Process to prepare nutritional composition with large lipid globules

Abstract

The present invention relates to a process for preparing a nutritional composition comprising lipid, protein and digestible carbohydrates, said composition being an infant formula, follow-on formula or growing-up milk, wherein the composition comprises large lipid globules that contain a phospholipids coating.

Description

[0001] PROCESS TO PREPARE NUTRITIONAL COMPOSITION WITH LARGE LIPID GLOBULES

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a process for preparing a nutritional composition comprising lipid, protein and digestible carbohydrates, said composition being an infant formula, follow-on formula or growing-up milk, wherein the composition comprises large lipid globules that contain a phospholipids coating.

[0004] BACKGROUND OF THE INVENTION

[0005] Human milk is the uncontested gold standard concerning infant nutrition. However, in some cases breastfeeding is inadequate or unsuccessful for medical reasons or not available because of a choice not to breastfeed. For such situations infant or follow-on formulas have been developed. Commercial infant formulas are commonly used today to provide supplemental or sole source of nutrition early in life. These formulas comprise a range of nutrients to meet the nutritional needs of the growing infant, and typically 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 existing of a triglyceride core coated by a tri-layer of membranes, the milk fat globule membrane (MFGM). Standard infant formula’s typically have lipid droplets with a mode diameter, based on volume, of about 0.3-0.5 pm due to industrial processing procedures applied to achieve stable products, and the lipid droplets are not surrounded by MFGM but mostly by milk proteins. Infant formula with lipid globules with an architecture more similar to the lipid globules in human milk have been described (e.g. WO2010 / 027258 or WO2010 / 027259).

[0007] Several processes to prepare infant milk formula’s containing larger phospholipid coated lipid globules are described in the art.

[0008] WO2021 / 12755 describes milk fat globules and a preparation method therefor; the milk fat globules have a structure composed of an inner layer and an outer layer; the inner layer is a spherical oil droplet; and the outer layer is formed by multiple nanospheres covering the surface of the spherical oil droplet, the nanospheres being fat coated by a protein and a phospholipid. The nanospheres are obtained by exposing an aqueous phase with protein, triglycerides, phospholipids to high shear mixing and three rounds of high-pressure homogenization at 300 bar to obtain a nano-emulsion. Subsequently, this nanoemulsion is mixed with a fat phase. The spherical oil droplet has an average particle diameter of 3-5 pm and said outer layer nanospheres have an average particle diameter ranging from 200-300 nm. WO2016 / 146496 relates to a two-step emulsification process for preparing a lipid and protein component-containing composition comprising large lipid globules, preferably coated with polar lipids, and to the compositions obtained thereby. Optionally, the lipid and protein component-containing composition is spray-dried. The obtained compositions are for feeding infants and young children. The described process contains a step of making an aqueous phase containing protein and phospholipids and injecting the oil phase therein, followed by high shear mixing of the combined oil and water phase to obtain an oil in water emulsion with relatively large lipid globules that can be next subjected to a drying step in a spray drier.

[0009] WO2013 / 135739 describes a process for preparing a lipid and protein component-containing composition, which is an infant or follow-on formula or a growing up milk and comprises large lipid globules, comprising the steps of: a) providing an aqueous phase with a dry matter content of 10 to 60 wt.% (based on total weight of the aqueous phase), which comprises at least one protein component and phospholipids, b) providing a liquid lipid phase, which comprises at least one lipid and c) mixing the lipid phase with the aqueous phase in a ratio of 5 to 50 % (w / w) using an inline mixer with at least one mixing head so as to obtain a lipid and protein component-containing composition comprising large lipid globules.

[0010] EP3043659 discloses a process for preparing a nutritional composition with large phospholipid coated lipid globules. The process comprises the steps of: a) preparing as is known in the art an aqueous phase with a dry matter content of 30-40 wt.%, said aqueous phase comprising water-soluble ingredients and butter milk powder; b) preparing a liquid lipid phase as is known in the art; c) mixing the aqueous phase with the lipid phase to obtain an oil-in-water emulsion by applying two types of mixing: pre-mixing with a Typhoon propellor mixer to obtain a pre-emulsion, and emulsifying with a static mixer.

