Process for preparing infant formula

The use of non-homogenized dairy cream and vegetable oil in a spray-drying process achieves infant formula with large lipid globules resembling human milk, addressing stability and shelf-life issues.

WO2026008863A1PCT designated stage Publication Date: 2026-01-08NV NUTRICIA
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Patent Information

Application Number
PCT/EP2025/069189
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-04
Filing Date
2025-07-04
Publication Date
2026-01-08

AI Technical Summary

Technical Problem

Existing infant formulas fail to replicate the large lipid globule structure of human milk and often have high free fat content, leading to reduced shelf-life and processing issues.

Method used

A process using non-homogenized dairy cream and vegetable oil to create lipid globules with a diameter similar to human milk, encapsulating vegetable oil within these globules, and incorporating a low free fat percentage through spray-drying.

Benefits of technology

The process maintains large lipid globule size and reduces free fat content, resulting in a more stable, processable, and longer-shelf-life infant formula.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention concerns a process for preparing a nutritional composition selected from infant formula, follow-on formula, or young child formula comprising large lipid globules and having low free fat content. The invention further concerns the powdered nutritional composition obtained thereof.
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Description

[0001] PROCESS FOR PREPARING INFANT FORMULA

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a process for preparing an infant formula comprising large lipid globules using dairy cream.

[0004] BACKGROUND OF THE INVENTION

[0005] Human breast milk is universally considered to be the optimal nutrition for infants during the first months of life. However, in some cases breastfeeding is inadequate or unsuccessful for medical reasons or because of the choice to not breastfeed. For such situations infant or follow-on formulas have been developed. Commercial infant formulas are commonly used to provide a supplement or a sole source of nutrition early in life. These formulas comprise a range of nutrients to meet the nutritional needs of a growing infant. Typically, infant formula ingredients include fat, carbohydrate, protein, vitamins, minerals, and other nutrients helpful for optimal infant growth and development. Commercial infant formulas are designed to mimic, as closely as possible, the composition and function of human milk.

[0006] Human milk lipids are known to have a distinct physical structure composed of large lipid globules with a mode diameter, based on volume, of about 4 pm, containing a triglyceride core coated by a tri-layer membrane: the milk fat globule membrane (MFGM). In standard commercial infant formula, the mode diameter based on volume of lipid globules is typically about 0.3 - 0.5 pm, where the lipid globules are not surrounded by MFGM but instead mostly by milk proteins. This is due to the industrial processing applied to achieve stable and reproducible products. Infant formulas with lipid globules having an architecture more similar to that of lipid globules in human milk have been described in the art (e.g. WO2010 / 027258 or WO2010 / 027259).

[0007] WO2012191533 describes the use of specifically designed lipid component with a mixture of milk fat and vegetable fat and present as lipid globules with a large size, for an early in life diet for improving the development of a healthy body composition, in particular prevention of obesity, later in life.

[0008] Processes for preparing infant formula comprising lipid globules having an architecture more similar to that of lipid globules in human milk have been described in WO2013 / 135739, WO2013 / 135739, WO2015 / 036466, WO2015 / 036464 and WO2016 / 146496.

[0009] WO2020 / 251354 describes an extrusion process for making infant formula with large lipid globules. Such an extrusion process is not suitable for producing big volumes of infant formula and is less economical as it requires two drying steps, first the extrusion step followed by a further drying step.

[0010] Non-homogenised dairy cream is an emulsion typically comprising 10 - 50 wt.% milk fat and water, obtained from the higher-fat layer skimmed from the top of milk before homogenization. Typically, the milk fat in non-homogenised dairy cream is in the form of lipid globules having a mode diameter based on volume of about 2 - 6 pm, which are at least partially encapsulated by milk phospholipids [source: Mulder, H. & Walstra, P. “The milk fat globule. Emulsion science as applied to milk products and comparable foods” Commonwealth Agricultural Bureaux Farnham Royal, Bucks., England, 1974, Chapter 8], When cream is used as a fat source in nutritional compositions such as infant formula, the cream is typically homogenised.

[0011] WO2021 / 013862 describes a nutritional composition for infants comprising ruminant milk fat that is capable of activating the aryl hydrocarbon receptor. Cream can be selected as ruminant milk fat. W02020 / 178108 describes a fat composition comprising a mixture of fatty acid triacylglycerols originating from a bovine milk fat source (possibly cream) and a vegetable source.

[0012] The above disclosures teach the presence of cream in the nutritional compositions described therein, such as infant formulas. However, neither disclosure addresses the fat globule size in the final infant formulas, let alone neither obtains lipid globules having an architecture similar to that of lipid globules in human milk. It remains unknown whether dairy cream can be employed to obtain infant formula having large lipid globules resembling those of human milk.

[0013] Another known issue in the field of food technology, especially in infant milk formula, is the free fat percentage in powdered nutritional compositions. Free fat is the fat that can be reached and extracted with a hydrophobic solvent. Free fat is known to cause deterioration of whole milk powders during storage, leading to foul taste and / or smell and lumpiness of the product. Consequently, powdered nutritional compositions with a higher free fat percentage have a reduced shelf-life.

[0014] Vignolles et al. (“Free fat, surface fat and dairy powders: interactions between process and product. A review.” Le Lait, 2007, 87 (3), 187-236) describe that free fat is located at the powder particle surface and within the powder particles, such as in the pores and capillaries created in the particles or lipid globules during processing. Over time the free fat will diffuse from the pores and capillaries to the surface, leading to a ‘oilier’ nutritional composition. The nutritional composition can thus get more lumpy, irregular, or chunky, which is not desired as it decreases consumer acceptance.

[0015] WO2015 / 067325 describes a powdered nutritional composition comprising large lipid globules and micronized carbohydrate or carbohydrate microcrystals. Further described is the use of micronized carbohydrate or carbohydrate microcrystals for improving flow and reducing cohesiveness of a powdered nutritional composition with large lipid globules. In the examples a nutritional composition with large lipid globules, comprising a vegetable oil blend as fat source, is described with a free fat content of 4.6 wt.%, by weight of total fat.

[0016] To reduce free fat, homogenisation can be employed. However, homogenisation has the drawback of yielding small fat globules, with a mode diameter based on volume of about 0.3 - 0.5 pm, which do not resemble the large fat globules of human milk. There is a need in the art to modulate the processes to obtain an infant formula comprising large fat globules resembling those of human milk, i.e. having a mode diameter based on volume of around 2 - 6 pm, while containing a low free fat percentage.

[0017] SUMMARY OF THE INVENTION

[0018] The present invention aims at providing a process for preparing infant formula having lipid globules similar to those of human milk, while having a low free fat percentage and increased shelf-life.

[0019] The inventors have found that non-homogenised dairy cream can be used to obtain a nutritional composition having large lipid globules, similar to those of human milk. Typically, non-homogenised dairy cream is composed of an oil in water emulsion with a fat globule volume-based mode diameter of about 2 - 6 pm. Surprisingly, the mode diameter of the cream lipid globules was maintained throughout the manufacturing process to produce the nutritional composition (Examples 1 and 2). A volume-based mode diameter of > 3 pm was preserved and about 50 % of the lipid globules based on lipid volume had a diameter between 2 and 12 pm.

