High-protein vegan nutritional composition based on soy protein

Abstract

Heat sterilized liquid vegan nutritional compositions offering good mouthfeel and viscosity. The nutritional compositions provide high caloric densities of at least 1.4kcal / ml and high amounts of protein of at least 6.5g / 100ml in order to be used in therapy such as the prevention and treatment of malnutrition especially in patients for whom, e.g., proteins of animal origin cannot be used, may it be by personal choice or due to food allergies.

Description

High-protein vegan nutritional composition based on soy proteinFIELD OF THE INVENTION

[0001] The present disclosure relates to heat sterilized liquid vegan nutritional compositions offering good mouthfeel and viscosity. The nutritional compositions herein provide high caloric densities of at least 1 ,4kcal / ml and high amounts of protein of at least 6.5g / 100ml in order to be used in therapy such as the prevention and treatment of nutrient deficiencies associated with malnutrition especially in patients for whom, e.g., proteins of animal origin cannot be used, may it be by personal choice or due to food allergies.BACKGROUND OF THE INVENTION

[0002] There is an increasing global demand for plant-based nutrition due to several aspects, e.g., environmental considerations like a reduction of the world-wide meat consumption and production as well as the need for lactose-free diets due to widespread incidence of lactose- intolerance. Personal preferences like animal-free diets, alternative protein sources, or health concerns are aspects of upcoming importance and play a major role in the consumer behavior as well.

[0003] Additionally, there is a general medical need for nutritional compositions high in protein and calories in a low volume of formula for malnourished people, such as compositions having a protein content of at least 6.5g / 100ml of the composition and caloric densities of at least 1.4kcal / ml.

[0004] High-protein, high caloric compositions are difficult to produce due to several technical problems, especially on industrial scale. Additionally, plant-based ingredients - especially plant-proteins - often have an unpleasant taste and develop unpleasant mouthfeel when used in high concentrations. Both make the consumption of the respective formula less attractive resulting in low appetite and a risk of consuming only insufficient amounts of nutrients.

[0005] Hence, following a plant-based diet can be especially challenging for patients with or at risk of malnutrition due to low protein intake and low intake of micronutrients.

[0006] A commercially available plant-based liquid nutritional composition provides 6g / 100ml protein and a caloric density of 1.5kcal / ml equaling 16EN% of protein. The protein component predominantly consists of pea protein with a smaller fraction of soy protein.

[0007] Pea protein however is often considered a nutritionally less preferred source of plant protein compared to soy protein. It has a lower protein digestibility-corrected amino acid score (PDCAAs) indicating a lower protein quality due to a lower digestibility and amino acid score. Malnourished patients have increased protein requirements. Hence, provision of high-qualityprotein is essential to support protein synthesis in their bodies. Furthermore, allergies to pea protein have been emerging and reported in several studies and reports. There is increasing evidence for the allergic risk caused by the exposure of consumers to pea protein due to emerging use of pea protein as vegan protein source in vegan diets. Therefore, in order to minimize the likelihood of potential allergic reactions, it is preferable to provide products with proteins from single plants as a source (e.g. comprising only soy or pea, instead of both).

[0008] Consequently, a need to be addressed by the present disclosure is the provision of a high-energy, high-protein vegan liquid enteral nutritional composition with acceptable taste and mouthfeel that contains a high-quality protein component and minimizes allergic potential.SUMMARY OF THE INVENTION

[0009] In a first aspect, the present disclosure relates to a heat sterilized liquid vegan nutritional composition according to claim 1. The nutritional composition is inter alia characterized by comprising a protein component consisting of at least 6.5g of soy protein per 100ml of the nutritional composition, and in that the nutritional composition comprises at least 13mg phosphorus per gram of protein.

[0010] The inventors found that such nutritional compositions offer excellent taste, mouthfeel, stability, and viscosity properties.

[0011] These properties render them particularly suitable for use in therapy such as prevention and treatment of nutrient deficiencies associated with malnutrition (according to a second aspect of the present disclosure.

[0012] The inventors found that the soy protein blend characterized by the amount of phosphorus per gram of protein influences viscosity, taste, and mouthfeel of the nutritional compositions herein.DESCRIPTION OF THE FIGURES

[0013] Figure 1 : Results of taste testing indicating preference for the test composition of Example 3 over Examples 1 and 2.

[0014] Figure 2: Results of mouthfeel assessment indicating strong preference for the test composition of Example 3 over Examples 1 and 2.

[0015] Figure 3: Results of particle size distribution analysis of Examples 1 , 2 and 3 indicating enrichment of measured particle sizes between 1-10pm and 1-5pm with increasing phosphorus content of the samples, i.e., most pronounced for the test composition of Example 3.DETAILED DESCRIPTION OF THE INVENTION Definitions

[0016] Caloric density as used herein refers to the calorie content (kcal) of a nutritional composition relative to its volume (ml).

[0017] Energy percent (EN%) as used herein refers to the percentage of energy (kcal) provided by a specific component (for example the protein component) or a nutritional composition relative to the total energy (kcal) provided by the nutritional composition.

[0018] Dietary fibre components used herein refers to the entirety of indigestible carbohydrates in a nutritional composition, such as fructooligosaccharides, fructanes, e.g. inulin, galactooligosaccharides, pectin, gums, such as guar gum, locust bean gum and gum acacia, cocoa, xanthan, carrageenan, cellulose, such as microcristalline cellulose, dextrins, such as wheat and / or corn dextrin, including resistant dextrins, fruit purees, and mixtures thereof.

[0019] Protein component as used herein refers to the entirety of the nutritional composition declarable as protein. The protein component according to the present disclosure is essentially free of hydrolyzed proteins.

[0020] Protein source as defined herein refers to protein supplied by a separately provided ingredient. For example, two different soy protein sources refer to two proteins present in isolated form obtained by different raw material processing.

[0021] Protein blend as used herein refers to a mixture of at least two protein sources.

