NZ624548B2 - Dairy product and process - Google Patents

Abstract

The disclosure relates to a method of preparing a liquid nutritional composition. The method comprising heat-treating a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non-hydrolysed whey protein, wherein the whey protein comprises or is provided by an ingredient that comprises at least about 55% of the heat-denaturable protein present in a denatured state, and wherein the heat treatment has an Fo-value of at least equivalent to 900 degrees Celsius for 40s, and b) recovering the liquid composition, The recovered liquid composition has a viscosity of less than 200 cP when measured at 200 degrees Celsius and shear rate of 100 s-1, an average particle size of less than 20 micrometres as categorised by the volume weighted average particle size parameter D[4,3], and/or exhibits essentially no observable gelation or aggregation. The composition may further have from 0 to about 30% by weight fat and/or from about 0% to about 45% by weight carbohydrate. y an ingredient that comprises at least about 55% of the heat-denaturable protein present in a denatured state, and wherein the heat treatment has an Fo-value of at least equivalent to 900 degrees Celsius for 40s, and b) recovering the liquid composition, The recovered liquid composition has a viscosity of less than 200 cP when measured at 200 degrees Celsius and shear rate of 100 s-1, an average particle size of less than 20 micrometres as categorised by the volume weighted average particle size parameter D[4,3], and/or exhibits essentially no observable gelation or aggregation. The composition may further have from 0 to about 30% by weight fat and/or from about 0% to about 45% by weight carbohydrate.

Description

_ 1 _ DAIRY PRODUCT AND PROCESS FIELD OF THE INVENTION The invention relates to high protein liquid nutritional foods and methods for their preparation and use.

U1 BACKGROUND OF THE INVENTION A range of specialized foods (meal replacers and/or meal supplements) exist for elderly or convalescents or other patients that cannot get the nutrition required by eating normal foods or are unable to feed themselves or require assistance during feeding. Generic terms used to categorise these foods include “medical foods”, “enteral foods”, “enteral nutrition”, al liquids”, and the like, and are collectively used to refer to foods that are taken under the supervision of a medical professional. In some jurisdictions medical foods al ion has a legal definition. In the USA, the term l food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360cc (b) (3)) is “a food which is ated to be ed or stered enterally under the supervision of a physician and which is intended for the specific dietary ment of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation”. In some jurisdictions, such foods are available to the public only by prescription, in others they can be procured directly over the counter (OTC).

Enteral as are ingested both orally and through tubes. Oral ingestion is useful when nutrient supplements are necessary and both the digestive tract and the patient are capable of taking them.

Tube feeding is necessary for patients who need supplements but cannot take nutrition orally.

All these foods have very exacting requirements. They require a high degree of heat treatment to provide ity and long shelf life stability, high calorific density, i.e. highly concentrated doses of nutrients, but at the same time low viscosity so that they can be readily administered to the patient and ed easily. In order to obtain a long shelf life of the liquid compositions sterilization is the preferred heat treatment, in particular ultra high temperature (UHT), wherein the product is heated (indirectly by means of heating coils or directly by live steam under pressure) at 135—1500C and held at this temperature for 4—10 seconds, followed by c packaging. Another possibility is the so called retort process, wherein the product is sterilized by sealing in cans which are then heated in an ave at 110—13OOC for 10—20 minutes.

Liquid nutritional foods are also used by healthy subjects as meal replacers or when a rapidly consumable feed is required. Liquid nutritional foods are generally suitable for use by children, the 4429721—1 aged or by athletes and for these consumers the organoleptic properties of the product such as, for instance viscosity, mouthfeel, smell and colour are very important.

Whey protein is recognised as a suitable protein source to treat persons suffering from diseases or conditions or as a result of treatment for a disease or condition, such as from cachexia, sarcopenia, active elderly. As as well as a valuable source of nutrition for y persons, such as sportsmen and a source of whey protein to be used in the present invention, any commercially available whey n source may be used, i.e‘ whey obtained by any process for the ation of whey known in the art, as well as whey protein fractions prepared thereof, or the proteins that constitute the bulk of the whey proteins being fi—lactoglobulin, oc—lactalbumin and serum albumin, such as liquid whey, or whey in powder form, such as whey protein isolate (\WPI) or whey protein concentrate (WPC).

However, it will be appreciated that whey protein or whey protein ons without le processing will lly form a gel when heated under certain conditions (heating above pH 6.5 results in firm elastic gels; whilst coagula are formed below pH 6.5) and that the formation of a gel is detrimental to ation of the heat stable liquid nutritional compositions.

It has been reported that the heat stability of whey protein—stabilised emulsions is particularly sensitive to pH and ionic strength (Demetriades K & McClements DJ (1998), Irflaerzee (pr-I arzd rg on p/yuz'eor/Jwarm/properties ofwhey preteta—itabi/z'zed Mia/item 'lrz'ag a z'olzre surfactant. Journal of Agricultural and Food Chemistry, 46, 3936~3942; Demetriades K, CouplandJ N & McClements DJ (1997), P/ylrz'ea/propertz'er ofza/Jejprotez'lz Jtalri/z'zed emu/mm a; re/ated topH and NaC/. Journal of Food Science, 62, 342—347; HuntJ A & Dalgleish D G (1995), Heat Mala/2y afaz'l—z'rz—a/ater Mia/item eoataz'rzz'ag milk proteins: efleet gram rtreagt/a ande. Journal of Food Science, 60, 1120—1123). At a pH near the isoelectric point (pl) of the proteins the charge on the protein—containing droplets is low, and therefore protein—protein interactions are favoured and protein aggregation occurs rapidly.

However, when the pH is ed away from the pl (weighted average of the principal whey proteins is pH 50), charges on the protein molecules are increased. Greater electrostatic repulsive forces must be overcome for aggregation to occur, and therefore the rate of ation is slowed.

Previously, in order to e a low viscosity emulsion with a long shelf—life, whey proteins could only be used when the pH of the system was sufficiently t from the isoelectric point of the whey proteins, i.e. <pH 4 or >pH 6, to avoid the formation of a high—Viscosity liquid, paste or gel.

It is also reported that the ce of divalent (i.e. calcium and magnesium) and/or monovalent (i.e. sodium, potassium) cations adversely affect the physicochemical properties and stability of protein stabilised ons (Keowmaneechai E & McClements DJ (2002), Eject 2 and KC/ on p/eyiz'ee/aelrrtea/propertiei ofmode/ flatrz'tz‘oaa/ [Jeaeragei band 071 Mary) protein itabz'lz'zed ott—z'a—a/ater errza/rioai. 4429721—1 Journal of Food e, 67, 1; Kulmyrzaev A A, & Schubert H (2004), [Hf/7707700 (y‘KC/ 077 #70 ply/57000/767772'70/propert785 wry/[27371077010777 57007173007 077774470771. Food Hydrocolloids, 18, 13—19; Ye A & Singh H (2000), I77f/7/077m 0f 07710777777 0/7/0770’0 on 077 [/70 pmperfz'er 0f077777/57'0775 Haw/720d by 20/70} profein 00770077070727.

Food Hydrocolloids, 14, 337—346). Increasing the ionic strength of the aqueous phase by adding minerals can cause electrostatic screening of the s on the proteins, which leads to decreased electrostatic repulsion between droplets and thus promotes aggregation. Divalent ions can have more pronounced effects than monovalent ions. As will be appreciated by those skilled in the art, the higher the protein concentrations in the composition, lower quantities of minerals would be sufficient to te the e .

It is well known in the prior art that high temperature processing can lead to the generation of a sulphurous off—flavour in whey protein containing emulsions such as milk (SteelyJ S (1994) C007777/777777‘7705007700 07010077077 of17/40/7777” 00777756 7'77 [007%00’ 7777/76 In: Sulfur compounds in Foods, ACS Symposium Series 564). pH has been shown to have a icant effect on the heat—activated dryl (—SH) groups of skim milk whey that evolves during heating to at least 90° C. As the pH of the whey is lowered below pH 6.0, the quantity of sulphides evolved is decreased. In contrast, an increase in pH above 6 to about pH 9 is accompanied by an increase in the amount of heat volatile sulphides (Townley R C & Gould I A , A 07707277702707 grimy off/70 0007‘ [007/6 mlfider 0f7777/7é. III.

IMae/703 (y‘pH, added 00777100077715, /707770ge777'g:0f7‘077 077d rzz77/7'g/72‘]ournal of Dairy Science, 26, 853—867). In spite of the flavour benefits at pHs below 6.0, it is well known in the prior art that decreasing the pH of the composition to around the isoelectric point would lead to limited processability since whey proteins are prone to aggregation in this pH range.

It is an object of the invention to overcome these difficulties and to provide high protein liquid nutritional compositions having ble pH and heat stability, or to provide the public with a useful choice.

SUMMARY OF THE INVENTION Described herein is a liquid nutritional composition comprising a) from about 2% to about 25% by weight of protein that has been heated to at least 70°C or wherein at least about 55% of the heat—denaturable protein is denatured; b) from 0 to about 30% by weight fat; c) from about 0% to about 45% by weight carbohydrate; and n the nutritional composition has a pH of between about 4 to about 6, and d) a viscosity ofless than 200 cP at a temperature of 20°C and a shear rate of 100 3—1, or 4429721 —1 e) an average particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], or f) exhibits essentially no observable gelation or aggregation, or g) above. any combination of two or more of (d) to (0 Also described is a shelf stable liquid nutritional composition comprising a) from about 2% to about 25% by weight of non—hydrolysed whey protein ingredient that has been heated to at least 70°C or wherein at least about 55% of the heat—denaturable protein is pre—denatured; b) from 0 to about 30% by weight fat; c) from about 0% to about 45% by weight carbohydrate; and wherein the nutritional ition has a pH of between about 4 to about 6, and d) a viscosity of less than 200 cP at a temperature of20°C and a shear rate of 100 5—1, or e) an average particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], or f) exhibits essentially no observable gelation or aggregation, or g) any ation of two or more of (d) to (f) above.

In one aspect the invention provides a liquid nutritional composition comprising a) from about 2% to about 25% by weight of drolysed whey protein, wherein the whey protein comprises or is provided by an ingredient that comprises at least about 55% of the heat—denaturable protein present in a denatured state, b) from 0 to about 30% by weight fat c) from about 0% to about 45% by weight carbohydrate and wherein the ional composition has when at a pH of between 4 and 6 undergone a heat treatment with an FO—value of at least equivalent to 90°C for 405, and has d) a viscosity of less than 200 cP when measured at 200C and shear rate of 100 5'1, or e) an average particle size of less than 20 um as rised by the volume weighted average le size parameter D[4,3], or f) exhibits essentially no observable gelation or aggregation, or g) above. any combination of two or more of (d) to (0 In one embodiment, the heat treatment is at least lent to 121°C for 10 minutes, for example is at least equivalent to 140°C for 55, such as to provide microbial control and a shelf stable t.

In various embodiments the nutritional composition is heat—stable, for e the composition is in a liquid state in which ially no gelation, or aggregation is observed in the beverage, for 44297214 example either directly after heat treatment or after prolonged storage at temperatures of about °C., e.g. at least 3 months, or preferably at least 6 months or 12 months.

Further described is a liquid nutritional composition comprising a) from about 2% to about 25% by weight of drolysed whey protein b) from 0 to about 30% by weight fat c) from about 0% to about 45% by weight carbohydrate and wherein the liquid nutritional composition has undergone when at a pH of between 4 and 6 a heat ent with an ue of at least equivalent to 90°C for 40s, and wherein the liquid nutritional composition has a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 5‘1.

In certain ments, the protein in the nutritional liquid composition is provided by an ingredient, for example a dry ingredient, wherein at least about 55% of the heat rable protein is pre—denatured.

