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Title:
NUTRITIONAL COMPOSITION AND PROCESS OF PREPARATION THEREOF
Document Type and Number:
WIPO Patent Application WO/2018/039037
Kind Code:
A1
Abstract:
A process for preparing a nutritional composition comprises (i) providing a solution comprising intact soy protein; (ii) heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein; (iii) cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution; (iv) homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30°C or less to form a homogenized soy protein solution; and (v) blending the homogenized soy protein solution with a source of fat to form a nutritional composition.

Inventors:
LIANG YICHAO (US)
LI JASON XIANG (US)
Application Number:
PCT/US2017/047377
Publication Date:
March 01, 2018
Filing Date:
August 17, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ABBOTT LAB (US)
International Classes:
A23J3/16; A23L33/00; A23L33/185
Foreign References:
US20020127325A12002-09-12
GB1533084A1978-11-22
JPH1118687A1999-01-26
CN103211081B2014-09-10
CN101019600A2007-08-22
JPS5362850A1978-06-05
EP2757898B12015-10-21
US4687739A1987-08-18
Attorney, Agent or Firm:
KOZLOWSKI, Holly (US)
Download PDF:
Claims:
A process for preparing a nutritional composition, the process providing a solution comprising intact soy protein;

heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein; cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution;

homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution; and

blending the homogenized soy protein solution with a source of fat to form a nutritional composition.

2. A process according to claim 1 , wherein in step (ii), at least a portion of the partially denatured soy protein is aggregated, preferably wherein the partially denatured soy protein has a volume-weighted mean particle diameter of from 35 to 75 pm.

3. A process according to claim 1 or claim 2, wherein in step (ii), the solution comprising intact soy protein is heated at a temperature of from 80 to 100 °C for from 5 to 30 minutes, or at a temperature of from 120 to 150 °C for from 1 to 5 seconds.

4. A process according to any of the preceding claims, wherein step (iv) is carried out at a temperature of 20 °C or less.

5. A process according to any of the preceding claims, wherein the process further comprises homogenizing the nutritional composition, preferably at a lower pressure than the pressure of step (iv), to form a homogenized nutritional composition.

6. A process according to any of the preceding claims, wherein the process further comprises:

(vi) thermally treating the nutritional composition to form a sterilized nutritional composition.

7. A process according to claim 6, wherein in step (vi), the nutritional composition is heated to a temperature of from 130 to 150 °C for from 1 to 5 seconds; and/or

in step (vi), the nutritional composition is retort-sterilized at a temperature of from 90 to 130 °C for 10 to 30 minutes.

8. A process according to any of the preceding claims, wherein the process further comprises:

(vii) drying the nutritional composition to form a nutritional powder.

9. A process according to claim 8, wherein immediately prior to step (vii), the nutritional composition is a slurry comprising at least 10 wt% intact soy protein by total weight of the slurry.

10. A process according to claim 8 or claim 9, wherein the slurry has a viscosity of less than 200 mPa.s as measured at a temperature of 20 °C and at a shear rate of 100 s"1; and/or

wherein the slurry has a total solids content of at least 40 wt% by total weight of the slurry.

11. A nutritional composition obtainable by the process according to any of the preceding claims.

12. A process for preparing a soy protein powder, the process comprising:

(i) providing a solution comprising intact soy protein; heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein;

(iii) cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution;

(iv) homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution; and

(v) drying the soy protein solution to form a soy protein powder. 13. A soy protein powder obtainable by the process according to claim 12.

14. Use of a soy protein powder according to claim 13 as an additive in the manufacture of a nutritional composition. 15. A nutritional composition comprising the soy protein powder according to claim 14.

16. A nutritional liquid comprising at least 10 g/100 mL protein and at least 650 mg/100 mL minerals,

wherein the protein comprises at least 50 wt% vegetable protein by weight of the protein, and

wherein the vegetable protein comprises at least 50 wt% intact soy protein by weight of the vegetable protein. 17. A nutritional liquid according to claim 16, wherein the nutritional liquid is sterilized.

18. A nutritional liquid according to claim 16 or claim 17, wherein the nutritional liquid is stable for at least 12 months at 25 °C ± 2 °C.

19. A nutritional liquid according to any of claims 16 to 18, wherein the nutritional liquid comprises fat, preferably wherein the nutritional liquid has surface-weighted mean fat droplet diameter of less than 1 pm.

A nutritional liquid according to any of claims 16 to 19, wherein the nutritional id has a pH of at least 5, preferably from 6 to 8, more preferably from 6.6 to 7.

21. A nutritional liquid according to any of claims 16 to 20, wherein the nutritional liquid has a viscosity of less than 200 mPa.s as measured at a temperature of 20 °C and at a shear rate of 100 s"1.

22. A nutritional composition according to claim 11 or 15 or a nutritional liquid according to any of claims 16 to 21 for use as a medicament.

Description:
NUTRITIONAL COMPOSITION AND PROCESS OF PREPARATION THEREOF

FIELD OF THE INVENTION The present invention is directed to processes for preparing nutritional compositions containing high levels of intact soy protein. The processes have been found to allow for high levels of intact soy protein to be included without causing an undesired increase in viscosity during wet-processing or reconstitution. As a result of these processes, low-viscosity, highly-fortified nutritional compositions comprising high levels of intact soy protein can be prepared. The invention is also directed to a soy protein powder for use in the preparation of nutritional compositions.

BACKGROUND In conventional nutritional compositions, the majority of the protein component is sourced from dairy milk. As a result of major fluctuations in the price of milk proteins over the last decade, there is a need for sourcing viable alternatives that can be used to replace at least a portion of the dairy protein component in a cost-effective manner without adversely affecting product characteristics.

In this regard, plant proteins have been identified as good candidates for use in both pediatric and adult nutritional products. For example, significant ingredient cost savings can be achieved by replacing part of the dairy protein component with soy protein. However, replacing a large proportion of milk proteins with plant proteins can lead to product quality and processability issues, such as high viscosity, poor heat stability, increased sedimentation and increased grain size.

In particular, commercial nutritional formulations are frequently prepared by wet processing, for example by blending the protein-containing slurry with slurries containing carbohydrate, fat and mineral components. The slurries are typically combined and held under sustained heat and agitation in order to ensure adequate mixing. Moreover, due to a requisite of at least six months of shelf-life, commercial nutritional compositions need to undergo some sort of sterilization treatment during manufacture in order to reduce the number of or remove possible pathogens, for instance spores, bacteria and other microorganisms, which cause spoilage of the nutritional composition. This sterilization treatment involves the application of heat.

The application of heat during wet processing has a tendency to cause soy protein to denature, precipitate, and in some cases gel when it is present at a high concentration. The resulting increase in viscosity makes the composition difficult to process. For example, where a nutritional powder is prepared, the slurry must be restricted to a low amount of total solids prior to spray-drying, since otherwise the slurry would be too viscous to process. Because of the high amount of water present, the drying process is slow and inefficient.

Moreover, for both liquid nutritional compositions and powders upon reconstitution, the resulting nutritional liquid can be highly viscous and grainy at protein concentrations of 10 g/100 mL or more where a significant proportion of soy protein is used to substitute dairy protein.

These product quality and processability issues are amplified where a highly fortified nutritional composition is desired. This is thought to be due to certain minerals interacting with the soy protein during processing, thereby increasing the likelihood of soy protein precipitation and gelation.