[0022] Lipid component as used herein refers to the entirety of ingredients of the nutritional composition declarable as lipid, such as rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, medium chain triglycerides (MCT), and mixtures thereof.

[0023] Carbohydrate component as used herein refers to the entirety of ingredients of the nutritional composition declarable as carbohydrate, such as starch, maltodextrin, glucose syrup, mono- and disaccharides, such as sucrose, maltose, isomaltulose, glucose, fructose, galactose, and mixtures thereof. Preferably, the carbohydrate component is clinically free of lactose.

[0024] Amino acid as used herein includes the free amino acid, salts of the amino acid, chemically modified amino acids and metabolites of amino acids, such as alphaketoisocaproic acid (KIC), 3-Hydroxy-3-methyl-butyric acid (HMB) and (R)-3-Hydroxybutyl- (R)-3-hydroxybutyrate, and mixtures thereof. Free amino acids may be added to the compositions herein, but by definition are not regarded as part of or contributing to the protein component.

[0025] Nutritionally complete as used herein refers to nutritional compositions suitable as sole source of nutrition. To be nutritionally complete, it is required that a nutritional composition comprises - in addition to the lipid, carbohydrate, and protein components - minerals and vitamins. In order to be nutritionally complete, vitamins and minerals must be present in amounts in accordance with established nutritional guidelines. The recommended nutrient requirements, particularly with respect to minerals and vitamins, can be found in standard nutritional guidelines, such as Ell commission directive 1999 / 21 / EC. Suitable nutritional compositions according to the present disclosure fulfil the requirements of REGULATION (EU) No 2016 / 128.

[0026] Nutritional composition as used herein refers to a synthetically produced food composition. Thus, nutritional compositions are artificial nutritional products obtained by mixing I dissolving bulk ingredients whereby said ingredients are typically provided in solid form (e.g., powders) or liquid from (e.g., oils, water, syrup). The term “nutritional composition” excludes “food”, i.e., non-modified natural food products, such as meat, vegetables, fruits in their natural form and conventionally prepared (e.g., cooked) meals or drinks like tea, coffee or juices.

[0027] Minerals as used herein includes all minerals, including trace elements.

[0028] Homogenization as used herein refers to the process of diminishing the size of the lipid globules in a nutritional emulsion. A preferred homogenization process herein comprises two homogenization steps.

[0029] Homogenization pressure as used herein refers to the sum of all pressures applied in a specific homogenization step.

[0030] Soy protein as used herein refers to proteins derived from soybeans and is essentially free of hydrolyzed protein.

[0031] Industrial scale as used herein means batch sizes starting at 100001.

[0032] Vegan or plant-based as used herein refers to products free of ingredients from animal sources. Ideally, at no stage of the production of said products ingredients of animal origin have been used.

[0033] Protein digestibility-corrected amino acid score (PDCAAs) as used herein refers to a method of evaluating the quality of a protein based on both the amino acid requirements of humans and their ability to digest it. The formula for calculating the PDCAAS percentage is: (mg of limiting amino acid in 1 g of test protein I mg of same amino acid in 1 g of reference protein) x fecal true digestibility percentage. (Reference: "The protein digestibility-corrected amino acid score". The Journal of Nutrition. 130 (7): 1865S-7S)Nutritional composition

[0034] The heat sterilized liquid vegan nutritional composition according to the present disclosure comprises a lipid component, a carbohydrate component, a protein component, and water. The nutritional composition further comprises minerals and vitamins.

[0035] The nutritional composition has a caloric density of at least 1.4 kcal / ml.

[0036] Generally, the nutritional composition has a high energy density useful in treatment and prevention of malnutrition.

[0037] In one embodiment, the nutritional composition has an energy density of 1.4kcal / ml to 2.5kcal / ml, preferably of 1.4kcal / ml to 2.4kcal / ml, more preferred of 1.4kcal / ml to 2.0kcal / ml, even more preferred of 1.4kcal / ml to 1.8kcal / ml, most preferred of 1.4kcal / ml to 1.6kcal / ml, for example 1.5kcal / ml.

[0038] In another embodiment, the nutritional composition has an energy density of 1 ,5kcal / ml to 2.5kcal / ml, preferably of 1.5kcal / ml to 2.4kcal / ml, more preferred of 1.5kcal / ml to 2.0kcal / ml, even more preferred of 1.5kcal / ml to 1.8kcal / ml, most preferred of 1.5kcal / ml to 1.6kcal / ml, for example 1.5kcal / ml.

[0039] In yet another embodiment, the nutritional composition has an energy density of 1.8kcal / ml to 2.5kcal / ml, preferably of 1.8kcal / ml to 2.4kcal / ml, for example 2.4kcal / ml, more preferred of 1.8kcal / ml to 2.2kcal / ml, even more preferred of 1.8kcal / ml to 2.0kcal / ml, for example 2.0kcal / ml.

[0040] The nutritional composition preferably provides a high percentage of calories from protein useful in prevention and treatment of protein deficiencies.

[0041] In one embodiment, the nutritional composition provides at least 16EN%, preferably 16EN% to 25EN%, more preferred 18EN% to 20EN% based on the total nutritional energy provided by the nutritional composition.

[0042] In another embodiment, the nutritional composition provides at least 18EN%, preferably 18EN% to 25EN%, more preferred 18EN% to 22EN% based on the total nutritional energy provided by the nutritional composition.

[0043] In a further embodiment, the nutritional provides at least 20EN%, preferably 20EN% to 25EN%, for example 20EN% based on the total nutritional energy provided by the nutritional composition.

[0044] Advantageously, the nutritional composition provides both, a high caloric density and a high percentage of calories form protein rendering it useful in the treatment and prevention of nutrient deficiencies associated with protein energy malnutrition, sarcopenia and frailty.

