Baby formula (versions), method for reduction of risk of development of etinopathy of prematurity (versions) and method for maintenance of healthy retina condition and eyesight development (versions) due to formula usage

FIELD: food industry.

SUBSTANCE: invention relates to baby formulas. The formulas contain fat, protein, carbohydrates, vitamins and minerals including docosahexanoic acid and at least 0.075 mg/l of lutein on a base ready for consumption; the weight ratio of lutein (mg) to docosahexanoic acid (mg) varies from 0.001:2 to 0.01:1, the formulas containing no egg phospholipides.

EFFECT: combination of lutein and docosahexanoic acid in the said baby formulas promotes maintenance of healthy condition of retina and eyesight development with premature babies, reduced the risk of development of etinopathy of prematurity with premature babies.

17 cl, 2 dwg, 3 tbl, 5 ex

 

The technical field to which the invention relates.

The present invention relates to mixtures containing a specially selected combination of DHA and lutein to support healthy retina and eye development in children.

The level of technology

The infant formula currently is usually used to provide additional or sole source of food at an early age. These blends include protein, carbohydrate, fat, vitamins, minerals and other nutrients. They are commercially available in the form of powders, ready-to-use liquids, and liquid concentrates.

Although many types of mixtures provide a quality alternative to breast milk, they still do not provide the same high level of power, which is provided with the female milk. In this regard, many research works in the field of child nutrition in the last few years was aimed at a more complete study of the natural components of breast milk and subsequent modification of the mixtures in accordance with this or at least to the extent that this is possible with currently available technology.

Arachidonic acid and docosahexaenoic acid, for example, have been identified in wives who kω milk and subsequently introduced into a synthetic blend for baby food. These fatty acids contribute to the development of brain and vision in children, and currently they are commonly found in commercially available mixtures such as Similac®Advance®Infant Formula, Isomil®Advance®Infant formula and Similac®Special Care®Advance®infant formula, all of which are available in the firm of Ross Products Division, Abbott Laboratories, Columbus, Ohio, USA.

Lutein has also been identified in human milk. Although it is not currently added to the mixtures in the form of the selected ingredient, lutein can be found in low concentrations in mixtures in the form of ingredient that is inherent in a number of natural oils normally used in the preparation of these mixtures. Lutein is an antioxidant that also appear to be concentrated in the retina of the eye. In General it is known that dietary lutein may have a positive impact on the health of the eyes of patients and it can be assumed that these positive effects may apply to children receiving lutein or from breast milk or from mixtures with additive.

Now consider that the combination of lutein and docosahexaenoic acid may be especially important in that it promotes the healthy condition of the retina and visual development in children. Both components are present in the female mo is the eye and both as you know, are concentrated in the retina in healthy in other respects patients. Docosahexaenoic acid (DHA), as a polyunsaturated fatty acid, is highly sensitive to damage by oxidation and decomposition within the eye, while lutein is a known antioxidant. Consider that the addition of lutein to the mixtures, it will not only concentrate in the retina, but may also reduce the level of oxidative decomposition of DHA in the retina, even more thus, a healthy condition of the retina and visual development in children.

However, it is shown that the concentration of lutein in the mixtures should be higher concentrations of lutein, found in human milk, in order to achieve the same concentrations of lutein in the plasma, which detect children who are breastfeeding, due to a lower relative bioavailability of lutein from mixtures. Although infant formula currently typically includes less than about 20 μg/l of lutein, most of which comes mainly from added fats and oils, is now found that the concentration of lutein should exceed approximately 50 µg/l, preferably from about 100 μg/l to about 200 mg/l, d is I, to double the concentration of lutein in the plasma found in children exclusively breastfed.

In the result it was found that infant formula containing a combination of lutein and DHA, as described above, should be made with higher ratios (lutein to DHA)than normally found in human milk. The ratio by weight of lutein (mcg) and DHA (mg) should now be in the range from about 1:2 to about 10:1.

Disclosure of inventions

The present invention relates to a mixture of baby food, including fat, protein, carbohydrate, vitamins and minerals, including docosahexaenoic acid and at least about 50 mcg/liter of lutein, and the mass ratio of lutein (mcg) and docosahexaenoic acid (mg) is from about 1:2 to about 10:1. The present invention also relates to a method of applying power to contribute to maintaining the health of the retina and visual development in children, including reducing the risk of retrolateral fibroplasia in children, and protection from the damaging effects of excessive natural or artificial light in children's eyes.

It is shown that infant formula should be made with concentrations of lutein at least 50 µg/l, if they should create the substance of the same concentration of lutein in the plasma, found in children who are breastfeeding, though human milk typically contains no more than about 30 μg/l of lutein. The result found that the ratio by weight of lutein (mcg) and DHA (mg) in baby food should lie within the range from about 1:2 to about 10:1. Believe that the combination of lutein and docosahexaenoic acid are particularly useful in maintaining a healthy condition of the retina and eye development in children, provided that you are planning the introduction of infant formula sufficient quantities of each component, as described in this context.

Brief description of drawings

The Figure 1 shows a graph of the consumption of lutein (mcg/day) and the corresponding concentrations of lutein in plasma (µg/DL) in groups of children in breastfeeding women milk (NM) or infant formula containing different concentrations of lutein [CTRLc to 14.6 ág lutein/l (without adding lutein, all lutein is in the ingredients); L1 from 32.6 ág lutein/l (approximately 18 mg/l of added lutein, the rest is internal), L2 from 52.6 ág lutein/l (38 mg/l of added lutein the rest is internal).

The Figure 2 presents a graph showing the visual acuity, as measured by the expanded due to the potential of the optic nerve (logMAR) in monkeys in which the Rast 4, 8 and 12 weeks. Monkeys fed infant formula or with DHA and added lutein (n=8)or DHA without adding lutein (n=8) during the 12-week feeding period.

The implementation of the invention

The infant formula corresponding to the present invention, contains fat, protein, carbohydrate, vitamins and minerals, and includes a new combination of lutein and docosahexaenoic acid. Data and other basic elements or limitations relating to child nutrition, and appropriate methods presented in this invention, described in detail below.

The term "child"as used in this context, refers to the patients in age, not exceeding approximately one year, and includes children aged from 0 to about 4 months, children aged from about 4 to about 8 months, children aged approximately 8 to approximately 12 months, children with low body weight at birth less than 2500 g at birth, and preterm children born with intrauterine (gestational) age less than about 37 weeks, usually with fetal age from approximately 26 weeks to approximately 34 weeks.

The term "infant formula"as used in this context, refers to a nutritional composition that does not contain egg phospholipids, to area designed for children to include enough protein, carbohydrate, fat, vitamins and minerals to potentially serve as the only source of food while ensuring sufficient.

The term "ready to eat", as used in this context until otherwise specified, refers to a mixture of baby food in liquid form, suitable for use by a child, including the recovered powders, diluted concentrates and synthetic fluid.

As used in this context, all concentrations are expressed either as "ug/l" or as "mg/l", refer to the concentrations of ingredients in the formula corresponding to the present invention, as calculated on the basis of ready-to-eat product or consumption until determined otherwise.

All percentages, parts and ratios as used in this context, based on the total weight of the composition, until determined otherwise. All these masses as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, until determined otherwise. All references to specifications or limitations presented in the present invention, in the singular will include the relevant characteristics of the or restriction in the plural or Vice versa, unless otherwise indicated or the context in which reference is made, clearly not expected the opposite.

All combinations of method or process steps, as used in this context, can be done in any order, until otherwise specified or clearly not expected the opposite from the context in which make reference to the combination.

The infant formula presented in this invention can also practically do not contain any optional or special main ingredient or property described in this context, provided that the rest of the composition still contains all of the required ingredients or properties, as described in this context. In this context, the term "does not contain" means that the composition includes less than a functional amount of the optional ingredient, typically less than 0.1 wt.%, and also including zero wt.% this optional or special primary ingredient.

The infant formula and related methods presented in this invention can include, consist of, or consist mainly of the basic elements and limitations relevant to the invention described in this context, as well as any additional or optional ingredients, components, or limitations described in this context, or otherwise used in the methods of application of nutrients.

Lutein

The infant formula corresponding to the present invention, includes lutein, the concentration of which should be at least about 50 mcg/liter of lutein. Any source of lutein suitable for use in this context provided that the source is also known for or otherwise suitable for use in baby food and is compatible with other selected ingredients of the mixture, the ratio by weight of lutein (ág/l) and docosahexaenoic acid (mg/l) in the mixtures is in the range from about 1:2 to about 10:1.