Accordingly, it is one object of the present invention to provide a soy-protein- containing nutritional composition that has lower viscosity, improved heat stability, reduced sedimentation and/or reduced grain size relative to existing nutritional compositions having similar concentrations of soy protein.

It is an alternative and/or additional object to provide a soy-protein-containing nutritional composition that is more highly fortified than existing soy-protein- containing nutritional compositions without compromising viscosity, heat stability, sedimentation and/or reduced grain size. It is an alternative and/or additional object to provide a process for preparing a soy- protein-containing nutritional powder in which the slurry can be processed at higher total solids and/or in which the drying step can be carried out more quickly.

It is an alternative and/or additional object to provide a heat-stable soy protein powder for use in the preparation of nutritional compositions which gives a low- viscosity liquid upon reconstitution at a high concentration of soy protein.

SUM MARY OF INVENTION Heat treatment and ultra-high-pressure-homogenization (UHPH) are two separately known techniques in the art. Surprisingly, it has been discovered that applying these two techniques in sequence to a soy protein solution greatly enhances the soy protein characteristics such that the application of heat during subsequent wet processing does not induce the expected increase in viscosity. The low viscosity is maintainable even where high levels of minerals are present. This in turn allows for the preparation of highly-fortified nutritional liquids containing high concentrations of soy protein, while maintaining a low viscosity and favourable product

characteristics. The same combination of heat treatment and UHPH can be used to prepare a soy protein powder that has advantageous physical properties, such as low viscosity and high heat stability, upon reconstitution in water or another aqueous liquid.

Accordingly, in a first aspect, the present invention provides a process for preparing a nutritional composition, the process comprising:

(i) providing a solution comprising intact soy protein;

(ii) heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially aggregated soy protein;

(iii) cooling the solution comprising partially aggregated soy protein to form a cooled soy protein solution; (iv) homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution; and

(v) blending the homogenized soy protein solution with a source of fat and/or a source of carbohydrate and/or a source of minerals to form a nutritional composition.

In a second aspect, the present invention provides a nutritional composition obtainable by the process of the first aspect.

In a third aspect, the present invention provides a process for preparing a soy protein powder, the process comprising:

(i) providing a solution comprising intact soy protein;

(ii) heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein;

(iii) cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution;

(iv) homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution; and

(v) drying the soy protein solution to form a soy protein powder.

In a fourth aspect, the present invention provides soy protein powder obtainable by the process of the third aspect.

In a fifth aspect, the present invention provides the use of a soy protein powder as described herein as an additive in the manufacture of a nutritional composition.

In a sixth aspect, the present invention provides a nutritional compositi

comprising the soy protein powder as described herein. ln a seventh aspect, the present invention provides a nutritional liquid comprising at least 10 g/100 mL protein and at least 650 mg/100 mL minerals,

wherein the protein comprises at least 50 wt% vegetable protein by weight of the protein, and

wherein the vegetable protein comprises at least 50 wt% intact soy protein by weight of the vegetable protein.

In an eighth aspect, the present invention is directed to a nutritional liquid as described herein for use as a medicament. The present invention also

encompasses a method of treatment of a subject by therapy, the method comprising administering to the subject a nutritional liquid as described herein.

BRIEF DESCRIPTION OF DRAWINGS Figure 1 is a flowchart illustrating the steps followed in a known method for the preparation of a soy-protein-containing oil-in-water emulsion.

Figure 2 is a flowchart illustrating the steps of one embodiment of a process for preparing a nutritional liquid in accordance with the present invention.

Figure 3 is a graph illustrating the effect of pretreatment of soy proteins [pre-heat condition (90° for 15 min) and homogenization pressure (1400 bar)] on the viscosity of unheated and heated (90 °C for 15 min) 8.5% (w/w) soy protein stabilized 10% (w/w) oil-in-water emulsions. The dashed line indicates the 100 cP viscosity mark.

Figure 4 is a graph illustrating the evolution of storage modulus (G) and loss modulus (G") of an 8.5% (w/w) SPI stabilized 10% (w/w) oil-in-water emulsion prepared in accordance with the process of Figure 1 as a function of time during a heating and cooling cycle (20 to 90 to 20 °C) at pH 6.8. The solid line indicates the heating and cooling cycle. Figure 5 is a graph illustrating the evolution of storage modulus (G) and loss modulus (G") of an 8.5% (w/w) SPI stabilized 10% (w/w) oil-in-water emulsion prepared in accordance with the process of Figure 2 as a function of time during a heating and cooling cycle (20 to 90 to 20 °C) at pH 6.8. The solid line indicates the heating and cooling cycle.

Figure 6 is a graph illustrating the effect of pretreatment of soy proteins [pre-heat condition (90 °C fori 5 min) and homogenization pressure (200-2000 bar)] on the viscosity of unheated and heated (90 °C for 15 min) 8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsions with and without the addition of NaCI measured at 20 °C. PreH = pre-heat treated at 90°C.

Figure 7 is a graph illustrating the effect of pretreatment of soy proteins [pre-heat condition (90 °C for 15 min) and homogenization pressure (400-1400 bar)] on the viscosity of unheated and heated (90 °C for 15 min) 8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsions with and without the addition of CaCI 2 measured at 20 °C. PreH = pre-heat treated at 90°C.

Figure 8 is a bar chart illustrating the effect of microfluidization pressure and number of passes on the insolubility index of 10% (w/w) intact SPI solutions.

Figure 9 is a graph illustrating the effect of pretreatment of soy proteins [pre-heat condition (90 °C fori 5 min) and homogenization pressure (1000 bar)] on the viscosity of unheated and heated (90 °C for 15 min) 12% (w/w) MPC-SPI (30:70) measured at 20 °C. PreH = pre-heat treated at 90°C.

DETAILED DESCRIPTION

A. Definitions

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by the ordinary person skilled in the art to which the invention pertains. Without limiting any term, further clarifications of some of the terms used herein are provided below.

The terms "nutritional composition" as used herein refers to nutritional liquids, nutritional solids, nutritional semi-liquids, nutritional semi-solids, nutritional powders, nutritional supplements, and any other nutritional food product as known in the art. The nutritional powders may be reconstituted to form a nutritional liquid, all of which comprise one or more of fat, protein and carbohydrate, and are suitable for oral consumption by a human.

The term "nutritional liquid" as used herein refers to nutritional compositions in ready-to-drink liquid form, concentrated form, and nutritional liquids made by reconstituting the nutritional powders described herein prior to use. The term "nutritional powder" as used herein refers to nutritional products in flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption and includes both spray dried and dry-mixed/dry- blended powders. The term "nutritional semi-solid," as used herein, refers to nutritional products that are intermediate in properties, such as rigidity, between solids and liquids. Some semi-solids examples include puddings, gelatins, and doughs.

The term "nutritional semi-liquid" as used herein refers to nutritional products that are intermediate in properties, such as flow properties, between liquids and solids. Some semi-liquids examples include thick shakes and liquid gels.

The terms "administer," "administering," "administered," and "administration," as used herein, should be understood to include providing a nutritional composition to a subject, the act of consuming a nutritional composition (self-administration), and combinations thereof. In addition, it should be understood that the methods disclosed herein may be practised with or without doctor supervision or other medical direction.

The term "subject", as used herein, refers to a mammal, including companion animals, livestock, laboratory animals, working animals, sport animals, and humans. In preferred embodiments, the subject is a human.