[0045] In one embodiment of the nutritional composition a. the protein component provides 16-25EN%, preferably 18-22EN%, b. the carbohydrate component provides 30-50EN%, preferably 35-45EN%, more preferably 41 -44EN%, and c. the lipid component provides 25-40EN%, preferably 30-38EN%, more preferably 33-26EN%, each based on the total nutritional energy provided by the nutritional composition.

[0046] Preferably, a. the protein component provides about 20EN%, b. the carbohydrate component provides about 43EN%, and c. the lipid component provides about 34EN%, each based on the total nutritional energy provided by the nutritional composition

[0047] The nutritional composition has a pH in the range of 6 to 9, preferably from 7 to 9, more preferably from 8 to 9 e.g. 8.3.

[0048] The nutritional composition comprises at least 13mg phosphorus per gram of protein.

[0049] In one embodiment, the nutritional composition comprises 13mg to 19mg, preferably 14mg to 19mg, more preferably 14mg to 18mg, most preferred 14mg to 16mg phosphorus per gram of protein, for example 15mg phosphorus per gram of protein.

[0050] The inventors observed good viscosity, taste and mouthfeel for nutritional compositions with such phosphorus contents (see Table 1 , Examples 1 , 2 and 3 and Fig. 1 ,2 and 3).

[0051] In one embodiment, the ratio of phosphorous (in mg per gram of protein) to EN% of protein of the nutritional composition falls between 0.7 and 1.2, preferably 0.8 and 1.1.

[0052] In one embodiment, the nutritional composition has a caloric density of 1.4-2.0 kcal / ml and a protein content of 7.4-7.8g / 100ml of the total nutritional composition.

[0053] The nutritional composition is administered enterally, preferably orally.

[0054] Preferably, the nutritional composition is a food for special medical purposes (FSMP). The food for special medical purposes may be nutritionally complete or in the form of a nutritional supplement.

[0055] In one embodiment, the protein component of the nutritional composition consists of a soy protein blend, wherein the soy protein blend consists of two protein sources together providing the protein component, wherein the second protein source provides at least 19mgphosphorus per gram of protein , the carbohydrate components consist of glucose syrup and sucrose, the lipid component consists of rapeseed oil, and the nutritional composition comprises a dietary fibre component consisting of inulin, wheat dextrin and cellulose.

[0056] Preferably, the nutritional composition has a pH of 8.3, the second soy protein source represents 43wt.% based on the total mass of the protein component, the carbohydrate components consist of 16.1g of a mixture of glucose syrup and sucrose per 100 ml of the total nutritional composition, the lipid component consists of 5.7g rapeseed oil per 100ml of the total nutritional composition, and the nutritional composition comprises a dietary fibre component consisting of 2.25g inulin, wheat dextrin and cellulose per 100 ml of the total nutritional composition, and the nutritional composition has a caloric density of 1.5kcal / ml and a protein content of 7.5g / 100ml of the total nutritional composition.

[0057] Such compositions offer excellent taste, mouthfeel, and low viscosity. The low viscosity of the nutritional compositions allows for a good processability during preparation and easy administration. In a preferred embodiment the nutritional compositions are administered orally. In another preferred embodiment the nutritional compositions are administered via tube-feed.

[0058] Preferably, the nutritional composition has a viscosity of not more than 700 mPa s, measured at 20 °C and 50 s’1. The viscosity of the nutritional composition can for instance be not more than 700 mPa s, not more than 600 mPa s, not more than 500 mPa s, not more than 400 mPa s, not more than 300 mPa s, not more than 250 mPa s, not more than 200 mPa s, not more than 150 mPa s, or not more than 100 mPa s, all measured at 20°C and 50 s’1. In a preferred embodiment, the viscosity of the composition is not more than 250 mPa s, preferably not more than 200 mPa s, more preferably not more than 150 mPa s, more preferably not more than 100 mPa s, most preferably not more than 50 mPa s, all measured at 20 °C and 50 s’1.

[0059] In one embodiment the nutritional composition has a particle size distribution wherein at least 5 vol%, preferably at least 7 vol%, more preferably at least 10 vol%, even more preferably at least 15 vol% of the particles have a size in the range of 1-5 pm. In another embodiment, the nutritional composition has a particle size distribution wherein at least 15 vol%, preferably at least 17 vol%, more preferably at least 18 vol%, more preferably at least 20 vol%, even more preferably at least 22 vol% of the particle have a size in the range of 1- 10 pm.

[0060] In yet another embodiment, the nutritional composition has a viscosity of not more than 250 mPa, and a particle size distribution in which at least 5 vol%, preferably at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 15 vol%, preferably at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritionalcomposition has a viscosity of not more than 250 mPa s, and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 200 mPa s, and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 150 mPa s, and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 100 mPa s, and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 100 mPa s, and a particle size distribution in which at least 10 vol% of the particles have a size in the range of 1-5 pm, and at least 18 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 100 mPa s, and a particle size distribution in which at least 15 vol% of the particles have a size in the range of 1-5 pm, and at least 20 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 50 mPa s, and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 50 mPa s, and a particle size distribution in which at least 10 vol% of the particles have a size in the range of 1-5 pm, and at least 18 vol%, have a particle size in the range of 1-10 pm. In another embodiment, the nutritional composition has a viscosity of not more than 50 mPa s, and a particle size distribution in which at least 15 vol% of the particles have a size in the range of 1-5 pm, and at least 20 vol%, have a particle size in the range of 1-10 pm. All viscosities measured at T = 20°C and 50 s’1.Protein component

[0061] The protein component consists of at least 6.5g of soy protein per 100ml of the nutritional composition.

[0062] In one embodiment, the protein component consists of 6.5g to 15g, preferably of 6.5g to 10g, more preferred of 6.5g to 9g, most preferred of 6.5g to 8.5g of soy protein per 100ml of the nutritional composition.

[0063] In an alternative embodiment, the protein component consists of 7.0g to 15g, preferably of 7.0g to 10g, more preferred of 7.0g to 9g, most preferred of 7.0g to 8.5g of soyprotein per 100ml of the nutritional composition, for example of 7.5g of soy protein per 100ml of the nutritional composition.