The concentration of lutein in the mixtures of the present invention are in the range from approximately 50 to approximately 1150 mg/l, including from about 75 to about 230 μg/l, and also including from about 100 to about 200 mg/l, as calculated on the basis of product ready to use. All concentrations of lutein and ratios referred to in this context, relying on the free lutein, until determined otherwise.

The amount of lutein in the mixtures should be selected so that the ratio by weight of lutein (mcg) and docosahexaenoic acid (mg) was and is the interval from about 1:2 to about 10:1, including from about 1.5:1 to about 9:1, including from about 1.7:1 to about 5:1.

The term "lutein", as used in this context until otherwise specified, refers to one or more compounds from the group of free lutein esters, lutein, salts of lutein or other derivatives of lutein or related structures, as described, or otherwise provided for in this context. Lutein or lutein, suitable for use in the mixtures of the present invention, include free lutein, as well as esters, salts or other derivatives or related structures, including compound corresponding to the formula:

The above formula includes the overall structure of lutein and related derivatives or structures. Free lutein, for example, corresponds to the formula in which both R1and R2represent hydrogen, and includes the CIS - and TRANS-isomers, and its salts, e.g. sodium, potassium.

Esters of lutein, intended for use in the mixtures of the present invention include any ester of lutein above formula in which R1and R2are the same or different and represent Soboh is acceptable for food monovalent salt, hydrogen or the acyl residue of carboxylic acid, provided that at least one of R1or R2means acyl residue of carboxylic acid. Suitable esters of lutein include both CIS-and TRANS-isomers. Group R1and R2represent residues of saturated or unsaturated With1-C22fatty carboxylic acids, non-limiting examples of which include formic, acetic, propionic, butyric, valeric, Caproic, Caprylic, capric, lauric, myristic, palmitic, stearic and oleic acid.

Lutein designed for use in this context, includes natural or synthetic source, which is known as acceptable or is otherwise a source that is acceptable for use in oral food products, including infant formula. Sources of lutein can be presented as a separate ingredient or in any combination with any other materials or sources, including sources such as multivitamin premix, the premix mixtures of carotenoids, clean sources of lutein and internal lutein from other fat or oil components of mixtures. Concentrations and ratios of lutein, as described in this context, calculated on the basis of added or NR the domestic sources of lutein. Preferably, when the infant formula corresponding to the present invention includes at least about 25%, more preferably from about 50% to about 95% by weight of the total of lutein in the form of added lutein, the remaining part is an internal lutein, which accompanies the added fats and oils.

Non-limiting examples of some suitable sources of lutein, intended for use in this context include crystalline lutein FloraGLO®available in the company Kemin Foods, Des Moines, Iowa, USA and esters of lutein Xangold®presented by the company Cognis, Cincinnati, Ohio, USA.

The infant formula corresponding to the present invention includes preferred embodiments of containing a combination of free lutein and zeaxanthin in one source in purified crystalline extract of the flowers of marigold (Tagetes erecta), in which the free lutein is from 85% to 95% by weight of the combination and zeaxanthin constitutes from about 5% to about 15% by weight of the combination. The preferred combination of lutein-zeaxanthin is available in the company Kemin Foods, Des Moines, Iowa, USA, under the trade name FloraGLO®.

Docosahexaenoic acid (DHA)

The infant formula corresponding to the present invention, includes the t docosahexaenoic acid, organic carboxylic acid having a chain length 22 carbon atoms with 6 double bonds beginning with the third carbon atom from the methyl end (22:6 n-3). Any source of docosahexaenoic acid suitable for use in this context provided that the source is also known as acceptable or is otherwise acceptable for use in the mixtures and compatible with other specially selected ingredients of the mixture.

The concentration of docosahexaenoic acid in the mixtures of the present invention should be selected so that the resulting ratio by weight of lutein and docosahexaenoic acid were in the range as defined in this context. Most typically, when these concentrations are in the range of from about 36 to 360 mg/l, including from about 50 to about 144 mg/l, and also including from about 72 to about 130 mg/l, as calculated on the basis of ready-to-eat product.

Docosahexaenoic acid can be introduced into infant formula in the form of free fatty acids or in the form of compounds or materials that can otherwise provide the data source of free fatty acids during or after feeding of the child, including nejiznesposobnaya and complex glyceride esters (mono-, di-, tri-) docosahexaenoic acids. Polyunsaturated fatty acids and their sources are described in U.S. patent 6080787 (issued to Carlson, et al.) and in U.S. patent 6495599 (issued by Auestad, et al.), described in this context in the form of links. Some non-limiting examples of suitable sources of docosahexaenoic acids include fish oil, algal oil and oils of other unicellular organisms, and combinations thereof.

The infant formula corresponding to the present invention may, additionally, include in addition to docosahexaenoic acid, as described in this context, other polyunsaturated fatty acids with long chain, such as arachidonic acid (20:4 n-6), eicosapentaenoic acid or EPA (20:5 n-3), linoleic acid (18:2 n-6), γ-linolenic acid or GLA (18:3 n-6)α-linolenic acid (18:3 n-3), di-Homo-γ-linolenic or DHGLA (20:3 n-6), stereonova acid (18:4 n-3) and their combinations. Data polyunsaturated fatty acids with optional long chain can similarly be entered in the infant formula in the form of fatty acids or in the form of compounds or materials that can in other ways to provide the data source of free fatty acids during or after feeding of the child, including neaicina phospholipids and complex glyceride esters (mono-, di-, tri-) docosahexaenoic sour is.

Other nutrients

The infant formula corresponding to the present invention, includes fat, protein, carbohydrate, minerals and vitamins, all of which are selected from the types and quantities of appropriate food requirements of a given group of children.

There are many different sources and types of carbohydrates, fats, proteins, minerals and vitamins, and they can be used in the mixtures of the present invention, provided that these nutrients are compatible with the added ingredients in the selected mixture and are in other respects suitable for use in mixtures.

Carbohydrates suitable for use in the mixtures of the present invention, can be simple or complex, does not contain lactose or lactose, or combinations thereof, non-limiting examples of which include hydrolyzed, intact, naturally or chemically modified corn starch, maltodextrin, glucose polymers, sucrose, corn syrup, solid components of corn syrup, rice or potato carbohydrates, glucose, fructose, lactose, corn syrup high fructose, and indigestible oligosaccharides such as fructo-oligosaccharides (FOS), galactooligosaccharides (GOS) and their combinations.

Proteins suitable for use in the mixtures of the present invention include hydrolyzed, partially hydrolyzed and non-hydrolyzed or intact proteins or protein sources, and can be selected from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (such as rice, maize), vegetables (e.g., soy), or combinations thereof.

Proteins that are destined for use in this context may also include or be partially or completely replaced by free amino acids, known as applicable, or in other respects suitable for use in mixtures, non-limiting examples of which include alanine, arginine, asparagine, carnitine, aspartic acid, cystine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, Proline, serine, taurine, threonine, tryptophan, tyrosine, valine, and combinations thereof. These amino acids are most often used in their L-forms, while the corresponding D-isomers may also be used, when they are equal in nutritional value. You can also use racemic or isomeric mixture.

Fats suitable for use in the mixtures corresponding to the present invention, include coconut oil, soy oil, corn oil, olive oil, safflower oil, safflower oil with high oleic acid content, algal oil, MCT oil (medium chain triglycerides), sunflower oil, sunflower oil with high oleic acid, palm and stone fruits, palm oil, palm olein, canola oil, oils of marine organisms, cottonseed oil, and combinations thereof.

Vitamins and other ingredients suitable for use in the mixtures of the present invention include vitamin a, vitamin D, vitamin E, vitamin K, thiamine, Riboflavin, pyridoxine, vitamin B12, Niacin, folic acid, Pantothenic acid, Biotin, vitamin C, choline, Inositol, salts and derivatives and combinations thereof.

Minerals suitable for use in the mixtures of the present invention include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, chromium, iodine, sodium, potassium, chloride, and combinations thereof.

Preferably, when the infant formula includes nutrients in accordance with the relevant guidance on child nutrition for the target group of consumers or users, which could serve as Infant Formula Act, 21 U.S.C. Section 350(a) (Law on child nutrition, section 21 of the Code of law school is, part 350(a)).

The infant formula corresponding to the present invention also includes embodiments of which contain concentrations of carbohydrate, fat and protein, are described in the table below.