All percentages, parts and ratios as used herein, are by dry weight of the additive or nutritional composition, unless otherwise specified. All such weights, as they pertain to listed ingredients, are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified. For example, where the composition is a solid, the percentages are based on the total weight of the additive or nutritional composition prior to reconstitution. Where the composition is a liquid, the percentages are based on the total weight of the additive or nutritional composition minus the solvent, in other words by dry weight of the additive or nutritional composition.

Numerical ranges as used herein are intended to include every number and subset of numbers within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth. All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made. Unless otherwise specified, "a," "an," "the," and "at least one" are used interchangeably. Furthermore, as used in the description and the appended claims, the singular forms "a," "an," and "the" are inclusive of their plural forms, unless the context clearly indicates otherwise. ln the following passages different aspects and embodiments of the invention are defined in more detail. Each aspect/embodiment so defined may be freely combined with any other aspect(s) or embodiment(s) unless clearly indicated to the contrary.

B. Process for preparing a nutritional composition

In a first aspect, the present invention is directed to a process for preparing a nutritional composition. The process of the present invention involves a number of steps. As will be appreciated, while these steps are intended to be sequential, there may be some overlap between the steps when the process is carried out in a continuous manner.

The first step (step (i)) involves providing a solution comprising intact soy protein. By "intact" it is meant that at most 10 wt% of the soy protein is present in hydrolysed form. In certain exemplary embodiments, less than 5 wt% of the soy protein is present in hydrolysed form, or less than 2 wt%, or less than 1 wt% or 0 wt%. Suitable sources of intact soy protein are given below. In certain exemplary embodiments, the solution comprises at least 5 wt% intact soy protein by weight of the solution, or from 5 to 20 wt%, or from 6 to 15 wt%, or from 8 to 10 wt%. In certain exemplary embodiments, the solution consists essentially of, or consists of, water and intact soy protein. Alternatively, the solution may additionally comprise non-soy protein, such as dairy protein, and/or carbohydrate and/or minerals. It is preferably that the amount of non-soy protein in the solution is less than or equal to the amount of soy protein. It is to be understood that at this stage the soy protein is present in its native state, that is, in its properly folded and/or assembled form. In certain preferred embodiments, the solution provided in step (i) is substantially free of fat, that is, the total amount of fat is less than 1 wt% by weight of the solution, or less than 0.5 wt%, or less than 0.1 wt%, or 0 wt%. As is explained in more detail elsewhere, the beneficial effects of the presently described method require the fat component of the nutritional composition to be added after the soy protein heat-treatment and ultra high pressure homogenization (UHPH) steps. The present inventors have found that if, instead, the fat is added prior to the soy protein heat-treatment and UHPH steps, the beneficial effects on the soy protein properties are reduced.

As noted above, the solution provided in step (i) may further comprise carbohydrate and/or minerals. Alternatively or in addition, the carbohydrate and/or minerals, where desired, may be added during step (v).

The second step (step (ii)) involves heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein. By "partially denatured" it is meant that a portion of the soy protein, as a result of the heating step, loses the quaternary, tertiary and/or secondary structure which is present in its native state and is subjected to conformational change. In certain exemplary embodiments, step (ii) involves denaturing from 5 to 50 wt% of the soy protein by weight of the soy protein, or from 10 to 40 wt%, or from 20 to 30 wt%. The extent of soy protein denaturation can be determined quantitatively by reverse-phase high pressure liquid chromatography (RP-HPLC), by size exclusion HPLC or by SDS-PAGE (gel electrophoresis), allowing processing changes on the soy proteins to be tracked. Morphological changes of the denatured soy protein particles can be determined using microscopic image analyzer.

In certain exemplary embodiments, the conditions of step (ii) are such that at least a portion of the partially denatured soy protein is aggregated. In the context of the present invention, aggregated protein refers to protein which accumulates or clumps together due to protein mis-folding, which in turn is a result of the denaturation of step (ii). In these embodiments, at the end of step (ii) the solution will comprise a mixture of native soy protein, aggregated denatured soy protein, and optionally non-aggregated denatured soy protein. It is to be understood that the aggregated soy protein substantially remains in solution and preferably less than 5 wt%, or less than 1 wt%, or 0 wt% of the aggregated soy protein precipitates or gels. In certain exemplary embodiments, the partially denatured soy protein has a volume-weighted mean particle diameter of from 30 to 80 μηη, or from 35 to 75 μηη, or from 40 to 60 μηη. In other words, the volume-weighted mean particle diameter of all soy protein particles in the solution (whether in native form, aggregated denatured form, or non-aggregated denatured form) is within these ranges.

Volume-weighted mean particle diameter may be measured by static light scattering, for example using a Coulter LS 13302 (Beckman Coulter, USA). The soy protein can still be considered to be "intact" after step (ii), since the amino acid backbone has not been hydrolysed.

The present inventors have found that by inducing the soy protein to partial denaturation and optionally aggregation in step (ii), the soy protein is surprisingly inert to further denaturation and/or aggregation later in the process (for example during subsequent blending with other macronutrients under heat or during a subsequent sterilization step). The reasons for this stability are currently unknown and it is thought that the ability to control subsequent denaturation and aggregation in this manner is highly protein-specific and potentially limited to soy protein. For example, the present inventors have found that a subjecting pea protein to partial denaturation conditions does not prevent it from denaturing or aggregating further later during wet processing. Thus, the advantages of low viscosity described herein are not observed during the wet processing of pea protein under similar conditions.

In certain exemplary embodiments, step (ii) involves heating the solution comprising intact soy protein at a temperature of from 80 to 100 °C for from 5 to 30 minutes, or from 5 to 20 minutes, or from 5 to 15 minutes, or from 5 to 10 minutes, or at a temperature of from 80 to 90 °C for from 5 to 30 minutes, or from 5 to 20 minutes, or from 5 to 15 minutes, or from 5 to 10 minutes. It is to be understood that this time period refers only to the time for which the solution is at a temperature of from 80 to 100 °C. For example, it does not include an initial ramping up of the temperature from room temperature to 80 °C, or a ramping down of the temperature from 80 °C back to room temperature again. Moreover, in these embodiments, at no point in step (ii) is a temperature of over 100 °C, or over 90 °C, reached. The reported denaturation temperature for intact soy protein is about 90 °C (Beliciu & Moraru, 201 1 ; Shand, Ya, Pietrasik, & Wanasundara, 2007). Since the conditions in these embodiments do not involve subjecting the intact soy protein solution to a temperature significantly greater than the reported denaturation temperature, they are considered to be relatively mild. These conditions fall within the general class of high temperature short time (HTST) conditions.

Alternatively, step (ii) may involve heating the solution comprising intact soy protein at a temperature of from 120 to 150 °C for from 1 to 5 seconds, or from 2 to 4 seconds, or at a temperature of from 120 to 140 °C for from 1 to 5 seconds, or from 2 to 4 seconds. These ultra-high-temperature (UHT) conditions, while subjecting the solution to temperatures greater than the reported denaturation temperature for intact soy protein, still induce only partial soy protein denaturation owing to the brevity of the treatment.

