ES2575380T3

Nutritional products including a novel fat system including monoglycerides

Abstract

A nutritional product comprising a fatty system, wherein the fatty system comprises at least 10% by weight of a fatty acid component and at least 10% by weight of monoglycerides containing fatty acids, and wherein the nutritional product is selected from a liquid or a reconstitutable powder in a nutritional liquid, where the fatty acid component is selected from free fatty acids, salts of fatty acids and one of their combinations and the fatty acid component is obtained from a source of oil or fat containing a total of less than about 20% by weight of palmitic acid, stearic acid, myristic acid, or combinations thereof , where at least 70% of the fatty acids in the monoglycerides containing fatty acids are in the Sn-1 position.

ES2575380T3, drawing sheet 1 — Sheet 1 of 2

Term

5.2 yearsto projected expiry

Projected expiry 21 December 2031, counted from filing; an application has no term until it is granted.

13 claims: 8 independent, 5 dependent

1
ES 2 575 380 T3 REIVINDICACIONES 1. Un producto nutricional que comprende un sistema graso, en donde el sistema graso comprende al menos 10% en peso de un componente ácido graso y al menos 10% en peso de monoglicéridos que contienen ácidos grasos, y en donde el producto nutricional se selecciona entre un líquido nutricional o un polvo reconstituible en un líquido nutricional, en donde el componente ácido graso se selecciona entre ácidos grasos libres, sales de ácidos grasos y una de sus combinaciones y el componente ácido graso se obtiene de una fuente de aceite o grasa que contiene un total de menos de aproximadamente 20% en peso de ácido palmítico, ácido esteárico, ácido mirístico, o combinaciones de los mismos, donde al menos 70% de los ácidos grasos en los monoglicéridos que contienen ácidos grasos se encuentran en la posición Sn-1.
2
El producto nutricional de la reivindicación 1, en donde el sistema graso comprende de 20% en peso a 65% en peso de una mezcla del componente ácido graso y monoglicéridos que contienen ácidos grasos.
3
El producto nutricional de la reivindicación 1 o 2, en donde el sistema graso comprende de 25% en peso a 50% en peso de una mezcla del componente ácido graso y monoglicéridos que contienen ácidos grasos.
4
El producto nutricional de una cualquiera de las reivindicaciones 1 a 3, en donde los monoglicéridos que contienen ácidos grasos son palmitato de monoglicerol.
5
El producto nutricional de una cualquiera de las reivindicaciones 1 a 4, en donde el componente ácido graso está en una forma seleccionada del grupo que consiste en sales de calcio de ácidos grasos, sales de magnesio de ácidos grasos, y combinaciones de las mismas.
6
El producto nutricional de una cualquiera de las reivindicaciones 1 a 5, en donde el componente ácido graso comprende menos de 15% en peso de ácidos grasos libres saturados a con una longitud de cadena de más de 14 átomos de carbono.
7
El producto nutricional de una cualquiera de las reivindicaciones 1 a 6, en donde el componente ácido graso deriva de un aceite vegetal.
8
El producto nutricional de la reivindicación 7, en donde el aceite vegetal se selecciona del grupo que consiste en aceite de oliva, aceite de canola, aceite de maíz, aceite de soja, y combinaciones de los mismos.
9
El producto nutricional de la reivindicación 8, en donde el aceite vegetal es aceite de soja.
10
Una fórmula para bebés que comprende un sistema graso, en donde el sistema graso comprende al menos 10% en peso de un componente ácido graso y al menos 10% en peso de monoglicéridos que contienen ácidos grasos, en donde el componente ácido graso se selecciona entre ácidos grasos libres, sales de ácidos grasos y una combinación de los mismos, y el componente ácido graso se obtiene de una fuente de aceite o grasa que contiene un total de menos de aproximadamente 20% en peso de ácido palmítico, ácido esteárico, ácido mirístico, o sus combinaciones, en donde al menos 70% de los ácidos grasos en los monoglicéridos que contienen ácidos grasos se encuentran en la posición Sn-1.
11
La fórmula infantil de la reivindicación 10, en donde el sistema graso comprende de 20% en peso a 65% en peso de una mezcla del componente ácido graso y monoglicéridos que contienen ácidos grasos.
12
La fórmula para bebés de cualquiera de las reivindicaciones 10 o 11, en donde los monoglicéridos que contienen ácidos grasos son palmitato de monoglicerol.
13
La fórmula para bebés de cualquiera de las reivindicaciones 10 a 12, en donde el componente ácido graso está en una forma seleccionada del grupo que consiste en sales de calcio de ácidos grasos, sales de magnesio de ácidos grasos, y combinaciones de las mismas.

Independent claims13

365 paragraphs in 10 sections, as filed

ES 2 575 380 T3

DESCRIPTION

Nutritional products that include monoglycerides and fatty acids

Description field

The present description relates to nutritional products comprising predigested fat and to methods for the use of the nutritional products. More particularly, the present disclosure relates to infant, infant, and pediatric products comprising monoglycerides containing fatty acids and a fatty acid component as defined by the claims that provide nutritional benefits including improved digestion, tolerance, and absorption of nutrients, as well as reducing the incidence of necrotizing enterocolitis, colic, and short bowel syndrome.

Description background

Nutritional liquids and powders, including infant and pediatric formulas, comprising a specific selection of nutrients are well known and widely available, some of which may provide a single source of nutrition, while others may provide a supplemental source. These nutritional products include powders that can be reconstituted with water or other aqueous liquids, as well as concentrated, ready-to-drink nutritional liquids such as milk-based or protein-based emulsions. These nutritional liquids are especially helpful when formulated with selected nutritional ingredients.

Although it is recognized that breast milk is generally the best nutrition for newborn babies, not all mothers can breastfeed successfully. Breast milk substitutes (baby formulas) can provide complete nutrition, and have been shown to meet the normal growth and nutritional needs of the baby. Unfortunately, a small percentage of newborns fed infant formula may experience gastrointestinal (GI) intolerance issues, including loose stools, gas, necrotizing enterocolitis, colic, and the like.

The problem of GI intolerance may be due at least in part to incomplete digestion and absorption of nutrients in the baby. To address this tolerance problem, some infant formulas do not include lactose as an ingredient, while others replace intact milk protein with hydrolyzed proteins to lessen the burden on the baby's digestive system.

Also, some formula-fed newborn babies have a much lower rate of fat absorption than breastfed babies. This discrepancy in the rate of fat absorption decreases as babies become more mature. Presumably, newborns are deficient in lipase, and therefore do not digest and absorb fat as well as breastfed babies who receive lipase in their mother's milk.

The digestive system of a premature baby is less developed than that of a full-term baby, yet it requires more nutrients (calories) than full-term infants to promote growth and development. Medium Chain Triglycerides (TCM Oil) are easy to digest and absorb, and have been included in preterm formulas to enhance the absorption of fat, protein, and calcium from the formula. The medium chain fatty acids included in the medium chain triglycerides, however, are not used to re-synthesize triglycerides to form chylomicrons after the TCM oil is digested and absorbed. Since many lipid-soluble nutrients, such as carotenoids and vitamins A, D, E, and K, are believed to be packaged in chylomicrons before entering the general circulation, the benefit provided by TCM oil on absorption of lipid soluble nutrients, which is also important for growth and development, may be more limited.

Although attempts have been made in the past to solve previously established GI and other problems, it would be desirable to provide infant and pediatric formulas that could provide similar nutritional benefits to breast milk, and also provide good tolerance, digestion and absorption of hydrophobic nutrients insoluble in water, as well as a reduction in the incidence of conditions such as necrotizing enterocolitis, colic, and short bowel syndrome. Furthermore, it would be beneficial if these formulas were stabilizer free and specifically carrageenan free. US 2008/0089981 describes a solid or semi-solid nutritional composition comprising proteins, lipids and digestible carbohydrates from at least two different sources. US 2002/0176911 describes a pediatric formula comprising xanthan gum and a method for improving the tolerance of pediatric patients which comprises administering an effective amount of pediatric formula comprising xanthan gum. DE 2844861 describes a nutritional product comprising free fatty acids and monoglycerides mixed with diglycerides, fats and / or triglycerides.