[0020] Surprisingly, the process of the invention led to vegetable oil being encapsulated in the cream lipid globules (Example 1). These findings indicate that it is possible to achieve lipid globules having comparable size to those of human milk, when non-homogenised dairy cream and vegetable oil are used as fat source.

[0021] Furthermore, the inventors have surprisingly found that the free fat percentage in a nutritional composition is decreased when non-homogenised dairy cream and a vegetable oil are used as fat source compared to when anhydrous milk fat and vegetable oil are used as fat source (Example 2). The free fat percentage in the nutritional composition of the invention is 45% lower compared to a similar nutritional composition known in the art. Without wishing to be bound to a theory, it is believed that the lower free fat percentage is due to the encapsulation of the vegetable oil in the non-homogenised dairy cream globules.

[0022] A high free fat percentage may lead to oxidation of the free fat resulting in foul taste and / or smell and reduced shelf-life. Further issues are difficulties in processing, such as blockages in the spray dryer, due to fat bridges between particles that can create lumps, or difficulties to dissolve the powder, due to higher levels of fat at the surface of powder.

[0023] The use of non-homogenised dairy cream and vegetable oil as fat source leads to a more stable nutritional composition, resulting in a longer shelf-life, improved processing properties, and improved solubility in water.

[0024] Therefore, the invention relates to a process for preparing a nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1.0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; and ii. the lipid comprises 0.5 to 20 wt.% milk-derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; wherein the process comprises the steps of: a. providing at least three feeds: a first feed being an aqueous phase comprising water-soluble ingredients; a second feed being a fat blend and less than 1 wt.% of water; a third feed being an emulsion comprising 45-95 wt.% water and 5-55 wt.% phospholipid coated milk fat globules; b. mixing the at least three feeds to obtain a mixture of the at least three feeds; c. spray-drying the obtained mixture to obtain the nutritional composition.

[0025] The invention also relates to a nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising a digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1.0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; ii. the lipid comprises 0.5 to 20 wt.% milk-derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; and

[0026] Hi. the lipid comprises at least 10 wt.% of palmitic acid based on total fatty acids and wherein at least 15 wt.% of palmitic acid based on total palmitic acid is in the sn-2 position in a triglyceride; and wherein the composition has a free fat content of less than 3.5 wt.%.

[0027] BRIEF DESCRIPTION OF THE FIGURES

[0028] Figure 1 shows the particle size distribution of compositions 1 , A, and B of Example 1 before (Fig. 1A) and after (Fig. 1 B) spraying.

[0029] DETAILED DESCRIPTION

[0030] Definitions

[0031] The terms “lipid”, “lipid fraction”, “lipid component” or “fat” as used herein are synonyms and used interchangeably. The terms “globules” and “droplets” as used herein are synonyms and used interchangeably.

[0032] The term “non-homogenised dairy cream” as used herein refers to an emulsion comprising 10 - 50 wt.% milk fat globules and 50 - 90 wt.% water, wherein the milk fat globules have a mode diameter based on volume of about 2 - 6 pm and are at least partially encapsulated by milk phospholipids. Typically non-homogenised dairy cream is obtained from the higher-fat layer skimmed from the top of milk before homogenization.

[0033] The parameter “percentage of solids (Solids%)” in a nutritional composition as used herein refers to the percentage of any components (fat, proteins, sugar, fibres, minerals, vitamins, etc) except water to the total amount of the nutritional composition including water.

[0034] The term “free fat” as used herein refers to the fat from a powdered nutritional composition that can be reached and therefore extracted with a hydrophobic solvent.

[0035] The term “free fat weight percentage” or “free fat wt.%” or “free fat content” as used herein refers to the percentage of free fat determined by extraction in petroleum ether (an apolar solvent), for example as in the method discussed by Sorensen et al. (Analytical Methods for Dry Milk Products, 4thEdition, 1978) and adapted as discussed in Example 2. The free fat content (%) was calculated as follows:

[0036] , , weight of the solid residue free fat content (%) = - - - — — - - - x 100 weight of the sample

[0037] The terms “milk fat” and “mammalian milk fat” as used herein refers to all lipid components of milk, as produced by the mammalians, such as the cow.

[0038] The term “butter” as used herein refers to a water-in-oil emulsion comprised of over 80 wt.% milk fat. The term “butterfat” as used herein refers to all of the fat components in milk that are separable by churning, in other words, present in butter.

[0039] The term “anhydrous milk fat” (AMF) as used herein refers to a concentrated milk fat product or butter with a milk fat content of above 98 wt.%, inherently lactose-free, and with a maximum water content of 2 wt.%. The term “anhydrous butter oil” as used herein is a synonym of AMF.

[0040] The terms “unsaturated fat” and “unsaturated lipid” as used herein are synonyms and refer to lipid that comprises unsaturated fatty acids. The term “unsaturated fatty acid” as used herein refers to a fatty acid having one or more double bonds in its aliphatic chain. Fatty acids comprising one double bond in the aliphatic chain are called monounsaturated fatty acids, while fatty acids comprising more than one double bond in the aliphatic chain are called polyunsaturated fatty acids. Omega-x fatty acids are fatty acids with a double bond x carbon atoms away from the final methyl of the aliphatic chain, wherein x usually equals to 3, 6, or 9.

[0041] As used herein, SFA refers to saturated fatty acids and / or saturated acid chains; short chain fatty acids (SCFAs) refers to fatty acids and / or acyl chains with a chain length of 2 to 6 carbon atoms. BA refers to butyric acid (C4:0); CA refers to caproic acid (C6:0). PUFA refers to polyunsaturated fatty acids and / or acyl chains with 2 or more unsaturated bonds; LC-PUFA refers to long chain polyunsaturated fatty acids and / or acyl chains comprising at least 20 carbon atoms in the fatty acyl chain and with 2 or more unsaturated bonds; n3 LC-PUFA refers to omega-3 long chain polyunsaturated fatty acids and / or aryl chains and refers to a LC-PUFA with one of its double bonds located 3 carbon atoms from the methyl end. LA refers to linoleic acid and / or acyl chain (18:2 n6); ALA refers to a-linolenic acid and / or acyl chain (18:3 n3); DHA refers to docosahexaenoic acid and / or acyl chain (22:6, n3); EPA refers to eicosapentaenoic acid and / or acyl chain (20:5 n3); ARA refers to arachidonic acid and / or acyl chain (20:4 n6); DPA refers to docosapentaenoic acid and / or acyl chain (22:5 n3); PA refers to palmitic acid and / or acyl chains (C16:0).

[0042] The term ‘micronized carbohydrates’ as used herein refers to carbohydrate particles meeting one or more conditions selected from: i. being smaller than 30 micrometer, ii. at least 80 volume% has a size of less than 20 micrometer,

[0043] Hi. at least 80 volume% has a size less than 10 micrometer, iv. having a volume weighted median particle size D50 below 10 micrometer,

[0044] The particle size distribution of the micronized carbohydrates may be suitably determined by Sympatec laser diffraction (in dry dispersion). An example of a commercially available micronized carbohydrate is Lactochem®microfine (DFE Pharma).

[0045] The term “infant” as used herein refers to a child under the age of 12 months. The expression “young child” as used herein refers to a child aged between one and three years, also called toddler.