Table 1
The nutrients included in the mix for baby food1
NutrientScopeg/418,kJ (100 kcal)g/l(2
Carbohydrate1 an implementation option8-1654-108
option 2 implementation9-1361-88
Fat1 an implementation option3-820-54
option 2 implementation4-6,627-45
Protein1 an implementation option1-3,5 7-24
option 2 implementation1,5-3,410-23
1. All numerical values can be modified by the introduction of the term "approximately"
2. Mean ready-to-use liquid, the recovered powder or diluted concentrate.

The infant formula corresponding to the present invention includes embodiments of which include 418,7 kJ (100 kcal) a mixture of one or more of the following components: vitamin a (from about 250 to about 750 IU (international units)of vitamin D (from about 40 to about 100 ME), vitamin C (at least about 4 μg), vitamin E (at least about 0.3 to ME), vitamin C (at least about 8 mg), thiamine (at least about 8 g)vitamin B12 (at least about 0.15 g), Niacin (at least about 250 g), folic acid (at least about 4 g), Pantothenic acid (at least about 300 g), Biotin (at least approximately 1.5 g), choline (at least about 7 mg) and Inositol (vitamin B8) (at least about 4 mg).

The infant formula corresponding to the present invention, includes the also such options implementation which include on 418,7 kJ (100 kcal) a mixture of one or more of the following: calcium (at least about 50 mg), phosphorus (at least about 25 mg), magnesium (at least about 6 mg), iron (at least about 0.15 mg), iodine (at least about 5 g), zinc (at least about 0.5 mg), copper (at least approximately 60 grams), manganese (at least approximately 5 g), sodium (from approximately 20 to approximately 60 mg), potassium (from about 80 to about 200 mg) and chloride (from about 55 to about 150 mg).

Optional ingredients

The infant formula corresponding to the present invention may also include other optional ingredients that may modify the physical, chemical, aesthetic properties or processing characteristics of the compositions or serve as pharmaceutical or additional nutritional components when used in a targeted group of children. Many such optional ingredients are known or otherwise suitable for use in foods and can also be used mixtures of the present invention, provided that the data is optional substances described in this context and in other respects, suitable for use in mixtures.

Non-limiting examples of such optional ingredients include preservatives, additional antioxidants, emulsifiers, buffers, colorings, flavorings, nucleotides nucleoside, probiotics, prebiotics, lactoferrin and related derivatives, thickeners and stabilizers, etc.

Product form

The infant formula corresponding to the present invention, can be obtained in the form of any product intended for use by children, including the recovered powders, ready-to-use liquid designed for cultivation liquid concentrates, and the form data of the product are well known in the areas of nutrition and baby food.

The infant formula corresponding to the present invention, can have any caloric value that is appropriate for a particular group of children, or provides the calories in one embodiment, when restoring a powder or in another embodiment, at a dilution of a liquid concentrate. The most common values calorie baby food, relevant to the present invention are typically at least approximately 2550 kJ/l (18 kcal/fluid ounce), more typically from about 2826-2847 kJ/l (20 kcal/liquid unti is) to approximately 3433 kJ/l (25 kcal/fluid ounce), even more typically from about 2826-2847 kJ/l (20 kilocalories per fluid ounce) to approximately 3349-3391 kJ/l (24 kcal/fluid ounce). As a rule, mixtures containing 3116-4250 kJ/l (22-30 kcal/fluid ounce), more typically from about 3116-3400 kJ/l (22-24 kcal/fluid ounce), often used for premature infants or children with low body weight at birth and mixtures containing 2826-2930 kJ/l (20-21 kcal/fluid ounce) is often used for full-term infants. High-calorie meals may be used for premature babies with low body weight at birth. These products are typically from about 3968-3977 kJ/l (27 kcal/fluid ounce) to approximately 4187-4250 kJ/l (30 kcal/fluid ounce).

For embodiments of the present invention in the form of a powder, these powders are usually presented in the form of loose or substantially all solids compositions comprising solid particles or at least the compositions of the solid particles, which can be easily scooped and measured with a spoon or similar other device, and the intended user can easily restore compositions suitable aqueous liquid, typically water, to form a liquid nutrient mixture for immediate oral or enteral use. In this context, the use of the word "immediate", it usually means is for about 48 hours, most typically within about 24 hours, preferably immediately after recovery. Powder data options for implementation include dried, spray dried, agglomerated, mixed in dry form or another known or otherwise effective form of solid particles. The amount of nutrient powder to obtain a volume suitable for a single serving may vary.

The infant formula corresponding to the present invention can be packaged and sealed in containers for single or multiple use, and then stored in ambient conditions up to approximately 36 months or more long, more typically from about 12 to about 24 months. If reusable containers these containers can be open and then close for reuse main consumer, provided that the closed package is then stored in environmental conditions (e.g., avoiding extreme temperatures) and the contents used for about one month or so.

A healthy condition of the retina and the development of vision

The present invention relates also to methods of reception of compounds that contribute to the healthy condition of the retina and visual development in children. In this particular way children see the camping give full-term and preterm infants as a sole source, primary source or a secondary power source, while the mixture contain fat, protein, carbohydrate, vitamins and minerals, including docosahexaenoic acid and at least about 50 mcg/liter of lutein, and the ratio by weight of lutein (mcg) and docosahexaenoic acid (mg) is from about 1:2 to about 10:1. This method can be applied to any variation of the implementation of the mixtures described or otherwise proposed in this context.

As a consequence, this particular method should provide the child with an effective amount of lutein to ensure these benefits, including from about 7 to about 300 mg/kg/day, including from about 14 to about 220 mg/kg/day, and also including from about 22 to about 150 mg/kg/day (lutein/kg body weight of the child), and the ratio by weight of lutein and docosahexaenoic acid support in the framework of the relations described in this context.

The development of eye and vision occurs at a fast pace during the first year of life. At birth, the child can only see high-contrast objects at a distance, may 25-30, see the following months retin-a child develops enough to see and to distinguish fine detail. And with the development of baby's vision, to the / establishment, which mainly occurs during the first year, now it becomes possible to increase the child's ability to learn through visual stimulation using newly developed view. For children this vision further training plays a key role in the development of brain and cognitive development, especially during the first 2-3 years of life.

Promoting healthy condition of the retina and visual development in children, infant formula, corresponding to the present invention, can also help children develop their ability to visual training as early as possible, and potentially accelerate the development of brain and cognitive abilities associated with early visual stimulation through the developing retina. As a consequence, infant formula, corresponding to the present invention, effectively contributes to the development of vision in children and, therefore, effective in terms of stimulating secondary positive effects, such as the associated development of cognitive abilities and brain through early visual stimulation.

This particular method corresponding to the present invention can in particular be used for premature babies, in order to accelerate the development of normal vision, so as to reduce the time required is La, to make up the stages of development done full-term children of their age.

Petrolatina fibroplasia

The infant formula corresponding to the present invention is particularly effective for feeding premature infants to reduce the risk of retrolateral fibroplasia. In accordance with this method, a mixture is used as the only source, primary source or a secondary power source, and the mixture contain fat, protein, carbohydrate, vitamins and minerals, including docosahexaenoic acid and at least about 50 mcg/liter of lutein, in this case, the ratio by weight of lutein (mcg) and docosahexaenoic acid (mg) is from about 1:2 to about 10:1. This method can apply to any versions of the mixtures described or otherwise proposed in this context.

Petrolatina fibroplasia is a condition that commonly affects premature infants and is most often characterized by abnormal development of blood vessels in the retina, possibly as a result of oxidative stress, secondary, relatively high oxygen pressure. This lesion can occur in varying degrees, from mild lesions of vessels with minimal impact or no impact on vision, partial or complete detachment is atchade, leading to blindness. Previously, therapy for the relevant cases include laser therapy, and cryotherapy.

As a consequence, this particular method should provide the child with an effective amount of lutein to provide the stated benefits, including from about 7 to about 300 mg/kg/day, including from about 14 to about 220 mg/kg/day, and also including from about 22 to about 150 mg/kg/day (lutein/kg body weight of the child), and the ratio by weight of lutein and docosahexaenoic acid support in the framework described in the context of relationships.

The way to obtain

The infant formula corresponding to the present invention can be obtained by any known or otherwise effective method suitable for obtaining or preparing the mixture for baby food or other similar mixtures, changes which may depend on variables such as the selected product form, the combination of ingredients, packaging and choice of container, etc. for the desired mixture for baby food. Ordinary specialist in the field of mixtures or making baby food, easy to determine and will apply these methods and options for any given mixture.