[0011] 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) investigates the structure of human milk lipid globules, large phospholipid coated lipid globules in infant formula and small protein coated lipid globules in a standard infant formula using transmission electron microscopy (TEM). The TEM image of a MFGM layer on a human milk lipid globule (Fig. 5B) shows that the MFGM layer is about 20 nm thick. The TEM image of a large phospholipid coated lipid globule in infant formula (Fig 6D) shows that the phospholipid coating is about 10 nm thick. No nanospheres of about 200-300 nm at the interface of the lipid globules in human milk and in the assessed infant formulae are observed.

[0012] One of the challenges with these processes for producing infant milk formula’s with larger lipid globules (i.e. with a lipid globule size distribution more similar to human milk) is that it is challenging to produce infant formula’s with a constant lipid globule size distribution over time. As larger lipid globules are less stable, compared to the smaller lipid globules in standard infant milk formula’s, each change in the production process, such as (seasonal) variation in the sourcing of infant milk formula ingredients has an effect on the lipid globule size distribution of the final product, even if the process is kept the same. There is need for a more reproducible process for producing infant milk formula’s with larger phospholipid coated lipid globules.

[0013] SUMMARY OF THE INVENTION

[0014] The inventors of the present invention have found that introducing a step of homogenizing the aqueous phase containing at least the phospholipids source, and optionally other ingredients that are conveniently introduced via the aqueous phase such as protein and digestible carbohydrates, leads to a better reproducible process.

[0015] ‘A better reproducible process’ in the context of this invention means that the size distribution of the lipid globules hardly varies when changing from one phospholipid source to another and that the drying step which is optionally added at the end of the process hardly influences the lipid globule size distribution. Also very consistently lipid globules with a volume-weighted mode diameter between 3 and 6 pm is obtained in both the atomized emulsion and the obtained powder after drying.

[0016] The present invention thus provides a process for preparing a nutritional composition comprising lipid, protein and digestible carbohydrates, said composition being infant formula, follow-on formula or young child formula, wherein the lipid is in the form of lipid globules with a volume-weighted mode diameter between 1-10 pm and wherein the lipid globules have a coating comprising phospholipids, wherein the process comprises the steps of: a) providing an aqueous phase comprising by weight of the aqueous phase: at least 1 wt.% protein;

[0017] 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20; b) high pressure homogenizing the aqueous phase at a total pressure of 100-800 bar to obtain a homogenized aqueous phase; c) mixing the homogenized aqueous phase with a lipid phase comprising at least 80 wt.% triglycerides to obtain an oil-in-water emulsion; and d) optionally drying, preferably spray-drying, the obtained oil-in-water emulsion.

[0018] DETAILED DESCRIPTION OF THE INVENTION

[0019] A first aspect of the present invention thus pertains to a process for preparing a nutritional composition comprising lipid, protein and digestible carbohydrates, said composition being infant formula, follow-on formula or young child formula, wherein the lipid is in the form of lipid globules with a volume-weighted mode diameter between 1-10 pm and wherein the lipid globules have a coating comprising phospholipids, wherein the process comprises the steps of: a) providing an aqueous phase comprising by weight of the aqueous phase: at least 1 wt.% protein;

[0020] 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20; b) high pressure homogenizing the aqueous phase at a total pressure of 100-800 bar to obtain a homogenized aqueous phase; c) mixing the homogenized aqueous phase with a lipid phase comprising at least 80 wt.% triglycerides to obtain an oil-in-water emulsion; and d) optionally drying, preferably spray-drying, the obtained oil-in-water emulsion.

[0021] Nutritional composition

[0022] The nutritional composition is selected from infant formula, follow-on formula and young child formula. More preferably, the nutritional composition is an infant formula or a follow-on formula. Most preferably, the nutritional composition is an infant formula.

[0023] The terms as used herein, “infant formula” or “follow-on formula” or “young child formula” refers to compositions that are artificially made or that are 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.

[0024] In the present context, infant formula refers to nutritional compositions, artificially made, intended for infants of 0 to about 4 to 6 months of age and are intended as a substitute for human milk. Typically, infant formulae are suitable to be used as sole source of nutrition. Such formulae are also known as starter formula. Formula for infants starting for 4 to 6 months of life to 12 months of life are intended to be supplementary feedings to infants that start weaning on other foods. Such formulae are also known as follow-on formulae. Infant formulae and follow-on formulae are subject to strict regulations, for example the EU regulations no. 609 / 2013 and no. 2016 / 127. In the present context, young child formulae refers to nutritional compositions, artificially made, intended for infants of 12 months to 36 months, which are intended to be supplementary feedings to infants. Such formulae are also known as growing-up milks.

