WO2015095769A1

WO2015095769A1 - Low lactose nutritional compositions and methods of producing same

Info

Publication number: WO2015095769A1
Application number: PCT/US2014/071620
Authority: WO
Inventors: Douglas Wearly; Normanella Dewille; Kelley LOWE; Timothy Chapman; Robert RAGAN; Rachel BLUMBERG
Original assignee: Abbott Laboratories
Current assignee: Abbott Laboratories
Priority date: 2013-12-19
Filing date: 2014-12-19
Publication date: 2015-06-25
Anticipated expiration: 2016-06-19

Abstract

Low lactose nutritional compositions and methods of producing low lactose nutritional compositions are provided. The methods include producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. At least one high lactose protein source is utilized to provide 30-100% by weight of the total protein in the initial nutritional composition. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition to form a low lactose nutritional composition.

Description

LOW LACTOSE NUTRITIONAL COMPOSITIONS

AND METHODS OF PRODUCING SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and any benefit of U.S. Provisional Application No. 61/918,337, filed December 19, 2013, the content of which is incorporated herein by reference in its entirety.

FIELD

[0002] The present disclosure relates to low lactose nutritional compositions and methods of producing low lactose nutritional compositions. More particularly, the present disclosure relates to methods of producing a low lactose nutritional composition utilizing at least one high lactose source of protein.

BACKGROUND

[0003] Certain nutritional compositions are formulated to be suitable for consumption by individuals who are lactose intolerant. Formulations of such nutritional compositions with low levels of lactose present certain disadvantages, including the expense associated with low lactose protein sources as compared to protein sources that have a high lactose content (e.g. , more than 15% by weight of the protein source is lactose).

SUMMARY

Low lactose nutritional compositions and methods of producing low lactose nutritional compositions are provided. The exemplary methods described herein include producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals, and from 30- 100% by weight of the total protein is provided by at least one high lactose protein source. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition to form a low lactose nutritional composition. In addition, the low lactose nutritional composition comprises galactooligosaccharides (GOS) formed in situ from the hydrolysis of lactose by the added lactase. [0004] In a first embodiment, a method of producing a packaged low lactose nutritional composition having lactose in an amount of no more than 2000 milligrams per liter and from 1.2- 12.7 grams of galactooligosaccharides (GOS) per liter is provided. The method includes producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals, and from 30-100% by weight of the total protein is provided by at least one high lactose protein source. The initial nutritional composition comprises from 20-100 grams of protein per liter and optionally contains GOS, and the minerals comprise from 5-30 milligrams of zinc per liter and from 0.8-3 milligrams of copper per liter. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition, thereby forming a low lactose nutritional composition. The low lactose nutritional composition is packaged to form the packaged low lactose nutritional composition. The packaged low lactose nutritional composition comprises lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

[0005] In a second embodiment, a low lactose nutritional composition is provided. The low lactose nutritional composition comprises from 5-20 grams of total protein per serving, and 30- 100% by weight of the total protein is provided by at least one high lactose protein source. In addition, the low lactose nutritional composition comprises from 20-55 grams of carbohydrate per serving. The carbohydrate comprises GOS, glucose, and galactose, and other added carbohydrates (e.g., fructose and sucrose), and 0.5-15%) by weight of the carbohydrate is provided by GOS. The low lactose nutritional composition also comprises from 5-15 grams of fat per serving, and minerals selected from the group consisting of zinc, copper, free calcium, and combinations thereof. Furthermore, the low lactose nutritional composition comprises from 100-200 milligrams of lactase per serving. The low lactose nutritional composition comprises lactose in an amount of no more than 500 milligrams per serving, and at least a portion of the GOS is formed in situ in the low lactose nutritional composition.

[0006] In a third embodiment, a low lactose nutritional composition prepared by a specified process is provided. The process comprises producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. A portion of the total protein (e.g., from 30- 100% by weight) is provided by at least one high lactose protein source. The initial nutritional composition comprises from 20-100 grams of protein per liter. Additionally, the initial nutritional composition is substantially free of galactose and optionally contains GOS. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition to form the low lactose nutritional composition. The low lactose nutritional composition comprises lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

DETAILED DESCRIPTION

[0007] Low lactose nutritional compositions and methods of producing low lactose nutritional compositions are provided. The exemplary methods and low lactose nutritional compositions described herein feature one or more high lactose protein sources typically not utilized to formulate nutritional compositions suitable for consumption by individuals who are lactose intolerant. Moreover, utilization of high lactose protein sources reduces the cost of producing a low lactose nutritional composition because high lactose protein sources are generally significantly cheaper than lactose-free or low lactose protein sources. Furthermore, as will be described in more detail below, the exemplary methods described herein result in the in situ production of a significant amount of galactooligosaccharides (GOS) in the low lactose nutritional composition, which exhibit beneficial prebiotic activity when consumed.

[0008] The terminology as set forth herein is for description of the exemplary embodiments only and should not be construed as limiting the disclosure as a whole. Unless otherwise specified, "a," "an," "the," and "at least one" are used interchangeably. Furthermore, as used in the description and the appended claims, the singular forms "a," "an," and "the" are inclusive of their plural forms, unless the context clearly indicates otherwise.

[0009] The term "low lactose nutritional composition" as used herein, unless otherwise specified, refers to a nutritional composition having lactose in an amount of no more than 2000 milligrams per liter, or in certain embodiments no more than 500 milligrams per serving {e.g., 8 fl. oz.). In addition, the low lactose nutritional composition includes protein, carbohydrate, fat, and minerals. At least 30% by weight of the total protein in the low lactose nutritional composition is provided by at least one high lactose protein source. The low lactose nutritional composition may be formulated in various product forms including, but not limited to, liquids, solids, powders, semi-solids, semi-liquids, nutritional supplements, and any other nutritional product form known in the art. A nutritional composition in powder form may often be reconstituted to form a nutritional composition in liquid form. The low lactose nutritional compositions disclosed herein are generally suitable for oral consumption by a human.

[0010] The term "high lactose protein source" as used herein, unless otherwise specified, refers to a protein source in powder form that comprises at least 15% by weight of lactose. In certain embodiments, the term "high lactose protein source" may refer to a protein source in liquid form that contains at least 4% by weight of lactose. It should be understood that the amount of lactose contained in the high lactose protein source refers to the amount of lactose in the high lactose protein source prior to the addition of any lactase as described herein.

[001 1] The term "low lactose protein source" as used herein, unless otherwise specified, refers to a mammalian milk-based protein source in powder form that comprises less than 4% by weight of lactose.

[0012] The term "lactase" as used herein, unless otherwise specified, refers to a β-galactosidase enzyme, which catalyzes the hydrolysis of β-D-galactosides (e.g. , lactose) into their component sugars by hydrolysis of the terminal non-reducing β-D-galactose residues. When reference is made herein to a nutritional composition comprising lactase, it should be understood that the lactase may be active lactase or inactivated lactase.

[0013] The term "packaged low lactose nutritional composition" as used herein, unless otherwise specified, refers to a low lactose nutritional composition that is contained within a hermetically sealed container. In certain embodiments, the packaged low lactose nutritional composition is a nutritional liquid, while in certain other embodiments the packaged low lactose nutritional composition is a solid, such as a nutritional powder.