Description compendium

ES 2 575 380 T3

The present description refers to nutritional products, and specifically to infant formulas, including predigested fat that include a fat system, wherein the fat system comprises at least 10% of a fatty acid component and at least 10% of acid-containing monoglycerides. fatty acids, and wherein the fatty acid component is selected from free fatty acids, fatty acid salts and a combination thereof, and the fatty acid component is obtained from an oil or fat source that contains a total of less than about 20% palmitic acid, stearic acid, myristic acid, or combinations thereof, and wherein at least 70% of the acids Fatty acids in fatty acid-containing monoglycerides are in the Sn-1 position. These nutritional compositions can be used advantageously to provide better tolerance, digestion and absorption of nutrients, including water insoluble / lipid soluble nutrients, and to reduce the incidence of necrotizing enterocolitis, colic, and short bowel syndrome. In some embodiments, the fatty acid component may be in the fatty acid form or it may be provided in the form of the calcium or magnesium salts of the fatty acid, thereby providing the added benefit of additional nutrients.

The nutritional product is selected from a nutritional liquid or a reconstitutable powder in a nutritional liquid.

It has been discovered that nutritional products such as infant, infant and pediatric formulas, which include predigested fat, comprising monoglycerides and fatty acids described herein, can reduce the overall fat load on a baby's digestive system to improve digestion and fat absorption by the baby, including the absorption of water-insoluble / lipid-soluble nutrients. Specifically, the absorption of predigested fat in the proximal portion of the small intestine stimulates the secretion of CCK, which promotes the maturation of pancreatic alpha cells and the secretion of digestive enzymes. In addition, the secretion of GLP-1 and GLP-2 is stimulated, which further promotes intestinal maturation.

Surprisingly, the use of predigested fat and the subsequent secretion of CCK and GLP-1 delay GI transit and stimulate pancreatic enzyme secretion to allow for more complete digestion and absorption of nutrients. The reduction in the amount of nutrients that enter the baby's colon results in reduced fermentation in the colon, which is part of the cause of gas and loose stool problems. In addition, it has been found that the use of predigested fat can reduce the incidence of necrotizing enterocolitis, colic, and / or short bowel syndrome.

Additionally, it has been discovered that the unsaturated fatty acid component of predigested fat can react with sources of calcium or magnesium and the resulting salts formed are surprisingly bioavailable. In addition to providing a good source of calcium or magnesium, these calcium or magnesium salts are also surprisingly bland, in contrast to fatty acids which are generally bitter and impart a strong burning sensation in the throat. Furthermore, it has been found that calcium or magnesium salts of fatty acids surprisingly act to stabilize nutritional emulsions, since they do not form a difficult-to-disperse sediment in the emulsion like that which many insoluble calcium salts are prone to form. As such, in many embodiments, the inclusion of calcium salts of fatty acids or magnesium as part of the predigested fat can eliminate the need for stabilizers, such as carrageenans.

Brief description of the drawings

Figs. 1A and 1B show a drawing of a control emulsion and an experimental emulsion as prepared in Example 19.

Fig. 2 is a graph showing the effect of diet on stool consistency.

Detailed description of the description

The nutritional products described herein comprise predigested fat. Said products include monoglycerides containing fatty acids and a fatty acid component such that the predigested fatty system includes the two components defined above, as well as by the claims. By reducing the load on the digestive system of the baby, infant, or child, a number of benefits are realized while providing a stable, bioavailable product. These and other characteristics of nutritional products, as well as some of the many optional variations and additions, are described in detail hereinafter.

The terms retort packaging and retort sterilization are used interchangeably herein, and unless otherwise specified, refer to the common practice of filling a container, more typically a metal can or other similar container, with a nutritional liquid and then subjecting the liquid filled container to the necessary heat sterilization step to form a sterilized retort packaged nutritional liquid product.

The term aseptic packaging as used herein, unless otherwise specified, refers to the manufacture of a packaged product without relying on the retort packaging step described above, wherein the nutritional liquid and the package are sterilized separately before filling, and then

ES 2 575 380 T3 are combined under sterile or aseptic processing conditions to form a sterilized, aseptically packaged, nutritional liquid product.

The terms fat and oil, as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or transformed from plants or animals. These terms also include synthetic lipid materials as long as such synthetic materials are suitable for oral administration to humans.

The term "shelf-stable" as used herein, unless otherwise specified, refers to a nutritional product that remains commercially stable after packaging and then stored at 18-24 ° C for at least 3 months, even from about 6 months to about 24 months, and also including from about 12 months to about 18 months.

The terms nutritional formulation or nutritional product or nutritional composition, as used herein, are used interchangeably and, unless otherwise specified, refer to liquid and solid (including semi-liquid) breast milk fortification products. and semi-solid), liquid and solid premature infant formulas, liquid and solid infant formulas, liquid and solid follow-up formulas, liquid and solid pediatric formulas and liquid and solid infant formulas. The solids can be powders that can be reconstituted to form a nutritional liquid, all of which comprise one or more of fat, protein, and carbohydrates and are suitable for oral consumption by a human.

The term "nutritional liquid" as used herein, unless otherwise specified, refers to nutritional products in ready-to-drink liquid form, in concentrated form, and nutritional liquids prepared by reconstitution of the nutritional powders described herein. memory before use.

The term "nutritional powder" as used herein, unless otherwise specified, refers to nutritional products in fluid or collectible form that can be reconstituted with water or other aqueous liquid prior to consumption and include both spray-dried powders as dry mix / dry mix.

The term "baby" as used herein, unless otherwise specified, refers to a person 12 months or younger. The term "premature baby" as used herein refers to a baby born before 36 weeks gestation.

The term "infant" as used herein, unless otherwise specified, refers to a person between one year of age and three years of age.

The term "child" as used herein, unless otherwise specified, refers to a person between three years of age and twelve years of age.

The term "predigested fat" as used herein, unless otherwise specified, refers to monoglycerides containing fatty acids and / or a fatty acid component.

The term "infant formula" as used herein, unless otherwise specified, refers to liquid and solid nutritional products suitable for consumption by an infant as the primary source of nutrition.

The term "preterm infant formula" as used herein, unless otherwise specified, refers to liquid and solid nutritional products suitable for consumption by a preterm newborn as the primary source of nutrition.

The term "human milk fortification product", as used herein, unless otherwise specified, refers to liquid and solid nutritional products suitable for mixing with human milk or premature infant formula or infant formula. infants for consumption by a premature or full-term infant.

The term "fatty acid-containing monoglyceride" as used herein, unless otherwise specified, refers to a glyceride consisting of a fatty acid chain covalently linked to a glycerol molecule through an ester bond to one of the Sn-1 (a), Sn-2 (β), or Sn-3 (α ') positions of the glycerol molecule.

The term "fatty acid component" as used herein, unless otherwise specified, refers to free fatty acids or fatty acid salts such as calcium or magnesium salts of fatty acids derived from a source that has less 20% (by weight) of the total myristic, palmitic acid, and

ES 2 575 380 T3 stearic.

The term "lipid-soluble nutrient" as used herein, unless otherwise specified, refers to water-insoluble nutrients, such as oil-soluble (lipid-soluble) vitamins (eg vitamins A, D , E, and K), carotenoids (eg, lutein, beta-carotene, lycopene, etc.), glycolipids (gangliosides), sterols, and phytochemicals.

The number ranges herein are intended to include each number and subsets of numbers within that range, whether or not it is specifically described. Furthermore, these number ranges should be considered to provide support for a claim directed to any number or subset of numbers in that range. For example, a description from 1 to 10 should be interpreted as supporting a range of 2 to 8, 3 to 7, 5 to 6, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, and so on.

All references to unique features or limitations in the present disclosure will include corresponding plural features or plural limitations, and vice versa, unless the context in which the reference is made clearly specifies or implies otherwise.

All combinations of method or procedure steps used herein can be performed in any order, unless the context in which the referenced combination is made clearly specifies or implies otherwise.