[0064] In a further alternative embodiment, the protein component consists of 7.5g to 15g, preferably of 7.5g to 10g, more preferred of 7.5g to 9g, most preferred of 7.5g to 8.5g of soy protein per 100ml of the nutritional composition.

[0065] The protein component may comprise at least 13mg phosphorus per gram of protein.

[0066] In one embodiment, the protein component may comprise 13mg to 19mg, preferably 14mg to 19mg, more preferably 14mg to 18mg, most preferred 14mg to 16mg phosphorus per gram of protein, for example 15mg phosphorus per gram of protein.

[0067] In a preferred embodiment, the entire amount of phosphorus in the nutritional composition is provided by the protein component.

[0068] The inventors observed good viscosity, taste and mouthfeel when using a protein component with such phosphorus contents (see Table 1 , Examples 1 , 2 and 3 and Fig. 1 ,2 and 3).

[0069] The protein component is essentially free of hydrolyzed proteins.

[0070] Free amino acids may be added to the compositions herein, but by definition are not regarded as part of or contributing to the protein component. In one embodiment, the nutritional composition is essentially free of amino acids.Soy protein blend

[0071] Soy proteins characterized by a specific phosphorus content such as 13-19mg phosphorus per gram of protein may not be readily available. Therefore, the present disclosure further relates to a soy protein blend.

[0072] The soy protein blend consists of at least two soy protein sources. Suitable soy protein sources are for instance soy protein concentrates or soy protein isolates, preferably soy protein isolates. Examples of commercially available soy protein isolates are soy protein isolates sold under the tradename “Supro” e.g., Supro®1500 IP and Supro®XT 34N IP, available for instance from the company Solae LLC.

[0073] The soy protein blend provides 13-19mg phosphorus per gram of protein.

[0074] The soy protein blend consists of a first soy protein source providing less than 13mg phosphorus per gram of protein and a second soy protein source providing more than 19mg phosphorus per gram of protein.

[0075] In one embodiment, the second protein source represents 30-60wt%, preferably 40- 50wt.% more preferably 40-45 wt.%, such as 43wt% of the total weight of the soy protein blend.

[0076] Preferably, the protein component of the nutritional composition consists of a soy protein blend providing less than 13mg phosphorus per gram of protein and a second soy protein source providing more than 19mg phosphorus per gram of protein, wherein the second protein source represents 30-60wt%, preferably 40-50wt.% more preferably 40-45 wt.%, such as 43wt% of the total weight of the soy protein blend.

[0077] The soy protein blend may be used in the preparation of a heat sterilized liquid vegan nutritional composition comprising a lipid component, a carbohydrate component, a protein component, and water.Dietary fibre component

[0078] In one embodiment the nutritional composition comprises a dietary fibre component.

[0079] The dietary fibre component may comprise dietary fibre selected from the group consisting of fructooligosaccharides or fructans, e.g. inulin, cocoa powder, corn dextrin, wheat dextrin, tapioca dextrin, cellulose, microcrystalline cellulose, soy polysaccharides, xanthan, galactooligosaccharides, at least partially hydrolysed guar gum, acacia gum, pectin, oat fibre, poly dextrose, resistant starch, hemicellulose, and mixtures thereof, preferably the dietary fibre component comprises or consists of inulin, wheat dextrin and cellulose.

[0080] The dietary fibre content may be in the range of 1-3g / 100ml, preferably of 1.5- 2.5g / 100ml, e.g., 2.25g / 100ml of the total nutritional composition.

[0081] Preferably, the dietary fibre component of the nutritional composition of the present disclosure consists of 0.76g inulin, 0.44g cellulose and 1 ,05g wheat dextrin each per 100ml of the total nutritional composition.Carbohydrate component

[0082] The carbohydrate component may comprise a carbohydrate selected from the group consisting of starch, maltodextrin, glucose syrup, disaccharides, such as sucrose, maltose, isomaltulose, lactose, glucose, fructose, or galactose, and mixtures thereof.

[0083] Preferably, the carbohydrate component comprises or consist of glucose syrup and sucrose.

[0084] In one embodiment, the nutritional composition of the present disclosure has a carbohydrate content of 12-20g / 100ml, preferably of 14-18g / 100ml, more preferably of 16.1g / 100ml of the total nutritional composition.Lipid component

[0085] The lipid component may comprise oils selected from the group consisting of, rapeseed oil, safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, or medium chain triglycerides (MCT), and mixtures thereof.

[0086] Preferably, the lipid component comprises or consists of rapeseed oil.

[0087] The lipid content may be in the range of 4-8g / 100ml, preferably of 5-6.5g / 100ml, more preferably of 5.5-6.0g / 100ml, e.g., 5.7g / 100ml of the total nutritional composition.

[0088] In one embodiment, the lipid component comprises or consists of 5.7g / 100ml rapeseed of the total nutritional composition.Minerals and Vitamins

[0089] The nutritional composition of the present disclosure preferably comprises minerals and vitamins in order to render it nutritionally complete.

[0090] Suitable vitamins to be included in the nutritional composition of to the present disclosure are Vitamin A, Vitamin D, Vitamin K, Vitamin C, Thiamin, Riboflavin, Vitamin B6, Niacin, Folic acid, Vitamin B12, Pantothenic acid, Biotin and Vitamin E, and mixtures thereof.

[0091] Suitable minerals to be included in the nutritional composition of the present disclosure are Sodium, Chloride, Potassium, Calcium, Phosphorus, Magnesium, Iron, Zinc, Copper, Iodine, Selenium, Manganese, Chromium and Molybdenum and Fluoride, and mixtures thereof.Additives

[0092] In one embodiment the nutritional composition of the present disclosure comprises food additives of non-animal origin. Additives are typically present in total amount of less than 10wt%, 5wt% or even less than 1wt% based on the total weight of the nutritional composition. Exemplary additives are choline, beta-carotene, lutein, lycopene, caffeine, lecithin, taurine, carnitine, myo-inositol, colorants, aroma, and mixtures thereof. Aromas may be caramel, vanilla, yoghurt, chocolate, coffee, cappuccino, fruit aromas and the like.