[0014] The term "nutritional liquid" as used herein, unless otherwise specified, refers to nutritional compositions in ready-to-drink liquid form, concentrated liquid form, and nutritional liquids made by reconstituting nutritional powders described herein prior to use. The nutritional liquid may also be formulated as a suspension, an emulsion, a solution, and so forth. [0015] The term "nutritional powder" or "reconstitutable powder" as used herein, unless otherwise specified, refers to nutritional compositions in flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption and includes both spray dried and dry mixed or dry blended powders.

[0016] The term "nutritional semi-solid" as used herein, unless otherwise specified, refers to nutritional compositions that are intermediate in properties, such as rigidity, between solids and liquids. Some semi-solid examples include puddings, yogurts, gels, gelatins, and doughs.

[0017] The term "nutritional semi-liquid" as used herein, unless otherwise specified, refers to nutritional compositions that are intermediate in properties, such as flow properties, between liquids and solids. Some semi-liquid examples include thick shakes, liquid yogurts, and liquid gels.

[0018] The term "serving" as used herein, unless otherwise specified, is intended to be construed as any amount which is intended to be consumed by an individual in one sitting or within one hour or less.

[0019] The presently disclosed low lactose nutritional compositions and methods of producing the same are based on the unexpected discovery that an initial nutritional composition comprising protein with at least 30% by weight of the total protein provided by at least one high lactose protein source, carbohydrate, fat, and minerals can be transformed into a low lactose nutritional composition utilizing lactase. This discovery is particularly surprising since the current state of the art indicates that the presence of certain minerals, such as copper, zinc, and soluble calcium, as well as fat, can inhibit lactase activity. Moreover, the methods described herein result in the in situ formation of significant amounts of GOS in the low lactose nutritional compositions. Utilization of a high lactose protein source and a sufficient amount of lactase to hydrolyze the lactose to levels that permit consumption by individuals who are lactose intolerant provides significant cost savings. Furthermore, additional cost savings are recognized in that the low lactose nutritional compositions include GOS, a highly sought after nutritional ingredient that exhibits prebiotic activity, without the costs associated with purchasing, storing, or handling an actual GOS commodity ingredient. [0020] In a first embodiment, a method of producing a packaged low lactose nutritional composition having lactose in an amount of no more than 2000 milligrams per liter and from 1.2- 12.7 grams of GOS per liter is provided. The method includes producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals, and from 30-100% by weight of the total protein is provided by at least one high lactose protein source. The initial nutritional composition comprises from 20-100 grams of protein per liter and optionally contains GOS, and the minerals comprise from 5-30 milligrams of zinc per liter and from 0.8-3 milligrams of copper per liter. For example, it should be understood that the total amount of protein provided by the at least one high lactose protein source will be 6-20 grams per liter (assuming 20 grams of total protein per liter) to 30-100 grams per liter (assuming 100 grams of total protein per liter. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition, thereby forming a low lactose nutritional composition. The low lactose nutritional composition is packaged to form the packaged low lactose nutritional composition. The packaged low lactose nutritional composition comprises lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

[0021] In a second embodiment, a low lactose nutritional composition is provided. The low lactose nutritional composition comprises from 5-20 grams of protein per serving, and 30-100% by weight of the total protein is provided by at least one high lactose protein source. It should be understood that the total amount of protein provided by the at least one high lactose protein source will be 1.5-20 grams of protein per serving of the low lactose nutritional composition. In addition, the low lactose nutritional composition comprises from 20-55 grams of carbohydrate per serving. The carbohydrate comprises GOS, glucose, galactose, and other added carbohydrates (e.g., fructose and sucrose), and 0.5-15%) by weight of the carbohydrate is provided by GOS. The low lactose nutritional composition also comprises from 5-15 grams of fat per serving, and minerals selected from the group consisting of zinc, copper, free calcium, and combinations thereof. Furthermore, the low lactose nutritional composition comprises from 100-200 milligrams (or 1,900-15,000 GU of Biolactase L™ from Kerry Ingredients & Flavours) of lactase per serving. The low lactose nutritional composition comprises lactose in an amount of no more than 500 milligrams per serving, and at least a portion of the GOS is formed in situ in the low lactose nutritional composition. [0022] In a third embodiment, a low lactose nutritional composition prepared by a specified process is provided. The process comprises producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. A portion of the total protein (e.g., from 30- 100% by weight) in the initial nutritional composition is provided by at least one high lactose protein source. The initial nutritional composition comprises from 20-100 grams of protein per liter, is substantially free of galactose, and optionally contains GOS. For example, it should be understood that the total amount of protein provided by the at least one high lactose protein source will be 6-20 grams per liter (assuming 20 grams of total protein per liter) to 30-100 grams per liter (assuming 100 grams of total protein per liter. Lactase is added to the initial nutritional composition to digest the lactose in the initial nutritional composition to form the low lactose nutritional composition. The low lactose nutritional composition comprises lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

[0023] As mentioned above, the low lactose compositions according to the first, second, and third exemplary embodiments include protein, carbohydrate, fat, and minerals. According to the second embodiment, and certain embodiments of the first and third embodiments, the low lactose nutritional composition includes from 5-20 grams of total protein per serving of the low lactose nutritional composition. In certain exemplary embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 5 grams to about 20 grams, about 5 grams to about 15 grams, about 5 grams to about 10 grams, or about 10 grams to about 20 grams of total protein per serving of the low lactose nutritional composition. In certain other embodiments according to the first, second, and third embodiments described herein, the low lactose nutritional composition comprises from 20-100 grams of total protein per liter of the low lactose nutritional composition. For example, in certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition includes about 20 grams to about 100 grams, about 20 grams to about 90 grams, about 20 grams to about 75 grams, about 20 grams to about 50 grams, about 20 grams to about 30 grams, or about 90 grams to about 100 grams of total protein per liter of the low lactose nutritional composition.

[0024] In the embodiments described herein, from 30-100% by weight of the total protein is provided by at least one high lactose protein source. In certain embodiments according to the first, second, and third embodiments, from 30-80% by weight of the total protein is provided by at least one high lactose protein source. Non-limiting examples of the high lactose protein source include non-fat dry milk, skim milk powder, whole milk powder, certain whey protein concentrates (e.g., WPC34, WPC50), certain milk protein concentrates (e.g., MPC42, MPC56, MPC70), sweet whey, acid whey, concentrated skim milk, and combinations thereof. In certain embodiments according to the first, second, and third embodiments, 30-80% by weight of the total protein is provided by one or more high lactose protein sources, 0-40%> by weight of the total protein is provided by one or more vegetable protein sources, and 0-30%> by weight of the total protein is provided by one or more low lactose protein sources. Suitable vegetable protein sources for use in the methods and compositions described herein include intact, hydrolyzed, and partially hydrolyzed vegetable protein sources including, but not limited to, pea proteins, soy proteins, rice proteins, potato proteins, algae proteins, wheat proteins, canola proteins, and combinations thereof. In addition, suitable low lactose protein sources that may be utilized in the methods and compositions described herein include, but are not limited to, milk protein isolates, whey protein isolates, certain milk protein concentrates (e.g., MPC80), certain whey protein concentrates (e.g., WPC80), casein (including rennet casein and acid casein), casemates (including calcium caseinate and sodium caseinate), fish, mycoprotein, collagen, and combinations thereof.