The infant formula corresponding to the present invention, VK is UCA examples of mixtures, described below in this context, as a consequence, can be prepared by any of a variety of known or otherwise effective methods of blending or manufacturing. Most typically, when these methods include the initial formation of a water suspension containing carbohydrates, proteins, lipids, stabilizers or other AIDS for the preparation of mixtures, vitamins, minerals, or combinations thereof. Suspension emuleret, pasteurized, homogenized and cooled. To the resulting emulsion can be added various other solutions, mixtures or other materials before, during, or after further processing. Then this emulsion can then be diluted, to be subjected to heat treatment and packaging with receipt ready-to-use or concentrated liquid, or it can be subjected to heat treatment and then be processed and packaged in the form of recovered powder, for example, dried by spray drying, mixed in dry form, whether.

Other suitable methods of obtaining nutrient mixtures are described, for example, in U.S. patent 6365218 (issued Borschel, et al), U.S. patent 6589576 (issued Borschel, et al.), U.S. patent 6306908 (issued to Carlson, et al.), patent application U.S. 20030118703 Al (submitted Nguyen, et al.), described in this context by reference.

The experimental the orbital part of the

The objective of this experiment is the evaluation of changes in visual acuity in animals fed with mixtures, containing either DHA or DHA with added lutein. Sixteen monkeys fed one of two specific types of mixtures during the first 12 weeks of life. The first is a control mixture - infant formula Similac®Advance®Infant formula manufactured by Abbott Laboratories, Columbus Ohio, and the other is an experimental mixture comprising as the basis Similac®Advance®but with the addition of carotenoids containing lutein. Mixtures include the following components:

NutrientThe control mixtureExperimental mixture
DGK50 mg/l60 mg/l
Lutein0 µg/l added (18 µg/l internal)117 µg/l
Zeaxanthin0 µg/l added (4 µg/l internal)36 µg/l
Zeaxanthin/lutein22% 31%

The control mixture (Similac®Advance®Infant formula) contains water, skim milk, lactose, safflower oil high oleic acid soybean oil, coconut oil, whey protein think; oil .cohnii, oil .alpina, potassium citrate, calcium carbonate, ascorbic acid, mono - and diglycerides, soy lecithin, carrageenan, potassium chloride, magnesium chloride, sodium chloride, ferrous sulfate (II), choline chloride, choline bitartrate, taurine, m-Inositol, d-α-tocopherylacetate, L-carnitine, zinc sulfate, nicotinamide, calcium Pantothenate, Riboflavin, vitamin a palmitate, copper sulfate, teamengland hydrochloride, pyridoxine hydrochloride, beta-carotene, folic acid, magnesium sulfate, phylloquinone, Biotin, sodium selenate, vitamin D3, cyanocobalamin and nucleotides (adenosine 5'-monophosphate, citizen 5'-monophosphate, guanosine 5'-monophosphate disodium, uridine 5'-monophosphate disodium).

Monkeys randomisiert in terms of getting either the experimental (n=8)or control (n=8) mix in age from birth to 12 weeks. Animals do not receive any breast milk. Newborns and mothers separated at birth. During the study, monkeys exposed to light having the intensity and spectral characteristics of sunlight for 12 hours/day to stimulate the called sutomatically stress, potentially experienced by children. During the study, monkeys assessed by a number of parameters, including the concentration of lutein in the plasma and expanded due to the potential of the optic nerve (VEP).

The level of lutein in plasma

Concentrations of lutein, lycopene and β-carotene in plasma significantly not different in monkeys fed the control and experimental mixture at birth (age 0 weeks). The concentration of lutein in plasma is significantly higher in monkeys fed an experimental mixture than in monkeys fed the control mixture at the age of 4 (p<0,001), 8 (p<0.001) and 12 (p<0,001) weeks. Similarly, the concentration of lycopene in plasma is significantly higher in the experimental group compared with the control group at the age of 4 (p<0,001), 8 (p<0.001) and 12 (p<0,001) weeks. The concentration of β-carotene in plasma is significantly higher in the experimental group than in the control group at age 4 (p=0.005) and 8 (p=0,010), but not 12 (p=0,052) weeks.

Visual acuity

The monkeys assess changes in visual acuity at the age of 4, 8 and 12 weeks. Visual acuity is measured by the expanded due to the potential of the optic nerve (VEP)in a manner well known in the field of techniques for the measurement of evoked potential optic nerve in children. Visual acuity is measured by determining the minimum spatial frequency in sonocontrast lattice, which causes the measured response of the visual area of the cortex. VEP from the primary visual areas of the cortex are registered using a small disc electrodes EEG (electroencephalogram)placed on the scalp with a water-soluble paste for electrodes. Calves are kept on the knees of the experimenter, while he looks at the video monitor showing black-and-white gratings with varying phase. If necessary, the attention of the baby will be attracted to the center of the screen with the little hanging toys. During each "sweep" the spatial frequency of the grating will be progressively reduced from greater than to less than the threshold value of the visual acuity of the test within a few seconds of the registration period. The amplitude of the second harmonic response VEP, which reflects the response associated with the rate of change of the stimulus, will build on the chart as a function of spatial frequency to determine the visual acuity threshold of the test (see Neuringer M, Jeffrey BG: Visual development:neural basis and new assessment methods. (BG - development of vision: neural basis and new methods of evaluation) J Pediatr 2003; 143:S87-S95).

The results of the VEP results obtained in the study result in the graph shown in figure 2. Lower results VEP (logMAR) are an indication of better visual acuity. Although the results of VEP reduced (i.e. visual acuity improves) the sun is x monkeys during the 12-week study period, as expected, the values of VEP to 8 week are unexpectedly lower in the experimental group (blended with added lutein+DHA)than in the control group (blend with DHA without added lutein) (4 weeks, p=0,412 etc).

Data suggest accelerated development of the baby monkeys fed an experimental mixture at the age of 8 weeks - especially in terms of visual acuity, as measured by the values of VEP. About extrapolations of data on human children, the development of the eye in monkeys aged 4, 8 and 12 weeks corresponds to the development of the eye in human children aged 4, 8 and 12 months, respectively. As a consequence, the results suggest that even those of a human child experimental mixture would increase visual acuity in age from approximately 4 to approximately 12 months.

EXAMPLES

The following examples represent specific embodiments of the scope of the present invention, each of which produce solely for the purpose of illustration, and should not be construed as limiting the present invention, since there are numerous variants without leaving the scope of the present invention. All given as examples of the number represent weight percents based on the total weight of the composition, while not defined inac is.

Examples 1.1-1.3

The following material represents examples ready to use mixtures on the basis of milk of the present invention, including the method of application and receipt of mixtures. Ingredients mixtures for each download in the table below.

IngredientExample 1.1Example 1.2Example 1.3
Number/ 454 kgNumber/ 454 kgNumber/ 454 kg
WaterIn sufficient quantityIn sufficient quantityIn sufficient quantity
Lactose27 kg27 kg27 kg
ARA*-containing oil (40% ARA)0,167 kg0,167 kg0,167 kg
DHA-containing oil (40% DHA)0,063 kg0,095 kg0,145 kg
Non-fat dry milk11,33 kg11,33 kg11,33 kg
Safflower oil high oleic acid content6.5 kg6.5 kg6.5 kg
Mono - and diglyceridesrate £ 0.162 kgrate £ 0.162 kgrate £ 0.162 kg
Soybean oil5 kg5 kg5 kg
Whey protein2.8 kg2.8 kg2.8 kg
Calcium carbonate0,211 kg0,211 kg0,211 kg
Coconut oil4.6 kg4.6 kg4.6 kg
Citric acid0,014 kg0,014 kg0,014 kg
Potassium citrate0,245 kg0,245 kg 0,245 kg
Ascorbic acid178 g178 g178 g
Lecithin162 g162 g162 g
Magnesium chloride25 g25 g25 g
Potassium chloride88 g88 g88 g
Sulphate of iron (II)26 g26 g26 g
Carrageenan136 g136 g136 g
Choline chloride25 g25 g25 g

IngredientExample 1.1Example 1.2Example 1.3
Number/ 454 kgNumber/ 454 kgThe number is on/ 454 kg
Premix nucleotides and choline3133 g133 g133 g
Riboflavin1 g1 g1 g
L-carnitine1.5 g1.5 g1.5 g
The potassium hydroxide998 g998 g998 g
A solution of lutein4(activity 5%)0,882 g1,323 g1,764 g
The water soluble premix of vitamins165 g65 g65 g
The premix of vitamins ADEK221 grams21 grams21 grams
Vitamin a0.4 g0.4 g0.4 g
A solution of β-carotene (activity 30%)0,0485 g0,0485 g 0,0485 g
Total lutein (mg/l)0,10,150,2
Total DHA (mg/l)5075115
The ratio of lutein (mg):DHA (mg)0,0020,0020,00174
*arachidonic acid
1. the premix contains (65 g) and 19.8 g of taurine, 14.4 g of Inositol, 6.7 g of zinc sulfate, 4,2 g decontamina, 2.6 g of calcium Pantothenate, 2.3 g of iron sulfate (II), 0.8 g of copper sulfate, 0.6 g of thiamine, 0.3 g of Riboflavin, 0.26 g of pyridoxine, 0.1 g of folic acid, 0.07 g of magnesium sulfate, 0.03 g of Biotin, 0.025 g of sodium selenate, 0.002 g cyancobalamin.
2. the premix contains (21 g) 4.0 g of α-tocopherol acetate, 0.8 g vitamin a palmitate, 0.05 g of fellaheen, 0,006 grams of vitamin D3.
3. the premix contains (133 g): 23 g choline bitartrate, 15 g of 5'-CMP, 11 g of 5'-GMP, 10 g of 5'-MFIs, 6 g of 5'-AMP.
4. FloraGLO®Crist is lichecki lutein, Kenun Foods, Des Moines, Iowa, USA.