[0093] The additives may include the stabilizers and emulsifiers. Preferably, the stabilisers are selected from gums, and mixtures thereof. For example, microcrystalline cellulose (E460), sodium carboxymethylcellulose (E466), carrageenan (E407), diacetyl tartaric acid ester of glycerides, cellulose gel (cellulose, microcrystalline). The emulsifiers may be selected from (distilled) monoglycerides such as E471 , soy lecithins.Use in therapy

[0094] The nutritional composition according to the present disclosure may be used in therapy.

[0095] For example, the nutritional compositions may be used in nutritional therapy. In other words, the nutritional composition may be used as patient nutrition.

[0096] In one embodiment, the nutritional compositions are for use in prevention and treatment of nutrient deficiencies associated with malnutrition.

[0097] In one embodiment, the nutritional compositions are used in prevention and treatment of nutrient deficiencies associated with malnutrition in patients with food intolerance or allergies, e.g., patients with pea protein allergy, lactose intolerant patients, patients having milk protein allergy.

[0098] Additionally, the nutritional compositions are for use in prevention and treatment of nutrient deficiencies associated with increased energy and protein needs, for example in patients with cancer, inflammatory diseases, chronic wasting diseases, for example HIV, chronic kidney disease, cardiovascular disease including heart failure, liver disease, chronic obstructive pulmonary disease, anorexia, frailty or patients in the pre-, peri- and post-operative phase of surgery.Dose unit and daily dose

[0099] The nutritional compositions according to the present disclosure are typically provided in a dose unit.

[0100] A dose unit for oral administration herein refers to 100-300ml, preferably 150-250ml separately provided in package such as a bottle, tetra brick or bag.

[0101] Such a dose unit for oral administration provides 150-450kcal, preferably 225-375kcal.

[0102] Such a dose unit for oral administration provides 7.5-22.5g, preferably 11.25-18.75g, more preferably 12-16g of protein, such as 15g of protein.

[0103] An exemplary dose unit for oral administration provides 300kcal and 15g of protein in a dose unit of 200ml.

[0104] Accordingly, an exemplary daily dose for complete nutrition of 1500-2500kcal via oral administration of the nutritional compositions herein may be provided with 3-8 dose units, for example 5 dose units. Accordingly, a daily dose for complete enteral nutrition may be provided by 5 dose units each providing 225-375kcal.

[0105] A typical daily dose for supplemental nutrition of 300-900kcal of the nutritional compositions herein will be provided by 2-3 dose units each providing 225-375kcal.

[0106] The nutritional compositions according to the present disclosure may also be administered via tube feed. A typical dose unit of the nutritional compositions for administration via tube feed may for instance comprise between 400 and 1250 ml of the nutritional composition, preferably 1000 ml, or 750 ml, or 500 ml. In one embodiment the tube feed dosage unit comprises 1000 ml. In another embodiment, the tube feed dosage unit comprises 500 ml.

[0107] The dose unit for the tube feed can for instance be provided in a bottle, bag or pouch, such as a stand-up pouch, each adapted to for connection to a feeding tube, e.g., anasogastric tube. Such bottles or bags are well known in the art. An example of a suitable bag is the EasyBag® system by Fresenius Kabi.Process of manufacture

[0108] The nutritional compositions according to the present disclosure can be manufactured according to the following process. Water is provided in a mixing vessel and heated, e.g., to 60-70°C. The first fraction of the carbohydrate component (sucrose) and, optionally, the dietary fibre is added followed by the addition of the soy protein(s). The obtained mixture is stirred, e.g., for 5-10 min., and the remaining fraction of the carbohydrate component (glucose syrup) is added. The mixture of the lipid component with emulsifier (pre-heated, e.g., to 50- 80°C) is added and the obtained mixture stirred, e.g., for 5-10 min. Minerals, vitamins and, optionally, additives are added followed by the addition of aroma. The pH is adjusted to 8-9, e.g., to 8.3 and the mixture obtained stirred, e.g., for 5-15 min. The temperature of the mixing vessel is decreased, e.g., to 15-20°C. The mixture is homogenized at a pressure, e.g., of 100 / 50 bar (total pressure 150 bar), followed by a sterilization, e.g., at 138-140°C for 6-15 sec. Finally, a second homogenization step, e.g., at 80 / 20 bar (total pressure 100 bar) is applied.EXAMPLESSoy protein sources

[0109] SUPRO® 1500 IP and SUPRO® XT 34N IP. Both isolated soy proteins, obtained from Solae Europe. Characteristics, such as content of phosphorus, are listed in Table 2.METHODSViscosity

[0110] Determination of the shear viscosity by rotational rheometry.

[0111] Shear rheological measurements were performed at 20 °C , using a rotational rheometer (Haake RheoStress 1, Thermo Scientific GmbH, Germany) with double gap cylinder geometry (DG43). All the samples had a resting time in the measuring geometry prior to testing. The flow curves of the product were determined at shear rates between 0.1 and 500 s-1. The experimental data were fitted with the Oswald de Waele model. The power law index (n), the consistency index (K) were extracted and the viscosity at 50 s-1determined.