The above heating conditions were selected by the inventors to achieve the desired physical changes in the soy protein, that is, partial denaturation and optionally aggregation in solution, while attempting to minimise gelation. Gelation is more likely to occur when the concentration of intact soy protein at the start of step (ii) is overly high, because the aggregation kinetics of soy protein depends on

concentration as well as temperature. Thus, it is preferred that the concentration of soy protein in the solution of step (i) is kept within the above-described ranges. In particular, it is preferred that the solution comprises at least 5 wt% intact soy protein by weight of the solution, or from 5 to 20 wt%, or from 6 to 15 wt%, or from 8 to 10 wt%. It is to be understood that while the purpose of step (ii) is to induce partial denaturation and optionally aggregation of the soy protein and not to sterilize the solution, a degree of sterilization may occur depending on the precise conditions used. The third step of the process (step (iii)) involves cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution. The solution may be cooled, for example, by placement in an ice bath. In certain exemplary embodiments, the solution comprising partially denatured soy protein is cooled to a temperature of 25 °C or less, or 20 °C or less. The cooling step serves to prevent further heat-induced changes in the soy protein from occurring after step (ii). The fourth step (step (iv)) involves homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution. As a result of these pressures, step (iv) can be considered to be an ultra high pressure homogenization (UHPH) step, also known as microfluidization. In certain exemplary embodiments, the cooled soy protein solution is homogenized at a pressure of from 300 to 2000 bar, or from 400 to 2000 bar, or from 500 to 1500 bar. In certain exemplary embodiments, the

homogenization is carried out at a temperature of 25 °C or less, or 20 °C or less, or 15 °C or less. In certain exemplary embodiments, the homogenization is carried out at a temperature of at least 10 °C. These temperatures may be achieved, for example, by placing the homogenization apparatus in an ice bath. The use of low temperatures in the homogenization step serves to prevent further heat-induced changes in the soy protein from occurring. In certain exemplary embodiments, step (iv) is a 1-10 pass homogenization step, or 1-5 pass, or 3-5 pass. Suitable apparatuses for carrying out the UHPH step include Microfluidizer (Microfluidics, Newton, MA, USA) or Stansted Fluid Power high pressure homogenizaer

(Stansted, UK).

The UHPH step serves to reverse any slight increase in viscosity that may have occurred during step (ii) (for example due to a small amount of soy protein gelation). In other words, the UHPH step will break down insoluble soy protein aggregates formed in step (ii). Even once broken up, they remain inert to further heat treatment later in the process.

As is explained in more detail elsewhere, the combination of steps (ii) to (iv) serve to keep the viscosity of the soy protein solution low, even when subjected to further heat-treatment steps later in the manufacture of a nutritional composition. Thus, the present process serves to improve the functional properties of soy-protein-stabilized oil-in-water emulsions. This enables effective partial replacement of milk protein with higher proportion of plant protein, while maintaining or improving product quality. The fifth step of the process (step (v)) involves blending the homogenized soy protein solution with a source of fat to form a nutritional composition. The source is preferably in slurry form. As noted above, it is advantageous for the fat to be added at this stage rather than during step (i). In particular, the inventors have found that if the oil is added instead before steps (ii) to (iv), the advantages of low viscosity and improved stability are significantly reduced. In certain exemplary embodiments, as well as being blended with a source of fat, the homogenized soy protein solution is blended with a source of carbohydrate and/or a source of minerals. In certain exemplary embodiments, the homogenized soy protein solution is blended with the source of fat, and the source of carbohydrate and/or the source of minerals separately. In certain exemplary embodiments, two or more of these components may be pre-blended before being blended with the homogenized soy protein solution. The order in which the components are blended is not critical to the invention and will vary depending on the nature of the nutritional product being manufactured, and this order is readily optimisable by the person skilled in the art.

In certain exemplary embodiments, the blending of step (v) is carried out under heat and optionally under agitation. Such conditions ensure adequate mixing.

Advantageously, the nutritional composition formed from step (v) maintains a low viscosity even though it contains a significant amount of soy protein and has been subjected to heat. This is even the case when the nutritional composition is highly fortified, i.e. contains high levels of minerals. The viscosity continues to remain low even when the composition is subjected to heat later on, either during additional manufacturing steps or as the final product. Suitable blending temperatures are from 40 to 70 °C, or from 50 to 60 °C. Suitable blending time periods are from 10 min to 30 min, or from 15 to 20 min. ln one suitable blending process, a nutritional composition is prepared using at least three separate slurries, including a protein-in-fat (PI F) slurry, a carbohydrate- mineral (CHO-MI N) slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed by heating and mixing selected oils (e.g., canola oil, corn oil) and then adding an emulsifier (e.g. , soy lecithin), fat soluble vitamins, and a portion of the total protein (e.g. , milk protein concentrate) with continued heat and agitation. The CHO-MI N slurry is formed by adding with heated agitation to water: minerals (e.g. , potassium citrate, magnesium phosphate, calcium carbonate), trace minerals and ultra trace minerals (e.g. , TM/UTM premix), thickening or suspending agents (e.g. , gellan gum, carrageenan), HMB and THC. The resulting CHO-MI N slurry is held for 10 minutes with continued heat and agitation before adding additional minerals (e.g. , potassium chloride, magnesium carbonate, potassium iodide), and

carbohydrates (e.g. , fructooligosaccharide, sucrose). The PIW slurry is then formed by mixing with heat and agitation the homogenized soy protein solution produced from step (iv), remaining protein (e.g. , sodium caseinate, soy protein isolate, whey protein concentrate) and optionally additional water. The resulting slurries are then blended together with heated agitation and the pH adjusted to a desired range, typically from 6.6-7.0 In certain exemplary embodiments, the fifth step further comprises homogenizing the nutritional composition, preferably at a lower pressure than the pressure of step (iv), to form a homogenized nutritional composition. In certain exemplary embodiments, the homogenization pressure of step (v) is less than 200 bar, or less than 150 bar. In certain exemplary embodiments, the homogenization pressure of step (v) is at least 100 bar.

In certain exemplary embodiments, the process further comprises a sixth step (step (vi)) of thermally treating the nutritional composition to form a sterilized nutritional composition. This step may be carried out irrespective of whether the nutritional composition has been homogenized. In other words, step (vi) may be performed immediately after the blending of step (v). In certain exemplary embodiments, step (vi) involves heating the nutritional composition at a temperature of from 130 to 150 °C for from 1 to 5 seconds. These may be considered to be UHT conditions. These conditions are suitable for sterilizing the nutritional composition prior to packaging. Thus, in certain exemplary embodiments, the process further comprises packaging the sterilized nutritional composition, preferably under sterilized or aseptic processing conditions. In these embodiments, the packaging is sterilized separately, prior to being combined with the sterilized nutritional composition under sterilized or aseptic processing conditions to form a sterilized, aseptically packaged, nutritional liquid product. This technique is known in the art as "aseptic" sterilization. Alternatively, the sixth step may involve at least partially filling a package with the nutritional composition and subjecting the at least partially filled package to the necessary heat sterilization step to form a retort-sterilized nutritional liquid product. In certain exemplary embodiments, this involves heating the liquid-filled package at a temperature of from 90 to 130 °C for from 10 to 30 minutes, or from 15 to 20 minutes, or from 1 10 to 130 °C for from 10 to 30 minutes, or from 15 to 20 minutes. In other words, the sixth step may involve retort-sterilizing the nutritional composition at a temperature of from 90 to 130 °C, or from 1 10 to 130 °C, for from 10 to 30 minutes, or from 15 to 20 minutes. It is preferred that, after step (v) and/or step (vi), the nutritional composition is a nutritional liquid as described herein. In certain exemplary embodiments, this nutritional liquid is obtained by diluting the nutritional composition formed from step (v) and/or step (vi). In certain exemplary embodiments, the process further comprises a seventh step (step (vii)) of drying the nutritional composition to form a nutritional powder. In certain exemplary embodiments, step (vii) is a step of spray-drying. Conventionally, during drying processes, the solids contents in the fluids (i.e. slurries) must be carefully monitored to ensure that the viscosity of the slurry remains low, preventing fouling and clogging of the drying equipment. This requires a slower, longer evaporation and drying process, which can increase costs and reduce efficiency. The present process enables the evaporation and drying time to be reduced because the nutritional composition can be processed at higher solids content. This in turn is because, as noted above, the viscosity of the nutritional composition remains low even if the blending has been carried out under heating and the composition has been sterilized. Accordingly, it can be processed and dried at higher total solids than high-soy nutritional compositions of the prior art. As a result, the present process can be run at increased efficiency and lower production costs than the processes of the prior art.