The various embodiments of the nutritional products of the present disclosure may also be substantially free of any optional or selected ingredients or features described herein, as long as the remaining nutritional product still contains all of the required ingredients or characteristics described herein. . In this context, and unless otherwise specified, the term "substantially free" means that the selected nutritional product contains less than a functional amount of the optional ingredient, typically less than 1%, including less than 0.5%, including less than 0. , 1%, and also including zero percent, by weight of such optional or selected ingredient.

Nutritional products and methods may comprise, consist of, or consist essentially of the elements of the products as described herein, as well as any additional or optional elements described herein or otherwise useful in applications to products and nutritional methods.

Product form

The predigested fat-containing nutritional products and associated methods of the present disclosure may be formulated and administered in any known or otherwise suitable oral product form. Any solid, semi-solid, liquid, semi-liquid, or powder form, including combinations or variations thereof, is suitable for use in this invention, provided that such forms allow safe and effective oral administration to the individual of the ingredients. which are also defined herein.

The nutritional products of the present disclosure include predigested fat as described herein. The products can optionally include monoglycerides containing fatty acids or a fatty acid component combined with other sources of fat as indicated below.

Products can include any product form that comprises the ingredients described herein, and that is safe and effective for oral administration. Nutritional products can be formulated to include only the ingredients described herein, or they can be modified with optional ingredients to form several different product forms.

The nutritional products of the present disclosure are preferably formulated as diet product forms, which are defined herein as embodiments comprising the ingredients of the present disclosure in a product form that contains at least one of fat, protein and carbohydrates, and preferably also contains vitamins, minerals or combinations thereof. In many embodiments, the product will comprise predigested fat combined with proteins, carbohydrates, vitamins, and minerals to produce a nutritional product.

Nutritional products may be formulated with sufficient types and amounts of nutrients to provide a single, primary, or complementary source of nutrition, or to provide a specialized nutritional product for use in individuals suffering from specific diseases or conditions or with targeted nutritional benefit. .

ES 2 575 380 T3

Specific non-limiting examples of product forms suitable for use with the predigested fat as described herein include, for example, liquid and powdered breast milk fortification products, liquid and powdered preterm infant formulas. , liquid and powder infant formulas, liquid and powder elemental and semi-elemental formulas, liquid and powder pediatric formulas, and liquid and powder infant formulas.

Nutritional fluids

Nutritional liquids include both concentrated and ready-to-feed nutritional liquids. These nutritional liquids are very typically formulated as suspensions or emulsions.

Nutritional emulsions suitable for use can be aqueous emulsions containing proteins, fats and carbohydrates. These emulsions are generally self-suspending or drinkable liquids between about 1 ° C and about 25 ° C and are typically in the form of complex oil-in-water, water-in-oil, or aqueous emulsions, although such emulsions are most typically as oil-in-water emulsions having a continuous aqueous phase and a discontinuous oil phase.

Nutritional emulsions can be and typically are shelf-stable. Nutritional emulsions typically contain up to about 95% by weight of water, including from about 50% to about 95%, also including from about 60% to about 90%, and also including from about 70% to about 88%, water. by weight of nutritional emulsions. Nutritional emulsions can have a variety of product densities, but most typically have a density greater than about 1.03 g / ml, even more than about 1.04 g / ml, even greater than about 1.055 g / ml, including about 1.06 g / ml to about 1.12 g / ml, and also including from about 1.085 g / ml to about 1.10 g / ml.

Nutritional emulsions can have a caloric density adapted to the nutritional needs of the end user, although in most cases, emulsions generally comprise at least 660 kcal / liter (19 kcal / fl oz), more typically about 675-680 kcal / liter (20 kcal / fl oz) to about 820 kcal / liter (25 kcal / fl oz), even more typically from about 675 to 680 kcal / liter (20 kcal / fl oz) to about 800 to 810 kcal / liter (24 kcal / fl oz). In general, formulas from 740 to 810 kcal / liter (22-24 kcal / fl oz) are most often used in premature or low birth weight babies, and formulas from 675-680 to 700 kcal / liter (20 -21 kcal / fl oz) are most often used in full-term babies. In some embodiments, the emulsion may have a caloric density from about 100 kcal / liter to about 660 kcal / liter, including from about 150 kcal / liter to about 500 kcal / liter.

The nutritional emulsion may have a pH ranging from about 3.5 to about 8, but is more advantageously in a range from about 4.5 to about 7.5, including from about 5.5 to about 7.3, including from about 6.2 to about 7.2.

Although the serving size for the nutritional emulsion can vary depending on a number of variables, a serving size is generally at least about 2 ml, or even at least about 5 ml, or even at least about 10 ml, or even at minus about 25 ml, including ranges from about 2 ml to about 300 ml, including from about 4 ml to about 250 ml, and including from about 10 ml to about 240 ml.

As noted above, nutritional products can also be in the form of a semi-liquid, which includes those forms that have intermediate properties, such as flow properties, between liquids and solids. Illustrative semi-liquids include thick shakes and liquid gels.

Nutritional solids

The nutritional solids can be in any solid form, but are typically in the form of self-suspending or substantially self-suspending particulate compositions, or at least particulate compositions. Particularly suitable nutritional solid product forms include, spray-dried, agglomerated, or dry-blended powder compositions. The compositions can be easily scooped and measurable with a spoon or other similar device, wherein the compositions can be easily reconstituted by the intended user with a suitable aqueous liquid, typically water, to form a nutritional formulation for immediate oral or enteral use. In this context, immediate use generally means within about 48 hours, more typically within about 24 hours, preferably immediately after reconstitution.

Nutritional powders can be reconstituted with water prior to use at a caloric density adapted to the nutritional needs of the end user, although in most cases, powders are reconstituted with water

ES 2 575 380 T3 to form compositions comprising at least 660 kcal / liter (19 kcal / fl oz), more typically from about 675-680 kcal / liter (20 kcal / fl oz) to about 820 kcal / liter (25 kcal / fl oz), even more typically from about 675-680 kcal / liter (20 kcal / fl oz) to about 800-810 kcal / liter (24 kcal oz / FL). In general, formulas from 740 to 810 kcal / liter (22-24 kcal / fl oz) are most often used in premature or low birth weight babies, and formulas from 675-680 to 700 kcal / liter (kcal / fl oz 20-21) are most often used in full-term newborns. In some embodiments, the reconstituted powder may have a caloric density from about 50 kcal / liter to about 660 kcal / liter, including from about 100 kcal / liter to about 500 kcal / liter.

As noted above, nutritional products can also be in the form of a semi-solid, which includes those forms that have intermediate properties, such as rigidity, between solids and liquids. Some semi-solid examples include puddings, jellies, and pasta.

Predigested fat system

A. Monoglycerides containing fatty acids

The nutritional products of the present disclosure include fatty acid-containing monoglycerides, also known as monoacylglycerols, alone or in combination with a fatty acid component as described below. Monoglycerides are normal metabolites in the body formed during the breakdown of triglycerides and diglycerides. As noted, monoglycerides containing fatty acids can be included in nutritional products combined with a fatty acid component, such as fatty acids and / or fatty acid salts as described below, or they can be included in nutritional products. in the absence of the fatty acid component.

Suitable fatty acid-containing monoglycerides for use in nutritional products can include fatty acids having a chain length of 4 to 22 carbon atoms, including fatty acids having a chain length of 14 to 20 carbon atoms, and including palmitic acid (16 carbon atoms). According to the invention, monoglycerides are monoglycerides in which at least 70% of the fatty acids in the monoglycerides are in the Sn-1 position, including monoglycerol palmitate which has at least about 70% of the residues of palmitic acid at the Sn-1 position (also referred to as the alpha position), including at least about 80% at the Sn-1 position, and including from about 85% to about 100% at the Sn-1 position. Additionally, in some embodiments, the monoglycerides included in the nutritional products described herein may include small amounts of diglycerides, free glycerol, and / or free fatty acids. As used herein, the term "trace amounts" refers to amounts that do not exceed 10% by weight, but more commonly less than 7.5% by weight.