[0025] The nutritional composition is preferably an infant formula or follow-on formula and preferably comprises 3 to 7 g lipid / 100 kcal, preferably 4 to 6 g lipid / 100 kcal, more preferably 4.5 to 5.5 g lipid / 100 kcal, preferably comprises 1.7 to 5 g protein / 100 kcal, more preferably 1.8 to 3.5 g protein / 100 kcal, even 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, and most preferably 10 to 15 g digestible carbohydrate / 100 kcal. Preferably the nutritional composition is an infant formula or follow-on formula and when in a ready-to- drink format has an energy density of 60 kcal to 75 kcal / 100 ml, more preferably 60 to 70 kcal / 100 ml. This density ensures an optimal balance between hydration and caloric intake.

[0026] Preferably, the nutritional composition is a powder composition suitable for reconstitution with an aqueous liquid to form a ready-to drink liquid, or is in a liquid concentrate suitable for dilution with an aqueous liquid to form a ready-to-drink liquid. In another preferred embodiment, the nutritional composition is a ready-to-drink liquid.

[0027] Lipid

[0028] The term “lipid” or “total lipid” as used herein refers to one or more selected from the group consisting of triglycerides, polar lipids (such as phospholipids, glycosphingolipids and cholesterol), free fatty acids, monoglycerides and diglycerides.

[0029] The terms “lipid” or “fat” as used herein are synonyms and used interchangeably. The terms “globules” and “droplets” as used herein are synonyms and used interchangeably.

[0030] Based on dry weight, the nutritional composition preferably comprises 10 to 50 wt.%, more preferably 12.5 to 40 wt.% lipids, even more preferably 19 to 30 wt.% lipids.

[0031] The lipid preferably comprises vegetable lipids. The presence of vegetable lipids advantageously enables an optimal fatty acid profile, high in polyunsaturated fatty acids and / or more reminiscent to human milk fat. Lipids from mammalian milk alone, e.g. cow’s milk, do not provide an optimal fatty acid profile. The amount of essential fatty acids is too low in mammalian milk.

[0032] Preferably the nutritional composition comprises at least one, preferably at least two vegetable lipid sources selected from the group consisting of linseed oil (flaxseed oil), rape seed oil (such as colza oil, low erucic acid rape seed oil and canola oil), sunflower oil, high oleic sunflower oil, safflower oil, high oleic safflower oil, olive oil, coconut oil, palm oil and palm kernel oil.

[0033] In one preferred embodiment, the nutritional composition comprises 5 to 100 wt.% vegetable lipids based on total lipids, more preferably 10 to 95 wt.%, more preferably 20 to 80 wt.%, even more preferably 25 to 75 wt.%, most preferably 40 to 60 wt.% of vegetable lipids based on total lipids. Preferably, the nutritional composition also comprises non-vegetable lipids. Preferably, said nonvegetable lipids are one or more non-vegetable lipids selected from mammalian milk fat, and fish, marine and / or microbial oils as source of LC-PUFA.

[0034] Lipid globule size

[0035] The lipid is present in the nutritional composition in the form of lipid globules. When the nutritional composition is in liquid form, these lipid globules are emulsified in the aqueous phase. Alternatively, 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. The lipid globules comprise a core and a surface. Preferably, the lipid globules have a mode diameter, based on volume, between 1 and 10 pm, more preferably between 2 and 8 pm, and most preferably between 3 and 6 pm.

[0036] Preferably in addition, the size distribution of the lipid globules is preferably in such a way that at least 45 volume % (vol.%), more preferably at least 55 vol.%, even more preferably at least 65 vol.%, and most preferably at least 75 vol.% of the lipid globules have a diameter between 2 and 12 pm. In a more preferred embodiment, at least 45 vol.%, preferably at least 55 vol.%, more preferably at least 65 vol.%, and most preferably at least 75 vol.% of the lipid globules have a diameter between 2 and 10 pm. In an even more preferred embodiment, at least 45 vol.%, more preferably at least 55 vol.%, yet even more preferably at least 65 vol.%, and most preferably at least 75 vol.% of the lipid globules have a diameter between 4 and 10 pm. Preferably less than 5 vol.% of the lipid globules have a diameter above 12 pm.

[0037] The 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, or the peak value in a graphic representation, having on the X-axis the diameter and on the Y-axis the volume (%).

[0038] The volume of the lipid globules and its size distribution can suitably be determined using a particle size analyzer such as a Mastersizer 2000 (Malvern Instruments, Malvern, UK), for example by the method described in Michalski et al, 2001 , Lait 81 : 787-796.