[0025] As one of skill in the art will appreciate, the nomenclature MPC80 and WPC34, for example, refers to the protein source (MPC refers to milk protein concentrate; WPC refers to whey protein concentrate) and the protein source's approximate amount of protein, by weight percent (MPC80 refers to a milk protein concentrate that is about 80%, by weight, protein; WPC34 refers to a whey protein concentrate that is about 34%, by weight, protein). In general, as the weight percentage of protein in a protein source increases, the weight percentage of lactose decreases.

[0026] In certain embodiments according to the first, second, and third embodiments, the protein in the low lactose nutritional composition is provided entirely by at least one high lactose protein source. In certain embodiments of the first, second, and third embodiments, the protein in the low lactose nutritional composition is provided entirely by non-fat dry milk. In certain exemplary embodiments according to the first, second, and third embodiments, about 80%> by weight of the total protein is provided by non-fat dry milk and about 20% by weight of the total protein is provided by milk protein concentrate (e.g., MPC80 or other low lactose protein source). In certain exemplary embodiments according to the first, second, and third embodiments, about 70% of the total protein is provided by non-fat dry milk, about 15% of the total protein is provided by soy protein, and about 15% of the total protein is provided by pea protein. In yet other exemplary embodiments according to the first, second, and third embodiments, about 55% of the total protein is provided by non-fat dry milk, about 15% of the total protein is provided by milk protein concentrate (i.e., a low lactose protein source), about 15%) of the total protein is provided by soy protein, and about 15% of the total protein is provided by pea protein. In further exemplary embodiments according to the first, second, and third embodiments, about 60% of the total protein is provided by non-fat dry milk, about 10% of the total protein is provided by milk protein concentrate (i.e., a low lactose protein source), about 15%) of the total protein is provided by soy protein, and about 15% of the total protein is provided by pea protein. Although a few examples of protein systems have been described, various other protein systems are contemplated where at least 30% by weight of the total protein is provided by one or more high lactose protein sources.

[0027] The particular percentages of protein sources discussed above are based on the amount of protein in the low lactose nutritional composition that is provided by a particular source. For example, consider a low lactose nutritional composition that contains a total of 9 grams of protein in a serving. If the total protein is provided by three sources, those sources being about 70% from non-fat dry milk, about 15% from soy protein, and about 15% from pea protein, then about 6.3 grams of protein will be provided by the non-fat dry milk, and about 1.35 grams of protein will be provided by each of the soy protein and the pea protein. It should also be understood that in many instances the protein sources are not pure protein. For example, non-fat dry milk typically comprises about 36%, by weight, protein. Accordingly, if the composition includes about 6.3 grams of protein from non-fat dry milk, then the composition would include a total of about 17.5 grams of non-fat dry milk as a protein source.

[0028] In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition comprises at least one source of carbohydrate in addition to the glucose, galactose, and GOS created from the digestion of the lactose. The at least one source of carbohydrate suitable for use in certain embodiments of the low lactose nutritional compositions disclosed herein may be simple, complex, or variations or combinations thereof. Generally, any source of carbohydrate may be used so long as it is suitable for use in oral nutritional compositions and is otherwise compatible with any other selected ingredients or features present in the low lactose nutritional composition. Non-limiting examples of carbohydrate sources suitable for use in the low lactose nutritional compositions described herein include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, fructose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), isomaltulose, sucromalt, pullulan, potato starch, and other slowly-digested carbohydrates, dietary fibers including, but not limited to, fructooligosaccharides (FOS), inulin, oat fiber, soy fiber, gum arabic, sodium carboxymethylcellulose, methylcellulose, guar gum, gellan gum, locust bean gum, konjac flour, hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum acacia, chitosan, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low and high methoxy pectin, cereal beta-glucans (e.g., oat beta-glucan, barley beta-glucan), carrageenan and psyllium, other resistant starches, and combinations thereof.

[0029] In accordance with the second embodiment, and certain embodiments of the first and third embodiments, the low lactose nutritional composition comprises from 20-55 grams of carbohydrate per serving of the low lactose nutritional composition. For example, in certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition comprises about 20 grams to about 50 grams, about 20 grams to about 40 grams, about 20 grams to about 35 grams, about 35 grams to about 40 grams, or about 40 grams to about 55 grams of carbohydrate per serving of the low lactose nutritional composition. In certain other embodiments according to the first, second, and third embodiments, the low lactose nutritional composition comprises from 80-325 grams of carbohydrate per liter of the low lactose nutritional composition. For example, in certain embodiments, the low lactose nutritional composition comprises about 88 grams to about 300 grams, about 100 grams to about 250 grams, or about 165 grams to about 325 grams of carbohydrate per liter of the low lactose nutritional composition. According to the second embodiment and certain embodiments of the first and third embodiments, the carbohydrate comprises GOS, glucose, and galactose, and 0.5-15% by weight of the carbohydrate is provided by the GOS. For example, in certain embodiments, 0.6- 15% by weight of the carbohydrate is provided by GOS, including 0.75-8%, 1-6%, 1.5-4%, 5- 8%), 6-12%), and also including 8-15% by weight of the carbohydrate is provided by GOS. Furthermore, as will be explained in more detail below with respect to the methods, at least a portion of the total amount of GOS present in the low lactose nutritional composition is formed in situ during production of the low lactose nutritional composition. For example, in certain embodiments of the first, second, and third embodiments, about 80-95%) of the GOS present in the low lactose nutritional composition is formed in situ during production of the low lactose nutritional composition. In other words, in certain embodiments, the low lactose nutritional composition includes a significant amount of GOS that is not provided by a stand-alone source of GOS.

[0030] The low lactose nutritional composition according to the first and third embodiments, and in certain embodiments of the second embodiment, includes GOS in an amount of 1.2-12.7 grams per liter of the low lactose nutritional composition. For example, in certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 1.2 grams to about 12 grams, about 1.5 grams to about 10 grams, about 2 grams to about 8 grams, about 2 grams to 6 grams, or about 8 grams to about 12 grams of GOS per liter of the low lactose nutritional composition. In addition, in the embodiments of the first and third embodiment, and in certain embodiments of the second embodiment, the low lactose nutritional composition comprises glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter. For example, in certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 10 grams to about 40 grams, about 15 grams to about 35 grams, or about 30 grams to about 50 grams of glucose per liter of the low lactose nutritional composition. Additionally, in certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 5 grams to about 35 grams, about 15 grams to about 25 grams, or about 30 grams to about 40 grams of galactose per liter of the low lactose nutritional composition.

[0031] As used throughout the specification, when referring to components or ingredients of the low lactose nutritional composition, the units of milligrams per liter (or grams per liter) applies to the liquid form of the composition. In those embodiments according to the first, second, and third embodiments where the low lactose nutritional composition is a nutritional powder, or a concentrated liquid, when the concentration of components or ingredients in the composition are discussed in terms of milligrams per liter (or grams per liter), this should be understood to refer to the final concentration of the component or ingredient when the composition is reconstituted to a liquid (e.g., after addition of water or other aqueous solvent) and ready for consumption.