Shown as an example, the mixture can be prepared, receiving at least three separate suspensions, which are later mixed together, subjected to heat treatment, have been standardized, packaged and sterilized. First get the carbohydrate-mineral slurry by dissolving lactose in water at 65-71°C, followed by addition of magnesium chloride, potassium citrate, potassium chloride, choline chloride and citric acid. The resulting suspension support with stirring at a temperature of 55-65°C not more than eight hours as long as it is not mixed with other prepared suspensions.

The protein-oil suspension get mixing safflower oil high oleic acid soybean oil and coconut oil at 55-60°C and then adding the premix of vitamins ADEK, mono - and diglycerides, lecithin, carrageenan, vitamin a, ARA oil and oil DHA. Then add whey protein and calcium carbonate. The resulting protein-oil suspension support with moderate stirring at 40-43°C for no more than two hours until her later, not mixed with other educated suspensions.

Then the carbohydrate-mineral slurry combine with water and skim milk powder and stirred for 10 minutes. Then d is billaut protein-oil suspension and the resulting intermediate mixture is stirred for at least 10 minutes. Then added to the mixture of lutein and β-carotene and stirred for at least 15 minutes. the pH of the resulting mixture down to 6,68 to 6.75 with 1N potassium hydroxide.

Wait at least one minute and no more than two hours, the resulting mixture is heated to 71-82°C and Tegaserod under vacuum, emuleret through a single stage homogenizer at a pressure of 6,327-7,734 MPa (900-1100 pounds/inch2) and then heated to 99-110°C, and again heated to 146°C for approximately 5 seconds. The heated mixture is passed through the setup for ultrafast cooling to reduce the temperature to 99-110°C and then through the plate cooler to further reduce the temperature to 71-76°C. the cooled mixture is homogenized at 27,42-28,825 MPa/2,812-4,218 MPa (3900-4100/400-600 pounds/inch2) and then incubated at 74-80°C for 16 seconds and then cooled to 1-7°C. Taking samples for microbiological and analytical testing. The mixture was kept under stirring.

The solution of water-soluble vitamins (WSV) and the ascorbic acid solution is prepared separately and added to the processed mixed suspension. A solution of vitamins produced by adding the following ingredients to 9,4 kg of water under stirring: potassium citrate, ferrous sulfate (II), WSV premix, L-carnitine, Riboflavin and nucleotide-kalinovy premix Solution of ascorbic acid get adding potassium citrate and ascorbic acid to sufficient for dissolving the ingredients in water quantity. Then the solutions of vitamins and ascorbic acid added to the above mixture and bring the pH of the mixture to 7-10 using 45% potassium hydroxide solution.

Based on the analytical results of quality control tests, to boot, add appropriate amount of water with stirring to achieve the desired total quantity of solids. the pH of the product can fail to achieve optimal stability of the product. Then the prepared product is placed in suitable containers and subjected to a final sterilization.

The resulting mixture is used for feeding infants as a sole source of nutrition during the first 6-12 months of life to ensure that each child 7-300 µg/kg/day of lutein. Mixtures provide the improved state of the retina and the development of vision, as described in this context.

Examples 2.1-2.3

The following material represents examples of powder mixtures on the basis of the soybeans of the present invention, including the method of application and receipt of mixtures. Ingredients mixtures for each load listed in the table below.

Ingr dient Example 2.1Example 2.2Example 2.3
Number/ 454 kgNumber/ 454 kgNumber /454 kg
Safflower oil high oleic acid content52.1 kg52.1 kg52.1 kg
Coconut oil35,2 kg35,2 kg35,2 kg
Soybean oil38,1 kg38,1 kg38,1 kg
ARA-containing oil (40% ARA)1.3 kg1.3 kg1.3 kg
DHA-containing oil (40% DHA)0,381 kg0,762 kg0,876 kg
The premix of vitamins, soluble in oil0,173 kg0,173 kg0,173 kg
A solution of β-carotene (activity 30%)of 0.0004 kg of 0.0004 kgof 0.0004 kg
Ascorbyl palmitaterate £ 0.162 kgrate £ 0.162 kgrate £ 0.162 kg
Isolate soy protein66,1 kg66,1 kg66,1 kg
Corn syrup236,0 kg236,0 kg236,0 kg
Di - and tricalcium phosphate8,0 kg8,0 kg8,0 kg

0.05 kg
IngredientExample 2.1Example 2.2Example 2.3
Number/ 454 kgNumber/ 454 kgNumber/ 454 kg
Sulphate of iron (II)was 0.138 kgwas 0.138 kgwas 0.138 kg
A solution of lutein (activity 5%)17,06 g10,5903 g14,200 g
The water soluble premix of vitamins, minerals/taurine0,65 kg0,65 kg0,65 kg
Choline chloride0,23 kg0,23 kg0,23 kg
Potassium iodide0,0005 kg0,0005 kg0,0005 kg
Methionine0,722 kg0,722 kg0,722 kg
Ascorbic acid0.72 kg0.72 kg0.72 kg
Potassium hydroxide (45% solution)1.2 kg1.2 kg1.2 kg
Potassium chloride0,87 kg0,87 kg0,87 kg
Magnesium chloride0.4 kg0.4 kg0.4 kg
Carnitine0.05 kg0.05 kg
Total lutein (mg/l when feeding)0,10,150,2
Total DHA (mg/l when feeding)50100115
The ratio of lutein (mg):DHA(mg) feeding0,0020,0020,00174
1FloraGLO®crystalline lutein, Kemin Foods, Des Moines, Iowa, USA.

The first stage of the receipt is given as an example of the powder is getting oil mixture. Soybean oil, coconut oil and safflower oil with a high content of oleic acid are mixed in a suitable container or reservoir at 60-65°C. under stirring.

Ascorbyl palmitate and mixed Tocopherols added to the vessel followed by the addition of the premix of vitamins, soluble in oil, all procedures carried out under stirring. β-carotene (BASF, Mount Olive, New Jersey) and lutein (Kemin, Des Moines, Iowa) add to oil mixture and mix until until fully dispersed. Then to the mixture of oils add isolate soy protein and methionine and received the th resulting mixture is stirred and maintained at 54,0-60°C until further use in the method of manufacture.

Then prepare carbohydrate-mineral slurry. Potassium chloride, sodium chloride, magnesium chloride and potassium iodide bring in water at 60-65°C, then add di - and tricalciumphosphate, all procedures carried out under stirring. Then with stirring, add corn syrup and maintain the suspension at 54-60°C until further use in the manufacturing process.

The carbohydrate-mineral slurry is added to the oil mixture. If necessary add more water. To the mixture add oil ARA and DHA. the pH of the resulting mixture down to 6.75-6,85 using a KOH solution. Then summed mixture is maintained at 54-60°C With stirring for at least 15 minutes.

Then the resulting mixture is heated to 74-79°C and Tegaserod under vacuum, emuleret through a single stage homogenizer at 0-2,76 MPa, is passed through a two-stage homogenizer at a 6.2 to 7.6 MPa and 2.1 to 3.4 MPa. Gomogenizirovannogo mixture is maintained at 73-79°C for 16 seconds and then cooled to 1-7°C. Take samples for microbiological and analytical testing. The mixture was kept under stirring.

You can prepare a solution of calcium carbonate to regulate the level of calcium in the mixture, if it does not meet specifications.