[0039] Polar lipids

[0040] Phospholipids are amphipathic of nature and include glycerophospholipids and sphingomyelin. 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. (2015).

[0041] The phospholipids preferably comprise glycerophospholipids. Examples of glycerophospholipids are phosphatidylcholine (PC), phosphatidylserine (PS), phosphatidylethanolamine (PE), phosphatidylinositol (PI) and phosphatidylglycerol (PG). Preferably the lipid comprises one or more of PC, PS, PI and PE, more preferably the nutritional composition comprises at least PC.

[0042] The phospholipids 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.% sphingomyelin based on total lipid, more preferably 0.1 to 5 wt.%, even more preferably 0.2 to 2 wt.%. Preferably the nutritional composition comprises at least 5 wt.%, more preferably 5 to 40 wt.% sphingomyelin based on total phospholipid, more preferably 10 to 35 wt.%, even more preferably 15 to 35 wt.% sphingomyelin, based on total phospholipid. The lipid preferably comprises glycosphingolipids. 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 lipid contains gangliosides, more preferably at least one ganglioside selected from the group consisting of GM3 and GD3.

[0043] Preferred sources for providing phospholipid and / or glycosphingolipid are milk fat, egg lipids, soy lecithin and / or sunflower lecithin. Preferably, the phospholipids are selected from milk phospholipids, egg phospholipids, soy phospholipids, sunflower phospholipids and combinations thereof. In an embodiment, preferably the phospholipids are milk phospholipids, preferably milk phospholipids derived from or as part of milk fat globule membrane (MFGM).

[0044] The use of phospholipid from mammalian milk fat advantageously comprises the use of milk fat globule membranes, which are more reminiscent to the situation in human milk. The concomitant use of phospholipid derived from mammalian milk and triglycerides derived from vegetable lipids therefore enables the manufacture of coated lipid globules with a coating more similar to human milk, while at the same time providing an optimal fatty acid profile.

[0045] Milk phospholipids preferably includes phospholipids that are derived from milk lipid, cream lipid, cream serum lipid, butter serum lipid (beta serum lipid), whey lipid, cheese lipid and / or buttermilk lipid. Butter serum lipid or beta serum lipid is typically obtained during the manufacture of anhydrous milk fat from butter. Buttermilk lipid is typically obtained during the manufacture of buttermilk. More preferably the milk phospholipids are derived from whey lipid, e.g. in the form of a whey protein concentrate. Suitable commercially available sources for phospholipid from milk are BAEF, SM2, SM3 and SM4 powder of Corman, Salibra of Glanbia, Vivinal MFGM of FrieslandCampina, Lipamine M20 of Lecico and Lacprodan MFGM-10 or PL20 from Aria.

[0046] The lipid in the nutritional composition preferably comprises 0.5 to 20 wt.% phospholipids based on total lipid. Preferably, the nutritional composition comprises 0.6 to 10 wt.%, more preferably 0.7 to 8 wt.%, even more preferably 0.8 to 6 wt.%, and most preferably 1 to 5 wt.% phospholipids based on total lipid.

[0047] In a preferred embodiment, the weight ratio of phospholipids to total lipid in the nutritional composition is between 1 :200 to 1 :60, preferably between 1 :150 to 1 :45, most preferably between 1 :100 to 1 :30.

[0048] Protein

[0049] The term “protein” as used herein refers to proteinaceous matter in general, which includes proteins, peptides, free amino acids. Based on dry weight, the nutritional composition preferably comprises less than 12 wt.% protein, more preferably between 9 and 12 wt.%, most preferably between 9.5 and 11 wt.% protein.

[0050] The source of the protein is preferably selected in such a way that the minimum requirements for infants for essential amino acid content are met and satisfactory growth is ensured. Hence 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 based on acid whey, sweet whey, whey protein isolate or mixtures thereof. Preferably the protein in the nutritional composition is intact and / or non-hydrolyzed.

[0051] Digestible carbohydrates

[0052] The nutritional composition of the invention comprises digestible carbohydrates.

[0053] Based on dry weight, the nutritional composition preferably comprises 20 to 80 wt.%, more preferably 40 to 65 wt.% digestible carbohydrates.

[0054] Preferred digestible carbohydrate sources are lactose, glucose, sucrose, fructose, galactose, maltose, starch and maltodextrin. Lactose is the main digestible carbohydrate present in human milk. Lactose advantageously has a low glycaemic index. The digestible carbohydrate component preferably comprises lactose.

