NZ625992B2 - Stabilized nutritional compositions including starch - Google Patents

Abstract

Disclosed is a stabilised liquid nutritional composition comprising a stabiliser system, the stabiliser system comprising a native waxy starch and maltotriose, wherein the native waxy starch comprises from 0.02% to 0.07% by weight protein and wherein the maltotriose is present in an amount of from 0.01% to 15% by weight of the composition. Also disclosed is a process for manufacturing a stabilised liquid nutritional composition, the process comprising the steps of: - introducing a native waxy starch into a liquid nutritional composition comprising at least one of protein, fat, and carbohydrate, wherein the native waxy starch comprises from 0.02% to 0.07% by weight protein; and - heating the liquid nutritional composition including the native waxy starch to form the stabilised liquid nutritional composition. .01% to 15% by weight of the composition. Also disclosed is a process for manufacturing a stabilised liquid nutritional composition, the process comprising the steps of: - introducing a native waxy starch into a liquid nutritional composition comprising at least one of protein, fat, and carbohydrate, wherein the native waxy starch comprises from 0.02% to 0.07% by weight protein; and - heating the liquid nutritional composition including the native waxy starch to form the stabilised liquid nutritional composition.

Description

STABILIZED NUTRITIONAL COMPOSITIONS INCLUDING STARCH CROSS REFERENCE TO RELATED APPLICATIONS The present ation hereby claims the benefit of the provisional patent application Serial No. 61/581,640, filed on December 30, 2011, the disclosure of which is hereby incorporated by reference in its entirety. The present application also claims the benefit of the provisional patent application Serial No. 61/581,642, filed December 30, 2011, the disclosure of which is hereby orated by reference in its entirety.

FIELD OF THE SURE The present disclosure relates to nutritional compositions including a stabilizer system that provides improved emulsion stability and reduced itation without retrogradation. More particularly, the present disclosure s to liquid nutritional compositions including a stabilizer . The stabilizer system may se a starch or a combination of starch and maltotriose.

BACKGROUND OF THE DISCLOSURE Manufactured liquid nutritional compositions, also commonly referred to as nutritional liquids, comprising a targeted selection of nutrition ients are well known and widely available, some of which may provide a sole source of nutrition while others may e a supplemental source. These nutritional liquids include powders that can be reconstituted with water or other aqueous liquid, as well as concentrated liquids and ready to drink nutritional liquids such as milk or protein based emulsions or non-emulsified or ntially clear liquids for use in infant and pediatric formulas and medical and adult nutritionals.

Traditionally, native starches have been included in food ations, and particularly in liquid nutritional emulsions and other liquids, for their ability to stabilize emulsions and suspensions, increase Viscosity, reduce sedimentation, form film networks, and gelatinize. More particularly, these desired gelatinization and stable k formation abilities of natural starches occur with heat after starch granules are fully hydrated. Gelatinized starch molecules, however, also tend to re-associate over time, squeezing water out and causing recrystallization (also referred to herein as retrogradation). The retrogradation effect is a result of starch chains forming ordered chain structures that result in chain aggregation, which is revealed as phase separation in liquid nutritionals.

The retrogradation tendency of starches limits their functionality in food applications as it shortens the resulting shelf life of the product. radation may be further exaggerated with temperature fluctuations similar to those seen in process conditions during the manufacturing and sterilization of nutritional liquids.

To combat the undesired radation effect, many native starches are chemically modified to reduce chain formation in liquid ionals as described above. Although this approach has had some success, such al modification may t issues with multiple regulatory bodies around the world that do not generally approve of the use of chemically modified starches in nutritional liquids, and ularly in infant nutritional liquids.

Accordingly, there is a need in the art for alternative stabilizer systems that can provide improved emulsion stabilization and reduced itation without the drawbacks of retrogradation and reassociation. Additionally, it would be advantageous if the stabilizer system was carrageenan-free as such stabilizer systems including carrageenan are not universally accepted from a regulatory standpoint around the world.

The present sure is directed to ional compositions, particularly in the form of liquid nutritional compositions sing starch. The stabilizer system may comprise starch, more particularly waxy starch, more particularly, a native waxy starch such as a native hybrid waxy potato starch. In addition, or in the alternative, the stabilizer system may be a dual stabilizer system ing a starch and maltotriose. These nutritional compositions provide improved stability, longer shelf life, and are universally label friendly from a regulatory standpoint.

SUMMARY OF THE DISCLOSURE The present sure is generally ed to a stabilized solid (capable of being made into a liquid by reconstitution) or liquid nutritional composition comprising a stabilizer system such that the nutritional composition has improved emulsion stability and suspension ties. In some ments, the stabilizer system comprises, ts of, or consists essentially of starch and maltotriose. In a further embodiment, the stabilizer system ses, consists of, or consists ially of a native hybrid waxy potato starch. In any of the embodiments, the stabilizer system can be carrageenan and/or cellulose gum free. The nutritional composition may be designed to be suitable for use as an infant nutritional composition, such as a m infant liquid nutritional composition, or an adult liquid nutritional composition.

The present disclosure is further directed to a liquid nutritional composition, such as a liquid infant formula, comprising a stabilizer system. In some embodiments, the izer system comprises, consists of, or consists essentially of starch, and maltotriose. In some embodiments, the stabilizer system ses, consists of, or consists essentially of a native hybrid waxy potato starch. The t disclosure is further directed to a stabilized liquid infant formula comprising a stabilizer system and at least one of a protein, a fat and a carbohydrate.

The present disclosure is further directed to a process for manufacturing a stabilized liquid nutritional composition, such as a liquid infant formula. In some embodiments, the process comprises introducing a starch and maltotriose and/or introducing a native hybrid waxy potato starch, into a liquid nutritional composition comprising at least one of protein, fat, and carbohydrate and heating the liquid nutritional composition to form the stabilized liquid nutritional composition.

In some embodiments, the process comprises introducing maltotriose into a carbohydrate-mineral slurry and mixing the carbohydrate-mineral slurry with at least one of a n-in-water slurry and a protein-in-fat slurry to form a liquid nutritional ition and introducing a starch into the liquid nutritional composition and heating the liquid nutritional composition including the starch to form the stabilized liquid nutritional composition.

The present disclosure is further directed to a ized liquid infant formula comprising a stabilizer system, a protein component, a fat component, and a carbohydrate component. The stabilizer system comprises a native hybrid waxy potato starch. The n component comprises skim milk and whey n concentrate. The fat component comprises soy oil, t oil, and medium chain triglyceride oil. The carbohydrate component comprises corn syrup solids and e. [0012a] In one aspect, the present invention provides a stabilized liquid nutritional composition comprising a stabilizer system, the stabilizer system comprising a native waxy starch and maltotriose, wherein the native waxy starch comprises from 0.02% to 0.07% by weight protein and n the maltotriose is present in an amount of from 0.01% to 15% by weight of the composition. [0012b] In another aspect, the present invention provides a process for manufacturing a stabilized liquid nutritional composition, the process comprising the steps of: introducing a native waxy starch into a liquid nutritional composition comprising at least one of protein, fat, and carbohydrate , wherein the native waxy starch comprises from 0.02% to 0.07% by weight protein; and heating the liquid nutritional composition including the native waxy starch to form the stabilized liquid nutritional composition.

The ized nutritional itions as described herein not only provide sufficient nutritional benefits for individuals, including both infants and adults, but also allow for the use of an ed stabilizer system that may be sally label friendly. It has been unexpectedly found that when starch is used in a stabilizer , either alone or in combination with an additional stabilizer, the retrogradation effect commonly seen with starch stabilizers is substantially reduced or even eliminated such that the liquid nutritional composition remains stable for an extended period of time.