[0032] In certain embodiments of the first, second, and third embodiments of the methods and compositions described herein, the low lactose nutritional composition comprises 15-75 grams of reducing sugars per liter. For example, in certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition includes about 15 grams to about 50 grams, about 15 grams to about 30 grams, about 15 grams to about 20 grams, or about 50 grams to about 75 grams of reducing sugars per liter of the low lactose nutritional composition. A "reducing sugar" as used herein refers to sugars that include an aldehyde group or a hemiacetal group. For example, both glucose and galactose are reducing sugars. Without wishing to be bound by any particular theory, in certain embodiments of the presently disclosed low lactose nutritional compositions, the amount of reducing sugars is lowered by the formation of GOS, which utilizes a portion of the glucose and galactose monomers formed as a result of the lactose hydrolysis. This reduction in reducing sugars via the formation of GOS is particularly advantageous in that reducing sugars are well known for their involvement in Maillard browning, which can produce off- flavors and can affect the color of the resulting nutritional composition.

[0033] As previously mentioned, the low lactose nutritional compositions of the first, second, and third embodiments comprise at least one source of fat. In embodiments according to the second embodiment, and in certain embodiments of the first and third embodiments, the low lactose nutritional composition comprises from 5-15 grams of fat per serving. In certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition includes about 5 grams to about 10 grams, about 5 grams to about 8 grams, or about 8 grams to about 15 grams per serving. In certain other embodiments according to the first, second, and third embodiments, the low lactose nutritional composition comprises from 20-50 grams of fat per liter of the low lactose nutritional composition. For example, in some embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 20 grams to about 40 grams, about 20 grams to about 30 grams, or about 40 grams to about 50 grams of fat per liter of the low lactose nutritional composition.

[0034] In general, any source, or combination of sources, of fat may be used so long as it is suitable for use in oral nutritional compositions. The source of fat may be derived from plants, animals, and combinations thereof. Non-limiting examples of suitable sources of fat for use in the low lactose nutritional compositions described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, high gamma- linolenic acid (GLA) safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm kernel oil, palm olein, canola oil, marine oil, cottonseed oil, arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid, gamma-linolenic acid, conjugated linolenic acid from any source, borage oil, and combinations thereof.

[0035] As mentioned above, embodiments of the low lactose nutritional composition according to the first, second, and third embodiments disclosed herein, comprise one or more minerals. For example, the low lactose nutritional composition may comprise minerals including, but not limited to, zinc, copper, free calcium, and combinations thereof. In accordance with certain embodiments disclosed herein, the low lactose nutritional composition comprises from 5-30 milligrams of zinc per liter and from 0.8-3 milligrams of copper per liter. In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 5 milligrams to about 20 milligrams, about 5 milligrams to about 15 milligrams, or about 20 milligrams to about 30 milligrams of zinc per liter of the low lactose nutritional composition. In certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition includes about 0.8 milligrams to about 2.5 milligrams, about 0.8 milligrams to about 1.75 milligrams, about 0.8 milligrams to about 1.25 milligrams, or about 2.5 milligrams to about 3 milligrams of copper per liter of the low lactose nutritional composition. In addition, certain embodiments of the low lactose nutritional composition may include other minerals, non-limiting examples of which include calcium, selenium, potassium, iodine, phosphorus, magnesium, iron, manganese, sodium, molybdenum, chromium, chloride, and combinations thereof. As discussed below with regard to the methods according to the first and third embodiments, lactase is added to an initial nutritional composition that has a high lactose content (e.g., more than 2000 milligrams of lactose per liter), and that also includes minerals such as zinc, copper, and free calcium. These particular minerals are known to adversely affect the ability of lactase to sufficiently hydrolyze lactose. Accordingly, the final level of lactose achieved by adding lactase to an initial nutritional composition containing these minerals was particularly unexpected.

[0036] The low lactose nutritional compositions according to the second embodiment and certain embodiments of the first and third embodiment comprise from 100-200 milligrams of lactase per serving of the low lactose nutritional composition (or about 1 ,900 to about 15,000 GU of Biolactase L™ from Kerry Ingredients & Flavours). The lactase may be active lactase or inactivated lactase (e.g., inactivated by heat treatment of the nutritional composition). As briefly mentioned above, and as will be described further below, the lactase catalyzes the hydrolysis of lactose present in the high lactose protein source. Accordingly, the lactase digests the lactose to a level that is acceptable for consumption by individuals who are lactose intolerant. For example, in the embodiments according to the first and third embodiments, and in certain embodiments of the second embodiment, the low lactose nutritional composition includes lactose in an amount of no more than 2000 milligrams per liter of the low lactose nutritional composition. For example, in certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes about 10 milligrams to about 2000 milligrams, about 100 milligrams to about 1500 milligrams, or about 500 milligrams to about 1000 milligrams of lactose per liter. In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition includes lactose in an amount of no more than 500 milligrams per liter of the low lactose nutritional composition. As another example, and in accordance with the second embodiment, the low lactose nutritional composition comprises lactose in an amount of no more than 500 milligrams per serving of the low lactose nutritional composition. Generally, in the low lactose nutritional compositions according to the first, second, and third embodiments, the amount of lactose per serving will vary with the particular serving size of the low lactose nutritional composition, but will not exceed an amount of 2000 milligrams per liter.

[0037] In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition comprises no more than 725 milligrams of lactulose per serving. In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition contains no lactulose. The formation of lactulose is known to form when lactose is subjected to heat, such as during heat sterilization processes. Lactulose is a nondigestible sugar that is known to cause gastrointestinal discomfort, and is often used in the treatment of chronic constipation.

[0038] The low lactose nutritional compositions according to the methods and compositions disclosed herein include those suitable for oral administration. Oral administration, as defined herein, includes any form of administration in which the low lactose nutritional composition passes through the esophagus of the individual. For example, oral administration includes nasogastric intubation, in which a tube is run from through the nose to the stomach of the individual to administer food.

[0039] In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition is formulated as, and intended for consumption in, any known or otherwise suitable oral product form. Any solid, liquid, semi-solid, semi-liquid, or powder product form, including combinations or variations thereof, are suitable for use herein, provided that such forms allow for safe and effective oral consumption of the ingredients as also defined herein.

[0040] In certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition is a solid nutritional product. Non-limiting examples of solid nutritional products include snack and meal replacement products, including those formulated as bars, sticks, cookies or breads or cakes or other baked goods, frozen liquids, candy, breakfast cereals, snack chips or bites, frozen or retorted entrees and so forth. In certain embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a solid product, the serving may be about 25 grams to about 150 grams.

[0041] In certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition is a nutritional powder. Generally, the nutritional powder is in a flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption. The nutritional powders disclosed herein include both spray dried and dry mixed or dry blended powders. In certain embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a powder, the serving may be about 40 grams to about 50 grams, reconstituted in an appropriate volume of water or other aqueous liquid.

[0042] In certain embodiments of the first, second, and third embodiments, the low lactose nutritional composition is a nutritional liquid. Non-limiting examples of nutritional liquids include snack and meal replacement products, hot or cold beverages, shakes, and so forth. Generally, the nutritional liquids are formulated as suspensions or emulsions, but the nutritional liquids can also be formulated in any other suitable forms such as solutions, liquid gels, liquid yogurts, and so forth.