[0055] Process steps

[0056] Preferably, the protein in the aqueous phase in step a), by weight of the aqueous phase, is 1 .5-30 wt.%, more preferably 2-25 wt.%, and most preferably 3-30 wt.%.

[0057] Preferably, the total lipid in the aqueous phase in step a), by weight of the aqueous phase, is between 0.5 and 10 wt.%, more preferably between 0.75 and 8 wt.%, and most preferably between 1 and 6 wt.%.

[0058] The aqueous phase in step a) comprises phospholipids, by weight of the aqueous phase, between 0.3 and 5 wt.%, preferably between 0.4 and 4 wt.%, and more preferably between 0.5 and 3 wt.%.

[0059] The weight ratio phospholipids to total lipid in the aqueous phase of step a) is at least 1 :20, more preferably at least 1 :10, and most preferably between 1 :5 and 1 :1 .

[0060] Preferably, the dry matter content of the aqueous phase of step a) is 15-75 wt.%, more preferably 25- 75 wt.%, even more preferably 30-65 wt.% and most preferably 35-55 wt.%, by weight of the aqueous phase.

[0061] The lipid in the aqueous phase of step a) preferably comprises polar lipids, more preferably the lipid in the aqueous phase of step a) comprises phospholipids and / or glycosphingolipids. Preferably, the total lipid and phospholipids in the aqueous phase of step a) are provided by one single lipid source. Preferably, the weight ratio of the single lipid source to water in the aqueous phase of step a) is at least 1 :50, more preferably at least 1 :40, and most preferably 1 :35-1 :1 .

[0062] In one preferred embodiment A, the aqueous phase of step a) preferably comprises at most 20 wt.%, more preferably at most 15 wt.%, and most preferably at most 10 wt.% of all water-soluble ingredients in the nutritional composition. Hence, preferably at least 80 wt.%, more preferably at least 85 wt.%, and most preferably at least 90 wt.% of all water-soluble ingredients of the nutritional composition are added to the homogenized aqueous phase before step (c).

[0063] In embodiment A, the aqueous phase in step a) preferably comprises, by weight of the aqueous phase, i. 1-20 wt.% protein; ii. 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase;

[0064] Hi. 0-5 wt.% digestible carbohydrates; iv. 60-98 wt.% water; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20.

[0065] More preferably, in embodiment A, the aqueous phase in step a) comprises, by weight of the aqueous phase, i. 5-20 wt.% protein; ii. 1-6 wt.% total lipid comprising 0.4-2.5 wt.% phospholipids by weight of the aqueous phase;

[0066] Hi. 0-1 wt.% digestible carbohydrates; iv. 70-90 wt.% water; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :10.

[0067] In embodiment A, preferably at least 70 wt.%, more preferably at least 80 wt.%, and most preferably at least 90 wt.% of the aqueous phase of step a) is provided by the single lipid source and water.

[0068] In embodiment A, the high pressure homogenizing in step b) is preferably performed at a total pressure of at most 360 bar, more preferably at most 330 bar.

[0069] In an alternatively preferred embodiment B, the aqueous phase of step a) comprises at least 80 wt.%, more preferably at least 85 wt.%, and most preferably at least 90 wt.% of all water-soluble ingredients in the nutritional composition.

[0070] In embodiment B, the aqueous phase in step (a) preferably comprises, by weight of the aqueous phase, i. 1-15 wt.% protein; ii. 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase;

[0071] Hi. 20-40 wt.% digestible carbohydrates; iv. 25-75 wt.% water wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20. In embodiment B, preferably the high pressure homogenizing in step b) is performed at a total pressure of between 150 and 700 bar, most preferably between 200 and 600 bar.

[0072] In embodiment B, preferably the mixing of the homogenized aqueous phase in step c) directly follows the homogenization of step b), meaning this occurs without substantial alteration of the homogenized aqueous phase obtained in step b).

[0073] Preferably, the following embodiments equally apply to both embodiment A and B.

[0074] The high pressure homogenization in step b) preferably is performed at a temperature of 30-80 °C, more preferably at 35-70 °C, and most preferably at 40-65 °C.

[0075] In a preferred embodiment, at most two rounds of high pressure homogenizing are applied in step b), and more preferably one round of high pressure homogenizing is applied in step b). Several methods are suitable for high pressure homogenization as performed in step b). Such methods preferably include, a high pressure homogenizer, a cavitator or a microfluidizer. The high pressure homogenizing in step b) is preferably performed by a high pressure homogenizer.