AH26(10883211_1):JIN BRIEF DESCRIPTION OF THE DRAWINGS is a graph depicting step rate measurements as obtained in Example 2. is a graph depicting strain sweep measurements as obtained in e 2. is a graph depicting frequency sweep measurements as obtained in Example 2.

AH26(10139803_1):CCG is a graph depicting temperature rate measurements as obtained in Example 2. is a graph depicting strain sweep measurements for various infant nutritional emulsions including starches as analyzed in Example 3. is a graph depicting strain sweep measurements for various infant nutritional emulsions including es as analyzed in Example 4. depicting strain sweep measurements as obtained in Example is a graph ing strain sweep measurements for infant nutritional emulsions including ELIANETM food starch as analyzed in Example 6.

FIGS. 9A-9G are light microscopy photographs of s starches upon being gelatinized as analyzed in e 7.

DETAILED DESCRIPTION OF THE DISCLOSURE The liquid nutritional compositions of the present disclosure comprise a izer system including a starch. In some embodiments, the stabilizer system comprises starch and maltotriose. The starch may be a native (non- chemicallyumodified’) waxy starch and in some embodiments, a native hybrid waxy potato starch. In some embodiments, native hybrid waxy potato starch is the sole stabilizer in the liquid nutritional composition, while in other embodiments the native hybrid waxy potato starch is used in combination with other stabilizers. In some embodiments, the stabilizer system is a combination of starch and maltotriose, which results in a long term stable liquid nutritional composition that has reduced sedimentation.

The izer system including starch and in some embodiments, further comprising maltotriose, address a primary problem with liquid nutritional compositions and provides icant advantages over tional starch-based izers that over time can allow sedimentation and phase separation to occur in the liquid nutritional ition. When a stabilizer system of the present disclosure is in the liquid nutritional composition, precipitation is substantially minimized or even eliminated in some ments, while emulsion stability and viscosity is maintained. This reduction/elimination of precipitation and enhanced emulsion stability and viscosity is maintained even in liquid nutritional compositions that have very high concentrations of insoluble solutes. The described stabilizer systems e the additional advantage ofperforming very well in the e of carrageenan such that the liquid nutritionals can be formulated to be eenan-free.

This may allow liquid nutritional compositions, including liquid infant formulas, to be prepared that are emulsion stable over time, free or nearly free of sedimentation, and universally accepted from a regulatory standpoint, thus providing significant commercial advantages.

These and other es of the liquid nutritional compositions, as well as some of the many optional variations and additions, are described in detail hereafter.

The genus “starch” as used herein, unless otherwise specified, includes the species: “waxy starc ,” e waxy stare ,” and e hybrid waxy potato starch.” The term “nutritional product” as used herein, unless otherwise specified, refers to nutritional liquids and nutritional powders, the latter of which may be reconstituted to form a nutritional liquid, all of which se one or more of fat, protein, and carbohydrate and are suitable for oral consumption by a human.

The terms “liquid nutritional composition,” “liquid nutritionals,” and “nutritional liquid” are used interchangeably herein, and unless otherwise specified, refer to nutritional products in ready-to-drink liquid form and concentrated form.

The terms “substantially clear nutritional liquid” and mulsion” as used herein, unless otherwise specified, are used interchangeably to refer to a non- emulsified or similar other liquid having a visibly clear or translucent appearance, which liquid may and lly will have a thin or watery e with a consistency similar to that of a clear juice and most typically having a viscosity of less than about oises as determined by a Brookfield viscometer at 22°C using a #1 spindle at 60 rpm. [003 0] The terms “stabilizer” or “stabilizer system” refer to one or more components of a nutritional product that prevents retrogradation of the nutritional product for a period of at least 12 hours, including at least 24 hours, including at least 48 hours, including at least 7 days, including at least 1 month, including at least 2 months, including at least 4 months, including at least 6 months, and including at least 9 months, 12 months, 18 months, or longer.

The terms “fat” and “oil” as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials d or processed from plants or animals. These terms nclude synthetic lipid materials so long as such synthetic materials are suitable for oral administration to humans.

The terms “stable” and “shelf stable” as used herein, unless otherwise specified, refer to a liquid nutritional composition that remains commercially stable after being packaged and then stored at 18-24°C for at least 3 months, including from about 6 months to about 24 months, and also including from about 12 months to about 18 months.

The terms t packaging" and "retort sterilizing" are used interchangeably , and unless otherwise specified, refer to the common practice of filling a container, most typically a metal can or other similar package, with a liquid nutritional ition and then subjecting the liquid-filled package to the ary heat sterilization step, to form a sterilized, retort packaged, liquid nutritional product.

The term "aseptic packaging" as used herein, unless otherwise specified, refers to the manufacture of a packaged product without ce upon the above—described retort packaging step, wherein the liquid nutritional composition and e are sterilized tely prior to filling, and then are combined under sterilized or c processing conditions to form a sterilized, aseptically packaged, liquid nutritional t.

The term “infant formula” as used herein, unless otherwise specified, refers to liquid or solid infant formulas and toddler formulas, wherein infant formulas are intended for infants up to about 1 year of age and toddler formulas are intended for children from about 1 year of age to about 10 years of age.

The term rm infant formula” as used herein, unless otherwise specified, refers to liquid or solid nutritional compositions suitable for consumption by a m infant. The term “preterm infant” as used herein, refers to a person born prior to 36 weeks of gestation. [003 7] The term “adult nutritional product” as used herein includes formulas, including, but not limited to liquid formulas, for generally maintaining or improving the health of an adult, and includes those formulas designed for adults who need to control their blood glucose.

All percentages, parts and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore; do not e solvents or by-products that may be ed in commercially available materials, unless otherwise specified.

All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the nce is made.

All combinations ofmethod or process steps as used herein can be performed in any order, unless otherwise specified or clearly d to the contrary by the context in which the referenced combination is made.

The various embodiments of the nutritianal products of the present disclosure may also be substantially free of any optional or selected ingredient or feature described herein, provided that the remaining nutritional t still contains all of the required ingredients or features as 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 about 1%, including less than about 0.5%, including less than about 0.1%, and also ing zero percent, by weight of such optional or selected ingredient.

The nutritional product may comprise, consist of, or consist essentially of the elements of the ts as described herein, as well as any additional or optional element described herein or otherwise useful in nutritional product applications.

Product Form The nutritional products include both ready-to-feed liquids and trated s and liquids derived from nutritional powders (reconstituted liquids). The s may include solutions, suspensions, and ons, including clear solutions/suspensions that may be ee. The powders that are reconstituted to produce a liquid may include any flowable or scoopable particulate solid that can be diluted with water or other aqueous liquid to form a nutritional liquid prior to use.

The nutritional products may be formulated with sufficient kinds and amounts of nutrients to e a sole, primary, or supplemental source of nutrition, or to provide a specialized nutritional product for use in individuals afflicted with specific diseases or conditions or with a targeted nutritional benefit.

The nutritional products of the present disclosure comprising starch include human milk fortifiers, preterm and term infant as, pediatric and r formulas, follow-on formulas and adult nutritionals, medical ionals, sports , nutritional formulas, and sports drinks, all of which may be in liquid or powdered form.