Get the original solution of vitamins containing premix odorant arimah vitamins with minerals and taurine. Potassium citrate and ferrous sulfate (II) contribute to the water when 37-66°C. Then add the vitamin premix and mix the mixture. Add choline chloride and carnitine, and then the desired amount of the mixture of vitamins contribute in the download. Prepare a solution of ascorbic acid and slowly injected into the loading by stirring for at least 10 minutes. Then download pre-heated to 74-79°C. Then the download was incubated for 5 seconds when 107-111°C using the direct supply of steam. Then download cooled to 71-82°C before pumping the spray dryer and dried to obtain a free flowing powder. After the download is Packed in suitable containers and sealed with the content in the free space above the product less than 2.0% of oxygen.

Given as examples of the powders restore water to calorie 2830 kJ/L. the resulting liquid mixture is given to children as a sole source of nutrition during the first 6-12 months of life to ensure 7-300 µg/kg/day of lutein. The mixture leads to the improvement of the retina and the development of vision, as described in this context.

Examples 3.1-3.3

The following materials are examples of powder mixtures on the basis of milk of the present invention, including the method of application and obtain a mixture. Ing eventy mixture for each load listed in the table below.

IngredientExample 3.1Example 3.2Example 3.3
Number/ 454 kgNumber/ 454 kgNumber/ 454 kg
Soybean oil35,8 kg35,8 kg35,8 kg
Coconut oil23,8 kg23,8 kg23,8 kg
MCT oil (triglyceride medium chain)32,1 kg32,1 kg32,1 kg
Safflower oil high oleic acid content34,6 kg34,6 kg34,6 kg
Ascorbyl palmitateof) 0.157 kgof) 0.157 kgof) 0.157 kg
Vitamin a palmitate0,002 kg0,002 kg0,002 kg
The premix of vitamins ADEK10,192 kg0,192 kg0,192 kg
A mixture of Tocopherols0,075 kg0,075 kg0,075 kg
A solution of lutein (activity 20%)47,06 g10,590 g13,714200 g
Concentrate protein whey32,7 kg32,7 kg32,7 kg
Calcium carbonate1.2 kg1.2 kg1.2 kg
Lactose54,5 kg54,5 kg54,5 kg
Solids corn syrup117,1 kg117,1 kg117,1 kg
Magnesium chloride0,724 kg0,724 kg0,724 kg
Potassium citrate 2.8 kg2.8 kg2.8 kg
Sodium chloride0,39 kg0,39 kg0,39 kg

IngredientExample 3.1Example 3.2Example 3.3
Number/ 454 kgNumber/ 454 kgNumber/ 454 kg
Sodium citrate0.001 kg0.001 kg0.001 kg
Non-fat dry milk116,9 kg116,9 kg116,9 kg
Tricalcium phosphate1.8 kg1.8 kg1.8 kg
ARA-containing oil (40% ARA)1.3 kg1.3 kg1.3 kg
DHA-containing oil (40% DHA)0.43 kg0,65 kg 1.00 kg
Ascorbic acid1.29 kg1.29 kg1.29 kg
The potassium hydroxide, 1 N solution9,8 kg9,8 kg9,8 kg
Sulphate of iron (II)has 0.168 kghas 0.168 kghas 0.168 kg
Carnitine0,136 kg0,136 kg0,136 kg
Choline chlorideof 0.182 kgof 0.182 kgof 0.182 kg
The premix of vitamins and minerals20,825 kg0,825 kg0,825 kg
Inositol0,734 kg0,734 kg0,734 kg
Premix nucleotides, choline bitartrate31.1 kg1.1 kg1.1 kg
Total lutein (mg/l when feeding)0,10,150,2
Total DHA (mg/l when feeding)5075115
The ratio of lutein (mg):DHA (mg) feeding0,0020,0020,00174
1. The premix contains 71 g of d-α-tocopherol acetate, 7,29 g vitamin a palmitate, 0,422 g fellaheen and 0.051 g of vitamin D3 in terms of product.
2. The premix contains 252 g of taurine, 183 g of Inositol, 84.5 g of zinc sulfate, 53,8 g nicontinamide, of 32.6 g of calcium Pantothenate, 29 g of iron sulfate (II), the 10.1 g of copper sulfate, and 8.4 g of thiamine, 3.7 g of Riboflavin, 3.4 g of pyridoxine (Hcl), 1.1 g of folic acid, 1.0 g of magnesium sulfate, 0.3 g of Biotin, 0.2 g of sodium selenate and 0.03 g cyancobalamin in terms of product.
3. The premix contains 188 g choline bitartrate, 118 g cytidine 5'-monophosphate, 92 g of guanosine 5'-monophosphate disodium, 80 g of uridine 5'-monophosphate disodium and 51 g of adenosine 5'-monophosphate.
4. FloraGLO®crystalline lutein, Kemin Foods, Des Moines, Iowa, USA.

This item is Raskovoy mixture is made, receiving at least two suspensions are then mixed together, subjected to heat treatment, standardizes, is subjected to spray-dried and packaged. First get the carbohydrate-mineral slurry (45-50% solids), dissolving lactose in water at 66-76°C. Then add solids corn syrup and allow them to dissolve, and then add magnesium chloride, potassium citrate, potassium chloride, choline chloride and sodium citrate, all components are added under stirring. The resulting carbohydrate-mineral slurry support at 54-60°C under stirring until her later not used in the manufacturing process.

Protein-fat suspension get mixing safflower oil high oleic acid soybean oil and MCT oil when 40,5-49°C, followed by addition of ascorbyl palmitate, a mixture of Tocopherols, vitamin a palmitate and premix vitamins ADEK, all the components are introduced with stirring.

Then under stirring enter lutein (Kemin, Des Moines, Iowa). Then the suspension is added to the concentrate whey protein followed by the addition of calcium carbonate and tricalcium phosphate, all components are added under stirring. The obtained protein-fat suspension support with moderate stirring at 54-60°C for not more than twelve hours until it is dnee not mixed with other received suspensions.

Then the carbohydrate-mineral slurry is transferred into a tank, to which is added sufficient water to obtain a final slurry mixture containing approximately 50% solids. Then to the mixture add non-fat dry milk and allow it to dissolve. Then add the protein and fat suspension and allow the suspension of the entire mixture is mixed for at least 15 minutes. The resulting mixture of support at 60-65°C. the pH of the mixture down to 6.7 or 6.9 1H CON.

Through a period of not less than one minute and no more than two hours, the resulting mixture is heated to 71-79°C, emuleret when 2,75 of 4.1 MPa, and then heated to 115-127°C for approximately 5 seconds using the direct supply of steam. Then the heated emulsion sverhbystro cooled to 87-99°C and homogenized with a 9.7-11,0/2,75 of 4.1 MPa. Then gomogenizirovannogo suspension is cooled to 1.6 to 7.2°C. Selected samples for microbiological and analytical testing. The mixture of support under stirring.

A solution of vitamins-trace elements receive, adding the following ingredients to the desired amount of water with stirring: potassium citrate, ferrous sulfate (II), carnitine, a premix of vitamins and minerals, Inositol and premix nucleotides and choline bitartrate. Then a solution of vitamins-trace elements add to gomogenizirovannom the second suspension under stirring.

The ascorbic acid solution receive, adding potassium citrate and ascorbic acid to the water with stirring and then adding water to the mixture to homogeneous suspension with stirring.

The product is pre-heated to 65.5-77°C. the product is Then incubated at 82-90,5°C for 5 seconds before ultrafast cooling to 71-82°C and pumped into the spray dryer. The product is subjected to spray drying, getting the desired free-flowing powder. The resulting powder is Packed under nitrogen, in order to maximize stability and taste of the product.

Presents as an example, powders restore water to calorie 2830 kJ/L. the resulting liquid mixture is given to children as a sole source of nutrition during the first 6-12 months of life to ensure 7-300 µg/kg/day of lutein. The mixture provides improved condition of the retina and the development of vision, as described in this context.

Examples 4.1-4.3

The following materials are examples of concentrated liquids that increase the nutritional value of breast milk of the present invention, including the method of application and obtain a mixture. The ingredients of the mixture for each load listed in the following table.