[0043] In certain embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a liquid, the serving is within a range of from 30-500 milliliters (about 1 fl. oz. to about 17 fl. oz.). As discussed above, the lactose concentration of the low lactose nutritional composition is generally no more than 2000 milligrams of lactose per liter (or no more than about 60 milligrams of lactose per fl. oz.). In certain other embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a liquid, the serving is about 237 milliliters (about 8 fl. oz.), and contains no more than 500 milligrams of lactose. In other embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a liquid, the serving is from about 177 milliliters to about 417 milliliters (about 6 fl. oz. to about 14 fl. oz.). In yet other embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a liquid, the serving is from about 207 milliliters to about 266 milliliters (about 7 fl. oz. to about 9 fl. oz.). In still other embodiments according to the first, second, and third embodiments, when the low lactose nutritional composition is a liquid, the serving is from about 30 milliliters to about 120 milliliters (about 1 fl. oz. to about 4 fl. oz.).

[0044] In yet other embodiments according to the first, second, and third embodiments, the low lactose nutritional composition may be formulated as semi-solid or semi-liquid compositions (e.g., puddings, gels, yogurts, etc.). In other embodiments of the first, second, and third embodiments, the low lactose nutritional composition may be in the form of tablets (e.g., chewable, coated, etc.), pastes, gels, or yogurts. [0045] The low lactose nutritional compositions disclosed herein are useful to provide sole, primary, or supplemental sources of nutrition, as well as providing one or more of the benefits as described herein. In certain embodiments according to the first, second, and third embodiments, the low lactose nutritional composition provides up to 1000 kcal of energy per serving, including from 20-900 kcal, from 40-700 kcal, from 50-500 kcal, from 150-475 kcal, from 200-450 kcal, or from 200-400 kcal per serving.

[0046] In certain embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional composition may further comprise optional components or ingredients that may modify the physical, chemical, aesthetic, or processing characteristics of the low lactose nutritional composition or serve as a nutraceutical component. Many such optional ingredients are known or otherwise suitable for use in nutritional products and may also be used in the low lactose nutritional compositions disclosed herein, provided that such optional ingredients are safe for oral administration and are compatible with the essential and other ingredients in the selected product form.

[0047] Non-limiting examples of such optional ingredients include preservatives, emulsifying agents, buffers, creatine, fructooligosaccharides, polydextrose, prebiotics, probiotics (e.g., Lactobacillus acidophilus, Bifidobacterium infantis, etc.), vitamins, additional minerals, colorants, flavors, thickening agents and stabilizers, lubricants, and so forth.

[0048] In certain embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional composition may further comprise at least one sweetening agent. In certain embodiments, the at least one sweetening agent is at least one sugar alcohol such as maltitol, erythritol, sorbitol, xylitol, mannitol, isomalt, and lactitol, or at least one artificial or high potency sweetener such as acesulfame K, aspartame, sucralose, saccharin, stevia, tagatose, and combinations thereof. The sweetening agents may be useful in nutritional compositions to provide a desirable flavor profile. Moreover, the sweetening agents and combinations thereof are effective in masking undesirable flavors, for example, as sometimes associated with the use of vegetable proteins. In certain embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional composition may comprise at least one sweetening agent with a concentration in a range from at least 0.01%, including from about 0.01% to about 5%, and also including from about 0.1 % to about 1%, by weight of the low lactose nutritional composition.

[0049] A flowing agent or anti-caking agent may be included in certain embodiments of the low lactose nutritional composition according to the first, second, and third embodiments disclosed herein to retard clumping or caking of a nutritional powder embodiment over time and to make the nutritional powder flow easily from its container. Any flowing or anti-caking agents that are known or otherwise suitable for use in a nutritional powder are suitable for use herein, non-limiting examples of which include tricalcium phosphate, silicates, and combinations thereof. The concentration of the flowing agent or anti-caking agent in certain embodiments of the low lactose nutritional composition according to the first, second, and third embodiments disclosed herein varies depending upon the product form, the other selected ingredients, the desired flow properties, and so forth, but most typically range from about 0.01% to about 4%, including from about 0.1% to about 2%, by weight of the low lactose nutritional composition.

[0050] In certain embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional composition may comprise a stabilizer. Any stabilizer that is known or otherwise suitable for use in a nutritional composition is also suitable for use herein, some non-limiting examples of which include gums such as xanthan gum. In certain embodiments according to the first, second, and third embodiments disclosed herein, the stabilizer may represent from about 0.01% to about 5%, including from about 0.5% to about 3%, including from about 0.7% to about 1.5%, by weight of the low lactose nutritional composition.

[0051] In certain other embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional composition may further comprise any of a variety of vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin E, vitamin D2, vitamin D3, vitamin A palmitate, vitamin E acetate, vitamin C palmitate (ascorbyl palmitate), vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids (e.g., beta- carotene, zeaxanthin, lutein, lycopene), niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts and derivatives thereof, and combinations thereof.

[0052] In certain embodiments according to the first, second, and third embodiments disclosed herein, the low lactose nutritional compositions optionally include one or more masking agents to reduce or otherwise obscure the development of any residual bitter flavors and after taste in the low lactose nutritional compositions over time. Suitable masking agents include natural and artificial sweeteners, sodium sources such as sodium chloride, and hydrocolloids, such as guar gum, xanthan gum, carrageenan, gellan gum, and combinations thereof. The amount of masking agent in certain embodiments of the low lactose nutritional composition may vary depending upon the particular masking agent selected, other ingredients in the formulation, and other formulation or product target variables. Such amounts, however, most typically range from 0.01% to 3%), including form 0.15% to 3%, and also including from 0.2%> to 2.5%, by weight of the low lactose nutritional composition.

[0053] The various embodiments of the low lactose nutritional compositions described herein may be advantageously produced in accordance with the methods of the first and third embodiments disclosed herein. As previously mentioned, the methods according to the first and third embodiments disclosed herein comprise producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. The phrase "initial nutritional composition" as used herein refers to a nutritional composition that has more than 2000 milligrams of lactose per liter, includes from 20-100 grams of protein per liter and has not been treated with lactase. In addition, the initial nutritional composition includes minerals selected from the group consisting of zinc, copper, free calcium, and combinations thereof. In certain embodiments, the initial nutritional composition includes from 5-30 milligrams of zinc per liter and from 0.8-3 milligrams of copper per liter. In certain embodiments, the initial nutritional composition optionally includes GOS. In general, the initial nutritional composition is substantially free of galactose, substantially free of glucose, or substantially free of both galactose and glucose. For example, the initial nutritional composition may be considered "substantially free of galactose" if the initial nutritional composition contains less than 0.1%, less than 0.05%, and also including 0% galactose by weight of the initial nutritional composition. Similarly, the initial nutritional composition may be considered "substantially free of glucose" if the initial nutritional composition contains less than 0.1 %, less than 0.05%>, and also including 0%> glucose by weight of the initial nutritional composition.