In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry having a total solids content of at least 40 wt% by total weight of the slurry, or at least 45 wt%, or at least 50 wt%. In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry having a total solids content of at most 65 wt% by total weight of the slurry, or at most 60 wt%.

In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry having a viscosity of less than 200 mPa.s as measured at a temperature of 20 °C and at a shear rate of 100 s "1 , or less than 150 mPa.s, or less than 100 mPa.s. In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry having a viscosity of at least 50 mPa.s as measured at a temperature of 20 °C and at a shear rate of 100 s '

In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry comprising at least 10 wt% intact soy protein by total weight of the slurry, or at least 15 wt%. Surprisingly, even at high levels of soy protein, the viscosity of the slurry remains low after steps (i) to (v). In certain exemplary embodiments, immediately prior to step (vii), the nutritional composition is a slurry comprising at most 25 wt% intact soy protein by total weight of the slurry. Step (vii) is preferably performed on a sterilized nutritional composition. ln certain preferred embodiments, the nutritional powder formed from step (vii) is reconstitutable in water and/or another aqueous liquid to form a nutritional liquid as described herein. The nutritional compositions resulting from the process described herein exhibit a number of surprising properties as a result of the combination of the pre-heat treatment and UHPH steps. Relative to liquids having the same concentration of soy protein but produced by conventional processes, these properties include: reduced viscosity;

- improved heat stability;

improved ionic stability;

reduced sedimentation; and

reduced grain size.

Thus the process allows for the preparation of more compact products with higher soy protein and higher mineral density than those that can be produced using prior art methods, without compromising the product characteristics.

Thus, in a second aspect, the present invention is directed to a nutritional composition obtainable by the process of the first aspect. In certain exemplary embodiments, the nutritional composition is a nutritional liquid as described herein or is reconstitutable in water and/or another aqueous liquid to form a nutritional liquid as described herein.

C. Process for preparing a soy protein powder and use thereof

In a third aspect, the present invention is directed to a process for preparing a soy protein powder. The process involves the same synergistic combination of soy protein heat treatment and UHPH as the process of the first aspect. The first four steps (steps (i) to (iv)) involve:

(i) providing a solution comprising intact soy protein;

(ii) heating the solution comprising intact soy protein under conditions effective to form a solution comprising partially denatured soy protein; cooling the solution comprising partially denatured soy protein to form a cooled soy protein solution; and

homogenizing the cooled soy protein solution at a pressure of from 200 to 2000 bar at a temperature of 30 °C or less to form a homogenized soy protein solution.

These steps (i) to (iv) are the same as steps (i) to (iv) of the process of the first aspect and any optional features of these steps in the process of the first aspect may be present in process of the second aspect.

The fifth step of the process (step (v)) involves drying the soy protein solution to form a soy protein powder. In certain exemplary embodiments, step (v) is a step of spray-drying. Because the homogenized soy protein solution is of a low viscosity and remains so even if subjected to heat, it can be processed and dried at higher total solids than high-soy solutions of the prior art. As a result, less water needs to be removed and the drying process is less energy-intensive. This is explained in more detail in relation to the first aspect above. In certain exemplary embodiments, immediately prior to step (v), the homogenized soy protein solution is a slurry having a total solids content of at least 40 wt% by total weight of the slurry, or at least 50 wt%, or at least 60 wt%. In certain exemplary embodiments, immediately prior to step (vii), the homogenized soy protein is a slurry having a total solids content of at most 70 wt% by total weight of the slurry.

In certain exemplary embodiments, the soy protein powder comprises at least 90 wt% soy protein by weight of the powder, or at least 95 wt%, or at least 99 wt%. In certain preferred embodiments, the soy protein powder consists essentially of or consists of soy protein.

Like the process of the first aspect, the combination of soy protein heat treatment and UHPH in the process of the second aspect renders the partially denatured soy protein inert to subsequent further denaturation and/or aggregation. Thus, the process provides a heat-stable soy protein powder. By "heat-stable" it is meant that upon reconstitution in water at a soy protein concentration of 100 mg/mL and upon heating of the reconstituted solution at a temperature of 90 °C for up to 30 minutes, the viscosity, as measured at 20°C and 60 rpm, increases by no more than 200%, preferably by no more than 100%.

The heat-stable soy protein powder obtained by the presently described process has a number of uses. For example, it can be dry blended with other macronutrient powders to form a dry blend which, upon reconstitution in water, gives a low- viscosity, high-soy, and preferably highly-fortified nutritional beverage. Alternatively, it can be reconstituted in water and used as a wet-processing additive in the manufacture of a nutritional composition, the additive being stable to heat applied during the wet processing.

Thus, in a fourth aspect, the present invention is directed to a soy protein powder obtainable by the process of the third aspect.

In a fifth aspect, the present invention is directed to the use of a soy protein powder as described herein in the manufacture of a nutritional composition. In a sixth aspect, the present invention is directed to a nutritional composition comprising the soy protein powder obtained or obtainable as described herein. Such a nutritional composition can be prepared by dry blending the soy protein powder with a source of fat and/or a source of carbohydrate and/or a source of minerals. In these embodiments, the nutritional composition is preferably in the form of a nutritional powder. Alternatively, such a nutritional composition may be prepared by reconstituting the soy protein powder to form a solution or slurry followed by subsequent wet-processing and optionally drying to form a nutritional powder. In certain preferred embodiments, the nutritional powder is reconstitutable in water or another aqueous liquid to form a nutritional liquid as described herein. In other words, a nutritional powder of the present disclosure has, upon reconstitution, the same advantageous properties as the nutritional liquids described herein. Thus, all of the processes described herein confer the same advantageous properties on the nutritional products that ultimately result therefrom.

In particular, the processing techniques described herein result in a protein- stabilized emulsion that has low viscosity, high heat stability, low sedimentation and low grain score. This protein matrix is effective even when high levels of soy protein are used, for example where a high proportion of milk protein is replaced with soy protein. Some possible applications are: 1. Incorporating more soy protein (> 50% wt. of total protein) into powdered and/or liquid nutritional products without compromising the product characteristics.

2. Increase the functional properties of soy protein, and in particular its heat stability and dispersibility. At the same protein concentration, the heat stability is increased with reduced sedimentation. Heat stability is highly correlated to product's viscosity performance. The plant-protein-stabilized emulsion has a relatively low viscosity even upon heat treated at 90 °C for 15 minutes. In this case, more soy protein can be incorporated in the formulation during the wet processing of powdered or liquid products without compromising the product's viscosity.