Nutritional Powders The ional powders including starch may be reconstituted by the intended user with a suitable aqueous , typically water or other aqueous liquid, in an amount or volume sufficient to form a nutritional liquid for immediate oral or enteral use. The starch present in the reconstituted liquid will improve the emulsion stability and suspension characteristics of the reconstituted liquid.

In this context, “immediate” use generally means within about 48 hours, more typically within about 24 hours, most typically right after or within 20 s of reconstitution. Further, when reconstituted, the nutritional s provide the desired ingredient concentrations as described hereinafter for the nutritional liquid embodiments.

The nutritional powders may include spray dried powders, dry mixed powders, agglomerated powders, combinations thereof, or powders prepared by other le methods. The starch may be included in the nutritional powders by either adding the native starch to one or more liquid slurries prior to the slurries being spray dried or it may be dry-blended into a base powder.

Nutritional Liguids The nutritional liquids may be formulated in a variety of forms, including emulsions such as oil-in-water, water-in-oil, or complex aqueous ons, although such emulsions are most typically in the form of oil—in—water emulsions having a uous s phase and a discontinuous oil phase, suspensions, or clear or substantially clear liquids. The stabilizer s of the t disclosure improve the emulsion stability and suspension teristics of the nutritional liquids.

The nutritional liquids may be and typically are shelf stable. The nutritional liquids 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 85%, [of water by weight of the nutritional liquid.

The nutritional liquids may have a calorie density tailored to the nutritional needs of the ultimate user, although in most instances the liquids comprise generally at least 19 kcal/fl oz (660 kcal/liter), more typically from about 20 kcal/fl oz (675-680 kcal/liter) to about 25 kcal/fl oz (820 kcal/liter), even more lly from about 20 kcal/fl oz (675-680 iter) to about 24 kcal/fl oz (800-810 kcal/liter).

Generally, the 22-24 kcal/fl oz formulas are more ly used in preterm or low birth weight infants, and the 20-21 kcal/fl oz (675-680 to 700 kcal/liter) formulas are more often used in term infants. In some embodiments, the liquid may have a calorie y of from about 100 kcal/liter to about 660 iter, including from about 150 kcal/liter to about 500 kcal/liter.

The nutritional liquid may have a pH ranging from about 3.5 to about 8, but are most advantageously in a range of from about 4.5 to about 7.5, including from about 4.5 to about 7.0, including from about 4.5 to about 6.7, including from about 4.5 to about 6.5, and including from about 4.5 to about 6.0. In some embodiments, the pH range includes from about 5.5 to about 7.3, including from about 5.5 to about 7.0, ing from about 5.5 to about 6.5, and ing from about 5.5 to about 6.0. In still other embodiments, the pH range may be from about 6.2 to about 7.2, including from about 6.2 to about 7.0, and including from about 6.2 to about 6.5.

Although the serving size for the nutritional liquid can vary depending upon a number of_variab1es, a typical serving size is generally at least 2 mL, or even at least 5 mL, or even at least 10 mL, or even at least 25 mL, ing from about 4 mL to about 250 ranges from about 2 mL to about 300 mL, including mL, and including from about 10 mL to about 240 mL.

Starch Component of the Stabilizer System In some embodiments, the nutritional liquids include a stabilizer system including starch and maltotriose. In some embodiments, the nutritional liquids comprise at least one native (non-chemically modified) starch. In some embodiments, the nutritional liquids comprise at least one waxy starch. In some embodiments, the nutritional liquid comprises at least one hybrid waxy potato starch. As used herein, the term “hybrid” means the offspring of two , such as two potato plants, of different breeds, varieties or species. The native hybrid waxy potato starch in the liquid nutritional is both a stabilizer as described herein and a carbohydrate nutritional component, as noted below. [005 5] The stabilizer system may comprise, consist essentially of, or t of starch and maltotriose. In some embodiments, the stabilizer may comprise native hybrid waxy potato . In some embodiments, starch may be used in ation with other, conventionally known stabilizers such as xanthan gum, carrageenan, and the like. In some embodiments, the nutritional composition including the native hybrid waxy potato starch is substantially carrageenan-free. In other embodiments, the nutritional product including the native hybrid waxy potato starch is substantially cellulose gum-free. In these embodiments, the term “substantially free” means no more than a trace amount that would not impact the ties of the t, and include a zero amount.

In some embodiments, the liquid nutritional products of the t disclosure comprise a stabilizer system including a waxy starch and maltotriose, and in some embodiments include only a waxy starch and maltotriose, such that the liquid nutritional only contains a waxy starch and maltotriose as the stabilizer. The waxy starch component may be any starch known for use in oral nutritional products, and may include, for example, waxy and non-waxy starches, including native waxy and native non-waxy starches, all of which can serve as both a nutritional component as well as a stabilizer. Exemplary waxy and non-waxy starches e native waxy and non-waxy potato starch, native waxy and non-waxy wheat , native waxy and non—waxy corn starch, native waxy and xy rice starch, and the like.

Additionally, modified (including chemically modified) waxy and non—waxy starches can be used with maltotriose in the stabilizer system, in some embodiments in accordance with the present disclosure.

One particularly suitable starch is a waxy starch, including a native (non-chemically d) hybrid waxy potato starch. Native hybrid waxy potato starches have now been unexpectedly found to be advantageous stabilizers for nutritional products, and in particular, liquid nutritional compositions, as waxy potato starches ed from native potato hybrids may, in some embodiments, advantageously be ed to have a very low (less than 20% by weight) amylose content, large (greater than about 5 um) granule size, and low (less than 0.07% by weight) protein content, all of which may provide beneficial emulsion stability and suspension properties in liquid nutritionals as described in detail below. [005 8] Utilizing a native hybrid waxy potato starch with a low amylose content as a stabilizer in a liquid nutritional ition may allow for a d possibility of retrogradation in the resulting nutritional liquid as amylase is a generally linear carbohydrate polymer that may tend in some nutritional solutions to symmetrically align against itself and thus have a repulsion effect on other components, which can lead to retrogradation such that emulsion stability and suspension properties are d. As such, in some embodiments of the present disclosure, the native hybrid waxy potato starch for use in the ional compositions of the present disclosure will have an amylose content of less than 20%, including less than 10%, including less than 5%, including less than 4%, including less than 3%, including less than 2%, and including less than 1% by weight.

Additionally, the large granular size and branching of any amylopectin polymers t, which may retard radation due to their branched structure, in the native hybrid waxy potato starch may provide for a cohesive, stronger network formation when the starch is heated, such as during retort or aseptic processing of the final nutritional product, and thus, further t the potential retrogradation effect. Using larger granular sizes of the native hybrid waxy potato starch may provide for slower mobility ofmany ydrate polymers present in the liquid, which can also further inhibit retrogradation and the resulting unwanted emulsion and sedimentation effects. Suitable large granular sizes include typically from about 5 um to about 100 um, including from about 10 mm to about 100 um, ~ including from about 20 um to about 100 um, ing from about 30 mm to about 100 um, ing from about 50 um to about 90 um, including from about 50 pm to about 80 um.

In addition to the benefit of a reduction in retrogradation effect, the starch used in the nutritional products described herein has a relatively low protein content, thus ng the resulting liquid nutritional products to have reduced incidences of allergic reactions. This is particularly desirable when the nutritional product is to be used in infant and preterm infant nutritional products. The starch for use in the nutritional products of the present disclosure has a protein t by weight of less than 0.07%, including less than 0.05%, and including less than 0.04%, including less than 0.03%, including less than 0.02%. In some embodiments, the protein t by weight is from about 0.02% to about 0.07%, including from about 0.02% to about 0.05%.