[0046] The term “infant formula” as used herein refers to a nutritional composition, artificially made, intended as main or sole source of nutrition or supplement to human milk for infants of 0 months to about 4 months to 6 months of age. The term “follow-on formula” as used herein refers to a nutritional composition, artificially made, intended to be supplementary feeding for infants that start weaning on other foods, wherein the infant is weaning is starting at 4 months to 6 months of life to 12 months of life. Infant formulae and follow-on formulae are subject to strict regulations, for example for the EU regulations no. 609 / 2013 and no. 2016 / 127. The term “growing up milk” as used herein refers to a nutritional composition, artificially made, intended to be supplementary feeding for a young child.

[0047] The terms “infant formula”, “follow-on formula”, or “growing up milk” as used herein refer to nutritional compositions that are artificially made or in other words that are synthetic compositions. Therefore, “infant formula”, “follow-on formula”, or “growing up milk” as used herein are not human milk or breast milk.

[0048] All percentages are by weight unless otherwise stated. A weight percentage of fatty acids based on total fatty acids is calculated as if all fatty acids are free fatty acids, hence it is not taken into account whether a fatty acid is attached to a glycerol backbone or not. In addition, in the context of the invention, the terms “comprising” or “comprises” do not exclude other possible elements. The product of the present invention, including the many embodiments described herein, can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs. Any reference to prior art documents in this specification is not to be considered an admission that such prior art is widely known or forms part of the common general knowledge in the field.

[0049] The invention will now be described in further details. It is noted that the various aspects, features, examples and embodiments described in the present application may be compatible and / or combined together.

[0050] Process

[0051] In a first aspect, the invention concerns a process for preparing a nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising digestible carbohydrates, protein and lipid, wherein the lipid is the is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1 .0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; and ii. the lipid comprises 0.5 to 20 wt.% milk derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; comprising the steps of: a. providing at least three feeds: a first feed being an aqueous phase comprising water-soluble ingredients; a second feed being a fat blend and less than 1 wt.% of water; a third feed being an emulsion comprising 45-95 wt.% water and 5-55 wt.% phospholipid coated milk fat globules; b. mixing the at least three feeds to obtain a mixture of the at least three feeds; c. spray-drying the obtained mixture to obtain the nutritional composition.

[0052] Step (a) - providing the feeds

[0053] In step (a), at least three feeds are provided.

[0054] The first feed comprises an aqueous phase comprising water-soluble ingredients. Preferably the water- soluble ingredients are selected from one or more of protein, digestible carbohydrate, non-digestible oligosaccharides, water-soluble vitamins and minerals. Preferably the digestible carbohydrate is lactose. Preferably the protein is milk protein, preferably whey protein, casein, or a combination thereof, more preferably both whey protein and casein. More preferably the aqueous phase comprises skimmed milk, skimmed milk powder, whey protein powder, and / or low fat milk. Preferably the pH of the aqueous phase is set at 6.0 - 8.0, more preferably a pH of 6.5 - 7.5. Preferably the first feed comprises less than 5 wt.% of fat by weight of the first feed, more preferably less than 3 wt.%.

[0055] The second feed is a fat blend and less than 1 wt.% water. Preferably the fat blend comprises 50 to 100 wt.% vegetable fat based on total weight of the fat bland, more preferably at least 80 wt.% vegetable fat, most preferably at least 90 wt.% of vegetable fat. Preferably the fat blend comprises at least one, more preferably at least two vegetable oils selected from linseed oil (flaxseed oil), rape seed oil (such as colza oil, low erucic acid rape seed oil and canola oil), salvia oil, perilla oil, purslane oil, lingonberry oil, sea buckthorn oil, hemp oil, sunflower oil, high oleic sunflower oil, safflower oil, high oleic safflower oil, olive oil, black currant seed oil, echium oil, coconut oil, palm oil and palm kernel oil. More preferably the fat blend comprises at least one, preferably at least two vegetable oils selected from linseed oil, canola oil, coconut oil, sunflower oil and high oleic sunflower oil. The fat blend may further comprise milk fat, preferably selected from butter, butter fat, butter oil, and / or anhydrous milk fat. The fat blend may further comprise one or more lipid selected from fish oil, egg lipid, microbial oil, algal oil, or fungal oil. In a preferred embodiment, the fat blend consists of vegetable fat.

[0056] The third feed is an emulsion comprising 45-95 wt.% water and 5-55 wt.% phospholipid coated milk fat globules. More preferably the emulsion comprises 50 - 90 wt.% water and 10 - 50 wt.% phospholipid coated milk fat globules, most preferably the emulsion comprises 60 - 90 wt.% water and 10 - 40 wt.% phospholipid coated milk fat globules. Preferably the milk fat globules have a volume-based mode diameter of 1 - 12 pm, more preferably 1.5 - 8 pm, most preferably 2 - 6 pm. Preferably the phospholipids are milk phospholipids present in the milk fat globular membrane (MFGM). Typically nonhomogenised dairy cream comprises phospholipids coated milk fat globules emulsified in water. Typically, the milk fat globules of non-homogenised cream already have a volume-based mode diameter or 2 - 6 pm, but in homogenised cream the size of the milk fat globules is not retained. In a preferred embodiment, the emulsion of the third feed is non-homogenised dairy cream, most preferably a non-homogenised sweet dairy cream. Preferably, the non-homogenised dairy cream is from animal milk selected from milk from cows, sheep, goats, buffalos, horses, yak, reindeer and camels or combinations thereof. More preferably the non-homogenised dairy cream is from cow milk. Preferably, the third feed is pasteurised.

[0057] In a preferred embodiment, a fourth feed is provided comprising a source of phospholipid. Preferably the phospholipids are selected from plant phospholipids, milk phospholipids or combinations thereof. If plant phospholipids are present, they are preferably provided as part of oleosomes. If milk phospholipids are present, they are preferably provided as MFGM sources such as MFGM-enriched beta serum, MFGM-enriched whey powder, or MFGM-enriched buttermilk. Examples of suitable commercially available sources for phospholipid from milk are BAEF, SM2, SM3 and SM4 powder of Corman, Salibra of Glanbia, Lipamin M20 of Lecico, Vivinal ® MFGM of FrieslandCampina and LacProdan MFGM-10 or PL20 of Aria. In other words, preferably the source of phospholipid in the fourth feed is selected from oleosomes, MFGM sources such as MFGM-enriched beta serum, MFGM-enriched whey powder, or MFGM-enriched buttermilk, or combinations thereof. Preferably the source of phospholipid in the fourth feed is a powdered composition comprising at least 3 wt.% by dry weight of phospholipids, more preferably milk-derived phospholipids. Most preferably the source of phospholipid in the fourth feed is an MFGM source selected from MFGM-enriched beta serum, MFGM-enriched whey powder, or MFGM- enriched buttermilk. Preferably at least 85 wt.%, more preferably at least 90 wt.%, most preferably at least 95 wt.% of (milk-derived) phospholipids in the nutritional composition are provided by the phospholipids in the third and optional fourth feed. Preferably the weight ratio of the milk phospholipids in third feed to the phospholipids in the fourth feed is between 1 :100 to 10:1 , more preferably between 1 :50 to 5:1 and most preferably between 1 :25 to 2:1 .

[0058] In a preferred embodiment, the third feed and optional fourth feed are the sole source of milk fat in the nutritional composition.

[0059] Step (b) - mixing

[0060] In step (b), the at least three feeds of step (a) are mixed to obtain a mixture of the at least three feeds.