Some of the advantages of the processing techniques described herein over existing processing techniques are:

1. The heat stability of soy-protein-enriched formula is improved significantly.

Typically, the viscosity of a soy-protein-stabilized emulsion increases with heat treatment during wet processing. Surprisingly, with this method, the viscosity of the formula remains low and the processability of the formula is not compromised even at high solid content. This method enables possible cost reduction with the replacement of more milk proteins with soy protein, but also improves the efficiency of the drying process. The processability of the formula is maintained even with replacement of a higher proportion of milk protein with soy protein. This is particularly important for high protein products or products formulated using a high proportion of soy protein. The methods also allow for higher overall protein concentration. This facilitates the formulation of more concentrated products with reduced consumption volume. This concept allows consumers to consume a reduced volume but yet enjoy the nutritional benefits of milk with reference to a standard serving. 3. The ionic stability of the soy protein enriched formula is enhanced. Typically, metal ions such as Na + and Ca 2+ are added to formula for mineral fortification. High concentrations of Na + and Ca 2+ ions cause clumping of protein, particularly in the presence of heat. Using this proposed method helps to improve the stability of the protein, resulting in less susceptibility to clumping, which in term enables the production of products with higher mineral fortification or in a denser format. Again, this allows consumers to receive the complete nutrition while only having to consume a smaller volume. 4. On a long term perspective, the shelf-life stability of the soy protein enriched formula is improved due to the reduced tendency for sedimentation to occur. The number of large and insoluble soy protein particles is reduced drastically. This is important not just for improving the mouthfeel of the product, but also in improving the processing efficiency of the product by reducing the product reject tendency due to factors such as grain issues.

Using the processes disclosed herein, oil droplet sizes are reduced by 3-5 times, resulting in improved creaming stability, which is important for liquid products to avoid phase separation. The creaming stability is important for liquid products and certain powdered products which have a tendency to phase separate too quickly after reconstitution. D. Nutritional liquids

In a seventh aspect, the present invention is directed to a nutritional liquid. The nutritional liquid is obtainable from the processes described herein. The nutritional liquid comprises at least 10 g/100 mL protein. In certain exemplary embodiments, the nutritional liquid comprises at least 12 g/100 mL protein, or at least 15 g/100 mL, or at least 20 g/100 mL. In certain exemplary embodiments, the nutritional liquid comprises at most 25 g/100 mL protein. The protein comprises at least 50 wt% vegetable protein by weight of the protein. In certain exemplary embodiments, the protein comprises at least 60 wt% vegetable protein by weight of the protein, or at least 70 wt%, or at least 80 wt%, or at least 90 wt%, or at least 95 wt%. In certain exemplary embodiments, the protein consists essentially of or consists of vegetable protein. The non-vegetable protein, where present, may come from various sources including more than one source. Non- vegetable proteins suitable for use in the nutritional liquids according to the embodiments disclosed herein include, but are not limited to, hydrolyzed, partially hydrolyzed or non-hydrolyzed proteins or protein sources, and can be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g. , meat, fish), cereal (e.g. , rice, corn), or combinations thereof.

Non-limiting examples of the source of non-vegetable protein include whey protein concentrates, whey protein isolates, whey protein hydrolysates, acid caseins, sodium caseinates, calcium caseinates, potassium caseinates, casein hydrolysates, milk protein concentrates, milk protein isolates, milk protein hydrolysates, skim milk, low fat milk, nonfat dry milk, skim milk powder, condensed skim milk collagen proteins, collagen protein isolates and combinations thereof.

The vegetable protein comprises at least 50 wt% intact soy protein by weight of the vegetable protein. In certain exemplary embodiments, the vegetable protein comprises at least 60 wt% intact soy protein by weight of the vegetable protein, or at least 70 wt%, or at least 80 wt%, or at least 90 wt%, or at least 95 wt%. In certain exemplary embodiments, the vegetable protein consists essentially of or consists of intact soy protein. As noted above, the combination of soy protein pre-heat treatment and UHPH as used in the processes of the present disclosure enables a high level of substitution of dairy protein with intact soy protein, and a high overall protein level, without compromising the product characteristics. Advantageously, the present invention allows the inclusion of high levels of intact soy protein, rather than relying on the use of hydrolysed soy protein, which may detrimentally affect the sensory profile above certain levels and which may require label change above a certain degree of hydrolysis.

Soy protein can be divided into different categories according to its production method. For the purposes of this disclosure, "soy protein concentrate" (SPC) will be understood to be a generic term referring to products which are basically soybean without the water soluble carbohydrates and which contain about 60 to 90 wt% or more soy protein. More commonly, these products contain 60 to 85 wt% soy protein, and even more typically 70 to 80 wt% soy protein. Meanwhile, "soy protein isolate" (SPI) will be understood to mean a type of SPC which contains about 85 to 90 wt% protein. SPI is the most refined form of soy protein and is mainly used in meat products to improve texture and eating quality. Textured soy protein (TSP) is made from soy protein concentrate by giving it some texture. TSP is available as dry flakes or chunks. It will keep its structure when hydrated. Hydrated textured soy protein chunks have a texture similar to ground beef. It can be used as a meat replacement or can be added to meat. Textured soy protein contains about 70 wt% protein. Any of these concentrated soy protein sources can be used to provide the intact soy protein of the compositions and processes of the present invention.

Several soy protein sources are readily available to the skilled person, for example, from The Solae Company of St. Louis, Mo., USA, and the Arthur Daniels Midland Company of Decatur, Illinois, USA. Where the vegetable protein includes a component that is not intact soy protein, this component may come from various sources including more than one source. Non-limiting examples of the source of vegetable protein include soy protein hydrolysates, pea protein concentrates, pea protein isolates, pea protein hydrolysates, potato protein, rice protein, corn protein, wheat protein, sunflower protein, chickpea protein, quinoa protein and combinations thereof. The nutritional liquid comprises at least 650 mg/100 mL minerals. In certain exemplary embodiments, the nutritional liquid comprises at least 700 mg/100 mL minerals, or at least 800 mg/100 mL, or at least 900 mg/100 mL, or at least 1000 mg/100 mL. In certain exemplary embodiments, the nutritional liquid comprises at most 1500 mg/100 mL minerals, or at most 1200 mg/100mL. As noted above, certain minerals have a tendency to interact with soy protein and cause it to clump, giving rise to unfavourable product characteristics such as high viscosity and/or sedimentation. The combination of soy protein pre-heat treatment and UHPH as used in the processes of the present disclosure has, for the first time, enabled the preparation of nutritional compositions having a high concentration of soy protein and high mineral density without compromising the product characteristics. Non- limiting examples of suitable minerals for use in the present invention include calcium, potassium, iodine, phosphorus, magnesium, iron, zinc, manganese, copper, sodium, chromium, chloride, and combinations thereof. Moreover, the present inventors have found that calcium chloride, calcium from milk protein concentrate, sodium chloride, sodium from hydrolyzed sodium caseinate, potassium chloride, potassium hydroxide, magnesium chloride, magnesium phosphate dibasic, potassium chloride and potassium hydroxide have a particularly notable effect on the heat-stability of soy-protein-containing formulations.