[0054] The initial nutritional compositions according to the methods disclosed herein utilize a protein system wherein from 30-100% by weight of the total protein is provided by at least one high lactose protein source. In certain embodiments according to the first, second, and third embodiments, the protein system is such that about 80% by weight of the total protein is provided by one or more high lactose protein sources. In certain embodiments according to the first, second, and third embodiments, the protein system is such that about 50%> by weight of the total protein is provided by one or more high lactose protein sources. The high lactose protein source may be selected from any one or more of the previously discussed high lactose protein sources, such as non-fat dry milk, skim milk powder, whole milk powder, whey protein concentrates, and so forth. In accordance with the method of the first embodiment and in certain embodiments of the third embodiment, the initial nutritional composition comprises from 20-100 grams of protein per liter.

[0055] Although embodiments are contemplated where the initial nutritional composition includes a protein system consisting entirely of one or more high lactose protein sources, certain high lactose protein sources inherently include a significant amount of minerals (e.g., sodium, potassium, phosphorus), which could result in compositions having mineral levels beyond recommended dietary limits. Accordingly, in certain embodiments according to the methods of the first and third embodiments, more than 30% by weight of the total protein in the initial nutritional composition is provided by one or more high lactose protein sources, but less than 100% by weight of the total protein in the initial nutritional composition is provided by one or more high lactose protein sources. In certain such embodiments, the initial nutritional composition includes protein comprising, by weight, 30-80%) from one or more high lactose protein sources, 0-40%> from one or more vegetable protein sources, and 0-30%> from one or more low lactose protein sources. By incorporating up to 40% (by weight) of the total protein from vegetable protein and up to 30% (by weight) of the total protein from low lactose protein, the overall mineral content of the resulting composition can be tuned and maintained within the recommended dietary limits. In addition, the use of a high lactose protein source provides an additional advantage in that the inherent mineral load can offset the amount of mineral salts that are generally used to fortify nutritional compositions, which can lead to further cost savings.

[0056] The initial nutritional composition may be prepared by any process or suitable method (now known or known in the future) for making a selected product form. Many such techniques are known for any given product form such as nutritional liquids or nutritional powders and can readily be applied by one of ordinary skill in the art to the various embodiments of the methods disclosed herein.

[0057] For example, in one suitable process for producing the initial nutritional composition, at least three separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate- mineral (CHO-MIN) slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed by heating and mixing an oil (e.g., canola oil, corn oil) and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein (e.g., non-fat dry milk) with continued heat and agitation. The CHO-MIN slurry is formed by adding with heated agitation to water: minerals (e.g., potassium citrate, dipotassium phosphate, sodium citrate), trace and ultra trace minerals (TM/UTM premix), and thickening or suspending agents (e.g., avicel, gellan, carrageenan). The resulting CHO-MIN slurry is held for 10 minutes with continued heat and agitation before adding additional minerals (e.g., potassium chloride, magnesium carbonate, potassium iodide), or carbohydrates (e.g., fructooligosaccharides, sucrose, corn syrup), or combinations thereof. The PIW slurry is then formed by mixing with heat and agitation the remaining protein.

[0058] In accordance with this process, the three resulting slurries are blended together with heated agitation and the pH is adjusted to the desired range, e.g., 6.6 to 7, after which the nutritional composition may be subjected to a heat treatment, such as high-temperature short- time (HTST) or ultra high temperature (UHT) processing. The nutritional composition can be heat treated, emulsified, homogenized, and cooled. Water soluble vitamins and ascorbic acid may be added (if applicable), the pH may be adjusted (if necessary), flavors are added, and any additional water can be added to adjust the solids content to the desired range.

[0059] According to the methods disclosed herein, after the initial nutritional composition is produced or during the production of the initial nutritional composition, lactase is added to the initial nutritional composition to digest (i.e., hydro lyze) the lactose in the initial nutritional composition to thereby form a low lactose nutritional composition. In certain embodiments according to the methods of the first and third embodiments, the amount of lactase added to the initial nutritional composition ranges from 0.4-2 grams per liter of the initial nutritional composition, including from 0.5-1.75 grams of lactase per liter, from 0.6-1.5 grams of lactase per liter, and also including from 0.75-1.5 grams of lactase per liter. In certain embodiments according to the first, second, and third embodiments, the amount of lactase added to the initial nutritional composition is based on the amount of the high lactose protein source present. For example, in certain embodiments according to the first, second, and third embodiments, the weight ratio of lactase added to the initial nutritional composition to the high lactose protein source ranges from 1 :400 to 1 : 18. Virtually any lactase may be utilized in the methods disclosed herein. Examples of suitable commercially available lactases include Biolactase L™, produced by fermentation of a selected strain of Kluyveromyces lactis (Kerry Ingredients & Flavours, Cork, Ireland), and Maxilact® LGX 5000, a purified lactase preparation isolated from a strain of the dairy yeast Kluyveromyces marxianus var. lactis (DSM Food Specialties B.V., Delft, The Netherlands).

[0060] In accordance with certain embodiments of the methods of the first and third embodiments disclosed herein, after the lactase is added to the initial nutritional composition, the method further comprises subjecting the initial nutritional composition with added lactase to a holding period of 12-24 hours to form the low lactose nutritional composition, including from 14-24 hours, from 16-24 hours, from 18-24 hours, from 20-24 hours, from 12-18 hours, from 12- 16 hours, and also including from 12-14 hours. This holding period allows time for the lactase to digest the lactose, particularly when the initial nutritional composition with added lactase is maintained at a reduced temperature {e.g., 2-7 °C). In certain embodiments according to the first, second, and third embodiment, the holding period is carried out in the packaging container. For example, in certain embodiments according to the first, second, and third embodiments, the initial nutritional composition is transferred to a packaging container. Lactase is then added to the packaging container, which is then hermetically sealed or otherwise closed. The initial nutritional composition with added lactase in the packaging container is then subjected to the holding period, during which a packaged low lactose nutritional composition is formed. In certain embodiments, the initial nutritional composition with added lactase in the packaging container is maintained at a temperature between 2-7°C during the holding period In certain embodiments, after the holding period, the packaged low lactose nutritional composition may be subjected to a sterilization process, such as retort sterilization.

[0061] In certain embodiments of the methods disclosed herein, the initial nutritional composition with added lactase is maintained at a temperature between 2-7°C during a 12-24 hour holding period to form the low lactose nutritional composition. This temperature range is beneficial for limiting microbial growth, particularly where the initial nutritional composition is not sterilized prior to the addition of the lactase.

[0062] In certain other embodiments of the methods of the first and third embodiments, the initial nutritional composition with added lactase is held for a period of 1-5 hours at a temperature between 35-40°C to form the low lactose nutritional composition. This temperature range is beneficial for increasing the rate of hydrolysis of the lactose and reducing cycle time.

[0063] After the low lactose nutritional composition is formed by the addition of lactase to the initial nutritional composition, in certain embodiments, the methods according to the first and third embodiments may further comprise heating the low lactose nutritional composition, thereby inactivating residual lactase. In other words, the low lactose nutritional composition is heated to a particular temperature, or temperature range, and is held at the particular temperature, or within the temperature range, for a sufficient amount of time to inactivate residual lactase. For example, in certain embodiments, the method further comprises heating the low lactose nutritional composition to a temperature between 70-85°C and maintaining the low lactose nutritional composition within the temperature range for 5-30 seconds to inactivate residual lactase. In certain other embodiments, the method further comprises heating the low lactose nutritional composition to a temperature between 55-65°C and maintaining the low lactose nutritional composition within the temperature range for 25-35 minutes to inactivate residual lactase.