Additionally, the starch es phosphorus, generally present in the form of phosphate monoesters. Phosphate monoesters are negatively d molecules, and thus may increase the repulsion of many polymers from each other such that the polymers present are less likely to align as described above‘and cause retrogradation. This repulsion phenomena may cause an se in water binding capacity, swelling power and paste y as the network formation is improved as the starch molecules are less likely to associate.

The amount of starch in the nutritional products to provide sufficient stabilization will generally depend on the product form, other components of the nutritional product and/or the ed use of the nutritional product.

One suitable native hybrid waxy potato starch for use in the nutritional itions of the present disclosure is commercially available as an ELIANETM native hybrid waxy potato starch, ble from Avebe Food (The Netherlands). ' For ed nutritional compositions that are reconstituted with a liquid prior to use, embodiments comprising suitable amounts of starch in the powder may range from about'0.05% by weight to about 20% by weight total nutritional product, including from about 2.0% by weight to about 15% by weight total nutritional product, and including from about 5% by weight to about 8% by weight total ional product. In one c embodiment, when used in powdered infant nutritional products, le amounts of native hybrid waxy potato starch in the powder may include from about 0.05% by to about 5.0% by weight total nutritional composition, including from about 1.0% by weight to about 5.0 % by weight total nutritional composition.

In embodiments comprising starch and maltotriose components of the stabilizer system, suitable amounts of starch may range from about 0.05% by weight to about 60% by weight total nutritional product, including from about 0.1% by weight to about 15% by weight total nutritional t, and including from about 0.5% by weight to about 2% by weight total nutritional product. More particularly, when used in infant nutritional products, suitable amounts of starch may include no more than 2% by weight total infant nutritional product, ing from 0.5% by weight to 2% by weight total infant nutritional product.

Liquid nutritional products may be either in ready to drink or concentrated fonn. Suitable amounts of native hybrid waxy starch may range from about 0.5% by weight to about 15% by weight of the total nutritional product including from about 0.5% to about 10% by weight total nutritional product and including from about 1.0% by weight to about 5.0% by weight total nutritional product. In one specific embodiment, when used in ready—to-drink or concentrated liquid infant ional products, suitable amounts of native hybrid waxy potato starch may include no more than 2% by weight total liquid infant nutritional product, including from about 0.5% to about 2% by weight total liquid infant nutritional product, including from about 0.5% to about 1.4% by weight liquid infant nutritional product, including about 0.8% by weight total liquid infant nutritional t.

Maltotriose Componentof the Stabilizer System The stabilizer system of the nutritional products may include maltotriose in combination with the starch. Maltotriose is a droxy nd, and particularly a trisaccharide, consisting of three glucose molecules linked with (1,- 1,4 glycosidic bonds as shown in the formula below.

Maltotriose is most ly ed by the digestive enzyme amylase on e in starch. The creation of both maltotriose and maltose during this process is due‘to the random manner in which alpha-amylase hydrolyses a-1,4 glycosidic bonds.

Maltotriose may be found in some maltodextrin sources. The percentage of maltotriose in conventional maltodextrin sources, however, is relatively low. A particularly suitable maltotriose source includes maltodextrin including about 50% by weight maltotriose, available from National Starch (Bridgewater, New Jersey) .

The amount of maltotriose in the nutritional product will typically depend on the amount and type of starch present in the nutritional product. For example, higher concentrations of maltotriose may be required when non-waxy starches are used as the starch in the nutritional product. The ional products typically include riose in an amount of from about 0.01% by weight to about % by weight, including from about 0.01% by weight to about 10% by weight, and including from about 0.01% by weight to about 2% by weight total nutritional product.

Protein The nutritional products may further comprise any proteins or sources thereof that are suitable for use in oral ional products and are compatible with the essential elements and features of such products. Total protein concentrations in the nutritional products may range from about 0.5% to about 30%, including from about 1% to about 15%, and also including from about 2% to about %, by weight of the nutritional product.

Non-limiting examples of le protein or s thereof for use in the nutritional products include yzed, partially hydrolyzed or non-hydrolyzed proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e. g., rice, corn), vegetable (e.g., soy), or ations thereof. Non-limiting examples of such proteins include milk protein isolates, milk protein concentrates as described herein, casein protein isolates, whey protein, sodium or calcium caseinates, whole cow’s milk, partially or completely ed milk, soy protein isolates, soy protein concentrates, and so forth. Particularly preferred protein s include skim milk, including sed skim milk, and whey protein concentrate, alone or in combination.

The optional protein in the ional products may e soluble proteins as that term is defined herein to improve product ity and minimize the development of bitter flavors and after taste in the composition during shelf life.

The soluble protein may represent up to 100% of the total protein in the nutritional product, including from about 65% to 100%, including from 80% to 100%, including from about 85% to about 100%, including from about 90% to about 100%, including from about 95% to about 100%, and also including about 100%, by weight of the total protein in the nutritional product. The concentration of soluble protein may range from-at least 0.5%, including from about 1% to about 30%, and also including from about 2% to about 15%, also including from about 3% to about %, and aISO including from about 3% to about 5%, by weight of the nutritional liquid.

The term “soluble protein” as used herein, unless otherwise specified, refers to those proteins having a protein solubility of at least 40%, including from 50% to 100%, and also including from 60% to 90%, as measured in accordance with the following process: (1) d protein ingredient in purified water at 5.00 g per 100 g of sion; (2) adjust the pH of the sion to 3.5 or the desired product pH (e.g., 4.6 or other) using HCl, phosphoric acid, citric acid or combinations thereof; (3) stir vigorously at room temperature (20°C-220C) for 60 minutes; (4) measure total protein in the suspension by any suitable technique (including the HPLC technique described below); (5) centrifuge an aliquot of the suspension at 31,000 x g and at °C for 1 hour; (6) measure the supernatant for protein by the selected technique as described in step (4); and (7) calculate protein solubility as the supernatant protein percentage of the total protein.

Protein concentrations (per step 4 above) can be ed in the protein solubility process by any known or ise suitable method for determining such trations, many of which are well known in the analytical art. An example of one such suitable method is by HPLC analysis in ance with the following specifications: (1) Column: Shodex KW-804 protein size exclusion tography column, Waters P/N WAT036613; (2) Mobile Phase: 0.05M NaHzPO4, 0.15M NaCl, pH = 7.0; (3) Flow Rate: 0.3 mL/minute; (4) Temperature: 22°C; (5) Detection: UV at 214 nm; (6) Injection: 10 uL; (7) Run Time: 90 minutes; (8) System Calibration: protein standard ons prepared at 0.5 — 3.0 g/L in mobile phase; and (9) Sample Preparation: dilute to about 1.5 g/L protein with mobile phase.

Any soluble protein source is suitable for use herein provided that it meets the solubility requirement as defined herein, some non-limiting examples of which include whey protein concentrate (>90% lity), whey protein isolate (>90% solubility), casein hydrolysate (>60% solubility), hydrolyzed collagen, combinations thereof. Non-soluble ns may of course also be included in the nutritional products described herein provided that the remaining soluble protein component is represented in accordance with the ements as set forth herein.

The composition may be substantially free of proteins other than the soluble protein as described herein.

It should be noted that any protein selected for use herein as a soluble protein should also meet the solubility testing requirements noted above even if the protein is whey protein concentrate, casein hydrolysate, or other typically soluble protein since protein solubility can vary significantly with the selection of raw material lots, sources, brands, and so forth.