[0076] In mixing step c), the homogenized aqueous phase obtained in step b) is mixed with a lipid phase to obtain an oil-in-water emulsion. The mixing can take place in any suitable way, suitable mixing equipment preferably include a static mixer, an inline mixer, a rotor stator machine, a cavitator or by membrane emulsification. The mixing of step c) is preferably performed with an inline mixer.

[0077] Preferably, the lipid phase introduced in step c) comprises at least 80 wt.% triglycerides, more preferably at least 85 wt.% triglycerides and most preferably 90-100% of triglycerides.

[0078] Preferably the lipid phase in step c) comprises 40-98 wt.% vegetable oil by weight of the lipid phase, more preferably 45 - 95 wt.% vegetable oil.

[0079] The wt. ratio of lipid phase to homogenized aqueous phase in step c) is preferably 1 :99 to 35:65, more preferably 5:95 to 30:70, and most preferably 10:90 to 25:75.

[0080] Preferably, the oil-in-water emulsion in step c) comprises a dry matter content of 5-70 wt.%, more preferably 7-65 wt.% and most preferably 9-60 wt.%, by weight of the oil-in-water emulsion.

[0081] Preferably, the oil-in-water emulsion in step c) comprises 10 to 50 wt.%, more preferably 12.5 to 40 wt.% lipids, even more preferably 19 to 30 wt.% lipids, by dry weight of the oil-in-water emulsion. Preferably, the oil-in-water emulsion in step c) comprises less than 12 wt.% protein, more preferably 9- 12 wt.%, most preferably 9.5-11 wt.% protein, by dry weight of the oil-in-water emulsion.

[0082] Preferably, the oil-in-water emulsion in step c) comprises 20-80 wt.%, more preferably 40-65 wt.% digestible carbohydrates by dry weight of the oil-in-water emulsion.

[0083] Preferably, the obtained oil-in-water emulsion obtained in step c) is subjected to a heat treatment step using a module that is designed to obtain a microbial safe nutritional composition with a good shelf life. Any suitable type of heat treatment known in the art may be employed, e.g. pasteurization or sterilization, such as HTST, ESL, UHT, dry heat or moist heat sterilization. Preferably, the obtained oil-in-water emulsion obtained in step c) is pasteurized or sterilized.

[0084] In one preferred embodiment, the nutritional composition is a ready-to-drink liquid and the drying of step d) is not performed. In this embodiment, the obtained oil-in-water emulsion in step c) has a volume- weighted mode diameter of between 1 and 10 pm, more preferably between 2 and 8 pm, and most preferably between 3 and 6 pm. The ready-to-drink liquid (and thus the oil-in-water emulsion of step c) preferably has a dry matter content of 5-25 wt.%, more preferably 7-20 wt.% and most preferably 9-15 wt.% dry matter content, by weight of the ready-to-drink liquid.

[0085] In an alternative preferred embodiment, the nutritional composition is a powder composition suitable for reconstitution with an aqueous liquid. In this case, the oil-in-water emulsion obtained in step c) is dried in step d). In this preferred embodiment, the oil-in-water emulsion obtained in step c) preferably has a volume-weighted mode diameter of 9-20 pm, more preferably 10-18 pm, most preferably 11-15 pm and the volume-weighted mode diameter is further reduced due to atomization during spray drying in step d). The atomization during spray-drying preferably reduces the volume-weighted mode diameter of the oil-in-water emulsion at least 2 pm, preferably at least 4 pm. In this embodiment, the oil-in-water water emulsion before drying has a dry matter content of 30-70 wt.%, more preferably 35-65 wt.% and most preferably 40-60 wt.% dry matter content, by weight of the oil-in-water emulsion.

[0086] Preferably, the spray-drying in step d) is performed by a pneumatic nozzle or a rotary atomizer, more preferably by a pneumatic nozzle and most preferably the pneumatic nozzle is a 2-fluid nozzle. If a pneumatic nozzle atomizer is used the pressure is preferably at most 10 bar, more preferably at most 8 bar. The use of a pneumatic nozzle atomizer is advantageous for an economical production, since the pneumatic nozzle atomizer allows for much lower pressures during spray-drying compared to other spray-drying processes known in the art.