In a specific embodiment, the monoglycerides (and optionally the fatty acid component discussed below) in the nutritional product are partially or fully provided to the product through the use of hydrolyzed lard or hydrolyzed tallow. Lard, tallow, and other products of animal origin can be added to the nutritional product and hydrolyzed to monoglycerides and fatty acids by pancreatic lipase. Alternatively, the lard or tallow can be hydrolyzed prior to incorporation into the nutritional product to produce monoglycerides and fatty acids, which can be introduced into the nutritional product. Lard, tallow, or hydrolyzed lard or tallow can provide some or all of the monoglycerides and / or fatty acids in the nutritional product.

In another embodiment, the monoglycerides in the nutritional product are derived partially or totally from oils such as vegetable oils, marine oils, fish oils, algae oil, mushroom oils, tree resin, and combinations thereof. Suitable vegetable oils include, for example, olive oil, canola oil, corn oil, palm oil, soybean oil, and combinations thereof.

Fatty acid-containing monoglycerides are present in nutritional products in amounts of at least about 10% by weight of the fat component included in the nutritional product, including at least about 15% by weight of the fat component included in the nutritional product, including minus about 20% by weight of the fat component included in the nutritional product, including from 12% to 45%, including from 15% to 25%, and including about 10%, including about 15%, including about 20%, including about 25%, including about 30%, and further including about 35%, or even about 40%, or even about 50%, or even about 60% , or even about 70%, or even about 80%, or even about 90%, or even about 100% by weight of the fat component included in the nutritional product.

In a specific embodiment, when the nutritional product is a nutritional powder that includes a fat component of about 28% (by weight of the nutritional powder), the fatty acid-containing monoglycerides

ES 2 575 380 T3 are present at a level of about 10% (by weight of the fat component), or about 2.8 grams of fatty acid-containing monoglycerides per 100 grams of nutritional powder.

In another specific embodiment, when the nutritional product is a ready-to-feed nutritional liquid that includes a fat component of about 3.67% (by weight of the ready-to-feed nutritional liquid), the fatty acid-containing monoglycerides are present at a level of approximately 10% (by weight of the fat component), or approximately 0.367 grams of monoglycerides containing fatty acids per 100 grams of ready-to-feed nutritional liquid.

In another specific embodiment, when the nutritional product is a concentrated nutritional liquid that includes a fat component of approximately 7.34% (by weight of the concentrated nutritional liquid), the monoglycerides containing fatty acids are present at a level of approximately 10% ( by weight of the fat component), or approximately 0.734 grams of monoglycerides containing fatty acids per 100 grams of concentrated nutritional liquid.

In addition to providing the numerous benefits described above, fatty acid-containing monoglycerides have also been found to have antiviral and / or antibacterial activity in nutritional products. Specifically, the presence of fatty acid-containing monoglycerides in nutritional products has been found to destroy pathogens and / or slow their replication.

B. Fatty acid component

In addition to, or instead of, the fatty acid-containing monoglycerides described above, the nutritional products of the present disclosure include a fatty acid component that comprises fatty acids as a part of the predigested fatty system. Fatty acids are normal metabolites in the body specially formed during the breakdown of fat (triglycerides, diglycerides, cholesterol esters, and certain phospholipids). This fatty acid component is separate and distinct from the fatty acid-containing monoglycerides mentioned above.

Any beneficial fatty acid in a nutritional product can be included in nutritional products as part of the predigested fat system. In one embodiment, the fatty acid is an unsaturated free fatty acid. In some embodiments that include unsaturated free fatty acids, the total amount of saturated free fatty acids with a chain length of more than 14 carbon atoms is less than 15% by weight. Illustrative fatty acids suitable for inclusion in the nutritional products described herein include, but are not limited to, arachidonic acid, linolenic acid, docosahexaenoic acid, stearidonic acid, oleic acid, eicosenoic acid, Mead acid, erucic acid, acid nervonic, and mixtures and combinations thereof. Particularly preferred fatty acids include arachidonic acid, linoleic acid, linolenic acid, docosahexaenoic acid, and oleic acid.

The fatty acid component for inclusion in the predigested fat system includes those derived from oils such as vegetable oils, marine oils, fish oils, algae oil, mushroom oils, animal fats, fractionated animal fats, and combinations thereof. Suitable vegetable oils include, for example, olive oil, canola oil, corn oil, soybean oil, and combinations thereof. In one embodiment, when animal fat is used, the fatty acids are derived from the enzymatic hydrolysis of lard or tallow and the level of palmitic and stearic acid in the resulting fatty acid mixture is reduced to less than 20% of those. total fatty acids, including less than 2% of total fatty acids. In another embodiment, at least some of the fatty acids are derived from soybean oil or tree resin. Once obtained from the oil source, the fatty acids are substantially free of monoglycerides, diglycerides, and triglycerides.

In accordance with the invention, the fatty acids are derived from an oil from a source containing less than about 20% (by weight) palmitic acid and / or stearic acid and / or myristic acid. In some embodiments, the fatty acids are derived from an oil from a source that contains less than about 15% (by weight), including less than about 10% (by weight), including less than about 5% (by weight), and including less than 2% (by weight) palmitic acid and / or stearic acid and / or myristic acid.

In a specific embodiment, the nutritional product includes palmitic acid in an amount of less than about 10% (by weight) of the total fatty acids.

In some embodiments, the nutritional products can include the fatty acids in salt form; that is, fatty acids can be added to nutritional products in the form of fatty acid salts. In a suitable embodiment, the fatty acids are added to the nutritional product in the form of calcium salts of fatty acids, fatty acid salts of magnesium, or a combination thereof.

Fatty acid salts can be prepared by one of skill in the art based on the present disclosure. In a suitable process, emulsions may be prepared that include calcium salts of acids

ES 2 575 380 T3 C10-C24 fatty acids by first preparing the fatty acid salts by using several starting sources of calcium mixed with at least one source of C10-C24 fatty acids.More specifically, in one method, a starting source comprising C10-C24 fatty acids in a triglyceride mixture or in free form by contact with calcium hydroxide and / or calcium carbonate and / or calcium phosphate. In another method, C10-C24 fatty acids can be prepared in a triglyceride mixture or in free form by contact with hydrated CaCl2 or Ca (AcO) 2 at a pH of 6 to about 7.5.

The above methods can be carried out under an inert atmosphere, for example, under N2 or argon. In other examples, any of the described methods can be carried out under an ambient atmosphere (eg, where the reaction is not carried out under a low oxygen atmosphere).

The source comprising the C10-C24 fatty acids and the calcium source can be mixed by any method known in the art. Mixing is not intended to imply a particular mixing result, such as dissolving the components at a particular level or forming a particular composition, such as a homogeneous mixture, although such mixtures can be produced and some of the components may be dissolved by mixing. Mixing can be vigorous and can be done manually or by means of a mechanical device such as, but not limited to, a static mixer, a magnetic stirrer, a shaker, a mixing bar, or a rotating device. Mixing can be accomplished by passing or bubbling a gas through the mixture or by sonication.

Mixing of the C10-C24 fatty acid source with a calcium source can be done for at least 1 minute. Mixing can also be done for at least 1.5, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 minutes , where any of the indicated values can form an upper or lower end point, as appropriate.

Mixing can be carried out at various temperatures, but typically the method is carried out at an elevated temperature. The precise elevated temperature may depend on the particular starting sources of C10-C24 fatty acids or calcium and quantities thereof being used. Suitable temperatures at which the described mixing can be performed include, but are not limited to, from about 4 to about 100 ° C, from about 10 to about 100 ° C, from about 15 to about 100 ° C, or from about 20 to about 70 ° C.

Sources comprising C10-C24 fatty acids or calcium can also be heated prior to mixing. Such a preheating step can be performed at any of the temperatures or temperature ranges described herein.

In some embodiments, the mixing of the C10-C24 fatty acids and calcium can be carried out under reduced pressure. A suitable pressure is less than or equal to about 133.32 Pa or less than or equal to about 13.332 Pa.