[0061] The at least three feeds are mixed together, i.e. added together, preferably blended, in any order. When the fourth feed is present, preferably the fourth feed is pre-mixed with the first feed and / or with the third feed, prior to the mixing in step b) of the process. In another preferred embodiment, the first feed is premixed with the optional fourth feed and with the third feed, prior to the mixing in step (b). In another preferred embodiment, the second feed is pre-mixed with the third feed, prior to the mixing in step (b).

[0062] In a more preferred embodiment, step (b) comprises

[0063] • premixing the first feed with the fourth feed,

[0064] • optionally premixing the second feed with the third feed,

[0065] • adding the second feed and third feed orthe mixture of second feed and third feed to the mixture of first feed and fourth feed,

[0066] • mixing the at least three feeds.

[0067] Preferably the third feed is only exposed to low shear mixing to avoid buttering of the emulsion in the third feed.

[0068] The at least three feeds may be added together at any weight ratio between them. When the second feed is pre-mixed with the third feed, preferably the weight ratio between the dry weight of the second feed and the dry the weight of the third feed is 30 : 70 - 70 : 30, more preferably 40 : 60 - 60 : 40, most preferably about 50 : 50. Preferably the at least three feeds are heated before adding together, preferably are heated to a temperature of 30 °C to 80 °C, more preferably heated to a temperature of 50 °C to 70 °C, even more preferably heated to a temperature of 55 °C to 65 °C.

[0069] The mixing in step (b) is preferably blending at a low shear rate. With low shear rate is intended a shear rate of 1000 - 6000 rpm, more preferably 1000 - 5000 rpm, most preferably 2000 - 4500 rpm. Preferably step (b) is carried out in a static mixer, an inline mixer, a rotor stator machine, a cavitator or by membrane emulsification, more preferably the blending is carried out in an inline-mixer or static mixer. Even more preferably the mixing in step (b) is carried out in an inline mixer, most preferably wherein the shear rate in the inline mixer is low enough to maintain the volume-based mode diameter of the non-homogenized cream. Preferably the shear rate in the inline mixer is 1000 - 6000 rpm, more preferably 1000 - 5000 rpm, most preferably 2000 - 4500 rpm.

[0070] Preferably the second feed or the mixture of second feed and third feed is heated prior to step (b) to a temperature of 30 °C to 80 °C, more preferably 50 °C to 70 °C, even more preferably 55 °C to 65 °C. Preferably step (b) is carried out at a temperature of 30 °C to 80 °C, more preferably 50 °C to 70 °C, even more preferably 55 °C to 65 °C.

[0071] Preferably the total solid content of the obtained mixture in step (b) is 30 - 70 wt.%, more preferably 40 - 60 wt.%, most preferably 45 - 55 wt.%.

[0072] The process of the invention preferably comprises a step of pasteurization. The pasteurization is carried out at any point in the process and before step (c) of the process.

[0073] In a most preferred embodiment, step (b) comprises

[0074] • premixing the first feed with the fourth feed;

[0075] • pasteurizing the mixture of the first feed and fourth feed;

[0076] • premixing the second feed with the third feed, preferably wherein the weight ratio between the dry weight of the second feed and the dry the weight of the third feed is 30 : 70 - 70 : 30, more preferably 40 : 60 - 60 : 40, most preferably about 50 : 50;

[0077] • heating the mixture of the second feed and the third feed to a temperature of 30 °C to 80 °C, preferably to a temperature of 50 °C to 70 °C;

[0078] • mixing the heated mixture of the second feed and third feed with the mixture of the first feed and fourth feed, preferably at a total weight ratio of [wt. second feed + wt. third feed] : [wt. first feed + wt. fourth feed] of 15 : 85 - 30 : 70;

[0079] • emulsifying the mixture of the four feeds in an inline-mixer.

[0080] In another most preferred embodiment, step (b) comprises

[0081] • premixing the first feed with the fourth feed;

[0082] • pasteurizing the mixture of the first feed and fourth feed;

[0083] • heating the second feed to a temperature of 30 °C to 80 °C, preferably to a temperature of 50 °C to 70 °C;

[0084] • adding the heated second feed and the third feed to the mixture of the first feed and fourth feed in any order,

[0085] • emulsifying the mixture of the four feeds in an inline-mixer.

[0086] Step (c) - spray drying In step (c), the mixture obtained from step (b) and optional steps is subsequently spray dried to give the final nutritional composition. Spray drying is known in the art. Preferably the mixture is spray-dried with an inlet temperature of the drying gas of 130 - 280 °C, more preferably 150 - 250 °C, most preferably 180 - 220 °C. Preferably the spray drying is carried out by a 2-fluid nozzle or a rotary atomizer, more preferably a 2-fluid nozzle.

[0087] Preferably, no extrusion is applied in the process of the invention.

[0088] Preferably, after the spray drying in step c) a powdered nutritional composition comprising nutritional composition particles is obtained. Preferably, these nutritional composition particles are not dry-blended with micronized carbohydrates to obtain nutritional composition particles with a coating comprising (or consisting of) micronized carbohydrates.

[0089] Nutritional composition

[0090] In a second aspect, the invention concerns a powdered nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising a digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1 .0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; ii. the lipid comprises 0.5 to 20 wt.% milk-derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; and

[0091] Hi. the lipid comprises at least 10 wt.% of palmitic acid based on total fatty acids and wherein at least 15 wt.% of palmitic acid based on total palmitic acid is in the sn-2 position in a triglyceride; and wherein the composition has a free fat content of less than 3.5 wt.% by weight of the powdered composition.

[0092] The powdered nutritional composition of the invention has a free fat content of less than 3.5 wt.%, preferably less than 3.4 wt.%, more preferably less than 3.3 wt.%, and most preferably less than 3.2 wt.% by weight of the powdered composition.

[0093] The process of the invention yields the powdered nutritional composition of the invention. Thus, the powdered nutritional composition is preferably obtained or obtainable by the process of the invention. The powdered nutritional composition comprises digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules. Preferably the nutritional composition further comprises one or more of non-digestible oligosaccharides, vitamins, minerals and more preferably combinations thereof. Each of these fractions is described in details below.

[0094] Lipid

[0095] The nutritional composition according to the present invention comprises lipid. Preferably the lipid comprises one or more selected from the group consisting of triglycerides, polar lipids (such as phospholipids, cholesterol, glycolipids, sphingomyelin), free fatty acids, monoglycerides and diglycerides. Preferably the composition comprises at least 70 wt.%, more preferably at least 80 wt.%, even more preferably at least 85 wt.%, most preferably at least 90 wt.% triglycerides based on total lipid.

[0096] Preferably the lipid provides 30 to 60%, more preferably 35 to 55%, most preferably 40 to 50% of the total calories of the nutritional composition. Preferably the lipid is present in an amount of 3 to 7 g, more preferably 4 to 6 g, most preferably 4.5 to 5.5 g lipid per 100 kcal. When in liquid form, e.g. as a ready- to-feed liquid, the nutritional composition preferably comprises 2.1 to 6.5 g, more preferably 3.0 to 4.0 g lipid per 100 ml. Based on dry weight, the nutritional composition preferably comprises 10 to 50 wt.%, more preferably 12.5 to 40 wt.%, most preferably 19 to 30 wt.% lipid.