[0087] In this document and in its claims, the verb “to comprise” and its conjugations is used in its non-limiting sense to mean that items following the word are included, but items not specifically mentioned are not excluded. In addition, reference to an element by the indefinite article “a” or “an” does not exclude the possibility that more than one of the element is present, unless the context clearly requires that there be one and only one of the elements. The indefinite article “a” or “an” thus usually means “at least one”. EXAMPLES

[0088] The particle size distribution of the lipid globules was measured with a Mastersizer 2000 (Malvern Instruments, Malvern, UK), for example by the method described in Michalski et al, 2001 , Lait 81 : 787- 796

[0089] Example 1

[0090] A powdered infant formula was prepared comprising per kg final product about 5200 kcal, about 315 g lipid, about 445 g digestible carbohydrates, about 39 g non-digestible oligosaccharides and about 118 g protein. The composition was prepared using a milk phospholipid source, whey protein, skimmed milk powder, lactose, a oil blend (fat) and non-digestible oligosaccharides. Also vitamins, minerals, trace elements as known in the art were used.

[0091] An aqueous phase, comprising milk phospholipids (0.27 wt.% phospholipid by weight of the aqueous phase; wt. ratio phospholipid to total lipid was 1 :2.6), protein, digestible carbohydrates and the other ingredients, except the fat and fat soluble vitamins, was prepared by combining the components under mild mixing. The dry matter content of the aqueous phase was 43 wt.%. The aqueous phase was pasteurized for 30 seconds at 85°C.

[0092] The aqueous phase was subsequently homogenized using a high pressure homogenizer (GEA Ariete homogeniser ns3006) at 550 bar (Stage 1) and 50 bar (Stage 2) at a temperature of 60°C.

[0093] A fat phase was prepared by adding together the lipid and fat soluble vitamins. The fat phase was heated to 60°C and added to the water phase in a fat to water phase w / w ratio of 20:80 and premixed with a Typhoon propeller mixer. The total dry matter content of the fat and aqueous phase mixture was 52 wt. %.

[0094] The pre-emulsion was fed into a stator rotor machine (IKA process pilot 2000 / 04 generator 4M) with a speed of 4000 rpm. After the first emulsification step, the product was collected and emulsified a 2nd time using pneumatic atomizers (2-fluid) at 2 bar air pressure. The diameter of the lipid globules was determined. The sprayed emulsion was dried with an inlet temperature of the drying gas at 195°C. The diameter of the lipid globules was determined again and it was established that the spraying step did not change the fat droplet size distribution.

[0095] Example A

[0096] The procedure of Example 1 was repeated, but no pre-homogenization of the aqueous phase was executed.

[0097] Results The measured particle size distribution of the powdered infant formulas prepared in Example 1 and A are provided in Table 1. In both formula’s no nanospheres at the interface of the lipid globules were observed.

[0098] Table 1

[0099] Example 2

[0100] A powdered infant formula was prepared comprising per kg final product about 5060 kcal, about 302 g lipid, about 462 g digestible carbohydrates, about 42 g non-digestible oligosaccharides and about 113 g protein. The composition was prepared using a milk phospholipid source, whey protein, skimmed milk powder, lactose, an oil blend (fat) and non-digestible oligosaccharides. Also vitamins, minerals, trace elements as known in the art were used.

[0101] The powdered milk phospholipid source was dispersed in water with a ratio 1 :4 to obtain an aqueous phospholipid source comprising 1.4 g milk phospholipid per 100 ml (wt. ratio phospholipid to total lipid was 1 :2.6). This aqueous phospholipid source was homogenized using a high pressure homogenizer (GEA Ariete homogeniser ns3006) with pressures of 250 bar (Stage 1) and 50 bar (Stage 2) at a temperature of 60°C to obtained a homogenized aqueous phospholipid source.

[0102] An aqueous phase, comprising the homogenized phospholipid source, protein, digestible carbohydrates and the other ingredients, except the fat and fat soluble vitamins, was prepared by combining the components under mild mixing. The dry matter content of the aqueous phase was 46 wt.%. The aqueous phase was pasteurized for 30 seconds at 85°C.

[0103] A fat phase was prepared by adding together the lipid and fat soluble vitamins. The fat phase was heated to 60°C and added to the water phase in a fat to aqueous phase w / w ratio of 20:80 and premixed with a Typhoon propeller mixer. The total dry matter content of the fat and aqueous phase mixture was 50 wt.%.