In a desirable embodiment, the calcium salts of C10-C24 fatty acids are prepared by adding free C10-C24 unsaturated fatty acids and a source of calcium, such as Ca (OH) 2, CaCl2, CaCO3, Ca-citrate or a mixture of these salts, to form a mixture of oils. More specifically, the fatty acids dissolve in a hot aqueous solution (eg, having a temperature of about 40 to about 80 ° C). The pH of the solution can be adjusted, generally to a pH of about 10-11, using KOH or NaOH. Calcium is then added to the solution containing dissolved fatty acid. Typically, the fatty acids and calcium are allowed to stand for 10 minutes to ensure a complete reaction between the fatty acids and the calcium ions. The mixture is then homogenized to form the oily mixture.

In another desirable embodiment, a mixture of calcium salts of fatty acids including fatty acids from fish oil, seaweed oil, mushroom oil, and soybean oil is prepared as part of the predigested fatty system. Fish oil oil, seaweed oil, mushroom oil and soybean oil are mixed and hydrolyzed by potassium hydroxide under a nitrogen blanket. A source of calcium, such as calcium chloride, is then added to the mixture to react with the fatty acids to produce calcium salts of insoluble fatty acids. Insoluble fatty acid salts can be isolated by filtration, and washed with water before drying under vacuum.

Surprisingly, it has been found that although fatty acid salts, such as calcium salts of fatty acids, are generally insoluble in nutritional products, they do not settle in solution to form a layer of sediment that is difficult to redisperse. Therefore, the use of magnesium and / or calcium fatty acid salts allows for better calcium / magnesium delivery and, in many embodiments, can eliminate the need for additional stabilizers, such as carrageenans, so that the product can be substantially or completely carrageenan free.

ES 2 575 380 T3

Accordingly, the use of fatty acid salts makes it possible to improve the bioavailability of calcium and / or magnesium and of fatty acids compared to products that use calcium phosphate or calcium carbonate in the calcium source.

Furthermore, it has been found that the use of the fatty acid salts in the nutritional products of the present disclosure provides bioavailable fatty acids, such as arachidonic acid (ARA) and the like, which have been shown to improve the growth of infants. . The use of predigested fat also provides a creamy nutritional product with improved product stability and longer shelf life.

Nutritional products include fatty acids or fatty acid salts in an amount of at least about 10% (by weight) of the fatty component included in the nutritional product, including at least about 15%, including at least about 20%, including about 10% to about 60%, including from about 15% to about 40%, and including from about 15% to about 35%, including about 10%, including about 15%, including about 20%, including about 25%, including about 30%, including about 35%, and further including about 40%, or even about 50%, or even about 60%, or even about 70%, or even about 80%, or even about 90%, or even about 100% by weight of the fat component included in the nutritional product.

Nutritional products include a mixture of a fatty acid component and fatty acid-containing monoglycerides as defined by the claims. In some embodiments, the nutritional product contains the mixture in an amount of at least 10% (by weight) of the fat component included in the nutritional product, including at least about 15%, including at least about 20%, including about 10%. to about 40%, including from about 20% to about 65%, including from about 25% to about 50%, including from about 15% to about 30%, and including from about 15% to about 25%, including about 10%, including about 15%, including about 20%, including about 25%, including about 30%, including about 35%, and further including 40% or even about 50% , or even about 60%, or even about 70%, or even about 80%, or even about 90%, or even about 100% by weight of the fat component included in the nutritional product.

In other embodiments, the nutritional products include the mixture of a fatty acid component and monoglycerides containing fatty acids in an amount of at least 0.2% (by weight), including at least 1% (by weight), including at least 2 % (by weight), and including at least 5% (by weight) of total dry matter in the nutritional product.

Macronutrients

Although the total concentrations or amounts of fat, protein, and carbohydrates may vary depending on the type of product (i.e., breast milk fortification product, baby formula, etc.), the product form (i.e. nutritional solid, powder, ready-to-feed liquid, or concentrated liquid) and the selective dietary needs of their end users, such concentrations or amounts are most typically within the following expressed ranges, in conjunction with all other fat, protein / or carbohydrate ingredients as described herein.

For liquid term and premature infant formula products, carbohydrate concentrations very typically range from about 5% to about 40%, including from about 7% to about 30%, including from about 10% to about 25%, by weight of formula for premature and full-term babies; fat concentrations (including both predigested fat and any other fat source) very typically range from about 1% to about 30%, including from about 2% to about 15%, and also including from about 3% to about 10% , by weight of formula for premature and full-term babies; and protein concentrations very typically range from about 0.5% to about 30%, including from about 1% to about 15%, and also including from about 2% to about 10%, by weight of the preterm infant formula and term born.

For liquid breast milk fortification products, carbohydrate concentrations very typically range from about 10% to about 75%, including from about 10% to about 50%, including from about 20% to about 40%, by weight of the product for the enrichment of breast milk; Fat concentrations (including both predigested fat and any other fat source) very typically range from about 10% to about 40%, including from about 15% to about 37%, and also including from about 18% to

ES 2 575 380 T3 about 30%, by weight of the product for the enrichment of breast milk; and protein concentrations very typically range from about 5% to about 40%, including from about 10% to about 30%, and also including from about 15% to about 25%, by weight of the breast milk fortification product. .

The level or amount of carbohydrates, fats, and / or proteins in the liquid nutritional products can also be characterized in addition to, or alternatively as a percentage of the total calories in the nutritional products as set forth in the following Table. These macronutrients for liquid nutritional products of the present disclosure are more typically formulated within any of the caloric ranges (embodiments AF) described in the following Table (each numerical value is preceded by the term "about").

<td>Nutrients% Cal. Total</td><td>Embodiment A</td><td>Embodiment B</td><td>Embodiment C</td>

<td>Carbohydrate</td><td> 0-98</td><td> 2-96</td><td> 10-75</td>

<td>Protein</td><td> 0-98</td><td> 2-96</td><td> 5-70</td>

<td>Grease</td><td> 0-98</td><td> 2-96</td><td> 20-85</td>

<td></td><td>Embodiment D</td><td>Embodiment E</td><td>Embodiment F</td>

<td>Carbohydrate</td><td> 30-50</td><td> 25-50</td><td> 25-50</td>

<td>Protein</td><td> 15-35</td><td> 10-30</td><td> 5-30</td>

<td>Grease</td><td> 35-55</td><td> 1-20</td><td> 2-20</td>

In a specific example, liquid infant formulas (both ready-to-feed and concentrated liquids) include those embodiments in which the protein component can comprise from about 7.5% to about 25% of the caloric content of the formula; the carbohydrate component may comprise from about 35% to about 50% of the total caloric content of the infant formula; and the fat component may comprise from about 30% to about 60% of the total caloric content of the infant formula. These ranges are provided as examples only, and are not intended to be limiting. Additional suitable ranges are listed in the following table (each numerical value is preceded by the term approximately).

<td>Nutrients% Cal. Total</td><td>Embodiment G</td><td>Embodiment H</td><td>Embodiment I</td>

<td>Carbohydrates:</td><td> 20-85</td><td> 30-60</td><td> 35-55</td>

<td>Grease:</td><td> 5-70</td><td> 20-60</td><td> 25-50</td>

<td>Protein:</td><td> 2-75</td><td> 5-50</td><td> 7-40</td>

When the nutritional product is a powdered term or preterm infant formula, the protein component is present in an amount of from about 5% to about 35%, including from about 8% to about 12%, and including from about 10%. % to about 12% by weight of the formula for premature or full-term babies; the fat component is present in an amount of from about 10% to about 35%, including from about 25% to about 30%, and including from about 26% to about 28% by weight of the formula for premature or full-term babies; and the carbohydrate component is present in an amount of from about 30% to about 85%, including from about 45% to about 60%, and including from about 50% to about 55% by weight of the formula for premature babies or born to finished.

For breast milk fortification products the protein component is present in an amount from about 1% to about 55%, including from about 10% to about 50%, and including from about 10% to about 30% by weight. of the product for the enrichment of breast milk; the fat component is present in an amount from about 1% to about 30%, including from about 1% to about 25%, and including from about 1% to about 20% by weight of the product for fortification of breast milk; and the carbohydrate component is present in an amount from about 15% to about 75%, including from about 15% to about 60%, and including from about 20% to about 50% by weight of the product for fortification of breast milk .