[0064] In certain embodiments of the methods disclosed herein, the initial nutritional composition is sterilized to form a sterilized initial nutritional composition prior to the addition of the lactase. Virtually any sterilization process known to those of ordinary skill in the art may be utilized for sterilizing the initial nutritional composition. Non-limiting examples of such sterilization processes include ultra-high temperature processing and high temperature short time processing. In an ultra-high temperature processing sterilization process, the initial nutritional composition is heated to a high temperature (e.g., from 135-145°C) for a short period of time, such as 1-6 seconds. In a high temperature short time sterilization process, the initial nutritional composition is heated to a temperature within a range of about 70-80°C for a time period of about 15-30 seconds.

[0065] In those embodiments of the methods disclosed herein where the initial nutritional composition is sterilized prior to the addition of the lactase, the lactase added to the sterilized initial nutritional composition is a sterile lactase so as to avoid potential contamination by addition of the lactase. In certain embodiments, a sterile lactase is added to the sterilized initial nutritional composition by aseptic dosing. For example, lactase may be passed through a sufficiently sized mesh (e.g., less than about 0.2 microns) that prevents microorganisms and the like from passing through as the lactase is added to the sterilized initial nutritional composition. Suitable aseptic dosing equipment for use in the methods disclosed herein is commercially available and is well known to those of ordinary skill in the art. In certain embodiments where lactase is aseptically dosed into the sterilized initial nutritional composition, the sterilized initial nutritional composition with the aseptically dosed lactase may be subjected to a holding period of 12-24 hours at a temperature between 20-25°C to ensure that the lactase adequately digests the lactose.

[0066] In certain embodiments of the exemplary methods disclosed herein where a sterile lactase is added to the sterilized initial nutritional composition, the sterilized initial nutritional composition with the sterile lactase may be packaged by aseptic filling. In this embodiment, the container is sterilized (e.g., by hydrogen peroxide treatment) prior to being filled with the nutritional composition. In certain embodiments, the sterilized initial nutritional composition with the sterile lactase will form an aseptic low lactose nutritional composition within the sterilized container. Since the packaged low lactose nutritional composition is already sterile, no additional heat treatment is required. Accordingly, in certain embodiments of the methods disclosed herein, the low lactose nutritional composition includes residual active lactase. However, in other embodiments, the packaged low lactose nutritional composition may be subjected to a heat treatment, as previously described, to inactivate residual lactase.

[0067] In certain other embodiments of the methods of the first and third embodiments, after the low lactose nutritional composition is formed, the low lactose nutritional composition is sterilized. For example, as described above, after lactase is added to the initial nutritional composition, the initial nutritional composition with added lactase may be held for a period of 1- 5 hours at a temperature between 35-40°C to form the low lactose nutritional composition, which may then be subjected to a sterilization process. A wide variety of sterilization processes known to those of skill in the art may be utilized to sterilize the low lactose nutritional composition, including the sterilization processes described above. In certain embodiments according to the first and second embodiments, the low lactose nutritional composition is packaged and sterilized by techniques such as aseptic, retort, or hot-fill sterilization. Such sterilization techniques are well known to those of ordinary skill in the art.

[0068] As previously mentioned, the low lactose nutritional composition produced in accordance with the first and third embodiments described herein may be a nutritional powder. Accordingly, in certain embodiments of the methods of the first and third embodiments, after the low lactose nutritional product is formed, the method further comprises spray drying the low lactose nutritional composition to form a powdered low lactose nutritional composition prior to packaging. Virtually any spray drying method may be utilized to produce the powdered low lactose nutritional compositions contemplated herein. After production of the powdered low lactose nutritional compositions, the powder may be appropriately packaged in a sterile container.

[0069] In an exemplary embodiment of the methods and compositions described herein, a packaged low lactose nutritional composition having lactose in an amount of no more than 2000 milligrams per liter and from 1.2-12.7 grams of GOS per liter is produced. The method includes producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. The initial nutritional composition comprises more than 2000 milligrams of lactose per liter, from 5-30 milligrams of zinc per liter, from 0.8-3 milligrams of copper per liter, is substantially free of galactose, substantially free of glucose, and optionally contains GOS. At least one high lactose protein source is utilized to provide 30-100% by weight of the total protein in the initial nutritional composition. Lactase is added to the initial nutritional composition in an amount of 0.4-2 grams per liter to digest the lactose in the initial nutritional composition, thereby forming a low lactose nutritional composition. The low lactose nutritional composition is packaged to form the packaged low lactose nutritional composition. The packaged low lactose nutritional composition comprises from 20-100 grams of protein per liter, from 80-325 grams of carbohydrate per liter, from 20-50 grams of fat per liter, lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

[0070] In another exemplary embodiment of the methods and compositions described herein, a packaged low lactose nutritional composition having lactose in an amount of no more than 2000 milligrams per liter and from 1.2-12.7 grams of GOS per liter is produced. The method includes producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals. The initial nutritional composition comprises more than 2000 milligrams of lactose per liter, from 5-30 milligrams of zinc per liter, from 0.8-3 milligrams of copper per liter, is substantially free of galactose, and optionally contains GOS. The initial nutritional composition includes 30- 80% by weight of total protein from a high lactose protein source, 0-40% by weight of total protein from a vegetable protein, and 0-30% by weight of total protein from a low lactose protein source. Lactase is added to the initial nutritional composition in an amount of 0.4-2 grams per liter to digest the lactose in the initial nutritional composition, thereby forming a low lactose nutritional composition. The low lactose nutritional composition is packaged to form the packaged low lactose nutritional composition. The packaged low lactose nutritional composition comprises from 20-100 grams per liter of protein, from 80-325 grams of carbohydrate per liter, from 20-50 grams of fat per liter, lactose in an amount of no more than 2000 milligrams per liter, GOS in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

EXAMPLES

[0071] The following examples illustrate certain embodiments or features of low lactose nutritional compositions according to the first, second, and third embodiments disclosed herein. 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 thereof are possible without departing from the spirit and scope of the disclosure. Examples 1 & 2

[0072] Examples 1 and 2 illustrate certain exemplary embodiments of a low lactose nutritional composition in powder form according to the first, second, and third embodiments disclosed herein. All ingredient amounts are listed in Table 1 as kilogram per 1000 kilogram batch of product, unless otherwise specified.

Examples 3 & 4

[0073] Examples 3 and 4 illustrate certain exemplary embodiments of a low lactose nutritional composition in powder form according to the first, second, and third embodiments disclosed herein. All ingredient amounts are listed in Table 3 as kilogram per 1000 kilogram batch of product, unless otherwise specified.