0,170
IngredientExample 4.1Example 4.2Example 4.3
g/kgg/kgg/kg
Sucroseoutput reached 125.5output reached 125.5output reached 125.5
Isolate milk protein64,664,664,6
Coconut oil30,230,230,2
Concentrate protein whey24,424,424,4
MCT oilof 21.9of 21.9of 21.9
Soybean oilof 21.9of 21.9of 21.9
Tricalcium phosphate14.4V14.4V14.4V
Potassium chloride5,185,18 5,18
Calcium carbonate3,443,443,44
The magnesium phosphate3,053,053,05
Potassium citrate1,321,321,32
Oil DHA (docosahexaenoic acid)0,20,20,2
Soy lecithin0,7560,7560,756
Oil ARA (arachidonic acid)advanced 0.729advanced 0.729advanced 0.729
Dailypost0,5960,5960,596
The monokaliy0,4660,4660,466
Vitamin E0,3570,3570,357
Sodium chloride0,1700,170
KOH, 5% solutionas neededas neededas needed
Lutein (20% solution)10,000180,000640,00091
m-Inositol0,06980,06980,0698

IngredientExample 4.1Example 4.2Example 4.3
g/kgg/kgg/kg
Ascorbic acid0,9130,9130,913
Taurine0,06630,06630,0663
Nicotinamid0,05820,05820,0582
Vitamin a 0,04940,04940,0494
Zinc sulfate0,04610,04610,0461
Calcium Pantothenate0,02860,02860,0286
Sulphate of iron (II)0,01360,01360,0136
The copper sulfate0,008360,008360,00836
Riboflavin0,007630,007630,00763
Thiamine chloride Hcl0,005070,005070,00507
Pyridoxine Hcl0,004590,004590,00459
Folic acid0,0007780,0007780,000778
Manganese sulfate0,0005730,000573 0,000573
Biotin0,0005070,0005070,000507
Vitamin K0,0008350,0008350,000835
Vitamin D30,0002350,0002350,000235
Selenate sodium0,00004910,00004910,0000491
Potassium iodide0,00001050,00001050,0000105
Cyanocobalamin0,00001030,00001030,0000103
Total lutein (mg/l when feeding)0,20,71
Total DHA (mg/l when feeding)200200200
The ratio of lutein (mg):DHA (mg) feeding0,0015 0,00320,0045
1. FloraGLO®crystalline lutein, Kemin Foods, Des Moines, Iowa, USA.

The ingredients listed in the table above, are combined and processed, obtaining the option of implementing the present invention in the form of a concentrated product that improves the nutritional value of breast milk. One way to obtain this option, perform the following.

The source of the intermediate mixture obtained by heating to 32-37°With certain quantities of coconut oil, MCT oil, soy oil, oil DHA oil and AA (arachidonic acid), all products are introduced with stirring. Emulsifier soy lecithin added under stirring to the heated mixture and allow it to dissolve. Then vitamins A, D5 and natural vitamin E and lutein are introduced with stirring into the resulting mixture. In the mixture entering the milk protein isolate (25,8 kg) and a certain number of ultramicrobalance tricalcium phosphate and calcium carbonate. The resulting intermediate mixture of support when 26-48°C With moderate stirring in a period of time not to exceed six hours, before adding to the aqueous protein mixture described below.

Then get aqueous protein mixture by heating 573 kg water ingredient at 48-60°C With the consequences of the decisions added to it under stirring milk protein isolate (38,8 kg) and a certain amount of protein concentrate of whey. After that, and when mixing all of the above intermediate mixture is added to aqueous protein mixture. Then to the resulting mixture add the following ingredients in the following order: potassium citrate, dailypost, monokaliy, magnesium phosphate, sodium chloride, potassium chloride, potassium iodide and sucrose. Through no less than five minutes the pH of the mixture down to 6,60-6,80 using 1N solution of KOH, and then maintain at 51-60°C in a period of time not exceeding two hours before further processing.

The mixture is then connected to a pH of homogenized using one or more built-in in-line homogenizer at pressures from 7 MPa to 28 MPa (1000 to 4000 pounds/inch2with or without using the second stage homogenization from 0.7 to 3.5 MPa (100 to 500 lbs/inch2with subsequent heat treatment using the HTST method (short-term high-temperature processing, 74°C for 16 seconds) or UHTST (short ultra-high-temperature processing, 132-154°C for 5-15 seconds). The choice UHTST or HTST, as a rule, based on the analysis of the bioburden of each ingredient of the mixture. After appropriate heat treatment load is cooled in a plate cooler to 1,0-5,0°C and then transferred into a cooling tank for aging, where it is subjected to analytical analysis and then the article is horticult according to the technical requirements of the final product, which include the addition of ascorbic acid solution and a solution of water-soluble vitamins and trace elements, all components are prepared separately before adding in the previously described chilled loading.

The ascorbic acid solution is produced by adding a certain amount of ascorbic acid to 11,1 kg 1N solution of KOH with stirring. The solution of water-soluble vitamins and trace elements obtained by heating 25,2 kg BW of an aqueous ingredient to 37°C To 48°C. water-Soluble vitamins and minerals added to the water in the form of a premix, which contains m-Inositol, taurine, nicotinamide, zinc sulfate, calcium Pantothenate, ferrous sulfate (II), copper sulfate, Riboflavin, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, manganese sulfate, Biotin, sodium selenate, and cyanocobalamin. As noted above, the two solutions are then added to the cooled load, and all components are added under stirring. As part of the standardization of the download, then the download add appropriate amount of water to dilute the ingredients to obtain a given level of solids 31% and bring the pH to 7.1 1 N KOH solution. Download fill the generously sized containers containing 5 ml of product.

Shown as an example, concentrates, which increases the nutritional value of breast milk, with eshivot female milk (5 ml concentrate with 20-25 ml of breast milk). Women's milk with a high nutritional value then fed premature infants, providing 7-300 µg/kg/day of lutein. The mixture provides improved condition of the retina and the development of vision, as described in this context, including a reduced risk of developing retrolateral fibroplasia.

Examples 5.1-5.3

This example illustrates a variant implementation of the present invention in the form of ready-to-use mixture for premature babies. This mixture is close to the mixture for premature infants with the addition of iron Similac®Special Care®Advance®to the mixture for premature babies available in the firm of Abbott Laboratories, Columbus, Ohio, with the exception of elevated concentrations of lutein and subsequent ratios of lutein and docosahexaenoic acid.

Mixture for premature infants includes nonfat milk solids, corn syrup, lactose, triglycerides of medium chain length, the protein concentrate of whey, soybean oil, coconut oil, butter .cohnii (source of docosahexaenoic acid), butter .alpina (a source of arachidonic acid), calcium phosphate, calcium carbonate, potassium citrate, ascorbic acid, magnesium chloride, soy lecithin, mono - and diglycerides, m-Inositol, sodium citrate, carrageenan, ferrous Sulfate (II), choline bitartrate, taurine, choline chloride, nicotinamide, d-α-tocopherol acetate, L-carnitine, Sul is at zinc, potassium chloride, dailypost, calcium Pantothenate, copper sulfate, vitamin a palmitate, Riboflavin, teamengland hydrochloride, pyridoxine hydrochloride, folic acid, β-carotene, manganese sulfate, Biotin, phylloquinone, sodium selenate, vitamin D3, cyanocobalamin and nucleotides (citizen 5'-monophosphate, guanosine 5'-monophosphate disodium, uridine 5'-monophosphate, adenosine 5'-monophosphate).

The above ingredients combine conventional methods to obtain the following profile power supply:

NutrientsExample 5.1Example 5.2Example 5.3
Number/ 418,kJ (100 kcal or 123 ml)Number/ 418,kJ (100 kcal or 123 ml)Number/ 418,7 kJ (100 kcal or 123 ml)
Protein (from nonfat milk, whey protein think)3.00 g3.00 g3.00 g
Fat (form a mixture of 50:30:18,3 MCT oil, soybean oil and coconut oil; --- mg DHA, --- mg ARA, 700 mg linolenic acid)5,43 g5,43 g5,43 g
The carbohydrate source is a 50:50 mix of solids corn syrup, lactose)10.3 g10.3 g10.3 g
Lutein18,4 mcg37 mcg9141 mcg
Vitamin a1250 ME1250 ME1250 ME
Vitamin D150 ME150 ME150 ME
Vitamin E4,0 ME4,0 ME4,0 ME
Vitamin K12 mcg12 mcg12 mcg
Thiamine250 mcg250 mcg250 mcg
Riboflavin620 mcg620 mcg620 mcg
Vitamin B6250 mcg250 mcg250 mcg
Vitamin B120,55 mcg0,55 mcg0,55 mcg
Niacin5000 mcg5000 mcg5000 mcg
Folic acid37 mcg37 mcg37 mcg
Pantothenic acid1900 mcg1900 mcg1900 mcg
Biotin37,0 mcg37,0 mcg37,0 mcg
Ascorbic acid37 mg37 mg37 mg
Choline10 mg10 mg10 mg
Inositol40,0 mg40,0 mg40,0 mg