The total amount or concentration of fats, carbohydrates and proteins in the powdered nutritional products of the present description can vary considerably depending on the selected product and the needs 11

ES 2 575 380 T3 dietary or medical purposes of the intended user. Additional suitable examples of macronutrient concentrations are set out below. In this context, total amount or concentration refers to all sources of fat, carbohydrates, and proteins in the powdered product. For powdered food products, such total amounts or concentrations are more typically and preferably formulated within any of the stated ranges described in the following Table (all numbers have approximately in front of them).

<td>Nutrients% Cal. Total</td><td>Embodiment J</td><td>Embodiment K</td><td>Embodiment L</td>

<td>Carbohydrate</td><td> 1-85</td><td> 30-60</td><td> 35-55</td>

<td>Grease</td><td> 5-70</td><td> 20-60</td><td> 25-50</td>

<td>Protein</td><td> 2-75</td><td> 5-50</td><td> 7-40</td>

Grease

The nutritional products of the present disclosure may comprise, in addition to the predigested fat, one or more additional sources of fat (the total amount of fat being referred to herein as the fat component or fat system of the nutritional product). Suitable additional sources of fat for use herein include any fat or fat source that is suitable for use in an oral nutritional product and is compatible with the elements and characteristics of such products.

Non-limiting examples of suitable additional fats or sources thereof for use in the nutritional products described herein include coconut oil, fractionated coconut oil, soybean oil, corn oil, olive oil, safflower oil. , high oleic safflower oil, oleic acids (EMERSOL 6313 OLEIC ACID), TCM oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, Canola oil, marine oils, fish oils, mushroom oils, algae oils, cottonseed oils, and combinations thereof. In one embodiment, the fats and suitable sources thereof include oils and oil blends that include long chain polyunsaturated fatty acids (LC-PUFA), preferably LC-PUFA having four or more double bonds. Some specific non-limiting polyunsaturated acids for inclusion include, for example, docosahexaenoic acid (DHA), arachidonic acid (ARA), eicosapentaenoic acid (EPA), and the like.

Generally, the predigested fat described herein is included in the nutritional product in combination with one, two, three, four, or more additional fat sources. In one embodiment, the monoglycerides (desirably in the form of monoglycerol palmitate), the fatty acids (desirably in the form of calcium salts), a high oleic oil, and a coconut oil are combined together to provide the fatty component in a nutritional product. In this embodiment, the monoglycerides are present in an amount from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, about 23%, and about 25%. % by weight of the fatty component, the fatty acids are present in an amount of from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, and about 25% by weight of the fat component, the high oleic oil is present in an amount from about 1% to about 40%, including from about 10% to about 30% , including about 10%, about 15%, about 20%, about 25% and about 30% by weight of the fat component, and coconut oil is present in an amount from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 17%, about 20%, and about 25% in weight of fat component.

In another embodiment, monoglycerides containing fatty acids (desirably in the form of monoglycerol palmitate), a fatty acid component (desirably in the form of calcium salts), a high oleic safflower oil, and a coconut oil are combined with each other. to provide the fat component in a nutritional product. In this embodiment, the monoglycerides are present in an amount of from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, about 23%, and about 25%. By weight of the fatty component, the fatty acids are present in an amount of from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, and about 25% by weight of the fat component, the high oleic oil is present in an amount from about 1% to about 40%, including from about 10% to about 30% , including about 10%, about 15%, about 20%, about 25% and about 30% by weight of the fat component, and coconut oil is present in an amount from about 1% to about 40%, including from about 10% to about 30%, including about 10%, 12

ES 2 575 380 T3 about 15%, about 17%, about 20% and about 25% by weight of the fat component.

In another embodiment, monoglycerides containing fatty acids (desirably in the form of monoglycerol palmitate), a fatty acid component (desirably in the form of calcium salts), a high oleic safflower oil, a coconut oil, an oil containing DHA and an oil containing ARA combine with each other to provide the fat component in a nutritional product. In this embodiment, the monoglycerides are present in an amount from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, about 23%, and about 25%. % by weight of the fatty component, the fatty acids are present in an amount of from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 20%, and about 25% by weight of the fat component, the high oleic oil is present in an amount from about 1% to about 40%, including from about 10% to about 30% , including about 10%, about 15%, about 20%, about 25% and about 30% by weight of the fat component, and coconut oil is present in an amount from about 1% to about 40%, including from about 10% to about 30%, including about 10%, about 15%, about 17%, about 20%, and about 25% in weight of fat component. The DHA-containing oil is present in an amount of about 1% to about 10%, including about 5% by weight of the fat component and the ARA-containing oil is present in an amount of about 1% to about 10%, including about 5% by weight of the fat component.

In another embodiment, the fat component comprises about 38% (by weight) of high oleic safflower oil, about 17% (by weight) of coconut oil, about 23% (by weight) of monoglycerol palmitate, 20% (by weight) of weight) calcium salts of fatty acids, about 0.5% (by weight) of DHA-containing oil, and about 1.0% (by weight) of ARA-containing oil.

Protein

The nutritional products of the present disclosure may optionally additionally comprise protein in addition to predigested fat. Any protein source that is suitable for use in oral nutritional products and is compatible with the elements and characteristics of such products is suitable for use in combination with predigested fat.

Non-limiting examples of suitable protein or sources thereof for use in nutritional products include hydrolyzed, partially hydrolyzed, or non-hydrolyzed protein or protein sources, which may be derived from any known or otherwise suitable source, such as milk. (eg, casein, whey), animals (eg, meat, fish), cereals (eg, rice, corn), vegetables (eg, soy), or combinations of the themselves. Non-limiting examples of such proteins include milk protein isolates, milk protein concentrates as described herein, casein protein isolates, hydrolyzed casein, whey protein, sodium or calcium caseinates, milk. whole cow, partially or fully skimmed milk, soy protein isolates, soy protein concentrates, etc.

Carbohydrates

The nutritional products of the present disclosure may optionally additionally comprise any carbohydrates that are suitable for use in an oral nutritional product and are compatible with the elements and characteristics of such products.

Non-limiting examples of carbohydrates or suitable sources thereof for use in the nutritional products described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids. , carbohydrates derived from rice, carbohydrates derived from pea, carbohydrates derived from potato, tapioca, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (eg, maltitol, erythritol, sorbitol), artificial sweeteners (eg, sucralose, acesulfame potassium, stevia), and combinations thereof.

Other optional ingredients

The nutritional products of the present invention may further comprise other optional components that can modify the physical, chemical, aesthetic or processing characteristics of the products or serve as additional pharmaceutical or nutritional components when used in the target population. Many of these optional ingredients are known or otherwise suitable for use in foods.

ES 2 575 380 T3 medical or other nutritional products or pharmaceutical dosage forms and may also be used in the compositions herein, provided such optional ingredients are safe for oral administration and are compatible with the ingredients in the product form. selected.

Non-limiting examples of such optional ingredients include preservatives, antioxidants, emulsifying agents, buffers, fructooligosaccharides, galactooligosaccharides, prebiotics, pharmaceutical active agents, additional nutrients as described herein, colorants, flavors, thickening agents and stabilizers, emulsifying agents, lubricants, etc.

The nutritional products may further comprise a sweetening agent, preferably including at least one sugar alcohol such as maltitol, erythritol, sorbitol, xylitol, mannitol, isolmalt, and lactitol, and also preferably including at least one artificial or high potency sweetener such as acesulfame K, aspartame, sucralose, saccharin, stevia, and tagatose. These sweetening agents, especially in the form of a combination of a sugar alcohol and an artificial sweetener, are especially useful in formulating the liquid beverage embodiments of the present disclosure that have a desirable flavor profile. These sweetener combinations are especially effective in masking undesirable flavors sometimes associated with the addition of plant proteins to a liquid beverage. Optional sugar alcohol concentrations in the nutritional product can range from at least 0.01%, including from 0.1% to about 10%, and also including from about 1% to about 6%, by weight of the nutritional product. Optional artificial sweetener concentrations can range from about 0.01%, including from about 0.05% to about 5%, also including from about 0.1% to about 1.0%, by weight of the nutritional product.