In a particularly desirably embodiment, the protein system includes a combination of condensed skim milk and whey protein concentrate.

Carbohydrate The nutritional products may further comprise any carbohydrates or sources thereof that are suitable for use in an oral nutritional t and are cOmpatible with the ial elements and features of such products in addition to the native hybrid waxy potato stabilizing starch and/or the starch and maltotriose combination, which is also a carbohydrate component. Carbohydrate concentrations in the liquid nutritional itions, for example, may range from about 5% to about 40%, including from about 7% to about 30%, and including from about 10% to about %, by weight of the liquid nutritional composition.

Non-limiting examples of le carbohydrates or sources thereof for use in the nutritional products described herein, in addition to the starch and maltotriose, may include maltodextrin, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, e, glucose, fructose, lactose, high se corn syrup, honey, sugar alcohols (e. g., maltitol, erythritol, sorbitol), ial ners (e.g., sucralose, acesulfame ium, stevia) and combinations thereof.

Lactose and corn syrup solids are ularly preferred carbohydrates, and can be used alone or in combination in the liquid nutritionals described herein.

The nutritional products may further comprise any fats or sources thereof that are suitable for use in an oral nutritional t and are compatible with the elements and features of such products, most typiCally as emulsified fat, concentrations of which may range from about 1% to about 30%, ing from about 2% to about 15%, and also ing from about 4% to about 10%, by weight of the liquid nutritional composition. le 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 essential elements and features of such products.

Non-limiting examples of suitable fats or sources thereof for use in the nutritional ons described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.

Particularly preferred fats include soy oil, coconut oil, and MCT oil, each of which may be used alone or in any combination.

The amount of carbohydrates, fats, and/or proteins in any of the nutritional products described herein may also be characterized in addition to, or in the alternative, as a percentage of total calories in the ional product as set forth in the following table. These macronutrients for nutritional products of the t disclosure are most typically formulated within any of the caloric ranges (embodiments A-F)described in the following table (each numerical value is ed by the term “about”).

Nutrient&Total Cal. EmbodimentA EmbodimentB T EmbodimentC j Carbohydrate 0-98 2-96 10-75 im .JV A} 0-98 2-96 5-70 Fat 0-98 2-96 20-85 '—_-——_——l—'EmbodimentD EmbodimentE EmbodimentF i Carbohydrate 30-50 25-50 25-50 In one specific example, liquid infant formulas (both ready—to—feed and concentrated liquids) include those embodiments in which the protein ent may comprise from about 7.5% to about 25% of the c content of the formula; the carbohydrate component may comprise from about 35% to about 50% of the total caloric t of the infant formula; and the fat component may comprise from about % 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 noted in the following table (each numerical value is preceded by the term “about”).

Nutrient & Total Cal. Embodiment G Embodiment H Embodiment I Carbohydrate 20-85 Protein 5-70 2-75 Optional Ingredients The nutritional products described herein may further se other optional ients that may modify the al, chemical, hedonic or processing characteristics of the products or serve as pharmaceutical or, additional nutritional components when used in the targeted population. Many such optional ingredients are known or otherwise suitable for use in other nutritional products and may also be used in the nutritional products described herein, ed that such optional ingredients are safe and effective for oral administratidn and are compatible with the essential and other ingredients in the selected product form.

Non-limiting examples of such al ingredients include preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as described herein, colorants, flavors, thickeners, additional izers, and so forth.

The products may further comprise ns or related nutrients, non- limiting examples of which include Vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.

The products may further comprise minerals, miting es of which include phosphorus, magnesium, calcium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations The products may also include one or more flavoring or masking . le flavoring or masking agents include natural and artificial sweeteners, sodium sources such as sodium chloride, and hydrocolloids, and combinations thereof.

Methods of Manufacture The ional products as described herein may be manufactured by form any known or ise suitable method for making the nutritional product ed. Nutritional liquids may be prepared, for example, by any of the well known methods of formulating nutritional liquids by way of retort, aseptic packaging, or hot fill processing methods. Such methods are well known in the nutrition formulation and manufacturing arts.

In one suitable manufacturing process, for example, at least three separate slurries are prepared, including a protein-in—fat (PIF) slurry, a carbohydrate— mineral (CHO—MIN) slurry, and a protein-in—wa’ter (PIW) slurry. The PIF slurry is formed by heating and mixing the oil (e.g., canola oil, corn oil,‘ etc.) and then adding an fier (e.g., lecithin), fat soluble Vitamins, and a portion of the total protein (e.g., milk protein concentrate, etc.) with continued heat and agitation. The CHO- MIN slurry is formed by adding with heated agitation to water: minerals (e.g., ium citrate, dipotassium phosphate, sodium citrate, etc.), trace and ultra trace minerals (TM/UTM premix), thickening or suspending agent. The resulting CHO— MIN slurry is held for 10 minutes with continued heat and ion before adding additional ls (e.g., potassium chloride, magnesium carbonate, potassium iodide, etc), and/or ydrates (e.g., HMOs, fructooligosaccharide, sucrose, corn syrup, etc.). The PIW slurry is then formed by mixing with heat and agitation the remaining protein, if any.

The ing slurries are then blended together with heated agitation and the pH adjusted to 6.6-7.0, after which the composition is subjected to high- temperature short-time (HTST) processing during which the composition is heat treated, emulsified and homogenized, and then allowed to cool. Water soluble vitamins and ascorbic acid are added, the pH is adjusted to the d range if solid necessary, flavors are added, and water is added to achieve the desired total level. The composition is then aseptically packaged to form an aseptically packaged nutritional emulsion. This emulsion can then be further diluted, heat-treated, and packaged to form a ready—to-feed or concentrated liquid.

To form the stabilized liquid nutritional composition, the starch, or the starch and riose can be introduced into the liquid nutritional composition prior to or after heat treatment. For example, in one ment, the starch or starch and maltotriose is introduced into the liquid nutritional ition formed from the blend of slurries described above, and then the liquid nutritional composition, ing the starch or the starch and maltotriose, is heated to form the stabilized liquid nutritional composition. The liquid nutritional composition, including the starch or starch and maltotriose, is heated to a temperature of from about 55°C to about 70°C for a period of from about 30 minutes to about 90 minutes to form the stabilized liquid nutritional composition.

In one embodiment, native hybrid waxy potato starch may be hydrated to provide partial network formation prior to being uced, in some embodiments with maltotriose, into the liquid nutritional composition. The starch may be hydrated at a temperature of from about 55°C to about 70°C for a period of from about 15 minutes to about 30 minutes to form the partial network. Typically, the starch is hydrated to a solids level of about 30%. Hydration and partial network formulation may then be completed by applying heat.

In one alternative embodiment, the maltotriose may be added into the CHO-MIN slurry and included in the resulting liquid nutritional composition. The starch is then introduced into the liquid nutritional composition, including the maltotriose, as bed above.

In another embodiment, the nutritional composition is a solid nutritional ition such as a nutritional powder. Any methods known in the nutritional art for preparing nutritional powders may be used herein. By way of example, the nutritional powders can be prepared by drying the heated, homogenized liquid nutritional composition bed above, such as by spray drying.