[0104] 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 (2-fluid) at 2 bar air pressure. The diameter of the lipid globules was determined. The sprayed emulsion was dried with an inlet temperature of the drying gas at 195°C. The diameter of the lipid globules was determined again and it was established that the spraying step did not change the fat droplet size distribution. Example B

[0105] The procedure of Example 2 was repeated, but no pre-homogenization of aqueous phospholipid source was executed.

[0106] Results

[0107] The measured particle size distribution of the powdered infant formulas prepared in Example 2 and B are provided in Table 2. In both formula’s no nanospheres at the interface of the lipid globules were observed.

[0108] Table 2

[0109] Conclusion

[0110] The pre-homogenization of an aqueous phase comprising phospholipids - before the addition of a fat phase - results in an optimized lipid globule size distribution of the phospholipid coated globules, i.e. with more volume% of the lipid globules having a diameter in the desired range of 2-12 pm and an increased volume weighed mode diameter that falls in the desired 3-6 pm range. This lipid globule size distribution is desired as it is close to the lipid globule size distribution of human milk. Also, comparative examples A and B provide more variable results.

[0111] It is evident that applying homogenization pressure on an aqueous phase containing phospholipids leads to a better reproducible process for preparing oil-in-water emulsions with a more constant lipid globule size distribution.

Claims

CLAIMS1. A process for preparing a nutritional composition comprising lipid, protein and digestible carbohydrates, said composition being infant formula, follow-on formula or young child formula, wherein the lipid is in the form of lipid globules with a volume-weighted mode diameter between 1-10 pm and wherein the lipid globules have a coating comprising phospholipids, wherein the process comprises the steps of: a) providing an aqueous phase comprising by weight of the aqueous phase: at least 1 wt.% protein;0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20; b) high pressure homogenizing the aqueous phase at a total pressure of 100-800 bar to obtain a homogenized aqueous phase; c) mixing the homogenized aqueous phase with a lipid phase comprising at least 80 wt.% triglycerides to obtain an oil-in-water emulsion; and d) optionally drying, preferably spray-drying, the obtained oil-in-water emulsion.

2. The process according to claim 1 , wherein the total lipid and phospholipids in the aqueous phase of step a) are provided by one single lipid source.

3. The process according to claim 2, wherein the wt. ratio of the single lipid source to water in the aqueous phase of step a) is at least 1 :50.

4. The process according to any of the previous claims, wherein the aqueous phase of step a) comprises at most 20 wt.% of all water-soluble ingredients in the nutritional composition.

5. The process according to claim 4, wherein the aqueous phase of step a) comprises by weight of the aqueous phase i. 1-20 wt.% protein; ii. 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase;Hi. 0-5 wt.% digestible carbohydrates; iv. 60-98 wt.% water; and wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20.

6. The process according to any one of claims 4-5, wherein at least 80 wt.% of the aqueous phase of step a) is provided by one single lipid source and water.

7. The process according to any of claims 1-3, wherein the aqueous phase of step a) comprises at least 80 wt.% of all water-soluble ingredients in the nutritional composition.

8. The process according to claim 7, wherein the aqueous phase comprises by weight of the aqueous phase i. 1-15 wt.% protein; ii. 0.5-10 wt.% total lipid comprising 0.3-5 wt.% phospholipids by weight of the aqueous phase;Hi. 20-40 wt.% digestible carbohydrates; iv. 30-75 wt.% water wherein the wt. ratio phospholipids to total lipid in the aqueous phase is at least 1 :20.

9. The process according to any of the previous claims, wherein the high pressure homogenizing in step b) is done by a high pressure homogenizer, a cavitator or a microfluidizer.

10. The process according to any of the previous claims, wherein the wt. ratio of lipid phase to homogenized aqueous phase in step c) is 1 :99 to 35:65.11 . The process according to any of the previous claims, wherein the aqueous phase in step a) has a dry matter content of 15-75 wt.% by weight of the aqueous phase.

12. The process according to any of the previous claims, wherein the mixing in step c) is performed by a static mixer, an inline mixer, a rotor stator machine, a cavitator or by membrane emulsification.

13. The process according to any of the previous claims, wherein the spray-drying in step d) is performed by a pneumatic nozzle or a rotary atomizer.

14. The process according to any of the previous claims, wherein the nutritional composition is a ready-to-drink liquid and wherein the drying of step d) is not performed.

15. The process according to any of claims 1-13, wherein the nutritional composition is a powder composition suitable for reconstitution with an aqueous liquid and wherein the drying of step d) is performed.

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