim 1, wherein the fucoidan is sulfonated.

3. The baby food composition of claim 1 , wherein the carrier is a flour.

4. The baby food composition of claim 3, further including an additional baby food composition in a soft finger food form, comprising partially hydrolyzed fucoidan, fruit, sweetener, and a gelling agent. 5. The baby food composition of claim 3, wherein the flour comprises quinoa flour.

6. The baby food composition of claim 1, wherein the carrier is a cereal.

7. The baby food composition of claim 6, wherein the cereal comprises quinoa.

8. The baby food composition of claim 6, wherein the cereal is toasted.

9. The baby food composition of claim 1, wherein the carrier is a fruit. 10. The baby food composition of claim 1 , wherein the carrier is a vegetable.

I 1. The baby food composition of claim 1 , wherein the carrier is a juice.

12. The baby food composition of claim 1 1, further comprising a milk product.

13. The baby food composition of claim 1 1 , wherein the baby food composition is dehydrated.

14. The baby food composition of claim 1 1 , further comprising mangosteen. 15. The baby food composition of claim 1, wherein the baby food composition is dehydrated.

16. The baby food composition of claim 1 , wherein the fucoidan is derived from one of the group consisting of: Japanese mozuku seaweed, Japanese kombu seaweed, Tongan limu moui seaweed, and combinations thereof.

\ 7. The baby food composition of claim 1, further comprising an anti-oxidant in addition to any anti-oxidant that may be present in the fucoidan.

18. The baby food composition of claim I, further comprising an electrolyte.

19. A baby food composition in the form of a soft Finger food, comprising partially hydrolyzed fucoidan, fruit, a gelling agent, sweetener, and a quinoa flour, wherein the baby food composition is a gel.

20. A baby food composition in the form of a prepared food, comprising partially hydrolyzed fucoidan, a food base, and quinoa flour.

21. An infant formula composition comprising: fucoidan, a protein, and a lipid.

22. The infant formula composition of claim 21, wherein the fucoidan is partially hydrolyzed.

23. The infant formula composition of claim 21, wherein the fucoidan is sulfonated.

24. The infant formula composition of claim 21 , wherein the fucoidan is a derivative of one of the group of: Japanese mozuku seaweed, Japanese kombu seaweed, Tongan limu moui seaweed, and combinations thereof.

25. The infant formula composition of claim 1, wherein the protein comprises a derivative of quinoa.

26. The infant formula composition of claim 1, further including an ω-3 fatty acid.

27. A concentrated infant formula composition kit that can be mixed in the field, wherein the kit includes: a dehydrated infant formula composition comprising fucoidan and a lipid; and a diluting agent.

28. The kit of claim 27, wherein the diluting agent comprises water and a mineral.

29. The kit of claim 27, wherein the diluting agent comprises water and a vitamin.

5 30. The kit of claim 27, wherein the dehydrated infant formula composition is substantially completely dehydrated.

31. The kit of claim 27, wherein the dehydrated infant formula is a concentrated liquid.

32. The kit of claim 27, wherein the fucoidan is partially hydrolyzed.

33. The kit of claim 27, wherein the fucoidan is sulfonated.

] 0 34. The kit of claim 27, further comprising a protein derived from quinoa.

35. An infant formula composition kit that can be mixed in the field, wherein the kit includes: an infant formula composition, comprising fucoidan and a lipid; and an additive in concentrated form.

36. The kit of claim 35, wherein the fucoidan is partially hydrolyzed.

37. The kit of claim 35, wherein the fucoidan is sulfonated.

15 38. The kit of claim 35, wherein the infant formula composition further includes a protein derived from quinoa.

39. The kit of claim 35, wherein the additive includes a protein derived from quinoa.

40. The kit of claim 35, wherein the additive includes dietary fiber.