[0097] The lipid preferably comprises vegetable fat and milk fat. Preferably the nutritional composition comprises 30 to 90 wt.%, more preferably 35 to 80 wt.%, even more preferably 40 to 70 wt.%, most preferably 40 to 60 wt.% vegetable fat based on total lipid. Preferably the composition comprises 10 to 70 wt.%, more preferably 20 to 65 wt.%, even more preferably 30 to 60 wt.%, most preferably 40 to 60 wt.% milk fat based on total lipid. Preferably the ratio of vegetable fat to milk fat ranges from 3 / 7 to 9 / 1 .

[0098] In a preferred embodiment, the lipid in the nutritional composition comprises: a) 35 to 80 wt.% vegetable lipid based on total lipid, and b) 20 to 65 wt.% mammalian milk fat based on total lipid, wherein the mammalian milk fat is preferably derived from non-homogenised dairy cream and a source of MFGM.

[0099] More preferably, the lipid in the nutritional composition comprises: a) 40 to 70 wt.% vegetable lipid based on total lipid, and b) 30 to 60 wt.% mammalian milk fat based on total lipid, wherein the mammalian milk fat is preferably derived from non-homogenised dairy cream and a source of MFGM.

[0100] Most preferably, the lipid in the nutritional composition comprises: a) 40 to 60 wt.% vegetable lipid based on total lipid, and b) 40 to 60 wt.% mammalian milk fat based on total lipid, wherein the mammalian milk fat is preferably derived from non-homogenised dairy cream and a source of MFGM.

[0101] Fatty acid composition

[0102] Compared to vegetable fat, milk fat is known to have a higher content of palmitic acid (PA) at the sn-2 position of a triglyceride. Thus, the lipid in the nutritional composition comprises at least 10 wt.%, preferably below 30 wt.%, more preferably from 12 to 26 wt.%, most preferably from 14 to 24 wt.% PA based on total fatty acids. At least 15 wt.%, preferably at least 20 wt.%, more preferably at least 25 wt.%, most preferably at least 30 wt.% PA based on total PA is in the sn-2 or beta position in a triglyceride. Preferably not more than 45 wt.%, more preferably not more than 40 wt.% PA based on total PA is in the sn-2 or beta position in a triglyceride. Most preferably from 25 to 40 wt.% PA based on total PA is in the sn-2 position in a triglyceride. Compared to vegetable fat, milk fat is known to have a higher content of short-chain fatty acids (SCFAs) butyric acid (BA) and caproic acid (CA). Preferably the lipid in the nutritional composition comprises 0.6 to 5 wt.% SCFA being the sum of BA and CA based on total fatty acids. Preferably the nutritional composition comprises 0.5 to 5 wt.%, more preferably 0.6 to 4 wt.%, most preferably 0.9 to 4 wt.% BA based on total fatty acids.

[0103] Preferably the nutritional composition comprises 5 to 35 wt.% PUFA based on total fatty acids.

[0104] Preferably the lipid in the nutritional composition comprises LA. Preferably the nutritional composition comprises less than 20 wt.%, more preferably 5 to 16 wt.%, even more preferably 10 to 14.5 wt.% LA based on total fatty acids.

[0105] Preferably the lipid in the nutritional composition comprises ALA. Preferably the nutritional composition comprises at least 1 .0 wt.%, more preferably 1 .5 to 10 wt.%, most preferably 2.0 to 5.0 wt.% ALA based on total fatty acids.

[0106] Preferably the nutritional composition comprises a weight ratio of LA / ALA from 2 to 20, more preferably from 3 to 16, even more preferably from 4 to 14, most preferably from 5 to 12.

[0107] Preferably the lipid in the nutritional composition comprises n3 LC-PUFA, more preferably selected from EPA, DPA, DHA, or combinations thereof, most preferably at least DHA. Preferably the nutritional composition comprises at least 0.05 wt.%, more preferably 0.1 to 2.0 wt.%, most preferably 0.2 to 1 .0 wt.% DHA based on total fatty acids.

[0108] Preferably the lipid in the nutritional composition comprises ARA. Preferably the nutritional composition comprises at least 0.05 wt.%, more preferably 0.1 to 2.0 wt.%, most preferably 0.2 to 1.0 wt.% ARA based on total fatty acids. Preferably the weight ratio between DHA and ARA is between 1 :4 to 4:1 , more preferably between 1 :2 to 2:1 , most preferably between 0.6 and 1 .5.

[0109] Lipid globules

[0110] The lipid in the nutritional composition is in the form of lipid globules, wherein: i. the lipid globules have a mode diameter, based on volume, of at least 1 .0 pm; and / or at least 40 vol. % of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; and ii. the lipid comprises 0.5 to 20 wt.% milk derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids.

[0111] When the nutritional composition is in powder form, the lipid globules are present in the powder and the powder is suitable for reconstitution with water or another food grade aqueous phase. When the powdered nutritional composition is reconstituted and is in liquid form, these lipid globules are emulsified in the aqueous phase. The lipid globules comprise a core and a surface. Preferably the lipid globules in the nutritional composition have a mode diameter, based on volume, of at least 1 .0 pm, more preferably at least 2.0 pm, most preferably at least 3.0 pm. Preferably, the lipid globules have a mode diameter, based on volume, between 1.0 and 10 pm, more preferably between 2.0 and 8.0 pm, most preferably between 3.0 and 6.0 pm.

[0112] Alternatively, or preferably in addition, the size distribution of the lipid globules is preferably in such a way that at least 40 volume % (vol.%), more preferably at least 45 vol.%, even more preferably at least 55 vol.%, and most preferably at least 60 vol.% of the lipid globules, based on total lipid volume, have a diameter between 2 and 12 pm. In a more preferred embodiment, at least 40 vol.%, preferably at least 45 vol.%, more preferably at least 55 vol.%, and most preferably at least 60 vol.% , based on total lipid volume, of the lipid globules have a diameter between 2 and 10 pm. In an even more preferred embodiment, at least 40 vol.%, more preferably at least 45 vol.%, even more preferably at least 55 vol.%, and most preferably at least 60 vol.%, based on total lipid volume, of the lipid globules have a diameter between 3 and 8 pm. Preferably less than 5 vol.%, based on total lipid volume, of the lipid globules have a diameter above 12 pm.

[0113] Standard infant formulae, follow-on formulae or young child formulae typically have lipid globules with a mode diameter, based on volume, of about 0.3-0.5 pm and / or less than 40 vol.%, based on total lipid volume, of the lipid globules have a diameter above 2 pm.

[0114] The volume percentage of lipid globules is based on volume of total lipid. The mode diameter relates to the diameter which is the most present based on volume % of total lipid, orthe peak value in a graphic representation, having on the X-as the diameter and on the Y-as the volume %.

[0115] The volume of the lipid globule and its size distribution can suitably be determined using a particle size analyser such as a Mastersizer 2000 (Malvern Instruments, Malvern, UK), for example by the method described in Michalski et al, 2001 , Lait 81 : 787-796.

[0116] Phospholipid

[0117] The lipid of the nutritional composition of the invention comprises 0.5 to 20 wt.% milk derived phospholipids based on total lipids, wherein the lipid globules have a coating comprising said phospholipids.