Choline Chloride 1.70 1.70

Potassium Chloride 1.40 3.03

Potassium Citrate 1.14 0.63

Ascorbic Acid 0.872 0.872

Calcium Carbonate 0.748 0.851

Sodium Chloride 0.661 -

Arachidonic Acid Powder 0.645 0.645

Ascorbyl Palmitate 0.502 0.502

Vitamin ADEK Premix 0.177 0.177

Lactobacillus Acidophilus 0.100 0.100

Tocopherol-2 Antioxidant 0.0837 0.0837

dl-Alpha Tocopherol Acetate 0.0495 0.0495

Bifidobacterium Infantis 0.0350 0.0350

Vitamin A Palmitate 0.00120 0.00120

Potassium Iodide 0.0000890 0.0000890

Example 5

[0074] Example 5 illustrates an exemplary embodiment of a low lactose nutritional composition in liquid form according to the first, second, and third embodiments disclosed herein. All ingredient amounts are listed in Table 5 as kilogram per 1000 kilogram batch of product, unless otherwise specified.

Potassium Iodide 0.000207

[0075] To the extent that the term "includes" or "including" is used in the specification or the claims, it is intended to be inclusive in a manner similar to the term "comprising" as that term is interpreted when employed as a transitional word in a claim. Furthermore, to the extent that the term "or" is employed (e.g., A or B) it is intended to mean "A or B or both." When the applicants intend to indicate "only A or B but not both" then the term "only A or B but not both" will be employed. Thus, use of the term "or" herein is the inclusive, and not the exclusive use. See Bryan A. Garner, A Dictionary of Modern Legal Usage 624 (2d. Ed. 1995). Also, to the extent that the terms "in" or "into" are used in the specification or the claims, it is intended to additionally mean "on" or "onto." Furthermore, to the extent the term "connect" is used in the specification or claims, it is intended to mean not only "directly connected to," but also "indirectly connected to" such as connected through another component or components.

[0076] While the present application has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the application, in its broader aspects, is not limited to the specific details, the representative compositions and processes, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the general inventive concept.

Claims

WHAT IS CLAIMED IS:

1. A method of producing a packaged low lactose nutritional composition having lactose in an amount of no more than 2000 milligrams per liter and from 1.2-12.7 grams of

galactooligosaccharides per liter, the method comprising:

producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals, wherein from 30-100% by weight of the total protein is provided by at least one high lactose protein source, wherein the initial nutritional composition comprises from 20-100 grams of protein per liter and optionally comprises galactooligosaccharides, and wherein the minerals comprise from 5-30 milligrams of zinc per liter and from 0.8-3 milligrams of copper per liter; adding lactase to the initial nutritional composition to digest the lactose in the initial nutritional composition, and thereby forming a low lactose nutritional composition; and

packaging the low lactose nutritional composition to form the packaged low lactose nutritional composition comprising lactose in an amount of no more than 2000 milligrams per liter, galactooligosaccharides in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

2. The method according to claim 1, further comprising subjecting the initial nutritional composition with added lactase to a holding period of 12-24 hours to form the low lactose nutritional composition prior to packaging.

3. The method according to claim 2, further comprising heating the low lactose nutritional composition, thereby inactivating residual lactase.

4. The method according to claim 1 , wherein the amount of lactase added to the initial nutritional composition is from 0.4-2 grams per liter of the initial nutritional composition.

5. The method according to claim 1, wherein from 30-80% by weight of the total protein is provided by a high lactose protein source, from 0-40%> by weight of the total protein is provided by a vegetable protein, and from 0-30%> by weight of the total protein is provided by a low lactose protein source.

6. The method according to claim 1, further comprising sterilizing the initial nutritional composition to form a sterilized initial nutritional composition prior to the addition of lactase, and wherein the lactase added to the sterilized initial nutritional composition is a sterile lactase.

7. The method according to claim 6, wherein the sterilization is performed by ultra-high temperature processing or high temperature short time processing.

8. The method according to any one of claims 1 and 4-5, wherein the initial nutritional composition with added lactase is maintained at a temperature between 2-7°C for a period of 12- 24 hours to form the low lactose nutritional composition.

9. The method according to any one of claims 1-8, wherein the packaged low lactose nutritional composition is a liquid.

10. The method according to any one of claims 1, 2, 4-5, and 8, further comprising spray drying the low lactose nutritional composition to form a powdered low lactose nutritional composition prior to packaging.

11. A low lactose nutritional composition comprising:

from 5-20 grams of protein per serving, wherein 30-100% by weight of the total protein is provided by at least one high lactose protein source;

from 20-55 grams of carbohydrate per serving, wherein the carbohydrate comprises galactooligosaccharides, glucose, and galactose, and 0.5-15%) by weight of the carbohydrate is provided by galactooligosaccharides;

from 5-15 grams of fat per serving;

minerals selected from the group consisting of zinc, copper, free calcium, and combinations thereof; and

from 100-200 milligrams of lactase per serving;

wherein the low lactose nutritional composition comprises lactose in an amount of no more than 500 milligrams per serving, and wherein a portion of the galactooligosaccharides are formed in situ in the low lactose nutritional composition.

12. The low lactose nutritional composition according to claim 11, wherein 80-95% of the galactooligosaccharides are formed in situ in the low lactose nutritional composition.

13. The low lactose nutritional composition according to claim 1 1, wherein the at least one high lactose protein source is selected from the group consisting of non-fat dry milk, whey protein concentrate, condensed skim milk, whole milk powder, milk protein concentrate, sweet whey, acid whey, concentrated skim milk, and combinations thereof.

14. The low lactose nutritional composition according to claim 13, wherein up to 40% by weight of the total protein is provided by a source of vegetable protein, wherein the source of vegetable protein is selected from the group consisting of soy protein, pea protein, rice protein, potato protein, algae protein, wheat protein, canola protein, and combinations thereof.

15. The low lactose nutritional composition according to any one of claims 11-14, wherein the nutritional composition is a liquid.

16. The low lactose nutritional composition according to any one of claims 11-14, wherein the nutritional composition is a powder.

17. A low lactose nutritional composition prepared by a process comprising:

producing an initial nutritional composition comprising protein, carbohydrate, fat, and minerals, wherein from 30-100% by weight of the total protein is provided by at least one high lactose protein source, wherein the initial nutritional composition is substantially free of galactose and optionally comprises galactooligosaccharides; and

adding lactase to the initial nutritional composition to digest the lactose in the initial nutritional composition to form the low lactose nutritional composition; and

wherein the low lactose nutritional composition comprises lactose in an amount of no more than 2000 milligrams per liter, galactooligosaccharides in an amount of 1.2-12.7 grams per liter, glucose in an amount of 10-55 grams per liter, and galactose in an amount of 5-40 grams per liter.

18. The low lactose nutritional composition according to claim 17, further comprising sterilizing the initial nutritional composition to form a sterilized initial nutritional composition prior to the addition of lactase, and wherein a sterile lactase is added to the sterilized initial nutritional composition, and wherein the low lactose nutritional composition includes residual lactase.

19. The low lactose nutritional composition according to claim 17, further comprising: holding the initial nutritional composition after the addition of lactase at a temperature of between 2-7°C for a period of between 12-24 hours to form the low lactose nutritional composition; and

sterilizing the low lactose nutritional composition.

20. The low lactose nutritional composition according to claim 17, wherein the initial nutritional composition comprises minerals selected from the group consisting of zinc, copper, free calcium, and combinations thereof.

21. The low lactose nutritional composition according to any one of claims 17-20, wherein the low lactose nutritional composition is a liquid.

22. The low lactose nutritional composition according to claim 17, further comprising spray drying the low lactose nutritional composition to form a powdered low lactose nutritional composition.