[0112] The person skilled in the art knows how to determine the shear viscosity in nutritional compositions of the present disclosure by rotational rheometry.Particle size distribution

[0113] Particle size distribution was determined by laser light scattering using a Mastersizer 3000 (Malvern). The methods are well established and known to the person skilled in the art. Results are provided in Volume% against particle size in pm (diameter).Sample preparation

[0114] Vegan liquid enteral nutritional compositions according to table 1 were prepared.Process description

[0115] Water was provided in a mixing vessel and heated to 60-70°C. The first fraction of the carbohydrate component (sucrose) and, optionally, the dietary fibres were added followed by the addition of soy protein. The obtained mixture was stirred for 5-10 min. and the remaining fraction of the carbohydrate component (glucose syrup) was added. The mixture of the lipid component with emulsifier (pre-heated to 50-80°C) was added and the obtained mixture stirred for 5-10 min. Minerals, vitamins and, optionally, additives were added followed by the addition of aroma. The pH was adjusted to 8.3 by adding a sodium hydroxide solution and the obtained mixture stirred for 5-15 min. The temperature of the mixing vessel was decreased to 15-20°C. The mixture was homogenized at a pressure of 100 / 50 bar (total pressure 150 bar), followed by a sterilization at 138-140°C for 6-15 sec. Finally, a second homogenization step at 80 / 20 bar (total pressure 100 bar) was applied.

[0116] Examples 1 , 2, 3, and 4 were prepared accordingly, using the same flavor. The nutrient profile only varied in terms of the composition of the soy protein component as indicated in table 1. Example 1 is a comparative example. In example 4, the amounts of macronutrients was adapted to provide an energy density of 2.0 kcal / ml.

[0117] An evaluation of the taste and mouthfeel of Examples 1 , 2 and 3 was undertaken by a test panel. The test was carried out under controlled conditions: The products were served at room temperature. Samples of each product were provided to panellists at the same time in random presentation. Water and white bread were served to allow for taste bud neutralisation in between testing samples. The panellists were required to identify the most preferred sample in taste preference and mouthfeel (e.g., pleasant, chalky, creamy, oily) in two evaluation cycles.

[0118] Results are displayed in Figure 1 (taste) and Figure 2 (mouthfeel). In terms of taste, most of the panellists (50%) selected Example 3 as highly acceptable, followed by Example 2 (33%) which was considered moderately acceptable, and Example 1 (17%). In terms of mouthfeel, Example 1 was often described as chalky, to viscous and having the least pleasant mouthfeel. Example 3 was chosen to have the most pleasant mouthfeel by almost 70% of the panellists.

[0119] The examples show that it is possible to prepare heat-sterilized, high-energy, high- protein, vegan, liquid enteral compositions with improved properties in terms of taste, mouthfeel, viscosity, and emulsion stability. These properties can be influenced by selecting the protein source.