A flow agent or anti-caking agent can be included in the nutritional products described herein to retard the clumping or agglomeration of the powder over time and to prepare a powder embodiment that flows easily from its container. Any known flow agents or anti-caking agents that are known or otherwise suitable for use in a powder or nutritional product form are suitable for use in this invention, non-limiting examples of which include tricalcium phosphate, silicates, and combinations thereof. The concentration of the flow agent or anti-caking agent in the nutritional product varies depending on the product form, the other ingredients selected, the desired flow properties, etc., but most typically range from about 0.1% to about 4%, including from about 0.5% to about 2%, by weight of the nutritional product.

In nutritional products it can also be included in stabilizer. Any stabilizer that is known or otherwise suitable for use in a nutritional product is also suitable for use in this invention, some of the non-limiting examples of which include carrageenan and gums such as xanthan gum. The stabilizer can represent from about 0.1% to about 5.0%, including from about 0.5% to about 3%, including from about 0.7% to about 1.5%, by weight of the nutritional product.

The nutritional product compositions may further comprise any of a variety of other vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids (eg ., beta-carotene, zeaxanthin, lutein, lycopene), niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts and derivatives thereof, and combinations thereof.

The nutritional products may further comprise any of a variety of other additional minerals, non-limiting examples of which include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, chloride, and combinations thereof. Furthermore, in some embodiments, the nutritional products may be free of carrageenans.

Manufacturing Methods

The nutritional products of the present disclosure can be prepared by any known manufacturing technique or otherwise effective to prepare the selected solid or liquid product form. Many of these techniques are known for any given product form, such as nutritional liquids or powders, and can be easily applied by one of ordinary skill in the art to the nutritional products described herein.

Thus, the nutritional products of the present disclosure can be prepared by any of a variety of known or otherwise effective products or manufacturing methods. In a suitable manufacturing procedure, for example, at least three separate suspensions are prepared, including a protein-in-fat suspension (PIF), a carbohydrate-mineral suspension (CHO-MIN), and a protein suspension.

ES 2 575 380 T3 in water (PIW). The PIF suspension is formed by heating and mixing the oil (eg, monoglyceride and / or fatty acids, oil containing fatty acids, canola oil, corn oil, etc.) and then adding an emulsifier (eg ., lecithin), fat-soluble vitamins, and a portion of the total protein (eg, milk protein concentrate, etc.) with continuous heat and agitation. The CHO-MIN suspension is formed by adding with heated stirring to the water: minerals (e.g. potassium citrate, dipotassium phosphate, sodium citrate, etc.), trace and trace minerals Ultra (TM / UTM premix), and / or thickening or suspending agents (eg, Avicel, gellan, carrageenan). The resulting CHO-MIN suspension was held for 10 minutes with continuous stirring and heat before the addition of additional minerals (e.g. g., potassium chloride, magnesium carbonate, potassium iodide, etc.), and / or carbohydrates (eg, fructooligosaccharide, sucrose, corn syrup, etc.). The PIW suspension is then formed by mixing the remaining protein, if any, with heat and stirring.

In a specific embodiment of the present description, all or a portion of the predigested fat included in the nutritional product can be added to the CHO-MIN suspension, which contains less than 5% (by weight of the CHO-MIN suspension). MIN) of fat in the form of triglycerides. In this embodiment, at least 5% (by weight) of the total fat present in the nutritional product is in the form of predigested fat and is added to the CHOMIN suspension. In some embodiments, at least 5% (by weight), including at least 10% (by weight), including at least 20% (by weight), including at least 30% (by weight) is added to the CHO-MIN suspension. ), including at least 40% (by weight), including at least 50% (by weight), including at least 60% (by weight), including at least 70% (by weight), including at least 80% (by weight ), including at least 90% (by weight), and including 100% (by weight) of the total predigested fat included in the nutritional product. In a particular embodiment, lipid soluble nutrients, such as mixed carotenoids or vitamins A, D, E, and K, are dissolved in the predigested fat before the predigested fat is added to the CHO-MIN suspension or during the manufacture of CHO-MIN suspension. By adding the predigested fat to the CHO-MIN suspension as opposed to the PIF suspension, the stability of the finished nutritional composition can be improved.

The resulting suspensions are then mixed together with heated stirring and the pH adjusted to 6.6-7.0, after which the composition is subjected to short time high temperature processing (HTST) during which the The composition is heat treated, emulsified and homogenized, and then allowed to cool. The water soluble vitamins and ascorbic acid are added, the pH is adjusted to the desired range, if necessary, the flavors are added, and water is added to achieve the desired total solids level. The composition is aseptically packaged to form an aseptically packaged nutritional emulsion. This emulsion can also be charged and then sterilized to form a ready-to-feed or concentrated liquid, or it can be spray-dried, dry-mixed, and / or agglomerated.

The nutritional solid, such as a spray-dried nutritional powder or dry-blended nutritional powder, can be prepared by any set of known or otherwise effective techniques suitable for the manufacture and formulation of a nutritional powder.

For example, when the nutritional powder is a spray dried nutritional powder, the spray drying step may likewise include any spray drying technique that is known to or otherwise suitable for use in the production of nutritional powders. Many different spray drying methods and techniques are known for use in the nutritional field, all of which are suitable for use in the manufacture of spray dried nutritional powders herein.

One method of preparing the spray dried nutritional powder comprises forming and homogenizing an aqueous or liquid suspension comprising predigested fat, and optionally protein, carbohydrates, and other sources of fat, and then spray drying the suspension or liquid to produce a powder. spray dried nutrition. The method may further comprise the step of spray drying, dry mixing, or otherwise adding additional nutritional ingredients, including any one or more of the ingredients described herein, to the spray dried nutritional powder.

Other suitable methods for the manufacture of nutritional products are described, for example, in US Patent No. 6,365,218 (Borschel, et al.), US Patent No. 6,589,576 (Borschel, et al. ), US Patent No. 6,306,908 (Carlson, et al.), and US Patent Application No. 20030118703 A1 (Nguyen, et al.).

Methods of use

In accordance with the present description, and as further described below, the nutritional products described herein can be used for various purposes, including, for example, improving digestion, improving nutrient absorption, improving tolerance, decreasing the incidence of necrotizing enterocolitis, decrease the incidence of colic, and decrease the incidence of short bowel syndrome. The individual (infant, infant, or child) who uses the nutritional products described herein may actually have or be affected by the described disease or condition (i.e., may actually have problems with

ES 2 575 380 T3 digestion, nutrient absorption and / or tolerance or may actually have necrotizing enterocolitis, colic, or short bowel syndrome), or may be susceptible to, at risk of, contracting the disease or condition (i.e., in You may not actually have the disease or condition yet, but you are at high risk for it compared to the general population due to certain conditions, family history, etc.). If the individual actually has the disease or condition, or is at risk of or susceptible to the disease or condition, the individual is classified herein as in need of assistance in treating and combating the disease or condition. For example, a child may actually have necrotizing enterocolitis or may be at risk for necrotizing enterocolitis (susceptible to necrotizing enterocolitis) due to premature birth. Similarly, in another example, a child may actually have tolerance and / or digestion and / or nutrient absorption problems, or may be at risk of (susceptible to) contracting one or more of these conditions due to having other diseases or conditions. , or a family history of such problems. If the person actually has the disease or condition, or is only at risk for or is susceptible to contracting the disease or condition, it is within the scope of the present disclosure to assist the individual with the nutritional products described herein.

Based on the foregoing, because some of the method embodiments of the present disclosure are directed at specific subsets or subclasses of identified individuals (i.e., the subset or subclass of individuals in need of assistance in treating one or more specific diseases or specific conditions noted herein), not all individuals can benefit from all embodiments of the method described herein as not all individuals will fall within the subset or subclass of individuals described herein for certain diseases or conditions.