Also described is a shelf stable liquid nutritional composition comprising a) from about 2% to about 25% by weight of non-hydrolysed whey protein ingredient wherein at least about 55% of the heat—denaturable protein is natured b) from 0 to about 30% by weight fat c) from about 0% to about 45% by weight ydrate d) as monovalent or divalent cations minerals at least to the levels as recommended by the European Commission Food for Special Medical Purposes (FSMP) directive. and wherein the nutritional composition has undergone when at a pH of between 4 and 6 a heat treatment with an FO—value of at least equivalent to 90°C for 40s, for example at least equivalent to 121°C for 10 minutes, or from at least equivalent to 140°C for 5s.

In one embodiment, the liquid nutritional composition comprises a) from about 2% to about 25% by weight of non—hydrolysed whey protein wherein at least 55% of the enaturable whey protein is denatured b) from 0 to about 30% by weight fat c) from about 0% to about 45% by weight carbohydrate and wherein the liquid nutritional ition has undergone when at a pH of between 4 and 6 a heat treatment with an FO—value of at least equivalent to 90°C for 405, and wherein the liquid nutritional composition has a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 /s. 4429721 —1 The heat treatment can preferably be at least lent to 121°C for 10 minutes or most preferably at least equivalent to 140°C for 55 to provide a shelf stable product, and wherein the nutritional composition is heat—stable meaning the formulation is in a liquid state in which essentially no gelation, or aggregation is observed in the beverage, either directly after heat treatment or after prolonged storage at temperatures of about 20°C., eg. at least 3 months, or preferably at least 6 months or 12 months.

In a r aspect, the invention s to a method of preparing a liquid nutritional ition, the method comprising a) heat—treating a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non—hydrolysed whey protein, wherein the whey protein comprises or is ed by an ingredient that comprises at least about 55% of the heat— rable protein present in a denatured state, and wherein the heat treatment has an F0- value of at: least lent to 90°C for 405, and b) recovering the liquid composition, wherein the liquid composition has c) a viscosity ofless than 200 CP when measured at 20°C and shear rate of 100 s—1, or d) an average particle size of less than 20 mm as categorised by the volume weighted e particle size parameter , or e) exhibits essentially no observable on or aggregation, or f) any combination of two or more of (c) to (e) above.

In one embodiment, the liquid composition has a pH of r than 4.5 when heat treated.

In various embodiments, the heat treatment is for microbial control, wherein the recovery of step (b) is of a sterile liquid composition.

In one exemplary embodiment, prior to packaging or consumption the liquid composition undergoes no heat treatment other than the heat treatment of step (a). In one exemplary embodiment, prior to packaging or consumption the liquid composition undergoes no further sterilisation. In one exemplary embodiment, prior to packaging or consumption no further ingredients are added to the liquid composition, such that its composition is unchanged.

In one embodiment, recovery of the liquid composition comprises or consists of aseptic handling, bottling, or packaging, or any combination thereof. 44297214 In another embodiment, the invention provides a method of preparing a liquid nutritional composition, the method sing a) providing a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non—hydrolysed whey protein wherein the whey protein is provided by a dry ingredient that comprises at least about 55% of the enaturable protein present in a denatured state, b) heat~treating the liquid composition with a heat treatment having an FO-value of at least equivalent to 90°C for 40s, and c) recovering the liquid composition, wherein the recovered liquid composition has d) or a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s—1, e) an average particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], or f) exhibits ially no observable on or aggregation, or g) any combination of two or more of (d) to (f) above.

In one embodiment, the invention provides a method of preparing a liquid nutritional composition, the method comprising a) providing a liquid ition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non—hydrolysed whey protein wherein the whey n comprises or is provided by an ingredient that comprises at least about 55% of the heat~denaturable protein t in a denatured state, b) with no pH adjustment reating the liquid composition with a heat treatment having an FO—value of at least equivalent to 90°C for 405, and c) recovering the liquid composition, wherein the liquid composition has d) a viscosity ofless than 200 cP when measured at 20°C and shear rate of 100 s—l, or e) an average particle size of less than 20 um as categorised by the volume ed average particle size parameter D[4,3], or Q exhibits essentially no observable gelation or aggregation, or 3O g) any combination of two or more of (d) to (i) above.

In a further embodiment, the ion provides a method of preparing a shelf stable liquid nutritional composition, the method comprising 4429721-1 a) providing a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non—hydrolysed, heat—denaturable whey protein wherein at least 55% of the whey protein is denatured, b) heat—treating the liquid composition to provide sterility, c) recovering the liquid composition wherein the liquid composition has d) a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s—l, or e) an average particle size of less than 20 pm as categorised by the volume weighted average particle size parameter D[4,3], or f) exhibits essentially no observable gelation or aggregation, or g) any combination of two or more of (d) to (f) above.

Exemplary heat treatments include heat treatment at least equivalent to 121°C for 10 minutes, including for example heat treatment at least equivalent to 140°C for 53.

In another aspect the invention provides a liquid nutritional composition prepared by a method of the invention.

In a further aspect the invention provides a ed ional composition sible in water to form a liquid nutritional composition of the invention.

In one embodiment the ion provides a powdered nutritional composition dispersible in water to form a liquid nutritional composition comprising a) from about 2% to about 25% by weight of non—hydrolysed whey protein that has been heated to at least 70°C or wherein at least about 55% of the heatndenaturable protein is denatured; b) from 0 to about 30% by weight fat; c) from about 0% to about 45% by weight carbohydrate. r described is a method of providing nutrition to a person in need thereof, the method comprising the steps of stering to the person a nutritional composition of the present invention.

In a further aspect the invention relates to the use of a liquid composition of the ion in the preparation of a medicament for providing nutrition to a subject in need thereof. 3O The ion further relates to a food or food t comprising, consisting essentially of, or ting of a liquid nutritional composition of the present invention. Foods or food products of 4429721-1 the invention for providing nutrition to a person in need thereof are specifically contemplated, as is the use of compositions of the invention as described herein in the preparation of a medicament for use in any of the treatment methods described herein.

The following embodiments may relate to any of the aspects of the invention described herein.

In s embodiments, the liquid ional composition has, for example when undergoing the heat treatment, a pH of between about 4.0 to about 6.0, or a) a pH of between about 4.5 to about 6.0, or b) a pH of between about 4.7 to about 6.0, or c) a pH of between about 4.8 to about 6.0, or d) a pH of between about 4.9 to about 6.0, or e) a pH of n about 5.0 to about 6.0, or o a pH of n about 4.5 to about 5.7, or a pH of between about 4.5 to about 5.5, or a pH of between about 4.5 to about 5.3, or a pH of between about 4.5 to about 5.2, or a pH of between about 4.7 to about 5.5, or a pH of between about 4.7 to about 5.3, or a pH of between about 4.7 to about 5.2, or a pH of between about 4.8 to about 5.3, or a pH of between about 4.8 to about 5.2, or a pH of about 5, or a pH of n about 4.2 to about 5.8, or a pH of between about 4.4 to about 5.8, or a pH of between about 4.6 to about 5.6, or a pH of between about 4.8 to about 5.4, or a pH of between about 4.9 to about 5.3, or a pH of between about 5.0 to about 5.2, or a pH of about 5.1, or a pH of between about 4.3 to about 5.1, or a pH of between about 4.6 to about 5.1, or a pH of between about 4.8 to about 5.1, or a pH of between about 5.1 to about 6.0, or aa) a pH of between about 5.1 to about 5.8, or bb) a pH of between about 5.1 to about 5.6, or 4429721—1 -10_ cc) a pH of between about 5.1 to about 5.4.

In certain embodiments, the nutritional composition has, for example when undergoing the heat treatment, a) a pH of within about 1 of the average pI of the protein present, or b) a pH of within about 05 of the average pI of the protein present, or c) a pH of within about 0.3 of the average pl of the protein t, or d) a pH of within about 0.1 of the e pI of the protein present, or e) a pH at about the average pI of the protein present.

In various ments, for example of the methods of the invention, the heat ent is at a pH of within about 1 of the average pI of the protein present, for example, within about 0.5 of the the heat treatment is at a pH of average pI of the whey protein present. In other embodiments, within about 0.3 of the average pI of n, or at a pH of within about 0.1 of the average pI of protein, or is at a pH at about the average pI of protein.

In various embodiments, the liquid nutritional composition of the invention has a ity of less than 200 cP when measured at 20°C and shear rate of 100 s'1 after having undergone a heat treatment with an FO—value of at least equivalent to 90°C for 40s, or at least equivalent to 100°C for 15s. In one example, the liquid nutritional composition has a viscosity of less than 150 CP when measured at 20°C and shear rate of 100 s'1 and no discernable change in particle size after having undergone a heat treatment with an ue of at least equivalent to 121°C for 10 minutes. This provides an easily drinkable product with no sedimentation and creaming.

In various embodiments, the liquid nutritional ition has a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s"1 after having undergone a heat treatment of at least equivalent to 121°C for 10 minutes. In one example, the liquid nutritional composition has a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s'1 no discernable change in particle size after having undergone an ultra heat treatment (UHT) with an FO—value of at least equivalent to 140°C for 55. This provides an easily drinkable product with no sedimentation and creaming In various embodiments, the liquid nutritional composition has a viscosity of less than 150 cP, or less than 100 cP, or less than 50 cP or less than 25 cP when measured at 20°C and shear rate of 100 s‘1 after having undergone a heat treatment when at a pH of from about 4 to about 6 with an F0— value of at least equivalent to 90°C for 408, or preferably at least equivalent to 121°C for 10 s or most preferably at least equivalent to 140°C for 5s. 44297214 -11_ In certain embodiments the protein present in the whey protein source, for example a whey protein concentrate (WPC), a whey protein isolate (\Y/PI), or a blend of whey n sources ing a blend of WPCs or \WPIs or both, comprises, consists essentially of, or consists of non—hydrolysed whey protein. In one exemplary embodiment, the protein present in the \WPC or WPI comprises at least about 65% drolysed protein, at least about 70% non—hydrolysed n, at least about 75% non~hydrolysed protein, at least about 80% non—hydrolysed protein, at least about 85% non— hydrolysed protein, at least about 90% drolysed protein, at least about 95% non~hydrolysed protein, or at least about 99% non—hydrolysed protein. In one embodiment, the \VPC or WPI is essentially free of hydrolysed n.

In one embodiment, the whey n is provided by an ingredient that comprises a protein content of 35% to 95% by weight of the dry matter of the ingredient.

In certain embodiments, the denatured WPC ses at least about 35% protein, at least about 50% protein, at least about 65% protein, at least about 70% protein, at least about 75% protein, or at least about 80% protein. In certain embodiments, higher protein content compositions are utilised, for example the denatured WPC or \WPI comprises at least about 85% protein, at least about 90% protein, or at least about 95% protein.

In various embodiments, the whey n comprises or is provided by an ingredient that comprises at least about 55% of the heat—denaturable protein present in a denatured state. In certain embodiments the whey protein comprises, consists essentially of, or consists of at least about 65% of the heat—denaturable protein present in a denatured state, at least about 70% of the heat— rable protein present in a denatured state, at least about 75% of the heat—denaturable protein in a present in a denatured state, at least about 80% of the heat—denaturable protein present denatured state, at least about 85% of the heat—denaturable protein present in a red state, at least about 90% of the heat—denaturable protein present in a denatured state, at least about 95% of the heat—denaturable protein present in a denatured state.

In one embodiment, the protein provides from about 10% to about 40% of the total energy content of the composition. In a further embodiment of the liquid composition, protein provides from about 10% to about 30% of the total energy content of the ition.