In one embodiment, the starch may first be hydrated and heated as described above and then dried to form a powdered, nized starch. The dry powdered starch and maltotriose may then be dry-blended with a dry nutritional base Methods of Use The nutritional itions comprising the stabilizer systems disclosed herein show minimal to no retrogradation effects, providing for ed stabilization and enhanced shelf life of the compositions while providing nutrition to individuals. As noted herein, the ional compositions including the stabilizer system described herein are suitable for use as numerous types of nutritional products, including preterm infant formulas, term infant formulas, pediatric formulas, toddler formulas and adult as. The nutritionals are desirably formulated as liquid nutritionals and can have the added benefit of being substantially or completely carrageenan-free.

The methods of the present sure include the use of desirable ments as described herein. In one embodiment, the stabilizer system comprising starch and the stabilizer system comprising starch and riose is a liquid nutritional ition comprising a protein, a carbohydrate, and a fat. The protein component includes skim milk, optionally in the form of condensed skim milk, and Whey protein concentrate. In embodiments in which the stabilizer system comprises hybrid waxy potato starch, the carbohydrate component additionally includes corn syrup solids and lactose. The fat component includes a combination of t oil, soy oil, and medium chain triglyceride (MCT) oil. This is a particularly desirable embodiment that may also include Vitamins, and minerals, as well as a source ofDHA and ARA oil. This particularly preferred embodiment is carrageenan- free.

EXAMPLES The following examples illustrate specific ments and or features of the nutritional compositions of the present disclosure. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present disclosure, as many variations f are le Without departing from the spirit and scope of the disclosure. All exemplified amounts are weight percentages based upon the total weight of the composition, unless otherwise specified.

The exemplified compositions are nutritional products that may be prepared in accordance with manufacturing methods well known in the nutrition industry for preparing nutritional emulsions, non-emulsions (e.g., substantially clear nutritional liquids), and nutritional s.

Example 1 In this Example, ready-to-drink liquid infant formulas including a native hybrid waxy potato starch as described above were prepared and evaluated.

The formulas were visually inspected for retrogradation effect.

Ready-to-drink liquid infant formulas (Similac® Special Care 24 HP) were prepared including 1.8% by weight ELIANETM native hybrid waxy potato starch. The formulas, 20 bottles for each storage condition, were stored for one month in conditioning rooms at a temperature of 5°C, 37°C, and 45°C. Visual inspection of these infant liquid formulas at the end of the condition period singly showed that none of the liquid infant as including the native hybrid waxy potato starch exhibited any retrogradation. There was no phase separation and/or sedimentation observed.

Example 2 In this Example, infant nutritional emulsions ing a waxy potato starch, with or without maltotriose, were prepared as described. The rheologies ofthe resulting emulsions were analyzed for radation effect.

Samples of a commercially available liquid infant formula were prepared adding 1.8% by weight waxy potato starch with (sample C34-7) or without (sample C34-1) 0.5% by weight maltotriose. Four rheologies measurements (frequency sweep measurements, step rate ements, strain sweep measurements and temperature sweep measurements) of the s were analyzed using an ARES- LSl rheometer, available from TA Instruments (New Castle, Delaware).

] Step rate measurements were obtained by ing shear rate Viscosity at 25°C. The shear viscosities at shear rates of 0.5“, 13“, and 1005'1 were recorded for 120 seconds. The last 90 seconds were averaged to obtain the Viscosity value. The values from duplicate measurements were averaged. The results are shown in Strain sweep measurements are obtained by recording dynamic modulus as a on of strain at 25°C. [The linear range in this data corresponds to c modulus wherein change as a function of strain is insignificant. The line fit is performed to identify the plateau elastic modulus. The frequency of the measurement is 10 rad/s. The plateau c moduli from duplicate measurements were averaged.

The results are shown in Frequency sweep measurements were obtained using the u G’ from the strain sweep measurements. The zero shear viscosity was calculated Via the Ellis model. The results are shown in ] The temperature rate measurements are a rheology measurement as a function of temperature. Particularly, the determined G’p from the strain sweep measurement was used for the temperature rate measurements. The frequency of the measurements was 10 rad/s. The moduli values from duplicate measurements were averaged. The results are shown in As shown in FIGS. 1-3, there was seen almost no difference in product qualities as the viscoelasticity of the products at room temperature were similar within the frequency domain se of time). As shown in however, at elevated temperatures the emulsion ning only the waxy potato starch (C34-1) started to p elasticity and viscosity, indicating gel network build-up, while the emulsion containing starch and maltotriose (C34-7) showed a steady decline as a function of sed temperature. For e, product viscosity and elasticity at around 67°C were, respectively, 149.3 mPa and 52.6 mPa for C34-1, and 101.2 mPa and 18.8 mPa for C34—7. These results indicate that the addition of maltotriose prevents the retrogradation effect, particularly at elevated temperature conditions.

Example 3 In this Example, multiple liquid infant nutritional emulsions including various types of starches were prepared and analyzed for emulsion/suspension stability.

Seven liquid infant ional emulsions were prepared using the starches as shown in the table below. Particularly, the starches were fully hydrated and heated to a temperature of about 150°F (656°C) for a period of about 15 minutes to allow for partial network formation. The aqueous heated starch slurry was then added to 15 mL samples of a commercially available ready-to-drink liquid infant formula.

Sam le Starch Tradename [ Amount of Starch in Cl6-l Modified Waxy Rice NovationTM 8300 l C16-2 Modified Waxy Rice NovationTM 8600 Cl6-3 Modified Potato NovationTM 1600 containing 21% by weight e Pre-gel Wax Rice National Starch Modified Tapioca TextraTM containing 18% by weight amylose Native Hybrid Waxy ELIANETM Potato Starch containing less than 1% by weighiamylose Locust Bean Gum GENU® Strain sweep measurements for each sample were then ed using an ARES-L81 rheometer, available from TA Instruments (New Castle, Delaware). For a sample to exhibit good emulsion/suspension stability, the strain in amplitude as a sweep would display a long linear range (no significant change on of ncy) and a large u amplitude. Additionally, the strain sweep moduli which may indicate a gel may identify undesirable sharp breaks in the u like structure. The results of‘the strain sweep measurements of the samples are shown in Strain sweep measurements are obtained by recording dynamic modulus as a function of strain at 25°C. The linear range in this data corresponds to elastic modulus wherein change as a function of strain is insignificant. The line fit is performed to identify the plateau elastic modulus. The frequency of the measurement is 10 rad/s. The u elastic moduli from duplicate measurements were averaged.

The results are shown in As shown in surprisingly the sample that exhibited good on/suspension stability (i.e., no retrogradation) was the sample including the native hybrid waxy potato starch (Cl 6-6). The other samples showed effects of gelling or no on/suspension stability as ted by sharp or short declines in strain sweep profiles (i.e., no linear range). This data indicates that the native hybrid waxy potato starch provides excellent stabilization properties.

Example 4 [001 18] In this Example, liquid infant nutritional emulsions including g starches were prepared and analyzed for emulsion/suspension stability. [001 19] Seven liquid infant nutritional emulsions were prepared using the starches as shown in the table below. The starches were added directly to 15 mL samples of a commercially available ready—to-drink liquid infant formula and the samples were then heated to a temperature of about 150°F (65.6°C) for a period of about 15 minutes. The samples were then subjected to a conventional retort processing process.