[0120] Without wishing to be bound by theory, it is assumed that taste and I or mouthfeel in the compositions are influenced by emulsion properties such as viscosity and particle size distribution of the nutritional emulsions. This is supported by the empirical finding when comparing taste and mouthfeel panel test results for Examples 1 , 2 and 3 with particle size distributions and viscosity data.TABLESTable 1 - Examples*(-) very low acceptance, (- / +) low acceptance, (+) good acceptance, (++) excellent acceptance, see Fig. 1 and 2Table 2 - Soy protein examplesEMBODIMENTSNutritional composition1. A heat sterilized liquid vegan nutritional composition comprising a lipid component, a carbohydrate component, a protein component, vitamins, minerals and water, wherein the nutritional composition has an energy density of at least 1.4kcal / ml, and wherein the protein component consists of at least 6.5g of soy protein per 100ml of the nutritional composition, and wherein the nutritional composition comprises at least 13mg phosphorus per gram of protein, and wherein the nutritional composition has a pH in the range of 6-9.2. The nutritional composition according to the preceding embodiment, wherein the nutritional composition has an energy density of 1.4kcal / ml to 2.5kcal / ml, preferably of 1.4kcal / ml to 2.4kcal / ml, more preferred of 1.4kcal / ml to 2.0kcal / ml, even more preferred of 1.4kcal / ml to 1.8kcal / ml, most preferred of 1.4kcal / ml to 1.6kcal / ml, for example 1.5kcal / ml.3. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition has an energy density of 1.5kcal / ml to 2.5kcal / ml, preferably of 1.5kcal / ml to 2.4kcal / ml, more preferred of 1.5kcal / ml to 2.0kcal / ml, even more preferred of 1.5kcal / ml to 1.8kcal / ml, most preferred of 1.5kcal / ml to 1.6kcal / ml, for example 1.5kcal / ml.4. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition has an energy density of 1.8kcal / ml to 2.5kcal / ml, preferably of 1.8kcal / ml to 2.4kcal / ml, for example 2.4kcal / ml, more preferred of 1.8kcal / ml to 2.2kcal / ml, even more preferred of 1.8kcal / ml to 2.0kcal / ml, for example 2.0kcal / ml.5. The nutritional composition according to any of the preceding embodiments, wherein the protein component provides at least 16EN%, preferably 16EN% to 25EN%, more preferred 18EN% to 20EN% based on the total nutritional energy provided by the nutritional composition.6. The nutritional composition according to any of the preceding embodiments, wherein the protein component provides at least 18EN%, preferably 18EN% to 25EN%, more preferred 18EN% to 22EN% based on the total nutritional energy provided by the nutritional composition.7. The nutritional composition according to any of the preceding embodiments, wherein the protein component provides at least 20EN%, preferably 20EN% to 25EN%, for example 20EN% based on the total nutritional energy provided by the nutritional composition.The nutritional composition according to any of the preceding embodiments, wherein the protein component consists of 6.5g to 15g, preferably of 6.5g to 10g, more preferred of 6.5g to 9g, most preferred of 6.5g to 8.5g of soy protein per 100ml of the nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the protein component consists of 7.0g to 15g, preferably of 7.0g to 10g, more preferred of 7.0g to 9g, most preferred of 7.0g to 8.5g of soy protein per 100ml of the nutritional composition, for example of 7.5g of soy protein per 100ml of the nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the protein component consists of 7.5g to 15g, preferably of 7.5g to 10g, more preferred of 7.5g to 9g, most preferred of 7.5g to 8.5g of soy protein per 100ml of the nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition comprises 13mg to 19mg, preferably 14mg to 19mg, more preferably 14mg to 18mg, most preferred 14mg to 16mg phosphorus per gram of protein, for example 15mg phosphorus per gram of protein. The nutritional composition according to any of the preceding embodiments, wherein the ratio of phosphorus (in mg per gram of protein) to EN% of protein of the nutritional composition falls between 0.7 and 1.2, preferably 0.8 and 1.1. The nutritional composition of the preceding embodiments, wherein the nutritional composition has a pH of 6-9, preferably a pH of 7-9, more preferably a pH of 8-9, for example a pH of 8.3. The nutritional composition according to any of the preceding embodiments, wherein a. the protein component provides 16-25EN%, preferably 18-22EN%, b. the carbohydrate component provides 30-50EN%, preferably 35-45EN%, more preferably 41 -44EN%, and c. the lipid component provides 25-40EN%, preferably 30-38EN%, more preferably 33-26EN%, each based on the total nutritional energy provided by the nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein a. the protein component provides about 20EN%, b. the carbohydrate component provides about 43EN%, andc. the lipid component provides about 34EN%, each based on the total nutritional energy provided by the nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition comprises a dietary fibre component. The nutritional composition according to any of the preceding embodiments, wherein the dietary fibre component comprises a dietary fibre selected from the group consisting of fructooligosaccharides or fructans, e.g. inulin, cocoa powder, corn dextrin, wheat dextrin, tapioca dextrin, cellulose, microcrystalline cellulose, soy polysaccharides, xanthan, galactooligosaccharides, at least partially hydrolysed guar gum, acacia gum, pectin, oat fibre, poly dextrose, resistant starch, hemicellulose, and mixtures thereof, preferably the dietary fibre component comprises or consists of inulin, wheat dextrin and cellulose. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition provides a dietary fibre content of 1-3g / 100ml, preferably of 1.5- 2.5g / 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, having a dietary fibre content of 2.25g / 100ml of the total nutritional composition. The nutritional composition according to any of embodiments 16 to 19, wherein the dietary fibre component comprises or consists of 0.76g inulin, 0.44g cellulose and 1.05g wheat dextrin each per 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the carbohydrate component comprises a carbohydrate selected from the group consisting of starch, maltodextrin, glucose syrup, disaccharides, such as sucrose, maltose, isomaltulose, lactose, glucose, fructose, or galactose, and mixtures thereof. The nutritional composition according to any of the preceding embodiments, wherein the carbohydrate component comprises or consist of glucose syrup and sucrose. The nutritional composition according to any of the preceding embodiments, having a carbohydrate content of 12-20g / 100ml, preferably of 14-18g / 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, having a carbohydrate content of 16.1g / 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the lipid component comprises oils selected from the group consisting of, rapeseed oil,safflower oil, sunflower oil, linseed oil, canola oil, tributyrin, or medium chain triglycerides (MCT), and mixtures thereof. The nutritional composition according to any of the preceding embodiments, wherein the lipid component comprises or consists of rapeseed oil. The nutritional composition according to any of the preceding embodiments, having a lipid content of 4-8g / 100ml, preferably of 5-6.5g / 100ml, more preferably of 5.5-6.0g / 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, having a lipid content 5.7g / 100ml of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the lipid component comprises or consists of 5.7 g / 100ml rapeseed of the total nutritional composition. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition is nutritionally complete. The nutritional composition according to any of the preceding embodiments, wherein the soy protein blend consists of two protein sources, wherein the second protein source provides at least 19mg phosphorus per gram of protein, the carbohydrate components consist of glucose syrup and sucrose, the lipid component consists of rapeseed oil, and wherein the nutritional composition comprising a dietary fibre component consisting of inulin, wheat dextrin, and cellulose. The nutritional composition according to any preceding embodiment, wherein the nutritional composition has a caloric density of 1.4-2.0 kcal / ml and a protein content of 7.4-7.8g / 100ml of the total nutritional composition. The nutritional composition according to any preceding embodiment, wherein the nutritional composition has a pH of 8.3, wherein the second soy protein source represents 43wt.% based on the total mass of the protein component, the carbohydrate components consist of 16.1 g / 100ml glucose syrup and sucrose of the total nutritional composition, the lipid component consists of 5.7g / 100ml rapeseed oil of the total nutritional composition, and wherein the nutritional composition comprising a dietary fibre component consisting of 2.25g / 100ml inulin, wheat or corn dextrin, and cellulose of the total nutritional composition, and wherein the nutritional composition has a caloric density of 1.5 kcal / ml and a protein content of 7.5g / 100ml of the total nutritional composition. The nutritional composition according to any preceding embodiment, wherein the nutritional composition has a viscosity of not more than 700 mPa s, not more than 600mPa s, not more than 500 mPa s, not more than 400 mPa s, not more than 300 mPa s, not more than 250 mPa s, not more than 200 mPa s, not more than 150 mPa s, not more than 100 mPa s, or not more than 50 mPa s, all measured at20°C and 50 s’1. In a preferred embodiment, the viscosity of the composition is not more than 250 mPa s, preferably not more than 200 mPa s, more preferably not more than 150 mPa s, more preferably not more than 100 mPa s, most preferably not more than 50 mPa s, all measured at 20 °C and 50 s’1.35. The nutritional composition according to any preceding embodiment, wherein the nutritional composition has a particle size distribution wherein at least 5 vol%, preferably at least 7 vol%, more preferably at least 10 vol%, even more preferably at least 15 vol% of the particles have a size in the range of 1-5 pm and / or wherein the nutritional composition has a particle size distribution wherein at least 15 vol%, preferably at least 17 vol%, more preferably at least 18 vol%, more preferably at least 20 vol%, even more preferably at least 22 vol% of the particle have a size in the range of 1-10 pm.36. The nutritional composition according to any preceding embodiments, wherein the nutritional composition has a viscosity of not more than 100 mPa s , and a particle size distribution in which at least 15 vol% of the particles have a size in the range of 1-5 pm, and at least 20 vol%, have a particle size in the range of 1-10 pm.37. The nutritional composition according to any of the preceding embodiments, wherein the nutritional composition has a viscosity of not more than 50 mPa s , and a particle size distribution in which at least 7 vol% of the particles have a size in the range of 1-5 pm, and at least 17 vol%, have a particle size in the range of 1-10 pm.Soy protein blend38. A soy protein blend consisting of at least two soy protein sources, wherein the soy protein blend provides 13-19mg phosphorus per gram of protein, wherein the soy protein blend consists of a first soy protein source providing less than 13mg phosphorus per gram of protein and a second soy protein source providing more than 19mg phosphorus per gram of protein.39. The soy protein blend according to the preceding embodiment, wherein the second protein source represents 30-60wt%, preferably 40-50 wt.% more preferably 40-45 wt.%, such as 43wt% of the total weight of the soy protein blend.40. The nutritional composition according to any of embodiments 1-33, wherein the protein component consists of the soy protein blend embodiment 34 or 35.41 . Use of the soy protein blend according to any of embodiments 34-36 in the preparation of a heat sterilized liquid vegan nutritional composition comprising a lipid component, a carbohydrate component, a protein component, and water.Dose unit42. A dose unit comprising the nutritional composition according to any of embodiments 1-33 or 36.43. The dose unit according to embodiment 38, wherein the dose unit comprises 100-300ml, preferably 150-250ml separately provided in a package.44. The dose unit according to embodiment 39, wherein the package is a bottle, a tetra brick or bag.45. The dose unit according to any of embodiments 38-40, wherein the dose unit provides 150-450 kcal, preferably 225-375 kcal.46. The dose unit according to embodiment 38-41 , wherein the dose unit provides 7.5-22.5g, preferably 11.25-18.75g, more preferably 12-16g of protein, such as 15g of protein.47. The dose unit according to embodiment 38-42, wherein the dose unit provides 300kcal and 15g of protein in a dose unit of 200ml.48. The dose unit according to embodiment 38, wherein the dose unit is packaged in a container adapted to for connection with a feeding tube.49. The dose unit according to embodiment 44, wherein the dose unit is packaged in a bottle or a bag.Use in therapy50. The nutritional composition according to any of embodiments 1-33 or 36 for use in therapy.51. The nutritional composition according to any of embodiments 1-33 or 36 for use in prevention and treatment of nutrient deficiencies associated with malnutrition.52. The nutritional composition according to any of embodiments 1-33 or 36 for use in prevention and treatment of nutrient deficiencies associated with malnutrition in patients with food intolerance or allergies, e.g. patients with pea protein allergy, lactose intolerant patients, patients having milk protein allergy.53. The nutritional composition according to any of embodiments 1-33 or 36 for use in prevention and treatment of nutrient deficiencies associated with increased energy and protein needs, for example in patients with cancer, inflammatory diseases, chronic wasting diseases, for example HIV, chronic kidney disease, cardiovascular diseaseincluding heart failure, liver disease, chronic obstructive pulmonary disease, anorexia, frailty or patients in the pre-, peri- and post-operative phase of surgery.