In some embodiments, the liquid ition is free of added izers, is free of added emulsifiers, is free of added minerals, or is free of any combination of two or more of added stabilizers, added minerals, or added emulsifiers. 4429721—1 In one embodiment, the liquid nutritional composition has an energy density of from about 0.5 L to about 3.5 L. In various embodiments, the liquid ional composition has an from about 0.8 kcal/mL to about energy density of from about 0.6 kcal/ml to about 3.0 kcal/mL, 3.0 kcal/mL, from about 1 kcal/mL to about 2.5 kcal, from about from about 1.5 kcal/mL to about 2.5 kcal, or about 2 L. In an exemplary embodiment of the liquid composition, the energy density is at least about 1 kcal/mL, at least about 1.5 kcal/mL, or at least about 2 kcal/mL.

In one ment, the liquid nutritional composition comprises of from about 10% w/W to about % w/W protein, or from about 10% w/W to about 20% w/w protein. In an exemplary embodiment of the liquid composition, the composition comprises from about 10% w/w to about 15% w/W n or from about 10% W/W to about 14% W/W protein.

In one embodiment, the liquid nutritional composition comprises of from about 10% w/w to about 40% W/W carbohydrate. In an exemplary embodiment of the liquid composition, the ition ses from about 10% w/W to about 35% \v/W carbohydrate, from about 10% w/W to about % w/w carbohydrate, from about 15% W/W to about 35% W/W carbohydrate, or from about 15% VV/W to about 30% W/W carbohydrate.

In one embodiment, the liquid nutritional composition comprises of from about 3% W/w to about % W/W fat. In an exemplary embodiment of the liquid composition, the composition comprises from about 5% w/w to about 20% w/W fat, from about 5% w/w to about 18% w/W fat, from about 5% w/w to about 16% W/w fat, or from about 5% W/W to about 15% w/w fat.

In certain embodiments, more than about 55% of the heat—denaturable protein present in liquid nutritional composition is denatured, or more than about 65% of the heat—denaturable protein present in liquid nutritional composition is denatured. In one example, more than about 70% of the heat—denaturable protein present in liquid nutritional composition is denatured, or more than about 75% of the heat—denaturable protein present in liquid nutritional composition is denatured. For e, in certain embodiments of the liquid nutritional composition of the invention, more than about 80%, more than about 85%,.more than about 90%, more than about 95% of the heat— denaturable protein present in the composition is denatured.

In one ment the heat treated, substantially denatured whey protein, for example the WPC or WPI, le for use in this invention may be blended with at least one other protein source to e a blend having at least 55% denaturation level. In certain embodiments the blend is a dry blend. Useful blends include blends of the heat treated, substantially denatured Whey protein with, for example, whey protein concentrates (\X/PCs) or isolates (\WPIS). 4429721-1 In certain embodiments, up to a further 10% hydrolysed protein can be added. In one example, less than about 8% hydrolysed n, less than about 5% hydrolysed protein, less than about 2.5% hydrolysed n, or less than about 1% hydrolysed protein is added. For example, in certain embodiments of the liquid ional composition of the invention, less than about 10%, less than about 8%, less than about 5%, less than about 2.5%, or less than about 1% hydrolysed protein is embodiments the use present in the liquid nutritional ition. As will be appreciated, in certain of 100% by weight of the heat—treated or substantially denatured protein is particularly advantageous, for example it allows a single easy to handle protein source to be used.

In one embodiment, the method of preparing a liquid nutritional composition comprises a) providing non—hydrolysed, enaturable whey protein wherein at least 55% of the whey protein is pre—denatured, b) admixing the whey protein with a liquid, for e water or water additionally comprising an anti—foaming agent (optionally), c) optionally admixing one or more ingredients selected from the group comprising stabilizers, minerals, trace elements, surfactants, or oils, d) homogenising the admixture, e) adjusting the pH of the liquid admixture to between about 4 to 6, f) heat—treating the liquid composition to provide microbial control with a heat treatment having an FO—value of at least equivalent to 90°C for 405, for example at least equivalent to 121°C for 10 minutes, ing for example at least equivalent to 140°C for 55, g) recovering the liquid composition, wherein the nutritional composition stays in the liquid form in which no gelation or aggregation is observed after having undergone the heat treatment and the liquid composition has a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s'1 and has no discernable change in the particle size.

In various embodiments, the liquid is heated to about 50°C or more prior to admixing with the whey n.

In s ments, when added the one or more ingredients admixed in step (c) are heated prior to admixing, for e to at least 50°C, or to at least 60°C, or to at least 70°C, or to at least 80°C, or more.

In various embodiments, when performed the homogenisation is performed at about 500C, or at about 600C, or more. 4429721—1 In s embodiments, a post homogenisation step can be performed after the heat treatment.

In one embodiment, the method of preparing a liquid nutritional ition is essentially as herein described, for example with reference to Figure 1.

In various embodiments, the person in need of nutrition may be ing from or predisposed to a disease or condition, or may be being or have been treated for a disease or condition, is an elderly that is malnourished. In person, a person that is ring from a disease or condition, or a person other embodiments, the person may also be a healthy person, such as a sportsman or active elderly, including persons having particular nutritional requirements.

It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also orates reference to all rational numbers within that range (for e, 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of al s within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7) and, therefore, all sub-ranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the t value enumerated are to be considered to be expressly stated in this application in a similar manner.

This invention may also be said broadly to consist in the parts, ts and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which this invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described by way of example only and with reference to the drawings in which: Figure 1 shows the process flow for manufacture of liquid nutritional composition of the invention.

Figure 2 shows the heat ity of an exemplary liquid formulation of the invention heated in an oil bath at 1400 C at a range of pH.

Figure 3 depicts liquid nutritional formulations of the invention ing retorting at a range of pH values.

Figure 4 shows the viscosity, volumetric mean particle size, creaming and sedimentation of liquid 3O nutritional formulations of the invention immediately following UI—IT/Direct Steam Injection (DSI) heat treatment and after 6 weeks e at ambient temperature following such heat treatment. 4429721-1 Figure 5 depicts liquid nutritional formulations of the ion comprising different whey protein sources following heat treatment by retorting at 121 °C for 10 minutes at pH 5.0.

Figure 6 shows the storage stability of nutritional ations comprising 10% and 13.8% protein by weight at pH 5.4.

Figure 7 depicts liquid nutritional formulations of the invention in smoothie form: a) viscosity over storage at 30 0C; b) nt after 3 months at 30 °C.

DETAILED DESCRIPTION OF THE INVENTION One of the major problems previously encountered in the tion of high protein nutritional liquid itions is the limited sability and heat—sensitivity of the protein component, and 1O thus of the liquid composition as a whole. The heat treatment given to nutritional composition to provide microbial control, meaning that the protein is heated above its denaturation temperature s in protein denaturation and polymerizing into aggregates or gels. As a consequence, previous heat—treated liquid compositions exhibit ed sensorial utes like chalkiness, sandiness, lumpiness, and high viscosity Shelf life of such products has been limited in that sediment and/or cream layers are formed soon after production. High temperature sing can also lead to the generation of sulphurous off~flavours in nutritional liquid compositions. In compositions with a high protein content, in particular high whey n content, these ms are bated, leading to products with unwanted aggregates, and a risk of ive fouling and blocking of production plant, such as UHT heating equipment.

The nutritional liquid compositions used in the present invention, in contrast, have good sensorial attributes and processability properties that are particularly suited to application in high protein medical foods and liquid nutritional compositions.

The present invention provides high protein liquid nutritional compositions, including nutritional liquids having good heat stability, good shelf stability, and low viscosity, at a pH in the range of about 4.0 to about 6.0 and optionally in the presence of substantial amounts. of monovalent and divalent cations.

The term “liquid nutritional composition” refers to an aqueous ition to be administered by mouth or by other means, generally by tube feeding, to the stomach or ines of a patient. Such other means include naso—gastric feeding, gastric feeding, jejunal feeding, naso—duodenal and naso— 3O jejunal feeding, and duodenal feeding. Liquid nutritional compositions include “medical foods”, “enteral nutrition”, “food for l medical purposes”, liquid meal replacers and supplements.

The liquid nutritional compositions of the present invention provide significant amounts of protein 4429721—1 —16— and carbohydrate and usually also fat. They may also include Vitamins and minerals. In exemplary embodiments they provide balanced meals.

The invention provides high protein liquid nutritional itions having good thermal stability, particularly at pHs at or approaching the pl of the n present in the composition. The exemplary \Y/PC ients employed in entative examples of the liquid nutritional composition can be applied advantageously wherein the heat—treated or at least substantially denatured WPC confers the surprising benefits of stability under high temperatures at pH of 4 to 6.

It would be reasonable to expect non—thermal denaturation methods found in the prior art can lead to r effect. The denatured WPC ingredient is especially useful in that it provides good thermal stability and low viscosity to medical, orally or enterally administered foods because the liquid nutritional composition can be delivered readily by flow through a tube or by mouth.

Good thermal (heat) stability, when used herein with reference to liquid ional compositions, contemplates compositions ing a liquid state of low Viscosity, ing for example liquid compositions in which essentially no gelation, or aggregation is observed, either directly after heat treatment or after prolonged storage at temperatures of about 2000, e.g. at least 3 months, or preferably at least 6 months or 12 months. Small particle size, or little or no apparent increase in le size on heating, are other indicia of a heat stable liquid ional composition, such as a liquid nutritional composition of the invention.

The term “comprising” as used in this specification means “consisting at least in part of”. When reting each ent in this specification that includes the term “comprising”, es other than that or those prefaced by the term may also be present. Related terms such as ise” and “comprises” are to be interpreted in the same manner.

As used herein, “non—hydrolysed” when used with reference to a protein-containing compositions, such as a liquid nutritional composition, powder, \X/ PC, WPI or the like, means less than 2% of the protein present in the composition has undergone hydrolysis, and in certain embodiments less than 1% of the protein present in the composition has one hydrolysis.

For the purpose of the present specification, viscosity is measured at 20°C using a rheometer such as unless otherwise an Anton Paar instrument using a cup and bob assembly at a shear rate of 1005”, indicated. It will be appreciated that other methods to measure or estimate viscosity are well known in the art and may be employed where appropriate. 4429721-1 For the purpose of the present specification, energy densities are measured by calculation using standard calorific values of food constituents. Again, it will be appreciated that other methods to measure or te energy density, such as calorimetry, are well known in the art and may employed where appropriate.

For the purpose of the present specification, mean particle size (characterised by D[4,3] or D[3,2]) is ed using a Malvern Mastersizer 2000 (Malvern Instruments Ltd, Worcs, UK) with a refractive index for the particles of 1.46 for emulsion based beverages and 1.52 for powders in suspension, and for the solvent of 133.

For the purpose of the present specification, primary ate size of reconstituted s is determined by homogenising (150/50 bar) 10% total solids (TS) suspension at natural pH and determining the mean particle size (characterised by D[4,3]) using a Malvern Mastersizer 2000 (Malvern Instruments Ltd, \Worcs, UK) with a refractive index for the particles of 1.52 and for the solvent of 1.33 as described above.

Primary ate growth after heating is determined by taking the 10% T8 protein suspension and g in an autoclave at 120°C for 15 minutes and measuring D[4,3] as described above.

Methods for assessin rotein concentrations are well—known in the art for exam le as measured g P a P protein en by the Kjeldahl method. This method is based on nitrogen determination and n concentration is calculated by multiplying the total nitrogen result by a conversion factor of 6.38 for dairy proteins.

Methods to determine the degree of protein denaturation are well known in the art. One ary method used herein relies on HPLC (Elgar et al (2000) J Chromatography A, 878, 183—196); and other methods suitable for use include methods t on an Agilent 2100 Bioanalyzer (Agilent Technologies, Inc. 2000, 2001—2007, Waldbronn, Germany) and microfluidic chips, and utilising Agilent 2100 Expert software (e.g. Anema, (2009) International Dairy], 19, 198—204), and polyacrylamide gel ophoresis (e.g. Patel et al, (2007) Le Lait, 87, 251—268).