Sam le Starch Tradename Amount of Starch in Emulsion Sample 1% b wt C 1 8-1 Modified Potato NovationTM 1600 0.8 ing 21% by weight amylose C18-2 d Waxy Rice NovationTM 8300 0.8 C18-3 Modified Waxy Rice NovationTM 8600 0.8 C18—4 d a TextraTM 0.8 containing 18% by weight amylosc C 1 8-5 Native Hybrid Waxy ELIANETM 0.8 Potato including less than 1% by weight [ I e [ 1 C18-6 I Modified Waxy Corn 1 NovationTM 5600 0.8 [ (318-7 [ Waxy Corn I Amioca 0.8 Strain sweep measurements for each sample were then obtained as described in Example 3. The results are shown in As shown in the two samples showing good product quality in strain sweep measurements were the samples ing the waxy corn starch (Amioca) and the native hybrid waxy potato .

Further, the shear Viscosity for each sample was measured using an ARES—L81 rheometer, available from TA Instruments. The results are shown in the table below.

Table: Average Viscosity of last 90 seconds 0.5 s (rate) I:_133 (rate) E10 5 1(—rate)—[ Viscosity mPa.5 69.25 I 16. 89 l 10.27 4 15.2489 7.132 128.608 14.1504 7.364 6.4463 5.245 4.6638 - 8.6024 5.7256 5.3141 C18-6 55.4791 9.9435 5.5662 C18-7 11.401 8.1513 _|_ 5.8096 As indicated by the shear Viscosity measurements, there was more shear thinning in the sample including Amioca, which is lly seen with starch retrogradation, resulting in a creaming effect. er, sample Cl 8-5, including the native hybrid waxy potato starch, showed improved emulsion stability and suspension as compared to all other samples evaluated. This data shows that the native hybrid waxy potato starch provides excellent stabilization properties. mus; In this Example, various sing conditions for adding a native hybrid waxy potato starch to infant nutritional emulsions were analyzed and evaluated to determine optimal processing conditions for the addition of the native hybrid waXy potato starch.

Six samples were prepared by adding a native hybrid waxy potato , either directly or after being hydrated and/or , to either Similac® Early Shield or Similac® Special Care 30 (both available from Abbott Nutrition, Columbus, Ohio). The six samples and their respective processing conditions are shown in the table below.

Amount of Nutritional Point of Addition Processing Starch 1% by Emulsion of Starch Conditions (temp weight) of heat ent, time l C24-1 Similac® Early Standardization 150°F, 30 min Point, heated, and Shield then sent to retort CZ4~2 0.8 Similac® Early Standardization 160°F, 20 min Point, heated, and l C24-3 Shleld then sent to retort Similac® Early Standardization 17O°F 1 0 min Point, heated, and Shield then sent to retort Similac® Early Prior to Blended with homogenization protein-in—fat slurry Shield C24-8 Similac® Special Standardization 160°F, 20 min Point, , and Care 30 then sent to retort Similac® Special Prior to Blended with homogenlzatlon Care 30 carbohydrate, , and fat slurries As shown in the optimal method of adding the native hybrid waxy potato starch into the liquid nutritional products is at the standardization point where the ature was raised to about 150°F for a period of about 30 minutes (Sample (324-1).

Example 6 [0l27] In this Example, various infant nutritional emulsions were prepared with 0.8% by weight ELIANETM food starch, added at standardization directly into cold formulations and heated to 150°F for a period of 30 minutes prior to retort. The s were compared, using strain sweep measurements, to the same infant nutritional emulsions including carrageenan as the stabilizer.

, The samples tested are shown in the table below. Strain sweep measurements for each sample were obtained as described in e 3. The results of the strain sweep test for the TM food starch-containing formulas are shown in Results of the carrageenan-containing formulas are not shown. As shown in all of the samples including ELIANETM food starch exhibited good strain sweep s, indicating improved emulsion/suspension stability. Unexpectedly, a trend was observed that 0.8% by weight starch addition level provided elevated stability at elevated caloric emulsions. Furthermore, Similac® l Care 20, although one of the lower calorie emulsions, showed the highest stability among the emulsions where, in the past, this emulsion has demonstrated to be one of the most difficult emulsions in terms of emulsion/suspension stability. ‘7Sample Infant Nutritional ELIANETM food-1 Carrageenan Emulsion starch P27-1 Similac® EarlLShield 0.8% - Similac® Shie1d 300.EL Sirnilac®§gcial Care 20 0.8% c®§pecial Care 20 -~ 300ppm Neosure® 0.8% Neosure® -- 80 pgn Similac® Special Care 24 0.8% Similac® Special Care 24 -- 300pp— Similac® Special Care 0.8% 24HP Similac® Special Care ~~ 80 ppm 24HP Similac® Special Care 30 0.8% Similac® Special Care 30 -- 80"pp_ Example 7 In this Example, infant nutritional emulsions including various starches were ed microscopically.

Seven samples were slurried. Starches (indicated in the table , at a concentration of about 0.8% by weight of the total batch in 20 gallons of water, were added to the slurries at standardization and heated treated at 150°F for a period of 15 minutes. The starch slurries were then added to a sterile infant nutritional emulsion at high shear and then filled into 8 oz. bottles and retorted. The various starches used in the s are shown in the table below.

S_an_1p_l_§ m Tradename Modified potato NovationTM 1600 Modified waxy rice onTM 8300 Modified waxy rice T'Novationm 8600 Modified tapioca TextraTM Native hybrid waxy potato ELIANETM 100 Modified waxy corn onTM 5600 Waxy corn AmiocaTM The samples were then observed visually. All samples were similar in color and all samples showed a “creamy ring” at the top of the e in the bottles. The sample with ELIANETM (C-S) food starch, however, appeared to have the smallest amount of creamy ring. The sample with NovationTM 5600 (C-6) appeared to be the worst from a homogeneity standpoint; not only was the creamy ring the widest of all the samples, but a layer of small particles had separated out of the bottom inch of the sample.

The samples were then diluted (approximately 1:40) in a 3.7 mL Vial with distilled water. The samples were stained with 0.1N iodine on and evaluated by light microscopy at 200X. The results are shown in FIGS. 9A-9G.

As shown in FIGS. 9A-9G, s C-5 and C-7 appeared to have no intact starch granules, and observation of the samples showed that the formula consisting of ELIANETM 100 was the most homogenous of all samples.

Examples 8-12 Examples 8-12 illustrate nutritional emulsions of the present disclosure including native hybrid waxy potato starch, the ingredients of which are listed in the table below. All ingredient amounts are listed as kilogram per approximately 1000 kg batch of product, unless otherwise specified.

In_redient Name I Example 8 Maggie 9 Example 10 1 Examplill Examgle 12 In_ edient Water I 766.4 766.4 766.4 766.4 766.4 Condensed Skim Milk 120.71 120.71 120.71 120.71 120.71 Corn_Sy£up Solids 35.35 35.35 35.35 35.35 So bean on 17.17 17.17 17.17 ] 17.17 2.26 2.26 2.26 2.26 Native Hybrid Waxy .3 14.0 5.0 15.4 Potato Starch Coconut Oil 11.14 11.14 i— 11.14 Whey Prom 10.04 10.04 I 10.04 Concentrate 9.58 9.58 9.58 Potassium H droxide 4.32 4.32 4.32 Ascorbic Acid 696.0 g 696.0 g 696.0 g 696.0 g Potassium Citrate 494.4 g 494.4 g 494.4 g 494.4 g m Carbonate 465.0 g 465.0 g 465.0 g Lecithin 403.0 g 403.0 g 403.0 g ] Emulsifier | 403.0 g 403.0 g 403.0 g 1 403.0 g .