Selenium
NutrientsExample 5.1Example 5.2 Example 5.3
Number/ 418,kJ (100 kcal or 123 ml)Number/ 418,kJ (100 kcal or 123 ml)Number/ 418,7 kJ (100 kcal or 123 ml)
Calcium180 mg(9.0 IEC)180 mg (9.0 IEC)180 mg (9.0 IEC)
Phosphorus100 mg100 mg100 mg
Magnesium12,0 mg12,0 mg12,0 mg
Iron1.8 mg1.8 mg1.8 mg
Zinc1,50 mcg1,50 mcg1,50 mcg
Manganese12 mcg12 mcg12 mcg
Copper250 mcg250 mcg250 mcg
Iodine6 mcg6 mcg6 mcg
a 1.8 mcga 1.8 mcga 1.8 mcg
Sodium43 mg (1.9 IEC)43 mg (1.9 IEC)43 mg (1.9 IEC)
Potassium129 mg (3.3 IEC)129 mg (3.3 IEC)129 mg (3.3 IEC)
Chloride81 mg (2.3 IEC)81 mg (2.3 IEC)81 mg (2.3 IEC)
Total lutein (mg/l when feeding)0,150,31,15
Total DHA (mg/l when feeding)112112115
The ratio of lutein (mg):DHA (mg) feeding0,0013:10,003:10,01:1

Given as an example ready-to-use mixtures (calories 3400 kJ/l) give premature babies, to provide from 7 to 300 mcg/kg lutein/day. Put the mixture improves the condition of the eye, as described the in this context, and is particularly effective when applied to preterm infants in reducing the risk of retrolateral fibroplasia and helps to protect eyes from natural or artificial light, especially blue light.

Experiment

The study was conducted to compare the concentrations of lutein in the plasma of children breastfed, with the concentration of lutein in the plasma of children who are fed infant formula. The latter receive one of the three mixtures, certain concentrations of lutein 32,6 µg/l (L1), for 52.6 ág/l (L2) or 14.6 ág/l (CTRL). The results of the study groups and the resulting concentrations of lutein in the plasma are listed in the following table.

Group feedingLutein plasma (ág/DL)*
Study day 1Study day 56
Control (CTRL) - no added lutein General internal lutein to 14.6 ág/l lutein1,37±0,29a
(0,40-5,10)
20
2,17±0,12a
(1,16-3,25)
18
A mixture of L1
Added lutein approximately 18 ág/l
Internal lutein about to 14.6 ág/l Total lutein 32,6 µg/l
0,78±0,09a
(0,27-2,09)
24
2,21±0,16a
(0,20-3,61)
22
The mixture L2
Added lutein about 38 μg/l
Internal lutein about to 14.6 ág/l Total lutein for 52.6 ág/l
0,97±0,13a
(0,20-2,31)
21
3,25±0,26b
(0,60-4,70)
19

Group feedingLutein plasma (ág/DL)*
Study day 1Study day 56
Women's milk (NM) 6.5 to 107,8 µg/l lutein6,53±0,54b
(1,69-14,12)
24
5,88±0,77c
(0,49-20,09)
26
Values are presented as mean ± SEM (standard error), (limits) n. Values in a column with superscripts without the usual letters differ (p<0,05). Cm. in the text regarding the actual values of R. Statistical comparisons between groups receiving the mixture is done using the criterion of the Kruskal-Wallis. Comparisons between groups receiving the mixture, and the group receiving breast milk, is done using the criterion rank-sum Wilcoxon signed.

p> The concentration of lutein in the plasma (study day 56) is used as the main variable in the study. The primary comparison is the difference of concentrations of lutein in the plasma in the groups receiving a mixture of L2 and CTRL. Secondary comparisons include the difference of concentrations of lutein in the plasma in the groups receiving the mixture (CTRL, L1, L2), and the difference between the groups receiving the mixture, and the group receiving breast milk. In these analyses use the concentration of lutein in plasma at day 56, obtained in General for 85 children (CTRL, n=18; L1, n=22; L2, n=19; NM, n=26), and the results are presented as mean ± SEM in the following table.

The children in the group receiving the mixture of L2, have significantly higher (p<0,05) concentration of lutein in the plasma than the children in the groups receiving a mixture of L1 and CTRL. Lutein plasma is not different in the groups receiving a mixture of L1 and CTRL. The group receiving human milk has a higher concentration of lutein in the plasma than in the group receiving the mixture CTRL (p<0.0001)and L1 (p<0,0001) and L2 (p=0,0052). The concentration of lutein in the plasma were significantly correlated with the intake of lutein (r=0,436, p=0.0014). The results of the intake of lutein and reactions of the plasma obtained in the study, also shown in Figure 1.

The data obtained in the study show that lutein unexpectedly is less bioavailable in a mixture of baby food than in human milk (see figure 1). In this with what you learn, to the infant formula was given concentration of lutein in the plasma, similar to the results obtained when feeding the female milk, infant formula should be prepared so that it contains at least about 50 mcg/liter of lutein, preferably from 100 μg/l to about 200 mg/L.

1. The infant formula, which includes fat, protein, carbohydrates, vitamins and minerals, including docosahexaenoic acid, and ready for use based at least about 0.075 mg/l of lutein, where the ratio by weight of lutein (mg) and docosahexaenoic acid (mg) is from about 0,001:2 to about 0.01:1, the mixture does not contain egg phospholipids.

2. The mixture according to claim 1, which comprises from about 0,075 to about 0.23 mg/l of lutein.

3. The mixture according to claim 1, which comprises from about 0.1 to about 0.2 mg/l of lutein.

4. The mixture according to claim 1, in which the ratio by weight of lutein (mg) and docosahexaenoic acid (mg) is from about 0,0015:1 to 0.01:1.

5. The mixture according to claim 1, in which the ratio by weight of lutein (mg) and docosahexaenoic acid (mg) is approximately a 0.002:1 to about 0,005:1.

6. The mixture according to claim 1, which has a caloric content of from 2,93 to 4.25 kJ/ml

7. The mixture according to claim 1, which includes a combination of free lutein and zeaxanth is on the crystalline extract gts rt, in which free lutein is from 85% to 95% by weight of the combination, and free zeaxanthin is from about 5% to about 15% by weight of the combination.

8. The mixture according to claim 1, which is prepared in powder form.

9. The mixture according to claim 1, which is prepared in liquid form.

10. The mixture according to claim 1, in which lutein from about 25 wt.% to about 95% of added lutein.

11. A mixture of baby food, including ready to use the basis of the following ingredients: from about 54 to about 108 g/l of carbohydrates, from about 20 to about 54 g/l of fat, from about 7 to about 24 g/l of protein, from about 0.1 to about 0.2 mg/l of lutein and docosahexaenoic acid, the ratio by weight of lutein (mg) and docosahexaenoic acid (mg) is approximately a 0.002:1 to about 0,005:1, and the mixture does not contain egg phospholipids.

12. The mixture according to claim 11, which includes a combination of free lutein and zeaxanthin crystalline extract gts rt in which free lutein is from 85% to 95% by weight of the combination and free zeaxanthin is from about 5% to about 15% by weight of the combination.

13. The way to reduce the risk of retrolateral fibroplasia in premature infants, which is what obespechenie in need of this child lutein in an amount of from about 0,007 to approximately 0.3 mg/kg/day, by introducing him to the mixture according to claim 1.

14. The way to reduce the risk of retrolateral fibroplasia in premature infants, which is to ensure the needs of this child lutein in an amount of approximately of 0.014 to about 0.22 mg/kg/day, by introducing him to the mixture according to claim 1.

15. The way to maintain the health of the retina and eye development in children, which is to ensure the needs of this child lutein in an amount of from about 0,007 to approximately 0.3 mg/kg/day, by introducing him to the mixture according to claim 1.

16. The way to maintain the health of the retina and eye development in children, which is to ensure the needs of this child lutein in an amount of approximately of 0.014 to about 0.22 mg/kg/day, by introducing him to the mixture according to claim 1.

17. The infant formula consisting of carbohydrates, fats, proteins, vitamins and minerals, including docosahexaenoic acid and ready for use basis from about 0.075 mg/l to approximately 1,15 mg/l of lutein, the ratio by weight of lutein (mg) and docosahexaenoic acid (mg) is from about 0,001:2 to about 0.01:1, and the mixture does not contain egg phospholipids.



 

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