Powders may be characterised by measuring the residual denaturable protein as a tion of total protein (TN x 638) according to the following formula: °/o Residual denaturable protein 2 (soluble denaturable protein) x100 3O (Total Nitrogen x 6.38) 4429721—1 —18— where the soluble whey protein is determined using reversed phase HPLC (Elgar et al., 2000) as described above and is expressed as grams protein/ 100 grams powder.

The denaturable whey protein is measured as 2(bovine serum albumin + oc—lactalbumin + B— lactoglobulin + lactoferrin + iminunoglobulins).

For a cheese WPCSO that has been carefully manufactured, the sum of the above components would typically be 60-63% of the TN and so the proportion of denaturable protein that has been denatured can be estimated according to the following a: 1 — (residual denaturable protein) x 100 Liquid nutritional foods are often calorifically dense in that they contain nutrients such as fat, protein and carbohydrates in levels and combinations to attain calorific values of at least 0.5 kcal/g or of at least 0.5 kcal/mL. In the group of l or enteric foods calorific densities up to 3 kcal/g or even above are known. Such high calorific densities are difficult to e with high concentrations of whey protein without having any adverse effect of heating i.e. gelling or g In certain ments of the invention, the liquid nutritional composition comprises 5—200/0 protein, for example 5—15%. In certain embodiments the liquid nutritional ition comprises 4—250/0 protein, for example 420% of the heat—treated or substantially denatured WPC‘ In certain embodiments of the invention, the fat content is 1—30% by weight, for example 5—20%, or between 5% and 15%. For example in exemplary low fat embodiments of the liquid nutritional ition, the fat content is 0% by weight to about 15% by weight, or from 0% by weight to about 10% by weight, or 0% to about 5% by weight. In other exemplary ments, for example higher fat itions, the fat content is from about 15% by weight to about 35% by weight.

In certain embodiments of the invention, the carbohydrate content is 0—45%, for example 10—35%, or 20—30%. For example in exemplary low carbohydrate embodiments of the liquid nutritional composition, the carbohydrate content is 0% by weight to about 15% by weight, or from 0% by weight to about 10% by weight, or 0% to about 5% by weight. In other ary embodiments, for example higher carbohydrate compositions, the carbohydrate content is from about 15% by weight to about 35% by weight.

The formulation of the liquid nutritional food may also contain a wide variety of vitamins and minerals required to sustain patients ionally for long periods of time, and minor components such as antioxidants, flavouring and colouring. The amounts of vitamins and ls to be used in 4429721—1 _19_ certain ments are those typical of meal replacement products known to those skilled in the art. The micro—nutritional requirements of various sub—groups of the population are also known.

The recommended daily requirements of vitamins and minerals can be specified for various population subgroups. See for ce, Dietary Reference Intakes: RDA and AI for vitamins and elements, United States National Academy of Sciences, Institute of Medicine, Food and Nutrition Board (2010) tables recommended s for infants 0—6 6—12 months, children 1—3, and 4—8 years, adults males (6 age s), females (6 age classes), pregnant (3 age s) and lactating (3 age classes). Concentrations of essential nutrients in the liquid nutritional composition can be tailored in the exemplary serve size for a particular subgroup or medical condition or application so that the ion and ease of delivery requirements can be met aneously.

For instance, the level of added minerals can be ed based on European sion guideline on Food for Special Medical Purposes (FSMP) directive. One can choose to add higher levels specific nutritional reasons. Examples of compositions of the invention having very good heat stability at pH from about 4 to 6 in the presence of s amounts of minerals, including those having very good heat stability despite high levels of minerals, are presented herein.

Typically the dried non-fat ingredients are dispersed in water, allowed to hydrate, mixed and then mixed vigorously with fat. In one embodiment the sugar (carbohydrate) and protein are mixed to assist in protein dispersion and solubilisation. Whilst n and sugar (carbohydrate) mixes are the exemplary method of dispersion and solubilisation, protein and fat mixes can also be used for improved dispersion and solubilisation.

The components of the composition of the invention are typically nised to reduce the fat/oil droplet size and form an oil—in—water emulsion, and then heat d.

The homogenization step used to form a ised food composition involves application of shear forces to reduce droplet or particle size. For some embodiments high shear stirring, for example, in a blade mixer (for example an Ultra Turrax or Waring blender) may be used. In certain embodiments the recombined base of liquid nutritional composition has an e particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], for example less than 10 um, even for example less than 2 mm, or in certain embodiments less than 1 3O In one embodiment, homogenisation of the nutritional composition is carried out prior to the final heat treatment, or may be conducted as part of the heat treatment, including for example during an initial, partial, pre—heating, or post—heating step. In certain ments, for example of the liquid 4429721—1 -20_ nutritional composition, the ition has after heating, and optionally after ng or homogenisation, a mean volume weighted particle size, D[4,3], of from about 0.3 um to about 2 um, or from about 0.5 pm to about 1.5 pm. For example, the composition has a mean particle size of about 1 mm.

In various exemplary ments, the liquid composition has a mean particle size that does not substantially increase when heated, for example, when heated with a heat treatment with an FO—value of at least equivalent to 90°C for 405, for e when heated at greater than 140°C for 5 s. For example, the composition has a mean particle size that does not increase by more than 4—fold when heated at greater than 140°C for 5 s, in certain examples does not increase by more than 3—fold, by more than 2—fold, when heated with a heat treatment with an FO—value of at least equivalent to 140°C for 5 s.

In one exemplary embodiment, the liquid composition has a mean particle size that does not increase when heated with an FO—value of at least equivalent to 90°C for 405.

Exemplary methods for preparing WPCs suitable for use in the present invention are provided in PCT International Application (published as WC 2007/ 108709) and PCT/N22010/000072 shed as W0 2010/ 120199 incorporated by nce herein in its entirety).

The protein, for e the WPC or \Y/PI, ient may be prepared from a e of WPCs, or from a mixture of proteins. In certain embodiments the protein is or comprises whey protein. In various embodiments, the protein is or comprises a whey protein concentrate (\WPC) or whey protein isolate (\WPI).

Heat ent is applied in the preparation of the protein, such as the WPC, to impart the required denaturation and to ensure it is suspendable. Whey protein comprises high levels of globular proteins that are sensitive to aggregation in the denatured state. The denaturation temperature of {3- lactoglobulin is pH—dependent, and at pH 6.7 irreversible denaturation occurs when the protein is heated above 65°C. This denaturation is believed to expose a free thiol group, which is reported to initiate inter~protein disulfide bond formation g to polymerization resulting in aggregate formation. Other disulfide bridges and cysteine residues are thought to play a role in the polymerization on. oc—lactalbumin also has a denaturation temperature of about 65°C.

The size, shape and density of the protein aggregates are influenced by a number of nmental and sing parameters including temperature, heating rate, pressure, shear, pH and ionic 4429721—1 strength. Depending on the combination of these parameters, the aggregates may form a gel, fibrils or compact micro—particles. For example microparticulated whey can be formed under specific ionic strength and shear conditions. These les have a t ure, a low sic viscosity and a low specific volume. Further, it is known that a relationship exists between aggregates size heating temperature for microparticulated whey produced under shear conditions.

In certain ments, the whey protein ingredient is made according to a process as specified ing to US 575 (Huss & Spiegel), U82006/0204643 (Merrill et al), US 4,734,827 (Singer et al), US 5,494,696 (Holst et al), (published as \Y/O 2010/120199), EP0412590 and EP0347237 (Unilever) or Robinson et al (1976) NZ] Dairy Science & Technology, 11, 114—126. Each method of making a whey protein ingredient would impart different properties so the protein ingredient to best suit their process. anyone using this invention should select The liquid nutritional ition is subjected to heat treatment after it has been prepared, primarily to increase shelf life of the product and minimise the potential for growth of food spoilage and pathogenic microorganisms.

As will be appreciated by those skilled in the art, the lethal effect of high temperatures on microorganisms is ent on both temperature and holding time, and the reduction in time required to kill the same number of rganisms as temperature is increased is well known. The time taken to reduce initial microbial numbers, at a ied temperature, by a particular amount, is commonly referred to as a “F value”. As described in Mullan, W.M.A. (2007) (Mullan, W.M.A., Calculator for determining the F value of a thermal process. [On—line]. Available from: www.dairyscienceinfo/calculators—models/134—f—value—thermal—process.html) and references therein, the F value of a thermal process can be calculated by plotting lethal rates against process time, where lethal rate can be calculated using the following on (Stobo, 1973): Lethal rate = 10 (TAM/Z where T is the temperature at which the lethal rate is calculated, Tr is the reference temperature at which the equivalent lethal effect is compared, and z is the reciprocal of the slope of the thermal death curve for the target microorganism or spore (all values in degrees Celsius). As Mullan asserts, a 2 value of 10° C is frequently used in F0 calculations performed on low acid foods.

F values can thus be used to describe the thermal input into a particular process. As discussed herein, the liquid nutritional compositions of the present invention are typically ted to a heat treatment step having an FO—value of at least lent to 90°C for 405, whilst exhibiting useful heat stability, such as not forming a gel. 44297214 Various heat treatments of the liquid nutritional composition may be used. Ultra—high temperature (UHT) treatment is exemplary. Typical UHT ions are 140 to 150°C for 2 to 18 seconds, but longer durations are possible, for example 10 seconds, 15 seconds, 20 s, or more. Another often 120—1300C for 10 to 20 minutes. process used to ensure sterility is retort heat treatment — Examples of such heat treatments can have F0 values well in excess of the minimum old.

Other ations of equivalent heat treatment are known and are applicable to the present invention given riate adherence to the requirements of ial ity and sterility. Other known art non—thermal ses can be used in combination with heat treatment to inhibit microbiological activity in the liquid nutritional composition. One skilled in the art can calculate the equivalent heat treatment time at a different temperature by using the 2 value, as demonstrated in the table below Reference Temp (°C) Equivalent time (s) at Reference Temp “—5000000 7553552 755355 476597 Heat stability of the liquid composition includes having no gelation, or aggregation either directly after heat ent or after prolonged storage at temperatures of about 20°C.> e.g. at least 3 months or preferably at least 6 months or 12 months.

Gelation of a liquid nutritional ition is considered to be a change in state from a liquid to a soft to firm solid. Gelation can be assessed visually and by touch. If the on no longer flows following heating, it is considered to have gelled.

To attain the required sterility while maintaining liquidity, the proteins must be stable to the heat treatment conditions. The nutritional composition has been found to be surprisingly stable to the required heat treatments in the pH range 4 to 6.

An exemplary method for assessing the heat stability of milk is well known in the art. The method of heat coagulation time (HCT) involves sealing a milk sample (1—2 mL) in a glass tube which is clipped onto a platform and placed in a silicone oil bath thermostatically controlled at 140°C with a defined rocking rate. The length of time that elapses between placing the container in the oil bath and onset of visible ates formation is defined as the HCT (Singh H & Creamer LK (1992), 4429721-1 Determination of heat stability, In: Advanced Dairy Chemistry e.d. Fox PF Elsevier). Applicants e, without wishing to be bound by any theory and based on their experience including that described herein, any liquid nutritional composition having a heat coagulation time of less than 655 has a high risk of extensive fouling and blocking of UHT heating ent, while any liquid composition with 65—805 HCT has a potential risk of fouling. As described herein, liquid nutritional compositions having heat coagulation time of higher than 805 is stable to UHT heating treatment at 140°C for 5 s.

In one embodiment, an exemplary liquid composition prepared with a native \WPC (392) having a pH of between about 4 and about 6 has an e coagulation time of 40 s. In the same embodiment, exemplary liquid compositions of the invention prepared with a non—hydrolysed whey protein wherein at least about 55% of the enaturable protein is denatured and having a pH of between about 4 and about 6 has an average coagulation time of greater than about 180 s (2 4 times the control) when heated at 140°C. For example, the liquid compositions of the invention having a pH of between about 4 and about 6 has an average coagulation time of greater than about 400 s, when heated at greater than about 800 s, greater than about 16 min, greater than about 30 min 140°C, depending on the method of making the protein ingredient. One skilled in the art should appreciate that any of these heat stability improvements greatly increases the ease of processing.