[0118] The nutritional composition comprises 0.5 to 20 wt.%, preferably 0.5 to 10 wt.%, even more preferably 0.75 to 8 wt.%, yet even more preferably 1 .2 to 8 wt.%, and most preferably 1 .5 to 5 wt.% phospholipid based on total lipid.

[0119] The lipid globules are at least partly coated on the surface with phospholipids. By ‘coating’ is meant that the outer surface layer of the lipid globules comprises phospholipid, whereas phospholipid is virtually absent in the core of the lipid globule. A suitable way to determine whether phospholipid is located on the surface of lipid globules is confocal laser scanning microscopy or transmission electron microscopy; see for instance Gallier et al. (A novel infant milk formula concept: Mimicking the human milk fat globule structure, Colloids and Surfaces B: Biointerfaces 136 (2015) 329-339).

[0120] The nutritional composition preferably comprises glycerophospholipids. Examples of glycerophospholipids are phosphatidylcholine (PC), phosphatidylserine (PS), phosphatidylethanolamine (PE), phosphatidylinositol (PI) and phosphatidylglycerol (PG). Preferably the nutritional composition comprises one or more of PC, PS, PI and PE, more preferably the nutritional composition comprises at least PC.

[0121] The nutritional composition preferably comprises sphingomyelin. Sphingomyelins have a phosphorylcholine or phosphorylethanolamine molecule esterified to the 1 -hydroxy group of a ceramide. They are classified as phospholipid as well as sphingolipid, but are not classified as a glycerophospholipid nor as a glycosphingolipid. Preferably the nutritional composition comprises 0.05 to 10 wt.%, more preferably 0.1 to 5 wt.%, most preferably 0.2 to 2 wt.% sphingomyelin based on total lipid. Preferably the nutritional composition comprises at least 5 wt.%, more preferably 5 to 40 wt.%, even more preferably 10 to 35 wt.%, most preferably 15 to 35 wt.% sphingomyelin based on total phospholipid.

[0122] The nutritional composition preferably comprises glycosphingolipids. Preferably the nutritional composition comprises 0.1 to 10 wt.%, more preferably 0.5 to 5 wt.%, most preferably 2 to 4 wt.% glycosphingolipids based on total lipid. The term glycosphingolipids in the present context particularly refers to glycolipids with an amino alcohol sphingosine. The sphingosine backbone is O-linked to a charged head-group such as ethanolamine, serine or choline backbone. The backbone is also amide linked to a fatty acyl group. Glycosphingolipids are ceramides with one or more sugar residues joined in a beta-glycosidic linkage at the 1 -hydroxyl position, and include gangliosides. Preferably the nutritional composition contains gangliosides, more preferably at least one ganglioside selected from the group consisting of GM3 and GD3.

[0123] Preferably the nutritional composition comprises phospholipid and glycosphingolipid. Preferably the weight ratio of phospholipid : glycosphingolipid is from 2:1 to 12:1 , more preferably from 2:1 to 10:1 and even more preferably 2:1 to 5:1 .

[0124] The composition may further comprise plant phospholipids.

[0125] Protein

[0126] The nutritional composition comprises protein. The protein concentration in a nutritional composition is determined by the sum of protein, peptides and free amino acids. A low protein concentration advantageously is closer to human milk as human milk comprises a lower amount of protein based on total calories compared to cow’s milk. Preferably the protein preferably provides 5 to 20%, more preferably 6 to 12% of the total calories of the nutritional composition. Preferably the nutritional composition comprises less than 3.5 g, more preferably 1 .5 to 2.1 g, most preferably 1 .6 to 2.0 g protein per 100 kcal. Based on total dry weight, the nutritional composition preferably comprises less than 12 wt.%, more preferably 9.6 to 12 wt.%, most preferably 10 to 11 wt.% protein. When reconstituted as a ready-to-drink liquid product, the nutritional composition preferably comprises less than 1.5 g, more preferably 1 .2 to 1 .5 g, most preferably 1 .25 to 1 .35 g protein per 100ml.

[0127] The source of the protein is preferably selected in such a way that the minimum requirements for essential amino acid content are met and satisfactory growth is ensured. Protein sources based on cows' milk proteins such as whey, casein and mixtures thereof and proteins based on soy, potato or pea are preferred. In case whey proteins are used, the protein source is preferably acid whey, sweet whey, whey protein isolate or mixtures thereof.

[0128] Digestible carbohydrate

[0129] The nutritional composition comprises digestible carbohydrates. Preferably the digestible carbohydrates provide 25 to 75%, more preferably 40 to 60% of the total calories of the nutritional composition. Preferably the nutritional composition comprises 5 to 20 g, more preferably 6 to 16 g digestible carbohydrates per 100 kcal. When reconstituted in liquid form, e.g. as a ready-to-feed liquid, the nutritional composition preferably comprises 3 to 30 g, more preferably 6 to 20 g, most preferably 7 to 10 g digestible carbohydrate per 100 ml. Based on total dry weight, the nutritional composition preferably comprises 20 to 80 wt.%, more preferably 40 to 65 wt.% digestible carbohydrates.

[0130] Preferably the digestible carbohydrates comprises one or more of lactose, glucose, sucrose, fructose, galactose, maltose, starch and maltodextrin. Lactose is the main digestible carbohydrate present in human milk. Lactose has a low glycaemic index. The nutritional composition preferably comprises lactose. Preferably at least 35 wt.%, more preferably at least 50 wt.%, even more preferably at least 75 wt.%, yet even more preferably at least 90 wt.%, most preferably at least 95 wt.% of the digestible carbohydrates in the nutritional composition is lactose. Based on total dry weight, the nutritional composition preferably comprises at least 25 wt.%, more preferably at least 40 wt.% lactose.

[0131] Non-digestible oligosaccharides

[0132] The nutritional composition preferably comprises non-digestible oligosaccharides. Preferably the nutritional composition comprises non-digestible oligosaccharides with a degree of polymerization (DP) between 2 and 250, more preferably between 3 and 60.

[0133] Preferably the nutritional composition comprises fructo-oligosaccharides, galacto-oligosaccharides and / or galacturonic acid oligosaccharides, more preferably fructo-oligosaccharides and / or galactooligosaccharides, even more preferably galacto-oligosaccharides, most preferably transgalactooligosaccharides. In a preferred embodiment the nutritional composition comprises a mixture of galactooligosaccharides and fructo-oligosaccharides, more preferably transgalacto-oligosaccharides and fructo-oligosaccharides. Suitable non-digestible oligosaccharides are for example VivinalOGOS (FrieslandCampina DOMO), RaftilinOHP or Raftilose® (Orafti).

[0134] Preferably the nutritional composition comprises 80 mg to 2 g, more preferably 150 mg to 1 .5 g, most preferably 300 mg to 1 g non-digestible oligosaccharides per 100 ml. Based on total dry weight, the nutritional composition preferably comprises 0.25 wt.% to 20 wt.%, more preferably 0.5 wt.% to 10 wt.%, most preferably 1 .5 wt.% to 7.5 wt.% non-digestible oligosaccharides.

[0135] Micronized carbohydrates

[0136] Preferably the nutritional composition comprises less than 0.4 wt.% of micronized carbohydrates, by weight of the nutritional composition, more preferably less than 0.1 wt.% of micronized carbohydrates and even more preferably less than 0.01 wt. % micronized carbohydrates by weight of the nutritional composition. Most preferably, the nutritional composition comprises no micronized carbohydrate.