ARA Oil 392.7 g 392.7 g 392.7 g 392.7 g _L 1 392.7 g gfigfififigflfle 376.0 g 376.0 g 376 0 g L3760 g 376.0 g Nucleotide/Choline Mix 293.2 g 2932 g 293.2 g 293.2 g 293.2 g n/Mineral Mix 254.1 g 254.1 g 254.1 g 2541 g 254.1 g DHA Oil 243.4 g 243.4 g 243.4 g 243.4 g 243.4 g Magnesium Chloride 233.0 g 233.0 g 233.0 g 233.0 g 233.0 g m-Inositol 208.6 g 208.6 g 208 6 g 208.6 g 2086 g Choline Chloride 74.0 g 74.0 g 74.0 g 74.0 g 74.0 g Vitamin ADEK Premix 64.5 g 64.5 g 64.5 g 64.5 g 64.5 g ium Chloride 63.0 g 63.0 g 63.0 g 63.0 g 63.0 g s Sulfate 53.2 g 53.2 g 53.2 g 53.2 g 53.2 g L-Carnitine 44.5 g 44.5 g 44.5 g 44.5 g 44.5 g Beta-Carotene I 1.74 g 1.74 g 1.74 g 1.74 g 1.74 g Vitamin APalmitate I 948.0 mg 948.0 mg 948.0 mg 948.0 mg 948.0 mg Riboflavin 624.8 mg 624.8 mg 624.8 mg 6248 mg 624.8 mg , | Sodium Chloride as needed as needed as needed as needed as needed Potassium Phosphate as needed as needed as needed as needed I as needed Examgles 13-17 Examples 13-17 illustrate nutritional emulsions of the present disclosure including waxy starch and maltotriose, the ingredients of which are listed in the table below. All ingredient amounts are listed as kilogram per approximately 1000 kg batch of product, unless otherwise specified.

In redient Name Example 13 Example 14 Example 15 Example 16 I e” Ingredient Water 761.4 761.65 761.15 l 760.9 sed Skim Milk 120.71 120.71 120.71 Corn S Solids Soybean Oil 17.17 17.17 Lactose " 2.26 2.26 Waxy Starch 14.0 13.3 Maltotriose 5.0 4.75 Coconut Oil 11.14 11.14 Whey Protein 10'04 Concentrate MCT on 9.58 Potassium ide 4.32 Ascorbic Acid 696.0 g Potassium Citrate 494.4 g Calcium Carbonate 465.0 g 4030 g 4030 g ARA Oil 392.7 g Tricalcium Phosphate 376.0 g Nucleotide Premix 293.2 g Vitamin/Mineral Premix 254.1 g 254.1 g DHA Oil 243.4 g 243.4 g Magnesium Chloride 233.0 g 233.0 g m~1nositol 208.6 g 208.6 g eenan 80.0 g 80.0 g Choline Chloride 74.0 g 74.0 g Vitamin ADEK Premix 64.5 g 64.5 g .

Potassium Chloride 6g); 63_.0_g 63.0 g Ferrous Sulfate 53.2 g 53.2 g 53.2 g L-Carnitine 44.5 g 44.5 g 44.5 g Beta-Carotene 1.74 g 1.74 g 1.74 g ' 1.74 g Vitamin A Palmitate 948.0 mg 948.0 mg 948.0 mg 948.0 mg 948.0 mg Riboflavin 624.8 mg 624.8 mg 624.8 mg 624.8 mg 624.8 mg { Sodium Chloride as needed as needed as needed as needed I as needed I Potassium Phosphate as needed Las needed as needed as needed J as needed I I/WE

Claims (14)

CLAIM :

1. A stabilized liquid nutritional composition comprising a stabilizer system, the stabilizer system comprising a native waxy starch and maltotriose, n the native waxy starch comprises from 0.02% to 0.07% by weight protein and wherein the maltotriose is present in an amount of from 0.01% to 15% by weight of the composition.

2. The stabilized liquid nutritional composition of claim 1, wherein the native waxy starch comprises less than 1% by weight amylose.

3 The stabilized liquid nutritional composition of any one of the preceding claims, wherein the native waxy starch is present in the composition in an amount of from 0.5% to 15% by weight of the composition.

4. The stabilized liquid nutritional composition of any one of the ing claims, wherein the composition is eenan-free or cellulose gum-free.

5. The stabilized liquid nutritional composition of any one of the preceding claims, wherein the stabilizer system consists of native waxy starch and maltotriose.

6. The stabilized liquid nutritional composition of any one of the ing claims, further sing: a protein component; a fat component; and a carbohydrate component; wherein the native waxy starch comprises a native hybrid waxy potato starch; wherein the protein ent comprises skim milk and whey protein concentrate; wherein the fat component comprises soy oil, coconut oil, and medium chain triglyceride oil; wherein the carbohydrate component comprises corn syrup solids and lactose; and wherein the nutritional composition is an infant formula. AH26(10883211_1):JIN

7. A process for manufacturing a stabilized liquid nutritional composition, the process comprising the steps of: introducing a native waxy starch into a liquid nutritional composition comprising at least one of protein, fat, and carbohydrate, n the native waxy starch comprises from 0.02% to 0.07% by weight protein; and heating the liquid nutritional composition including the native waxy starch to form the stabilized liquid nutritional ition.

8. The process for manufacturing a stabilized liquid nutritional composition of claim 7, wherein maltotriose is introduced into the liquid nutritional composition such that the liquid nutritional composition in the heating step comprises native waxy starch and maltotriose.

9. The process for manufacturing a stabilized liquid ional composition of claim 7 or 8, wherein the native waxy starch is introduced in an amount of from 0.5% to 15% by weight of the liquid nutritional composition and the maltotriose is introduced in an amount of from about 0.01% to about 15% by weight of the liquid nutritional composition.

10. The process of claim 7 or 8, further comprising the step of hydrating the native waxy starch prior to introducing the native waxy starch into the liquid nutritional composition, wherein the native waxy starch is hydrated at a temperature of from 55°C to 70°C for a period of from 15 minutes to 30 minutes prior to being introduced into the liquid nutritional composition.

11. The process of claim 7 or 8, wherein the native waxy starch is introduced in an amount of no more than 2% by weight of the liquid nutritional composition.

12. A process of claim 8, further comprising the step of subjecting the heated liquid nutritional composition sing the native waxy starch and maltotriose to further sing selected from the group consisting of retort processing and aseptic processing.

13. A process of claim 7, further sing the steps of: introducing maltotriose into a ydrate-mineral slurry; mixing the carbohydrate-mineral slurry with at least one of a protein-in-water slurry and a protein-in-fat slurry to form the liquid nutritional composition. AH26(10883211_1):JIN

14. The stabilized liquid nutritional composition of any one of claims 1 to 6, wherein the native waxy starch is a native hybrid waxy potato . Abbott Laboratories By the Attorneys for the Applicant SPRUSON & FERGUSON Per: AH26(10883211_1):JIN Nzofi Wm 2m. 38m hwwnw urea? adon adon «.w 0.8—. .53..” 2.23m .555 353.5 {19% 5-me 2E lledJr +$ $14 J1 m. tmlm xmlm 52% nannovad mmosrs‘o {sued} r1 mmdvmv 0.89 Nfiwow 902. 0.9. 38 38 v38 38 956 95am aswaw 39w 0; .fl { w m mums ro Ivor oo 35 rxv CAN; [Ed] .9 $6.va 0.99. 9.2. m >ncw>o 3me .3 3 an“; :95 2mg fin: t .v 3 . V 5.8 38 58 58 azmvm 95% “swam 1Tb? agmf¢4 + .m. m: .mm new mam—Nd ”9. 12. vorxv