In one ment, an exemplary the liquid composition of the invention has an average coagulation time of greater than about 150 s when heated at 140°C at a pH within 0.5 of the average isoelectric point (pl) of the protein present in the composition. For example, the liquid composition has an average ation time of greater than about 170 s, greater than about 200 s, greater than about 300 s, greater than about 330 s, greater than about 360 s, or r than about 400 s when heated at 140°C within 0.5 of the average pl of the protein present in the composition. In the same embodiment, the liquid composition has an e coagulation time of less than about 80 s when heated at 140°C at a pH greater than 6.0.

In certain embodiments, the heat—treated, substantially denatured whey protein, for example the WPC or \WPI, is dried and then rehydrated in the composition or in an aqueous component of it. In n ments, the heat—treated, substantially denatured WPC has at least 35%, at least 55% (on a moisture and fat—free basis), for e at least 70% protein and in certain embodiments at least 80% protein.

The heat d, substantially denatured liquid \WPCS (without drying) may also be used with the same n concentration characteristics as defined for the dried ingredient. 4429721—1 The heat—treated, substantially denatured W PC, or the liquid ional composition, may be treated with an enzyme to further reduce the lactose concentration e.g. by a alactosidase—treatment.

In certain embodiments the heat treated, substantially red whey protein, for example the WPC or \VPI, is dried to a moisture content of less than 5%, or a water activity level that facilitates storage of the dry ingredient for several months without undue deterioration.

Exemplary proteins for use in the invention include whey proteins, such as whey protein concentrates and whey protein isolates. Whey protein is recognised as a complete protein known for its excellent amino acid profile which provides all of the essential amino acids, high cysteine content, high e content, ease of ion, and for providing proteins associated with bioactivity, such as lactoglobulins, immunoglobulins, and lactoferrin.

WPC is rich in whey proteins, but also contains other components such as fat, e, and, in the case of cheese whey—based WPCs, glycomacropeptide (GMP), a casein— related non—globular protein that is non—denaturable. Typical methods of production of whey protein concentrate utilise membrane filtration, and alternative methods of production of WPC particularly suited to application in the present invention are described herein. ingly, as used herein “WPC” is a fraction ofwhey from which lactose has been at least partially removed to increase the protein content to at least 20% (w/w). In certain embodiments, the WPC has at least 35%, at least 40%, at least» 55% (w/w), at least 65%, and in certain embodiments at least 80% of the total solids (TS) as whey protein. In some examples, the proportions of the whey proteins are ntially unaltered relative to those of the whey from which the WPC is derived. In one embodiment, the \‘VPC is an evaporated whey protein retentate.

For the purposes of this specification, the term “WPC” es WPIs when the context .

Particularly plated WPI include \WPIs and \WPCs having at least 90% of the TS of whey protein.

WPI consists primarily of whey proteins with negligible fat and lactose content. Accordingly, the preparation of WPI typically requires a more rigorous separation process such as a combination of micro filtration and ultra— filtration or ion exchange chromatography. It is generally recognised that a WPI refers to a composition in which at least 90 weight 0/0 of the solids are whey proteins.

Whey proteins may originate from any mammalian animal species, such as, for instance cows, sheep, goats, horses, buffalos, and camels. Preferably, the whey protein is bovine. 44297214 _g5_ In certain exemplary embodiments, the whey protein source is available as a powder, preferably the whey protein source is a WPC or WPI‘ In certain embodiments, for example of the liquid nutritional composition, the heat-treated or denatured protein, for example the W PC, comprises less than 90% by weight n. For example the heat—treated or denatured protein comprises at least 51% by weight protein, in certain embodiments at least 70%, in certain ments at least 80% n, wherein at least 55% of the total denaturable protein is in red state.

Other protein that may be included in the liquid nutritional composition includes mixtures of milk proteins, in n ments provided from a milk protein concentrate, casein, caseinate, or similar, provided that it does not impact on heat stability of the nutritional composition, wherein at least 50%, or in certain embodiments at least 80%, of total solids as protein.

In one example, the invention relates to a method of preparing a liquid nutritional composition, the method comprising a) providing an s WPC or WPI solution having a protein concentration of 15—50% (w/v), at a pH of 5; b) heat treating the solution to more than 50°C, for a time that allows n denaturation to conditions of turbulent occur; the heat treating comprising heating the solution while under flow, for example with a Reynolds number of at least 500; c) at the end of the heat treatment combining the heat treated WPC or WPI with other ingredients to provide a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of protein from the heat treated WPC or \WI, d) heat treating the liquid ition with a heat treatment has an FO—value of at least equivalent to 90°C for 40s, and e) recovering the liquid composition, wherein the liquid composition has f) a viscosity ofless than 200 cP when measured at 20°C and shear rate of 100 5—1, or g) an average particle size of less than 20 pm as categorised by the volume weighted average particle size parameter D[4,3], or h) exhibits essentially no observable gelation or aggregation.

The fat used may be vegetable fat or animal fat, including dairy fat and fish oils. Vegetable oils are often ary because of their ease of formulation and lower saturated fatty acid content.

Exemplary vegetable oils include canola eed) oil, corn oil, wer oil, olive or soybean oil. 44297214 -26— The liquid nutritional composition typically will not require but may also include fiers such as in addition to the WPC. soya in or phospholipids and the like The ydrate used typically comprises digestible carbohydrate as 75—100% of the ydrate.

The carbohydrate may comprise monosaccharides, disaccharides, oligosaccharides and polysaccharides and mixtures thereof. Oligosaccharides of glucose are typically used. A number of these are commercially available as maltodextrin (3-20 DE) or corn syrup for the longer chain ydrates (>20 DE). gestible carbohydrates may also be included, for example, fructooligosaccharides, inulin, and galactooligosaccharides. These are typically present in amounts of 0.2-50/0 of the composition. Fibre, including insoluble fibre, can also be included.

In exemplary embodiments the liquid nutritional composition is a nutritionally te composition or a high energy liquid or powder for breakfast or other times of the day.

Examples The following es further illustrate practice of the invention.

Example 1 Heat stability of exemplary liquid nutritional ation prepared with whey proteins at varying denaturation levels This example demonstrates the heat stability of various exemplary liquid nutritional compositions prepared at pH 5.4, comprising substantially red whey protein to determine their suitability for use in formulations of the t invention. filer/Jodi The exemplary nutritional formulations were prepared according to Table 1 using denatured \VPC powders (Powder A to I) or native whey (\WPC 392) detailed in Table 2. The method of preparation of the nutritional formulations is described in Figure l. The pH of each formulation was adjusted to pH 5.4 prior to heating in oil bath at 90°C. The time of Visual aggregation for each formulation at 90°C was determined.

Table 1: Composition of exemplary liquid nutritional formulations Components 0/0 wt Protein powderi varies Corn oil 2 Sucrose 4.2 44297214 Maltodextrin 6.3 Lecithin O. 1 in powder was added to obtain 4% by weight protein in the final formulation 44297214 Ho Had 9“ 530a coflwfiawb? 3 wmcfiHuxo HEHHWHHAHHFH \Ho CH? kuHHmHHnHSnH \3 \HnH 038 uHéS whoH @8352.HEN d HouSwEonm< 0%? Hag? H u OUHH>H \lww “Sam “ 1638800 HEPUEEOU. MN.\10000\oHONNH/QFUnH coma H H wmw ooHomH\oHONO\x/ o MH nH me >aH< mN.\IOOOO\QHONNH/H\rH.UnH 0 an :oHunHHuoqu FHBHB GOHEmeabHS 9 u 8 NH OH ma H SHBQOHH SHBGOHH wcHHéoUUmN : : : : : HHU. HE: mm: MEGS mcHHVH0u0< QOHONH\OHONO\X/ u : : u Sou nE < 5m Boom avg/H Heady mHo\cOH oawmewmww 8: €380 migom .588m GcHusHom “H35 Ho oH H H o v Nb H5 0 0 .

H wNB RN HH.m CNN CNN 0 CNN Hud Hm Om.NH mmN HQH IWNI meeoHH Ewaim oaamouwm< 8: .Ho . oNHm 583m :oHasHom H35 on 0min NcH NON ONN mHN . HoH mom mo oH .

H 00H NoH - - H oHim Uufldmaofl . 533m o - \o 0 - mp co Hum on mm hm - mo No 0% NH. E Hum @8630 ZH «3 \ w. So Eu anHSawfivQ H 335.256 M 338m 0 \o mm? Ho mo mH HN wN wH HH w H aH m mo1 H‘H vH oH e\o A .Ho £33m 23:50 x m m H Hdw Dow odw 0.0m. 0.0m m 0 £350 ZH . . . . . cm :00 E. ow Qmm odw mm mHm 500 m‘Hw 500 ® ”N < U Q mH .nH E 58on m vH H SH No 38 H 8 283; wag/H mug mama? m MuuHuBonH EHUBOnH HoHuBonH HquBonH BHSVOAH UuuHuBoaH ESQHSUGH onH Hmg: BUNK/om HVBstuEmnHOSG/H Hu NEH? BO .m H SHE/om EHS/onH .UHUBOAH H.HNSNSN Table 3: Heat coagulation time of exemplary liquid nutritional formulations B C D E F G {H I coagulation 40$ >30niin >30min fin >30min >30min >30min 1805 400$ 800$ times Rem/Zr The formulations comprising denatured WPC (Powders A to F), showed superior heat stability compared with a native WPC (392) at pH 5.4 as shown in Table 3. The differences in heat stability for powders made using different manufacturing procedures demonstrates that producers have a wide choice of ingredients to use to make this invention work. One using this invention should select the protein ingredient to best suit their process.

These results show that the liquid nutritional formulations of the invention are heat stable following the heat treatment applied to control microbial growth at pH 4 to 6.

Example 2 Heat ity of exemplary liquid nutritional formulation (10g protein /100 ml) across a range of pH values This example describes the preparation of exemplary heat stable liquid nutritional formulations comprising substantially denatured W PC, and an assessment of their heat stability across a range of pH . 52’s A liquid nutritional formulation of 1.6 kcal/mL, comprising 10% protein in the form of powder A was prepared as shown in Table 4, following the method of Figure 1.

Table 4: Exemplary high protein liquid nutritional formulation % protein ’— :lO/ow/w \Water 6 8. 1 6 n powder A 11.7 Sucro s e 5.7 5 Maltodextrin Maltrin M180 Tri-Sodium Citrate Di—Hydrate .10 Di—sodium Phosphate 0.12 Potassium de 0.17 Magnesium Citrate 0.12 lcium Pho_sp_hate 0.19 Seakem 614 geenan) 0.06 442972171 j— —I Novagel GP2180 (microcrystalline cellulose) 0.20 hin 0.13 Corn Oil 5.00] ntifoam 0.005 Total batch size 100 The pH of the formulation was adjusted within the range of pH 5.1 — 7.1 and all samples underwent heating in an oil bath at 140 °C, or heating in a retort at 121 0C for 10 minutes. The formulations at pH 5.1 and 6.8 also underwent heat treatment h UHT/Direct Steam Injection (DST) unit at 140 CC for 5 seconds.

The heat coagulation times ing heating in oil bath at 140 °C were recorded, and the retorted The viscosity, cans were visually assessed for the presence of aggregates, gel formation or lumps. particle size, creaming and sedimentation of the formulation at pH 5.1 and pH 6.8 were assessed as described herein immediately following UHT/DSI heat treatment at 140 0C for 5 seconds, and after 1 and 3 months e at ambient temperature (20 OC) following UHT/DSI treatment. Sensory descriptive is of the organoleptic properties of the formulations was performed. Twelve panellists d in descriptive analysis of these beverages, were presented with the chilled coded samples and instructed to score them for aroma and flavour attributes using a 150 point scale, where 1 I absent and 150 : intense.