[0137] Alternatively preferred, the nutritional composition particles in the powdered nutritional composition are not coated with a layer comprising micronized carbohydrates, more preferably the nutritional composition particles are not coated with a layer consisting of micronized carbohydrates.

[0138] Said micronized carbohydrates preferably comprise one or more selected from the group consisting of micronized lactose, micronized glucose, micronized maltodextrin, micronized starch, micronized inulin and micronized sucrose, more preferably the micronized carbohydrates are micronized lactose.

[0139] Vitamins and minerals

[0140] The nutritional composition preferably comprises other ingredients, such as vitamins and minerals according to international directives for infant formulae.

[0141] Application

[0142] In a preferred embodiment, the nutritional composition is a powder. Suitably, the nutritional composition is in a powdered form, which can be reconstituted with water or other food grade aqueous liquid, to form a ready-to drink liquid, or is in a liquid concentrate form that should be diluted with water to a ready-to- drink liquid. It was found that lipid globules maintained their size and coating when reconstituted.

[0143] The nutritional composition of the invention is selected from infant formula, follow-on formula, or young child formula. Preferably the nutritional composition is an infant formula or follow-on formula, more preferably an infant formula. The nutritional composition of the invention is artificially made or synthetic. This means that the nutritional composition is not human milk. It also means that the nutritional composition is not native cow’s milk or native milk from another mammal.

[0144] The nutritional composition comprises digestible carbohydrates, protein and lipid, wherein preferably the lipid provides 30 to 60% of the total calories, the protein provides 5 to 20% of the total calories and the digestible carbohydrates provide 25 to 75% of the total calories. The nutritional composition preferably comprises 3 to 7 g lipid / 100 kcal, more preferably 4 to 6 g lipid / 100 kcal, most preferably 4.5 to 5.5 g lipid / 100 kcal, preferably comprises 1 .7 to 3.5 g protein / 100 kcal, more preferably 1 .8 to 2.1 g protein / 100 kcal, most preferably 1.8 to 2.0 g protein / 100 kcal and preferably comprises 5 to 20 g digestible carbohydrate / 100 kcal, more preferably 6 to 16 g digestible carbohydrate / 100 kcal, most preferably 10 to 15g digestible carbohydrate / 100 kcal.

[0145] Preferably the nutritional composition has an energy density of 60 to 75 kcal / 100 ml, more preferably 60 to 70 kcal / 100 ml, when in a ready-to-drink form. This density ensures an optimal balance between hydration and caloric intake.

[0146] EXAMPLES

[0147] Example 1

[0148] Three sprayed nutritional compositions were prepared: composition 1 , composition A and composition B. The three compositions were prepared identically, but using a different fat source: composition 1 was a composition according to the invention and contained non-homogenised cream and a vegetable oil blend as fat source, compositions A and B were control compositions and contained only nonhomogenised cream or only a vegetable oil blend as fat source, respectively. All the compositions comprised milk derived phospholipids. In this example, particle size distribution of the nutritional compositions before and after spraying was measured.

[0149] Methods

[0150] Composition preparation

[0151] Compositions 1 , A, and B were prepared according to Table 1 .

[0152] Table 1. Ingredients of the compositions of Example 1.

[0153] *by Lecico, comprising about 20 wt.% milk phospholipids by weight.

[0154] “comprises sweet whey protein concentrate comprising 35 wt.% whey protein (WPC35), acid WPC35, and demineralised whey protein.

[0155] For all compositions, an aqueous phase was prepared as known in the art and contained protein, digestible carbohydrates, MFGM-enriched whey protein concentrate and the other ingredients of Table 1 , except for the non-homogenised cream and / or the vegetable oil. The dry matter content of the aqueous phase was 49 wt.%. The aqueous phase was pasteurized for 30 seconds at 85°C.

[0156] For composition 1 , the fat source was derived from non-homogenised cream and vegetable oil. Vegetable oil was firstly heated to 60°C and then mixed with the non-homogenised cream to obtain an oil phase. In the resulting oil phase the weight ratio between the dry weight of the vegetable oil and the dry weight of the non-homogenised cream was 50:50. The oil phase was added to the aqueous phase in a oil phase to aqueous phase total weight ratio of 30:70 and premixed with a Typhoon propeller mixer. The total solid content of the oil phase and aqueous phase mixture was 48 wt.%.

[0157] For composition A, the non-homogenised cream was added to the aqueous phase in a cream to aqueous phase total weight ratio of 30:70 and premixed with a Typhoon propeller mixer. The total solid content of the fat and aqueous phase mixture was 48 wt.%.

[0158] For composition B, the vegetable oil was heated to 60°C and added to the aqueous phase in a oil to aqueous phase total weight ratio of 20:80. The mixture was premixed with a Typhoon propeller mixer. The total solid content of the fat and aqueous phase mixture was 48 wt.%.

[0159] The pre-emulsion was fed into a stator rotor machine (IKA process pilot 2000 / 04 generator 4M) with a shear of 4000 rpm. After the first emulsification step, the product was collected and emulsified a 2nd time using pneumatic atomizers (2F) at 1 .8 bar air pressure.

[0160] Particle size

[0161] Particle size distribution of the lipid globules in compositions 1 , A, and B was measured before spraying and after spraying with a Mastersizer 2000 (Malvern Instruments, Malvern UK).

[0162] Results

[0163] The particle size distribution for each composition before and after spraying are shown in Fig. 1 A and 1 B, respectively. Before spraying, the curve of cream + vegetable oil (composition 1) corresponds to the one peak of cream alone (composition A) and two peaks of vegetable oil alone (composition B). This indicates that cream and vegetable oil are only physically mixed. After spraying, the peak of cream + vegetable oil (composition 1) shifts towards the peak of cream only (composition A).

[0164] Conclusion

[0165] The results shown in Fig. 1 indicate that the vegetable oil is at least partially encapsulated in the milk fat globules of the cream.

[0166] Example 2

[0167] Two powdered nutritional compositions were prepared. Composition 2 was a composition according to the invention and contained non-homogenised cream and a vegetable oil blend as fat source. Composition C was a control composition prepared in manner comparable to composition 2, but using a different fat source: composition C contained anhydrous milk fat and a vegetable oil blend as fat source. Both compositions comprised milk derived phospholipid, in comparable amounts. Compositions 2 and C differed solely in the fat source. The particle size of the reconstituted powders and the free fat percentage during shelf-life at 25°C was measured at 0, 4, and 7 months of storage for compositions 2 and C.

[0168] Methods

[0169] Composition preparation

[0170] Compositions 2 and C were prepared being powders according to Table 2.

[0171] Table 2. Ingredients of the compositions of Example 2.

[0172] ‘comprising about 7 wt.% milk phospholipids by weight of the concentrate.

[0173] “comprises sweet whey protein concentrate comprising 35 wt.% whey protein (WPC35), acid WPC35, and demineralised whey protein.

[0174] For both compositions, an aqueous phase was prepared as known in the art and contained protein, digestible carbohydrates, MFGM-enriched whey protein concentrate and the other ingredients of Table 2, except for the non-homogenised cream, the anhydrous milk fat (AMF), and / or the vegetable oil. The dry matter content of the aqueous phase was 45 wt.%. The aqueous phase was pasteurized for 30 seconds at 85°C.