The nutritional products described herein comprise predigested fat desirably combined with one or more sources of fat to provide a source of nutrition for infants, infants and children to improve digestion and absorption of nutrients. Specifically, similar to the digestion of breastfed babies, since the fat source is at least partially digested before entering the duodenum, more time is allowed for the nutrients to be absorbed by the baby, particularly in the intestines, and the amount of nutrients entering the baby's colon is reduced, resulting in fewer nutrients being able to ferment and produce gas, which can lead to decreased tolerance to a product. As such, by utilizing a predigested fat source such as monoglycerides and / or fatty acids in a nutritional product, such as an infant formula, it is now possible to provide infants with an alternative, or supplement, to breast milk that more closely mimic its benefits.

Along with improving nutrient absorption as described above, it has been found that the use of predigested fat within a nutritional product also facilitates the formation of micelles when administered with one or more of water-insoluble hydrophobic compounds, such as vitamins (vitamins A, D, E, and K) soluble in oil (soluble in lipids), carotenoids (p. g., lutein, beta-carotene, lycopene etc.), glycolipids (gangliosides), sterols, and phytochemicals. The formation of these micelles allows insoluble hydrophobic compounds to dissolve in the digesta, which is a step for absorption by the villi of the intestine. Additionally, predigested fat is used to re-synthesize triglycerides to form chylomicrons. Chylomicrons carry the water-insoluble hydrophobic compounds to the lymph, where the insoluble hydrophobic compounds are transported by the circulation to the target organs and / or tissues to produce desired physiological effects.

In addition to the benefits discussed above, nutritional products that include predigested fat have been found to stimulate the production of cholecystokinin (CCK) in the duodenum, which stimulates the production of pancreatic lipase. This production results in additional digestion of nutrients and reduces contractions of the upper gastrointestinal tract, allowing more time for absorption. Therefore, the use of predigested fat in nutritional products reduces the total amount of nutrients that enter the colon, which can be fermented and produce gas and a bloated sensation. As such, the use of predigested fats in nutritional products can improve tolerance by improving digestion and absorption of nutrients with less gas. This can be particularly important with children, as tolerance can be a problem in some babies.

Along with stimulating CCK production, predigested fat has also been found to induce secretion of the intestinal growth hormone, glucagon-like peptide-2 (GLP-2). GLP-2 can improve the maturation of the baby's intestine, which results in better digestion and absorption of nutrients.

Additionally, it has been found that the nutritional products described herein that comprise predigested fat can be used to provide a source of nutrition for infants, infants, or children that can reduce the incidence of necrotizing enterocolitis (NEC), colic, and / or short bowel syndrome.

Furthermore, in embodiments where the nutritional product is manufactured by means of a process in which at least a portion of the predigested fat (or in some embodiments all of the predigested fat) is added to

ES 2 575 380 T3 the suspension of carbohydrates and minerals compared to the protein in the fat suspension, the resulting stability of the nutritional product (generally in the form of a nutritional emulsion) can be improved.

Examples

The following examples illustrate specific embodiments and / or characteristics of the nutritional products of the present disclosure. The invention itself, however, remains defined by the claims. All amounts illustrated are percentages by weight based on the total weight of the composition, unless otherwise specified.

The illustrated compositions are long shelf life nutritional products prepared in accordance with the manufacturing methods described herein, such that each illustrated product, unless otherwise specified, includes an aseptically processed embodiment and a retort packaging embodiment.

Nutritional liquid embodiments are aqueous oil-in-water emulsions that are packaged in 240 ml plastic containers and remain physically stable for 12-18 months after formulation / packaging at storage temperatures ranging from 1 to 25 ° C .

Examples 1-4

Examples 1-4 illustrate lactose-free baby nutritional emulsions of the present disclosure, the ingredients of which are listed in the following Table. All ingredient quantities are listed as kilogram per batch of 1000 kilograms of product, unless otherwise specified.

<td>Ingredient</td><td>Example 1</td><td>Example 2</td><td>Example 3</td><td>Example 4</td>

<td>Water</td><td>CS</td><td>CS</td><td>CS</td><td>CS</td>

<td>Maltodextrin</td><td> 53</td><td> 43,3</td><td> 50</td><td> 60</td>

<td>Saccharose</td><td> 16,5</td><td> 25</td><td> 19,2</td><td> 16,38</td>

<td>Milk protein isolate</td><td> 15,65</td><td> 15,65</td><td> 15,65</td><td> 15,65</td>

<td>High oleic safflower oil</td><td> 10</td><td> 10</td><td> 10</td><td> 10</td>

<td>Monoglycerol palmitate</td><td> 10</td><td> 9</td><td> 8</td><td> 7</td>

<td>C10-C24 Fatty Acid Calcium Salt</td><td> 6,0</td><td> 7</td><td> 8</td><td> 9</td>

<td>Coconut oil</td><td> 2</td><td> 2</td><td> 2</td><td> 2</td>

<td>Mushroom oil</td><td> 0,3</td><td> 0,3</td><td> 0,3</td><td> 0,3</td>

<td>Lecithin</td><td> 0,1</td><td> 0,1</td><td> 0,1</td><td> 0,1</td>

<td>Dibasic potassium phosphate</td><td> 0,96</td><td> 0,96</td><td> 0,96</td><td> 0,96</td>

<td>Potassium chloride</td><td> 0,3</td><td> 0,3</td><td> 0,3</td><td> 0,3</td>

<td>Ascorbic acid</td><td> 0,235</td><td> 0,235</td><td> 0,235</td><td> 0,235</td>

<td>Carrageenans</td><td> 0,150</td><td> 0,150</td><td> 0,150</td><td> 0,150</td>

<td>Potassium hydroxide</td><td> 0,136</td><td> 0,136</td><td> 0,136</td><td> 0,136</td>

<td>Premix TM / UTM</td><td> 0,1684</td><td> 0,1684</td><td> 0,1684</td><td> 0,1684</td>

<td>Vitamin A, D, E premix</td><td> 0,0758</td><td> 0,0758</td><td> 0,0758</td><td> 0,0758</td>

<td>Sun. of water. Vitamin premix</td><td> 0,0728</td><td> 0,0728</td><td> 0,0728</td><td> 0,0728</td>

<td>Potassium iodide</td><td> 0,00022</td><td> 0,00022</td><td> 0,00022</td><td> 0,00022</td>

<td>Chromium chloride</td><td> 0,000217</td><td> 0,000217</td><td> 0,000217</td><td> 0,000217</td>

Examples 5-8

Examples 5-8 illustrate lactose-based nutritional emulsions of the present disclosure, the ingredients of which are listed in the following Table. All ingredient quantities are listed as kg per 1000 batch

ES 2 575 380 T3 kg of product, unless otherwise specified.

<td>Ingredient</td><td>Example 5</td><td>Example 6</td><td>Example 7</td><td>Example 8</td>

<td>Water</td><td>CS</td><td>CS</td><td>CS</td><td>CS</td>

<td>Lactose</td><td> 58</td><td> 66</td><td> 71</td><td> 63</td>

<td>Skimmed milk powder</td><td> 25</td><td> 10</td><td> 0</td><td> 16</td>

<td>Whey protein concentrate</td><td> 6,4</td><td> 13</td><td> 18</td><td> 10,5</td>

<td>High oleic safflower oil</td><td> 14</td><td> 14</td><td> 14</td><td> 14</td>

<td>Coconut oil</td><td> 6,2</td><td> 6,2</td><td> 6,2</td><td> 6,2</td>

<td>Monoglycerol palmitate</td><td> 10</td><td> 8</td><td> 6</td><td> 4</td>

<td>C10-C24 fatty acids</td><td> 5,5</td><td> 7,5</td><td> 9,5</td><td> 11,5</td>

<td>Fructooligosaccharides / Galactooligosaccharides</td><td> 9</td><td> 9</td><td> 9</td><td> 9</td>

<td>Mushroom oil</td><td> 0,3</td><td> 0,3</td><td> 0,3</td><td> 0,3</td>

<td>Dibasic potassium phosphate</td><td> 0,96</td><td> 0,96</td><td> 0,96</td><td> 0,96</td>

<td>Calcium hydroxide</td><td> 0,78</td><td> 1,07</td><td> 1,36</td><td> 1,64</td>