Rem/fr The formulations showed increasing heat stability at decreasing pH. Figure 2 shows that the heat coagulation time of the formulation was increased at lower pH, particularly in the range of pH 5.1— .6. Figure 3 shows that at lower pH, the formulation did not gel after retorting and remained a low viscosity liquid at a range of pH, particularly pH 5.1 — 5.7, while at pH>6.0 gel ion and lumps were observed.

Figure 4 shows that the viscosity and particle size of the formulation was d following the heat ent applied to provide microbial control at pH 5.1 compared with pH 6.8. Table 5 shows that following heat treatment at pH 5.1, the formulation had reduced eggy aroma and taste, and increased sour taste compared with the formulation treated at pH 6.8. At pH 5.1, the formulation had a lower viscosity and was less y. 44297214 Table 5: Sensory descriptive analysis mean scores of exemplary high n liquid nutritional ations at pH 5.1 and pH 6.8 pH 5.1 pH 6.8 Eggy aroma 39.1 55.3 Creamy aroma 30.3 30.6 Cooked aroma 27.6 29.6 Cowy aroma 15.1 15.00 Cereal aroma 8.9 11.00 Sweet 62.4 70.7 Salt 10.6 10.6 Sour 81.8 1.1 Bitter 0.04 0.04 Eggy 23.7 40.6 Creamy 31.9 34.8 Cooked 31.1 32.8 Cowy 13.4 14.4 Cereal 9.4 12.7 Consistency 62.9 76.1 Powdery 0.7 4.2 Mouthcoating 27.4 29.3 These results te that the liquid nutritional ations of the invention are heat stable and exhibit favourable organoleptic properties following heat ent at lower pH. This also provides the manufacturer of beverages with the ability to flavour products differently.

Example 3 Heat stability of exemplary liquid nutritional formulation with varying protein This e demonstrates the heat stability of liquid nutritional formulations comprising powder A at low pH, compared with other whey protein sources.

Method; A liquid nutritional formulation at 1.6 kcal/mL was prepared comprising 10% protein in the form of Powder A, whey protein hydrolysate (\WPH 7080), native whey (\WPC 392) or whey protein isolate (\X/Pl 895) on the basis of the recipe shown in Table 4. A flow chart of the method is shown in Figure 1.

The pH of the formulations was adjusted to pH 5.0 prior to heat treatment applied to provide microbial control. All samples underwent heating in a rotary retort at 121 °C for 10 minutes. The retorted cans were visually assessed for the presence of aggregates, gel formation or lumps. 4429721-1 Rem/i5 The ation comprising powder A did not gel after heat treatment, whereas the formulations comprising native WPC and WPI gelled as shown in Figure 5. The formulation sing the whey protein hydrolysate did not gel, but showed severe phase separation of the oil phase, in on to the excessive browning making such a product undesirable to consumers. This result tes that the liquid nutritional formulations of the invention are heat stable and organoleptically favourable following heat treatment at pH 4-6.

Example 4 Robustness of exemplary liquid nutritional formulations to UHT conditions This example bes the preparation of an exemplary liquid nutritional formulation comprising powder A, and an assessment ofits heat ity at pH 5.4 and pH 6.8 across a range of UHT conditions.

Method; A liquid nutritional formulation at 1.6 kcal/mL was ed comprising 10% protein in the form of Powder A on the basis of the recipe shown in Table 4. A flow chart of the process is shown in Figure 1.

The pH of the formulation was adjusted to pH 5.4 or pH 6.8 prior to heat treatment applied to provide microbial control. The viscosity, particle size, creaming and sedimentation of the formulations were assessed following UHT/indirect steam injection treatment at a temperature in the range of 138—148 °C for a holding time in the range of 5—20 seconds and following subsequent homogenisation at 150/50 bar.

Rem/tr At pH 6.8, the formulation was not stable at any heating ions, including the at the lowest time/temperature conditions (138 °C for 5 seconds) and could not be processed at UHT/indirect because of extensive fouling and blocking of the UHT equipment. However, at pH 5.4, the formulation did not gel and sedimentation, ng, Viscosity and sedimentation remained favourable at all temperatures and all holding times as shown in Table 6. At pH range of 4.0—6.0, the liquid compositions are more robust to wider time/temperature heating conditions. 44297214 Table 6: Heat stability of exemplary high protein liquid nutritional formulation After UHT/Indirect treatment and post homogenization g times t (sec) at a flow TempOC characteristics rate of (UHT/lndi after Sedimentation Creaming Particle size Viscosity cP 1L/min rect) pgcessing % 0/o D(4,3 um) 100 5'1 '— 18.9 146.50 1 Smooth 4.52 i 0.14 0.90 15.87 18.9 139.50 Smooth 2.52 0.19 0.93 16.03 6.9 143.00 Smooth 2.78 0.32 0.88 17.13 6.9 138.00 Smooth 2.78 0.30 0.86 16.63 6.9 148.00 Smooth 3.12 0.30 0.90 16.86 8.9 139.50 Smooth 2.50 0.10 0.88 15.93 8.9 146.50 Smooth 2.36 |_0.22 0.88 15.86 Ii 13.9 138.00 Smooth 2.48 0.36 0.82 16.94 13.9 148.00 Smooth 2.60 0.28 0.85 17.19 13.9 143.00 Smooth 2.62 0.22 0.85 17.19 23.9 143.00 Smooth 3.00 0.40 0.82 15.83 23.9 138.00 Smooth 3.04 0.36 0.81 15.26 23.9 148.00 1 Smooth 3.20 L040 0.88 16.23 This result indicates that the liquid nutritional formulations of the invention are heat stable following heat treatment at pH 4—6.

Example 5 Heat stability of exemplary liquid nutritional formulation (13.8 g protein /100 This example describes the preparation of an exemplary liquid nutritional formulation comprising powder A, and an assessment ofits heat stability at pH 5.4 and pH 6.8 across a range of UHT conditions.

Mei/Jodi A liquid ional formulation at 2.4 kcal/mL was prepared comprising 13.8% protein in the form of powder A on the basis of the recipe shown in Table 7. A flow chart of the process is shown in Figure 1.

Table 7: Exemplary high n liquid nutritional formulation 13.8% protein Water total 58.4 Protein powder A 15.7 Sucrose 8.8 Maltodextrin Maltrin M180 4.4 44297214 Tri—Sodium Citrate Di—Hydrate 0.17 Tri-Potassium Citrate Monohydrate 0.19 Potassium Chloride 0.08 ium Chloride 0.16 Tri—Calcium ate 0.24 Novagel GP2180 (microcrystalline cellulose) 0.35 Lecithin 0.20 Corn Oil 11.23 Antifoam 0.005 Total batch size 100 The pH of the formulation was adjusted to pH 5.4 or pH 6.8 prior to heat treatment applied to provide microbial control. The viscosity, particle size, creaming and ntation of the formulation at pH 5.4 were determined after UHT treatment by D81 or indirect steam at a 01 temperature of 140 0C for 15 seconds, and following subsequent homogenisation.

Rem/Zr At pH 6.8, the formulation could not be processed by given heat treatment (140 0C for 15 seconds) because of fouling and blocking of the plant. At pH 5.4, the formulation did not gel; creaming, Viscosity and sedimentation ed acceptable following heat treatment and subsequent homogenisation (Table 8).

The formulation comprising 13.8% protein of this example, and the formulation of Example 2 comprising 10% n maintained their Viscosity after 6 months of storage following heat treatment as shown in Figure 6.

Table 8: Heat stability of exemplary high n liquid nutritional formulation Sedimentation Cream TS Viscosity D [3,2] D [4,3] 0/o ("/0 (0/0) (cP@100 5'1) (um) (um) Recombined base 40.8 0.96 0.33 66.5 0.25 0.66 UHT/DSI ent 40.9 2.01 1.83 44.7 0.36 0.92 UHT/DSI and post 40.6 2.07 0.65 41.8 0.30 0.75 homogenization.

UHT/indirect treatment 40.9 0.72 3.46 72.4 0.51 2.17 UHT/indirect and post 41.1 1.35 0.43 59.5 0.33 0.85 homogenization‘ 4429721—1 This result indicates that the liquid ional formulations of the invention are heat stable following heat treatment applied to provide microbial control at pH 4—6 and are stable over long term storage.

Example 6 Heat stability of ary liquid nutritional formulation with high mineral content This example demonstrates the heat stability at pH 4—6 of exemplary liquid nutritional itions with increasing mineral levels; Mei/90:75 Liquid ional formulations at 1.6 kcal/mL were prepared comprising 10% protein in the form of powder A, with differing mineral content as shown in Table 9‘ The levels of minerals (sodium, ium, calcium, phosphorous, magnesium, chloride) were selected according to the European Commission guideline on Food for Special Medical Purposes (FSMP) directive. For each mineral, the minimum and maximum concentrations were used according to the recommended levels, as well as the mid—point was ated.

Table 9: Mineral content of exemplary high protein liquid nutritional formulations lVlin mineral int of the Max l levels - levels recommendations Water 70.92 70.92 70.92 Protein powder A 11.66 11.66 11.66 Sugar 5.18 5.18 5.18 Maltodextrin Maltrin M18 5.18 5.18 5.18 SeaKem (carrageenanl 0.05 0.05 0,05 Novagel GP 2180 (microcrystallinc 0.20 0.20 0.20 cellulose) Lecithin 0.15 0.15 0.15 Canola Oil 6.66 6.66 6.66 Tri—Sodium e Dihydrate 0.08 0.54 0.99 Tri—Potassium Citrate Dihydrate 0.01 0.1 8 0.35 Potassium Chloride 0.05 0.24 0.42 Tri~Calcium Phosphate 0.06 0.30 0.56 Magnesium Chloride 0.03 0.14 0.25 Total 100 100 100 The pH of each formulation was adjusted to a pH in the range of pH 4.8, 5.1, 5.4 and 7.0.

Coagulation time of the formulations was ed during heating in an oil bath at 140 0C.

Rem/zit 4429721 -1 _ 36 - At pH 4.8, 5.1 and 5.4, all formulations had long coagulation times as shown in Table 10.

Table 10: Coagulation time (seconds) at 140 °C of exemplary high protein liquid nutritional formulations with added minerals Formulation pH 4.8 pH 5.1 pH 5.4 pH 7.0 Min minerals 150 357 372 point minerals 297 193 107 Max minerals 1 62 130 8315 Predictive behaviour of formulations at UHT based on heat coagulation times (3) >80 Sec Stable at UHT These results te that liquid nutritional formulations of the ion with high mineral content are heat stable following heat treatment at pH 4—6 compared to neutral pH. This provides considerable flexibility to producers of medical foods to adjust their composition of the nutritional compositions. Some nutritional compositions may require to contain high concentrations of ions to comply with specific nutritional benefits (bone , hydration etc.) Example 7 Heat stability of exemplary liquid nutritional formulation with high n content (20g protein /100 mL) This example investigated the heat stability at pH 4—6 of exemplary liquid nutritional formulations with high protein content.

Mex/m Liquid nutritional formulations at 2.4 kcal/mL were prepared sing 20% n in the form of Powder A, on the basis of the recipe shown in Table 11. A flow chart of the process is shown in Figure 1.

Table 11: Exemplary high protein liquid nutritional formulation Composition Protein 20% Fat 13% 4429721—1 Carbohydrate 1 1% Energy 2.4kcal/mL Formulation 0/0 \Water 57.3 Proteinpowder A 23.4 Sucrose 4.2 Maltodextrin IT47 4.2 Lecithin 0.2 Canola Oil 10.7 The pH of the formulation was adjusted to pH 5.0 and the formulation was subjected to heat treatment in a rninipasteuriser equipped with a plate heat exchanger for indirect heating at 90 °C for seconds. Process conditions were as follows: the flow rate was 30 litres/hour preheat temperature for 5 was 70°C; heat treatment was 90°C for 305, filling temperature was 4°C. The plant was run minutes prior to filling to ensure that all of the water was flushed out of the system. Product was filled into 200ml PET jars and stored at ambient temperature until required. The Viscosity and particle size of the formulation were ed before and after heat treatment.