Claims

CLAIMS1. A heat sterilized, liquid vegan nutritional composition comprising a lipid component, a carbohydrate component, a protein component, vitamins, minerals and water, wherein the nutritional composition has an energy density of at least 1 ,4kcal / ml, and wherein the protein component consists of at least 6.5g of soy protein per 100ml of the nutritional composition, and wherein the nutritional composition comprises at least 13mg phosphorus per gram of protein, and wherein the nutritional composition has a pH in the range of 6-9.

2. The nutritional composition according to the preceding claim, wherein the protein component provides 18EN% to 22EN% based on the total nutritional energy provided by the nutritional composition.

3. The nutritional composition according to any of the preceding claims, wherein the protein component consists of 7.0g to 10g of soy protein per 100ml of the nutritional composition.

4. The nutritional composition according to any of the preceding claims, wherein the nutritional composition comprises 14mg to 18mg phosphorus per gram of protein.

5. The nutritional composition according to any of the preceding claims, wherein the ratio of phosphorus (in mg per gram of protein) to EN% of protein of the nutritional composition falls between 0.7 and 1.2.

6. The nutritional composition according to any of the preceding claims, wherein a. the protein component provides 16-25EN% b. the carbohydrate component provides 30-50EN%, and c. the lipid component provides 25-40EN%, each based on the total nutritional energy provided by the nutritional composition.

7. The nutritional composition according to any of the preceding claims, wherein the nutritional composition comprises a dietary fibre content of 1-3g / 100ml.

8. The nutritional composition according to any of the preceding claims, having a carbohydrate content of 12-20g / 100ml.

9. The nutritional composition according to any of the preceding claims, having a lipid content of 4-8g / 100ml.

10. The nutritional composition according to any of the preceding claims, wherein the soy protein is a soy protein blend consisting of at least two soy protein sources wherein the soy protein blend provides 13-19mg phosphorus per gram of protein, wherein the soyprotein blend consists of a first soy protein source providing less than 13mg phosphorus per gram of protein and a second soy protein source providing more than 19mg phosphorus per gram of protein.11 . The nutritional composition according to the preceding claim, wherein the second protein source represents 30-60wt% of the total weight of the soy protein blend.

12. The nutritional composition according to any of the preceding claims wherein the carbohydrate components consist of glucose syrup and sucrose, the lipid component consists of rapeseed oil, and wherein the nutritional composition comprising a dietary fibre component consisting of inulin, wheat or corn dextrin, and cellulose.

13. The nutritional composition according to any of the preceding claims, wherein the composition has an energy density of at least 1.5 kcal / ml, preferably between 1.5 to 2 kcal / ml.

14. The nutritional composition according to any of the preceding claims, wherein the composition comprises between 7 to 8 g of protein per 100 ml composition, preferably 7.5 g / 100 ml.

15. The nutritional composition according to any of the preceding claims for use in therapy.

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