Surprisingly, the advantageous product characteristics of the present nutritional liquids are maintained even where high levels of these minerals are included. In certain exemplary embodiments, the nutritional liquid has a total content of calcium chloride, calcium from milk protein concentrate, sodium chloride, sodium from hydrolyzed sodium caseinate, potassium chloride, potassium hydroxide, magnesium chloride, magnesium phosphate dibasic, potassium chloride and potassium hydroxide of at least 400 mg/100 mL, or at least 500 mg/100 mL, or at least 600 mg/100 mL. In certain exemplary embodiments, the nutritional liquid has a total content of calcium chloride, calcium from milk protein concentrate, sodium chloride, sodium from hydrolyzed sodium caseinate, potassium chloride, potassium hydroxide, magnesium chloride, magnesium phosphate dibasic, potassium chloride and potassium hydroxide of at most 1000 mg/100 ml_, or at most 800 mg/100 mL.

In certain exemplary embodiments, the nutritional liquid is sterilized. As noted above, the combination of soy protein pre-heat treatment and UHPH imparts a stability to the soy protein that is maintained during a subsequent sterilizing heat- treatment step. Thus, the present disclosure has, for the first time, enabled the preparation of high-soy, highly-fortified, sterilized nutritional liquids having favourable product characteristics.

In certain exemplary embodiments, the nutritional liquid is stable for at least 6 months at 25 °C ± 2 °C, or for at least 12 months.

In certain exemplary embodiments, the nutritional liquid comprises fat. In certain exemplary embodiments, the nutritional liquid comprises from 0.1 to 15 g/100 mL fat, or from 1 to 10 g/100 mL, or from 2 to 8 g/100 mL, or from 4 to 6 g/100 mL. Advantageously, the soy protein of the present nutritional liquids remains stable in the presence of other macronutrients such as fats. Non-limiting examples of fats suitable for use in the exemplary nutritional compositions include canola oil, corn oil, coconut oil, fractionated coconut oil, soy oil, olive oil, safflower oil, high GLA safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, marine oils, cottonseed oils, algal and fungal derived oils, and combinations thereof. Where the nutritional liquid comprises fat, the nutritional liquid preferably has a surface- weighted mean fat droplet diameter (d3,2 value) of less than 1 μηη, or less than 0.8 μηη. The d3,2 value may be measured, for example, using a Beckman Coulter LS 13302 (Brea, CA USA). As noted above, using the processes described herein, oil droplet sizes are reduced by 3-5 times, resulting in improved creaming stability. This in turn helps to avoid phase separation and contributes to the shelf stability of the liquid product. ln certain exemplary embodiments, the nutritional liquid comprises from 5 to 50 g/100 mL carbohydrate, or from 10 to 40 g/100 ml_. Advantageously, the soy protein of the present nutritional liquids remains stable in the presence of other macronutrients such as carbohydrates. The carbohydrates may be simple, complex, or variations or combinations thereof. Generally, any source of carbohydrates may be used so long as it is suitable for use in oral nutritional compositions and is otherwise compatible with any other selected ingredient or feature present in the nutritional composition. Non-limiting examples of a source of carbohydrates which may be suitable for use in the exemplary nutritional compositions described herein include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g. , maltitol, erythritol, sorbitol), isomaltulose, sucromalt, pullulan, potato starch, and other slowly-digested carbohydrates, dietary fibers including, but not limited to, oat fiber, soy fiber, gum arabic, sodium carboxymethylcellulose, methylcellulose, guar gum, gellan gum, locust bean gum, konjac flour,

hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum acacia, chitosan, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low and high methoxy pectin, cereal beta-glucans (e.g. , oat beta-glucan, barley beta-glucan), carrageenan and psyllium, Fibersol™, other resistant starches, and combinations thereof.

In certain exemplary embodiments, the nutritional liquid has a pH of at least 5, or from 6 to 8, or from 6.6 to 7. As a result of the stability of the soy protein in solution (in turn a result of the processes described herein), there is no need to select a particularly acidic or alkaline pH in order to solubilize the soy protein in the liquid product and thereby keep the viscosity low.

In certain exemplary embodiments, the nutritional liquid has a viscosity of less than 200 mPa.s as measured at a temperature of 20 °C and at a shear rate of 100 s "1 , or less than 150 mPa.s, or less than 100 mPa.s. As noted above, in the products of the present invention, there is a reduced tendency for sedimentation to occur. Thus, in certain exemplary embodiments, the nutritional liquid has an insolubility index of less than 5%, or less than 4%, or less than 3%, or less than 2% or less than 1 %. In certain exemplary embodiments, the nutritional liquid has an insolubility index of at least 0.2%. The insolubility index of a liquid may be calculated using the following formula:

. . . .... . . Tsi=i cksHisoi sedimesit sites' iesi!-iiusaisos (siij . , -. _ - > „,

Insolubility Index % = ——— : ; ;— .« 100 %

In the context of the present invention, the centrifugation conditions are 3000g for 15 min using a total sample volume of 30 mL in a 50 mL tube.

In certain exemplary embodiments, the nutritional liquid has an energy density of at least 1 kcal/mL, or from 1 to 5 kcal/mL, or from 2 to 4 kcal/mL. As explained above, the present invention allows for the preparation of more compact product forms that provide a high energy density.

The present invention will now be described in relation to the following non-limiting examples.

EXAMPLES

Example 1

A nutritional powder was prepared in accordance with the method of the present invention. The process steps are shown in Figure 2.

In particular, a known amount of soy protein was hydrated at 60 °C in R.O. water for at least 1 hour. The liquid slurry was then passed through High-speed-disperser operating at 24,000 rpm for 10 min for enhanced hydration purpose. Next, the liquid slurry was pre-heated in a water bath at 90 °C for 5-30 min and cooled in an ice bath. The pre-heated liquid slurry was left at ambient temperature for at least 1 hour. The liquid slurry was then passed through ultra-high-pressure-homogenization at 400-2000 bar for 1 -5 passes. The homogenization took place in cool condition. An ice bath is used to cool the product outlet and prevent protein denaturation during the homogenization as the temperature increases dramatically due to the dissipated energy. Next, the homogenized slurry was mixed with oil to produce a coarse emulsion at 24,000 (2 min) in a high speed disperser. The liquid slurry was then passed through HTST/UHT process for sterilization purpose. It operated at 105 °C for 5 s. Finally, the liquid slurry was fed to an evaporator for concentrating the liquid and the concentrated slurry was spray dried to powders.

Example 2

An 8.5% SPI (soy protein isolate)-stabilized 10% (w/w) oil-in-water emulsion was prepared in accordance with the process of Example 1. The oil was soya oil. The pre-heat-treatment step was carried out at 90°C for 15 min. The UHPH was carried out at 1400 bar for 5 passes. As a control, an 8.5% SPI (soy protein isolate)- stabilized 10% (w/w) oil-in-water emulsion was prepared in accordance with the process shown in Figure 1. The viscosity of each of the emulsions was measured in an unheated state using a Brookfield digital viscometer (Model DV-II+, USA) fitted with spindle-3. As a measure of heat stability under wet-processing conditions, a secondary heating (90 °C for 15 min) was introduced into test emulsions and viscosity was measured at 60 rpm. A viscosity of less than 100 cP is required for efficient processing of powdered and liquid products.

The results are shown in Figure 3. As seen, the viscosity of 8.5% (w/w) SPI stabilized emulsion prepared in accordance with the process of Figure 2 remained low (≤ 100 cP) even after a secondary heating (90 °C for 15 min).