Rem/fr The formulation was successfully heat treated without fouling of the minipasteuriser. The formulation did not gel ing heat treatment and there was no significant change in viscosity or particle size as shown in Table 12, indicating the formulation withstood heat treatment t any s to its physical ties.

Table 12: Heat stability of exemplary high protein liquid nutritional formulation Viscosity {CP} at 1008'] (:143 (um) d32 (urnL _| Recombined base 193 0.74 0.29 Heated at 90°C for 305 157 | 0.78 0.29 These results indicate that liquid nutritional formulations of the invention with high protein content are heat stable following heat treatment at pH 4—6.

Example 8 Exemplary liquid nutritional formulation in smoothie form This example bes the preparation of an exemplary liquid nutritional formulation in the form of a ie.

Mei/70d; 4429721-1 —38— Smoothies were ed comprising 5% protein in the form of powder A, WPI 895 or WPC 392) 1% pectin, 10% sucrose and no added fat.

The sucrose was divided into two portions: the first portion of sucrose was dry blended with the pectin in the ratio of 1 part gum to 5 parts sucrose, the remaining sucrose was dry blended with the protein ingredients. The protein/ sucrose blend was recombined into ambient reverse osmosis water equal to approximately 45% of the final weight and stirred for a further 60 minutes to fully hydrate.

The pectin/ e blend was added with constant stirring to RO water (approximately 35% of the final weight) at 60—70°C and d for a further 30 minutes in order to fully hydrate. The pectin mix 1:1 blend of 50% citric and was then added to the protein mix and allowed to mix for 5 minutes. A 50% lactic acid was then added rapidly with stirring to bring down the pH to 4.0. The mixture was adjusted to the final weight with R0 water, then homogenised at 150/50 bar in an APV Rannie homogeniser.

Smoothies were heat treated in a minipasteurizer equipped with a plate heat ger for indirect heating. Process conditions were as follows: the flow rate was 30 litres/hour preheat ature was run for 5 was 70°C; heat treatment was 90°C for 305, filling temperature was 4°C. The plant minutes prior to filling to ensure that all of the water was flushed out of the system. Product was filled into 200mL PET jars and stored at ambient temperature until ed.

Samples were assessed for separation, sedimentation and viscosity at time zero and after 3 months storage at 30°C.

Rem/2‘5 The viscosity of the smoothies over three months is shown in Figure 7A. The smoothie comprising WPI 895 showed very rapid separation and ntation on storage at 30°C, therefore the viscosity over was not measured. The smoothie comprising WPC 392 did not separate but formed particles time (Figure 7B) and also began to increase in viscosity after the second month, which would detract from the mouthfeel of the product. The smoothie comprising denatured protein r A) ed a low ity and did not separate. The Viscosity of the product decreased with time, but appeared to be stabilising after three months.

Informal sensory analysis of the smoothies showed that the formulation comprising powder A had superior organoleptic ties to the smoothies comprising WPI 895 and \‘VPC 392. At 5% protein the WP1 895 was more astringent, whereas the WPC 392 had both high astringency and wet wool notes. 4429721-1 These results demonstrate that liquid nutritional formulations of the invention in ie form are stable following heat treatment at pH 4 and retain optimal viscosity and organoleptic properties following storage.

Example 9 ary liquid nutritional formulations sing 55% denatured protein blends This example investigated the heat ity at pH 5.4 of liquid formulations comprising 55% red protein. The formulations comprised a protein blend of denatured, and undenatured or hydrolysed proteins.

Met/Jody Liquid nutritional formulations of Table 13 were ed as per Figure 1. To obtain a nominal 55% denaturation level, powder A (comprising 75% denatured protein) was mixed with other protein of the protein was sources at a ratio of 75:25. For example, to prepare a 4% protein formulation, 3% provided by powder A, while 1% was obtained from other protein sources (whey protein isolate (\WPI), whey protein hydrolysate (\X/PH), whey protein concentrate (\WPC) or soy protein isolate (SP1). Heat stability testing was conducted by retorting at 121°C for 10 min. After retorting, the visual appearance of every sample was noted. If any of the samples after retorting were still liquid, and no visible aggregates were seen, then they were tested for viscosity and particle size. 4429721-1 Table 13: Liquid nutritional formulations comprising protein blends of 55% protein denaturation a 1 Formula 2 Formula 3 Formula 4 Formula 5 , Powder Powder Powder Powder A A+WPI A+\WPH A+VVPC Powder A+SPI (1000/31 75:25 (75$) 75:25) (75% Water 82.34 82.54 82.52 82.36 82.46 Powder A (791% protein) 5.06 3.79 3.79 3.79 3.79 WPI 895 (93.9% rotein) 0.00 1.06 0.00 0.00 0.00 WPH 821 (91.9% protiin) 0.00 0.00 1.09 000 0.00 we 392 (80.1% ‘l fltein) 0.00 0.00 0.00 1.25 i 0.00 SPI Supro (87% protein) 0.00 0.00 0.00 " 1.15 Sucrose 4.20i0.00 4.20 4.20 4.20 4.20 extrin Maltrin M18 6.30 6.30 630‘}, 6.30 6.30 Lecithin 0.10 0.10 0.10J_ 0.10 0.10 Canola on 2.00 l— 2.00 2.00 2.00 2.00 |_Total 100.00 100.00 100.00 100.00 100.00 Rem/2‘5 The Visual assessment, Viscosity and particle size of the formulations after retort treatment is shown in Table 14. The results show that when Powder A was blended with other proteins to achieve a nominal 55% denatured whey protein level, the blends had substantially longer heat coagulation times than WPC392 at pH 5.4.

The results indicated that the blends providing a nominal 55% denatured whey protein were heat stable to retort process and s did not gel after heating at 1210C for 10 min with the ion of the formulation comprising Powder A+SPI (formula 5) that was not stable after retorting at pH .4. 4429721—1 _41_ Table 14: Assessments of liquid nutritional formulations comprising n blends after retorting at 121°C for 10 min.

Formula 1 a 2 Formula 3 Formula 4 Formula 5 —l Powder Powder Powder Powder A A+WPI A+WPH A+WPC Powder A+SPI 100%) {415225) (75:25) £525) Q5225) Visual COflg‘flated’ Liquid Liquid Liquid Liquid assessment large aggregates Viscosity 2.9 1i“ 2.8 J 3.2 n.d.

CP at 1005.1 le size T 1.01 1.06 1.15 1.17 n.d di4>3l Hm Particle size 0.39 0.33 0.38 0.38 n.d. d[3,2] urn J— These results demonstrate that liquid nutritional formulations comprising blends of different n powders to obtain a minimal 55% n denaturation level showed ed stability to heating at pH 5.4 ed with native WPC. One skilled in the art would know to adjust blending ratios if powders have different denaturation levels.

Example 10 Heat stability of exemplary liquid nutritional formulations comprising denatured WPC ingredients with varying protein concentration 1O This example describes the preparation of an exemplary liquid nutritional formulation comprising denatured \WPC ingredient of varying protein concentration.

Met/70d; Four denatured whey protein powders with a protein t of 28%, 51%, 67% and 81% by weight the powders were ed (powders J—M in Table 2). Liquid nutritional formulations comprising were prepared according to Table 15 according to the method of Figure 1. Each formulation comprised a final protein concentration of 4% by weight. The formulations were homogenized at 250/50 bar twice, and the pH of each beverage was ed in the range 4.3 to 5.8 prior to heat treatment.

Table 15: Liquid nutritional formulations comprising powders of varying protein content Formula 1 Formula 2 l Formula 3 Formula 4 Formula 5 Powder A Powder ] ‘ Powder K Powder L Powder M 1 Water 82.34 72.89 1 79.60 81.40 82.49 1 Powder A J 5.06 0.00} 0.00 L 0.00 0.00 l Powder] 0.00 14.51 0.00 0.00 0.00 4429721-1 Powder K ._ 0.00 7.80 0.00__ 0.00 Powder L 0.00 0.00 , 6.00 0.00 Powder M l 0.00 4.91 . 0.00 0.00 Sucrose 4.20 4.20 4.20 4.20 4.20 Maltodextrin n M18 6.30 6.30 6.30 6.30 6.30 Lecithin 0.10 0.10 0.10 l 0.10 0.101 Canola 011 2.00 2.00 F 2.00 2.00 Total 41 100.002.00], 100.00 100.00 100.00 100.00 Heat stability testing was conducted by heating in an oil bath at 90°C, 120°C and 140°C as shown in Table 16. All samples were tested for retort stability at 121°C for 10 minutes. After retorting, the visual appearance of each sample was assessed. Samples that were still in liquid form with no visible aggregates were ted for Viscosity and particle size (Table 17).

Rem/tr All denatured whey n s showed substantial heat stability compared to native WPC (392) as shown in heat coagulation test in the oil bath at 90°C 120°C and 140°C (Table 16). Powder J was the least heat stable among all the powders and had the shortest heat coagulation times at all below 55% (46%, Table atures. However, this powder had a whey protein denaturation level Formulations that were stable to heat processing at pH 5.4 showed minimal increases in mean le size and viscosity as a result of retorting and would be considered commerciahrly acceptable.

Overall, the denatured \WPC powders comprising protein contents of 51% to 81% with similar whey protein denaturation levels provided better heat stability compared with native WPC (392). The result demonstrates that protein content of \WPC must be above 28%, while the ration level is above 55%.

Table 16: Coagulation times of liquid nutritional formulations comprising powders of varying protein content during heat treatment at 90°C, 120°C and 140°C. 90°C oil bath Tpliilj l RH 4.8 pH 5.1 [le5.4 H58 PowderA l > 30 min l > 30 min > 30 min > 30 min t_> 30 min Powder] 7145 6755 657s l 530s 315s Powder K 15585 > 30 min > 30 min l > 30 min 9205 Powder L 10895 > 30 min > 30 min > 30 min > 30 min Powder M l 532s > 30 min > 30 min > 30 min l > 30 min 4429721—1 W’PC 392 i 425 i 405 408 L40s J— 405 J 120°C oil bath Powder A Powder] Powder K Powder L Powder M 1735 1855 4915 2558 1825 WPC 392 345 L 365 375 405 425 140°C oil bath pH 4.3 pH 4.8 EH 5.1 EH 5.4 H 5.8 Powder A l 715 1205 94s 885 705 PowderJ 725 615 558 32s Powder K 938 525 Powder L 925 59s Powder M 833 WPC 392 Table 17: Visual assessment of liquid nutritional ations comprising denatured WPC powders of varying protein content after retorting at 120°C for 10 min. l a 1 Formula 2 Formula 3 ‘ Formula 4 Formula 5 1 Powder A ] Powder K ‘ Powder L Powder M Liquid, no Phase separation, Liquid, no Liquid, no Liquid, no Visual assessment Visible fine large coagulated Visible fine Visible fine Visible fine particles particles particles particles particles Viscosity 3.04 n.d. 3.93 2.99 cP at 1005'1 Parade Size “45] 1.08 n.d. 2.9 157 Pamleififle (”32] 0.36 n.d. 0.59 0.43 0.45 In this specification where nce has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context 4429721—1 for discussing the features of the invention. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of ation, in any jurisdiction, are prior art, or form part of the common general knowledge in the art.