[0175] For composition 2, the fat source was derived from non-homogenised cream and vegetable oil. Vegetable oil was firstly heated to 60 °C and then mixed with the non-homogenised cream to obtain an oil phase. In the resulting oil phase the weight ratio between the dry weight of the vegetable oil and the dry weight of the non-homogenised cream was 50:50. The oil phase was added to the aqueous phase in a oil phase to aqueous phase total weight ratio of 20:80 and premixed with a Typhoon propeller mixer. The total solid content of the oil and aqueous phase mixture was 48 wt.%.

[0176] For composition C, the fat source was derived from AMF and vegetable oil. Vegetable oil and AMF were mixed and heated to 60 °C to obtain an oil phase. In the resulting oil phase, the weight ratio between vegetable oil and AMF was 50:50. The oil phase was added to the aqueous phase in an oil phase to aqueous phase total weight ratio of 20:80 and premixed with a Typhoon propeller mixer. The total dry matter content of the fat and aqueous phase mixture was 48 wt.%.

[0177] The pre-emulsion was fed into a stator rotor machine (IKA process pilot 2000 / 04 generator 4M) with a shear of 4000 rpm. After the first emulsification step, the product was collected and emulsified a second time using pneumatic atomizers (2F) at 1 .8 bar air pressure. The composition was spray dried with an inlet temperature of the drying gas being 195°C.

[0178] Particle size

[0179] Compositions 2 and C were reconstituted in water. Particle size of the lipid globules was measured for the reconstituted powders with a Mastersizer 2000 (Malvern Instruments, Malvern UK).

[0180] Free fat content

[0181] The free fat content of compositions 2 and C was analysed as described by Sorensen et al. (Analytical Methods for Dry Milk Products, 4thEdition, 1978). The method from Sorensen et al. was adapted as follows; 5 g of sample from composition (2 or C) was mixed with 50 ml petroleum ether and agitated for 15 minutes. The mixture was filtered and the petroleum ether phase (filtrate) was collected. The extraction was repeated: the remaining solid was mixed with 50 additional ml of petroleum ether and agitated for 15 minutes. The mixture was filtered and the petroleum ether phase was collected and merged with the first filtrate. The petroleum ether was evaporated. The solid residue was dried at 102 °C for 90 minutes. The free fat content (%) was calculated as follows:

[0182] , , weight of the solid residue free fat content (%) = - - - — — - - - x 100 weight of the sample

[0183] Results

[0184] The effect of the fat source on globular size and free fat percentage is summarized in Tables 3 and 4.

[0185] Table 3. Particle size of reconstituted powders, (pm = micrometer; v% = vol.-%)

[0186] Both compositions contained lipid globules having a volume-based mode diameter of 3 - 4 pm, with at least 50 vol.% of the lipid globules having a diameter of 2 - 12 pm. Thus, both compositions have a lipid architecture similar to that of human milk.

[0187] Table 4. Free fat percentage over shelf-life at 25°C (free fat per sample weight % w / w)

[0188] Composition 2 had a lower free fat percentage compared to composition C. The percentage of free fat remained lower at months 4 and 7 of storage. When using non-homogenised cream (composition 2) instead of anhydrous milk fat (composition C) together with vegetable oil as a fat source, the free fat percentage decreased to 3.2 wt.% from 5.8 wt.%. This corresponds to a decrease of 45%.

[0189] Conclusion

[0190] Both compositions 2 and C had a lipid architecture similar to that of human milk. Composition 2 showed a lower free fat percentage over time compared to composition C.

[0191] These results indicate that the use of non-homogenised cream together with a vegetable oil blend as fat source led to oil encapsulation in the cream globules (Example 1), resulting in lower free fat over shelf-life, while maintaining the same lipid architecture, compared to when AMF and vegetable oil are used as fat source (Example 2).

Claims

CLAIMS1 . A process for preparing a nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1 .0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; and ii. the lipid comprises 0.5 to 20 wt.% milk derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; wherein the process comprises the steps of: a. providing at least three feeds: a first feed being an aqueous phase with water-soluble ingredients; a second feed being a fat blend and less than 1 wt.% of water; a third feed being an emulsion with 45-95 wt.% water and 5-55 wt.% phospholipid coated milk fat globules; b. mixing the at least three feeds to obtain a mixture of the at least three feeds; c. spray-drying the obtained mixture to obtain the nutritional composition.

2. The process according to claim 1 , wherein the phospholipid coated milk fat globules in the third feed have a mode diameter, based on volume, between 2 to 6 pm.

3. The process according to claim 1 or 2, wherein the third feed is a non-homogenized dairy cream.

4. The process according to any one of the preceding claims, wherein the second feed comprises at least 90 wt.% of vegetable fat.

5. The process according to any one of the preceding claims, wherein the first feed comprises less than 5 wt.% of fat by weight of the first feed.

6. The process according to any one of the preceding claims, wherein the mixing of step (b) is carried out in a static mixer or an inline mixer.

7. The process according to any one of the preceding claims, wherein in step a) of the process a fourth feed is provided, comprising a source of phospholipid.

8. The process according to claim 7, wherein the fourth feed comprises a powdered composition with at least 3 wt.% phospholipids by dry weight.

9. The process according claim 7 or 8, wherein at least 85 wt.% of milk-derived phospholipids in the nutritional composition are provided by the phospholipids in the third and fourth feed.

10. The process according to any one of claims 7-9, wherein the fourth feed is pre-mixed with the first feed or with the third feed prior to the mixing in step b) of the process.11 . The process according to any one of the preceding claims, wherein the first feed is pre-mixed with the optional fourth feed and with the third feed, prior to the mixing in step b) of the process.

12. The process according to any one of claims 1-9, wherein the second feed is pre-mixed with the third feed, prior to the mixing in step b) of the process.

13. The process according to any one of the preceding claims, wherein the nutritional composition is a powdered nutritional composition suitable for reconstituting to a ready-to-drink liquid formula, wherein the powdered nutritional composition has a free fat content of less than 3.5 wt.% by weight of the powdered composition.

14. A powdered nutritional composition selected from infant formula, follow-on formula, or young child formula, said nutritional composition comprising digestible carbohydrates, protein and lipid, wherein the lipid is in the form of lipid globules and wherein i. the lipid globules have a mode diameter, based on volume, of at least 1.0 pm; and / or at least 40 vol.% of the lipid globules based on total lipid volume have a diameter of 2 to 12 pm; ii. the lipid comprises 0.5 to 20 wt.% milk-derived phospholipids based on total lipids and wherein the lipid globules have a coating comprising said phospholipids; andHi. the lipid comprises at least 10 wt.% of palmitic acid based on total fatty acids and wherein at least 15 wt.% of palmitic acid based on total palmitic acid is in the sn-2 position in a triglyceride; and wherein the composition has a free fat content of less than 3.5 wt.% by weight of the powdered composition.

15. The powdered nutritional composition of claim 14, wherein the powdered nutritional composition comprises less than 0.4 wt.% of micronized carbohydrates by weight of the powdered nutritional composition.

16. The powdered nutritional composition of claim 14 or 15, wherein the powdered nutritional composition is obtainable, preferably obtained, by the process according to any one of claims 1-13.

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