During the secondary heating step, the storage modulus (G') and loss modulus (G") were measured for each of the two samples. In particular, oscillatory rheology was performed to track the structural changes in emulsion sample during heating. Dynamic strain sweeps were performed for each emulsion sample at a frequency of 1 Hz to determine the linear viscoelastic region (LVR). An aliquot (20 mL) of emulsion sample was gently poured into the cup and a layer of mineral oil was added to prevent water evaporation during the measurement. The sample was subjected to a heating and cooling cycle (20- 90 (hold 15 min)- 20 °C) at a constant rate of 3 °C/min. The experiment was conducted at a frequency of 1 Hz and at a strain of 0.01.. The results are shown in Figure 4 (control) and Figure 5. A marked improvement was observed for the emulsion prepared in accordance with the process of Figure 2. The storage modulus (G) and loss modulus (G') remained low during the entire heating processing at 90 °C for 15 min, whereas the control sample showed an increased in storage modulus and loss modulus about 4 times after heating.

Example 3

8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsions were prepared in accordance with the process of Figure 2 but employing a range of UHPH conditions. In particular, samples were prepared using the following homogenization pressures (all for 5 passes): 200 bar, 400 bar, 600 bar, 800 bar, 1000 bar, 1200 bar, 1400 bar, 2000 bar.

The pre-heat-treatment step was carried out at 90°C for 15 min.

A control sample (again an 8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsion) was prepared in accordance with the process of Figure 1 .

As a measure of heat stability and ionic stability under wet-processing conditions, a secondary heating (90 °C for 15 min) and different concentrations of NaCI were introduced into test emulsions and viscosity was measured at 60rpm at 20 °C. A viscosity of less than 100 cP is required for efficient processing of powdered (i.e. , pumping from evaporator to spray dryer) and liquid products. The viscosity measurements are shown in Figure 6.

As indicated in Figure 6, the soy protein pre-heat treatment has a marked effect on the unheated SPI-stabilized emulsions. With the use of pre-heat treatment and UHPH, the viscosity reduced more than 10 fold. Moreover, the viscosity reduced as the homogenization pressure increased. The viscosity reduction seemed to reach a plateau above 800 bars. In general, heat treatment (90 °C, 15 min) induced an increase in emulsion viscosity because inter-particle interactions (protein-protein, droplet-droplet, protein-droplet interactions) become more extensive when heating temperature is above the denaturation temperature of soy proteins (Beliciu & Moraru, 2013; Euston, Al- Bakkush, & Campbell, 2009). Compared to the control SPI-stabilized emulsions, the viscosity of 8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsions with pretreatment remained low (≤ 100 cP) after a secondary heating (90 °C for 15 min) in the presence of up to about 30 mM of NaCI, if the SPI was pre-heated at 90°C for 15 min and passed through UHPH at 1400 bar for 5 passes prior to emulsification. Example 4

8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsions were prepared in accordance with the process of Figure 2 but employing a range of UHPH conditions. In particular, samples were prepared using the following homogenization pressures (all for 5 passes): 400 bar, 600 bar, 800 bar, 1000 bar, 1200 bar, 1400 bar.

A control sample (again an 8.5% (w/w) SPI-stabilized 10% (w/w) oil-in-water emulsion) was prepared in accordance with the process of Figure 1.

As a measure of heat stability and ionic stability under wet-processing conditions, a secondary heating (90 °C for 15 min) and different concentrations of CaCI 2 were introduced into test emulsions and viscosity was measured at 60rpm at 20 °C. The results are shown in Figure 7.

As indicated in Figure 7, the SPI solution pre-heated at 90°C for 15 min and passed through 400-1400 bar for 5 passes prior to emulsification gave the best result. It can be seen that the viscosity remains low even in the presence of 7.5 mM of CaCI 2 after heating when the SPI solution was homogenized at 1000 bar and above for 5 passes. On contrary, the control samples all formed solid gels and are not presented in the Figure. By the combined use of pre-heat treatment and UHPH, SPI-stabilized oil-in-water emulsions with enhanced stability against divalent ions can be obtained.

Example 5 In this Example, the effect of pre-heat treatment and UHPH (microfluidization) on sedimentation of SPI solutions was measured.

10% (w/w) SPI solutions were prepared and subjected to pre-heat-treatment at 90°C for 15 min. The 10% (w/w) SPI solutions were then subjected to the following microfluidization conditions: 200 bar (control), 400 bar (1 pass), 400 bar (5 passes), 1400 bar (1 pass), 1400 bar (5 passes).

For measurements of the sedimentation volume, samples in 50 mL test tubes were centrifuged at 3000 χ g for 15 minutes in a Sorvall Centrifuge (Thermo Fisher, Waltham, MA). The amount of sediment formed was recorded as insoluble index %, based on total volume of sample. The calculation for insolubility index % was as follows:

, st=i vekssieoi sedime nt aftss* lesQ'Eissatsoa ίϊίΐί·) . 4

Insolubility Index % = ;— : : ; — - : L 100 %

Totas YOiutv.* et sample

The results are shown in Figure 8. As indicated in Figure 8, the microfluidization has a marked effect on the insolubility index. With the use of microfluidizer, the sedimentation reduced more than 10 times when a higher pressure (1400 bar) and a greater number of passes (5 passes) were applied. Figure 8 shows that the sediment layer reduced gradually as the homogenization pressure and number passes increased. The reduction of sediment layer is advantageous in product processing because insolubility and grain issue have a close relationship, that is, products with higher insolubility have high tendency to have more grain particles upon reconstitution.

Example 6 Five mixed protein solutions were prepared containing 12% w/w total protein. Of the total protein, 30% was standard MPC-80 and 70% was intact SPI. The mixed protein solutions were prepared by the following process:

(i) Reconstitution of known amount of protein solution at 60 °C for 1 h

(ii) The protein solution was dispersed for 10 min at 24, 000 rpm

(iii) Pre-heat treatment at 90 °C for 1 -15 min

(iv) Ultra-high-pressure-homogenization at (1000 bar), 5 passes

(v) 12% protein solutions For each solution, a different time period was used for step (iii): 1 min, 5 min, 10 min, 15 min.

For each of the resulting samples (as well as a control which was not subjected to steps (iii) or (iv)) the viscosity was measured in an unheated state at 60 rpm using a Brookfield digital viscometer (Model DV-II+, USA) fitted with spindle-3. As a measure of heat stability under wet-processing conditions, a secondary heating (90 °C for 15 min) was introduced into test emulsions and viscosity was measured at 60rpm. A viscosity of less than 100 cP is required for efficient processing of powdered and liquid products.

The results are shown in Figure 9. It can be seen from Figure 9 that the control samples showed very high viscosity, and after the heat stability test (heating at 90°C for 15 min), the sample became a stand-alone gel (not shown). The protein solutions prepared by modified process all showed lower viscosity although the viscosity increased after the heat stability test. The viscosity of modified protein solutions are still within the processing limit, 100-300 cP, for high total solid processing.

Example 7

Example 7 illustrates a nutritional liquid in accordance with the present invention, the ingredients of which are listed in the table below. All ingredients are listed as kg per 1000 kg batch of product, unless otherwise specified.

The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and accompanying figures. Such modifications are intended to fall within the scope of the appended claims. Moreover, all aspects and embodiments of the invention described herein are considered to be broadly applicable and combinable with any and all other consistent embodiments, including those taken from other aspects of the invention (including in isolation) as appropriate.

Various publications and patent applications are cited herein, the disclosures of which are incorporated by reference in their entireties.