It is not the intention to limit the scope of the invention to the entioned examples only. As would be appreciated by a skilled person in the art, many variations are possible without departing from the scope of the invention. For example, the percentage protein and the heat treatment of the WPC can be , as can the nature and proportions of the other components of the nutritional composition. 44297214

Claims (36)

1. A method of preparing a liquid nutritional composition, the method comprising a) reating a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non-hydrolysed whey protein, wherein the whey protein comprises or is provided by an ingredient that ses at least about 55% of the heat—denaturable protein present in a red state, and wherein the heat treatment has an Fo—value of at least equivalent to 90°C for 40s, and b) recovering the liquid composition, wherein the recovered liquid composition has c) a viscosity ofless than 200 cP when measured at 20°C and shear rate of 100 s—1, or d) an average particle size of less than 20 pm as categorised by the volume weighted average particle size ter D[4,3], or e) exhibits essentially no observable gelation or aggregation, or f) of (c) to any combination of two or more (e) above.

The method of claim 1 wherein the heat treatment is at least equivalent to 121°C for 10 minutes.

The method of claim 2 wherein the heat treatment is at least equivalent to 140°C for 5s.

The method of any of the preceding claims wherein the liquid nutritional composition exhibits no observable gelation, or no observable aggregation, or both, after storage for at least 3 months at room temperature.

The method of any of the preceding claims wherein the liquid nutritional composition comprises at least the amount of minerals as recommended by the European Commission Food for Special Medical es (FSMP) ive.

The method of any of the preceding claims wherein the liquid nutritional composition has when oing the heat ent a) a pH of n about 4.7 to about 6.0, or b) a pH of between about 4.8 to about 6.0, or c) a pH of between about 4.9 to about 60, or d) a pH of between about 5.0 to about 6.0, or e) a pH of between about 4.5 to about 5.7, or f) a pH of between about 4.5 to about 5.5, or g) a pH of between about 4.5 to about 5.3, or h) a pH of between about 4.5 to about 5.2, or i) a pH of between about 4.7 to about 5.5, or j) a pH of between about 4.7 to about 5.3, or 4429721-1 —46— k) a pH of between about 4.7 to about 5.2, or 1) a pH of between about 4.8 to about 5.3, or m) a pH of n about 4.8 to about 5.2, or n) a pH of about 5, or o) a pH of between about 4.2 to about 5.8, or p) a pH of between about 4.4 to about 5.8, or q) a pH of between about 4.6 to about 5.6, or r) a pH of between about 4.8 to about 5.4, or s) a pH of between about 4.9 to about 5.3, or t) a pH of between about 5.0 to about 5.2, or u) a pH of about 5.1, or V) a pH of between about 4.3 to about 5.1, or w) a pH of between about 4.6 to about 5.1, or X) a pH of between about 4.8 to about 5.1, or y) a pH of between about 5.1 to about 6.0, or z) a pH of between about 5.1 to about 5.8, or aa) a pH of between about 5.1 to about 5.6, or bb) a pH of between about 5.1 to about 5.4.

7. The method of any of the preceding claims wherein the liquid ional composition has when undergoing the heat treatment a) a pH of between about 4.1 to about 5.1, or b) a pH of between about 4.3 to about 5.1, or c) a pH of between about 4.5 to about 5.1, or d) a pH of between about 4.7 to about 5.1, or e) a pH of between about 4.9 to about 5.1, or f) a pH of between about 5.1 to about 6.0, or g) a pH of n about 5.1 to about 5.8, or h) a pH of between about 5.1 to about 5.6, or i) a pH of between about 5.1 to about 5.4, or j) a pH of between about 5.1 to about 5.2, or k) a pH of about 5.1

8. The method of any of the preceding claims wherein the liquid nutritional composition has when undergoing the heat treatment a pH of about 5.4.

9. The method of any of the preceding claims wherein the liquid nutritional composition has when undergoing the heat treatment a pH of about 5.1. 44297214

10. The method of any of the preceding claims wherein the liquid nutritional composition has when undergoing the heat treatment a pH of within about 0.5 of the average pl of the protein, or a) a pH of within about 0.3 of the average pl of the n, or b) a pH of within about 0.1 of the average pl of the protein> or c) a pH at about the average pI of the protein.

11. The method of any of the preceding claims wherein the non—hydrolysed whey protein is provided by a dry ingredient that comprises a protein content of 35% to 95% by weight of the dry matter of the ient.

12. A liquid nutritional composition comprising a) from about 2% to about 25% by weight of non-hydrolysed whey protein, wherein the whey protein comprises or is provided by an ingredient that comprises at least about 55% of the enaturable protein present in a denatured state, b) from 0 to about 30% by weight fat c) from about 0% to about 45% by weight carbohydrate and wherein the nutritional composition has when at a pH of between 4 and 6 undergone a heat treatment with an FO—value of at least equivalent to 90°C for 40s, and has d) a viscosity of less than 200 cP when measured at 20°C and shear rate of 100 s—1, or e) an average particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], or f) exhibits essentially no observable on or aggregation, or g) any combination of two or more of (d) to (i) above.

13. The liquid nutritional composition of claim 12 n the nutritional ition has a pH of between about 4 to about 6, and a viscosity of less than 200 cP at a temperature of 20°C and a shear rate of 100 s'1 and exhibits essentially no gelation or aggregation.

14. The liquid nutritional composition of claim 12 or 13 n the heat treatment is at least equivalent to 121°C for 10 minutes.

15. The liquid nutritional composition of claim 14 wherein the heat treatment is at least equivalent to 140°C for 5s

16. The liquid nutritional composition of any one of claims 12 to 15 wherein the liquid nutritional ition exhibits no observable gelation, or no observable aggregation, or both, after storage for at least 3 months at room temperature.

17. The liquid nutritional composition of any of claims 12 to 16 wherein the liquid nutritional composition ses at least the amount of minerals as recommended by the an Commission Food for Special Medical Purposes (FSMP) directive. 4429721-1 —48—

18. The liquid nutritional ition of any of one of claims 12 to 17 wherein the liquid nutritional ition has when undergoing the heat treatment cc) a pH of between about 4.7 to about 6.0, or dd) a pH of between about 4.8 to about 6.0, or ee) a pH of between about 4.9 to about 6.0, or ff) a pH of between about 5.0 to about 6.0, or gg) a pH of between about 4.5 to about 5.7, or hh) a pH of n about 4.5 to about 5.5, or ii) a pH of between about 4.5 to about 5.3, or jj) a pH of n about 4.5 to about 5.2, or kk) a pH of between about 4.7 to about 5.5, or ll) a pH of between about 4.7 to about 5.3, or mm) a pH of between about 4.7 to about 5.2, or nn) a pH of between about 4.8 to about 5.3, or 00) a pH of between about 4.8 to about 5.2, or pp) a pH of about 5, or qq) a pH of between about 4.2 to about 5.8, or Ir) a pH of between about 4.4 to about 5.8, or ss) a pH of between about 4.6 to about 5.6, or tt) a pH of between about 4.8 to about 5.4, or uu) a pH of between about 4.9 to about 5.3, or W) a pH of between about 5.0 to about 5.2, or w) a pH of about 5.1, or XX) a pH of between about 4.3 to about 5.1, or yy) a pH of between about 4.6 to about 5.1, or 22) a pH of between about 4.8 to about 5.1, or aaa) a pH of between about 5.1 to about 6.0, or bbb) a pH of between about 5.1 to about 5.8, or ccc) a pH of between about 5.1 to about 5.6, or ddd) a pH of between about 5.1 to about 5.4.

19. The liquid nutritional composition of any one of claims 12 to 18 wherein the liquid nutritional composition has when undergoing the heat treatment 1) a pH of between about 4.1 to about 5.1, or m) a pH of between about 4.3 to about 5.1, or n) a pH of between about 4.5 to about 5.1, or 4429721—1 o) a pH of between about 4.7 to about 5.1, or p) a pH of between about 4.9 to about 5.1, or q) a pH of between about 5.1 to about 6.0, or r) a pH of n about 5.1 to about 5.8, or s) a pH of between about 5.1 to about 5.6, or t) a pH of between about 5.1 to about 5.4, or u) a pH of between about 5.1 to about 5.2, or v) a pH of about 5.1

20. The liquid nutritional composition of any of any one of claims 12 to 19 n the liquid nutritional composition has when undergoing the heat ent a pH of about 5.4.

21. The liquid nutritional composition of any of any one of claims 12 to 20 wherein the liquid nutritional composition has when undergoing the heat treatment a pH of about 5.1.

22. The liquid nutritional composition of any one of claims 12 to 21 wherein the liquid nutritional composition has a viscosity of less than 150 cP at a temperature of 20°C and a shear rate of 100 54.

23. The liquid nutritional composition of any one of claims 12 to 22 wherein the liquid ional composition has a viscosity of less than 50 CP at a ature of 20°C and a shear rate of 100 s4.

24. The liquid nutritional composition of any one of claims 12 to 23 wherein the liquid nutritional composition has when oing the heat treatment a pH of within about 0.5 of the average pl of the protein, or d) a pH of within about 0.3 of the average pl of the protein, or e) a pH of within about 0.1 of the average pl of the protein, or f) a pH at about the average pl of the protein.

The liquid nutritional composition of any one of claims 12 to 24 having a) a pH of within about 0.5 of the average pl of the protein, or b) a pH of within about 0.3 of the average pl of the protein, or c) a pH of within about 0.1 of the average pl of the protein, or d) a pH at about the average pl of the protein.

26. The liquid nutritional composition of any one of claims 12 to 25 wherein the non— hydrolysed whey protein is provided by a dry ingredient that comprises a protein content of 35% to 95% by weight of the dry matter of the ient.

27. A powdered nutritional composition dispersible in water to form a liquid nutritional composition of any one of claims 12 to 26.

28. A method of ing a liquid nutritional composition, the method comprising 4429721-1 a) providing a liquid composition having a pH of between 4 and 6 and comprising about 2% to about 25% by weight of non—hydrolysed whey protein wherein the whey protein is provided by a dry ient that comprises at least about 55% of the heat— denaturable protein t in a denatured state, b) heat—treating the liquid composition with a heat ent having an Fo—value of at least equivalent to 90°C for 405, and c) recovering the liquid composition, wherein the liquid composition has d) a ity ofless than 200 cP when measured at 20°C and shear rate of 100 s~1, or e) an average particle size of less than 20 um as categorised by the volume weighted average particle size parameter D[4,3], or Q exhibits ially no observable gelation or aggregation, or g) any combination of two or more of (d) to (f) above.

29. A liquid nutritional ition prepared by the method of claim 28.

30. A food or food product sing, consisting essentially of, or consisting of a liquid nutritional composition of any one of claims 12 to 26.

31. Use of a liquid nutritional composition according to any one of claims 12 to 26 in the preparation of a medicament for providing nutrition to a subject in need thereof.

32. A method of claim 1 or 28 substantially as herein described with reference to any example thereof.

33. A liquid nutritional composition of claim 12 or 29 substantially as herein described with reference to any example f.

34. A powdered nutritional ition of claim 27 substantially as herein described with reference to any example thereof.

35. A food or food product of claim 30 substantially as herein described with reference to any example thereof.

36. A use of claim 31 substantially as herein described with reference to any example thereof. 44297214 ..___—__..__—.______ 9!;g Heat water to 500C Protein and r I 5 I l ' carbOhYdmte M a H ydrate for 30 min E blend I E i ________________ l " r________________; stabflyizejseat 8E°CH dr t th E :m’f Add the stabilizers blend. . I ________________i ‘ Prepare the oil— ' E surfactant blend 9 Add oil blend ..______.__________ Prepare a solution of I 2 ls & trace a Add mineral on ______...._____..___.n 5 Make up to the final volume and heat to 60°C r" W Homogenize at 600C (various j pressure recommendations) Cool down to 25C": 1 1 m“...mwm,w~-NWWH....muwu_wm.y Adjust to desired pl—l Heat treatment to provide microbial control Filling & Packaging