Nutritional composition for medical use formulated from a vegetable protein

Abstract

The present invention relates to the field of liquid nutritional compositions for medical use. More specifically, the invention relates to a liquid nutritional composition formulated from a protein exclusively of plant origin; the protein used is derived exclusively from yellow peas. The invention also relates to a method for producing such a composition.

Description

[0001] The present invention relates to the field of liquid nutritional compositions for medical use. More particularly, it relates to a liquid nutritional composition formulated from a protein of exclusively plant origin; the protein used comes exclusively from yellow peas. It also relates to a process for preparing such a composition.

[0002] The invention is defined by the attached claims 1-4. Scope of the invention

[0003] The supply of plant-based food products is growing rapidly in response to consumer demand for reduced or eliminated consumption of animal products. This includes meat, eggs, and dairy. Medical nutrition is no exception to this trend, and new plant-based nutritional formulations for medical use are emerging. Within the range of dietary products, functional beverages, and infant formulas, there are also products containing plant-based proteins; these are either combined with dairy proteins or used as the sole protein source, but in the latter case, the total protein content is low, around 4g / 100ml.The aim of these products is either to meet the growing "vegan" market trend (as with functional drinks) or to offer an alternative to dairy proteins for those with intolerances. Soy protein is frequently used, and rice protein is also common in infant formulas. Furthermore, some functional drinks marketed as "complete meals" combine several plant-based protein sources (including pea protein). However, these are often powdered products that need to be reconstituted, or, if they are ready-to-drink, their protein content typically ranges around 5g / 100ml. These products are not suitable for medical use.

[0004] Formulators of nutritional compositions for medical use have the same sources of plant proteins available on the market obtained from soy, rice, peas, lentils and other legumes.

[0005] The use of rice proteins is limited by their low soluble content, making it difficult to sufficiently enrich the composition to meet nutritional objectives. Furthermore, the organoleptic qualities are unsatisfactory, with some products having a bitter taste.

[0006] Pea protein has a higher protein content than other legumes, but the viscosity, taste (more or less bitter), and color of the formulated product vary depending on the quality of the starting pea protein. Furthermore, peas are less rich in minerals and amino acids than dairy ingredients, which explains why formulators of nutritional compositions for medical use have, until now, primarily used dairy proteins.

[0007] WO2017 / 129921 describes nutritional compositions containing pea protein isolate. The envisaged pea protein content is a maximum of 5g / 100ml. This document describes creams or frozen desserts formulated with a pea protein content of up to 3.5g / 100ml.

[0008] Tavarlin's "Keto-Drink with Banana Flavour" product, sold in Germany from June 2017, according to the Mintel database (see its ID 4815965), is a ready-to-drink, high-calorie meal replacement drink intended for the dietary management of malnutrition due to illness, containing 6.7g / 100mL of protein, provided by pea protein.

[0009] Regarding other legumes, the protein content of the ingredients is very low. Therefore, a very high dose must be added to achieve the desired protein level in the finished product. Consequently, the finished product, containing a very high protein content from legumes, is not heat-stable.

[0010] The use of plant proteins in medical nutrition therefore presents two major challenges: the stability of the composition after protein and mineral enrichment and obtaining organoleptic properties satisfactory to the consumer.

[0011] Plant-based protein nutrition products available on the market have a maximum protein content of 4g per 100 mL of composition.

[0012] There is a need for plant-based protein-based nutritional compositions that are sufficiently rich in protein, amino acids, and minerals to meet the needs of malnourished patients in hospital or home care settings. These compositions must be liquid and stable over time while also exhibiting desirable organoleptic properties. Description of the invention

[0013] The objective is to meet a growing need among the population for an alternative to milk protein, including in the context of medical nutrition.

[0014] The present invention addresses this need by proposing a new formulation based solely on whole proteins derived from yellow peas. It comprises between 6 and 10 g of protein, between 5 and 10 g of lipids and between 15 and 25 g of carbohydrates per 100 ml of composition, at least 53 mg / 100mL of Ca for a composition of 150kcal and it has an energy value between 150 and 250 kcal / 100 ml, at least 65% of the calcium being supplied in insoluble form, and a viscosity of less than 120 mPas -1 (measured at 20°C on a rotary viscometer of the "cup and bob" type), as well as a pH between 7.1 and 7.4.

[0015] The invention also relates to a method for preparing such a composition comprising the steps of: Hydration of a whole yellow pea protein isolate. Mixing of said isolate with other ingredients, including lipids, carbohydrates, minerals and vitamins. Adjustment of the pH between 7.1 and 7.5. Sterilization of the resulting mixture by direct steam injection. in which at least 65% of the calcium supplied is in insoluble form. Advantages of the invention

[0016] The present invention proposes a novel nutritional composition for medical use in which the protein is supplied exclusively by whole yellow pea protein, and in which the protein content is at least 6 g per 100 ml of composition. No such product is currently available on the market, and it addresses an unmet medical need.

[0017] This composition meets the requirements for so-called "Foods for Special Medical Purposes" (FSMP). FSMP is defined in EU Regulation 2016 / 128 as a "category of foods intended for a particular nutritional purpose. Specially processed or formulated, they are intended to meet the nutritional needs of patients and may only be used under medical supervision." The compositions presented here have a complete mineral and vitamin profile in accordance with the FSMP Regulation.

[0018] In particular, the compositions have a calcium mineral profile that complies with this Regulation. The amount of calcium is therefore at least 53 mg / 100 mL for a 150 kcal composition. However, calcium ions are known to destabilize compositions when added in large quantities. The invention addresses this problem by proposing that at least 65% of the calcium be in insoluble form. This proportion ensures the stability of the composition (no separation, no creaming on the surface, no white spots). Furthermore, the inventor has shown that the form of calcium used influences the taste.

[0019] Furthermore, the compositions according to the invention fall into the category of hypercaloric products, due to their energy value greater than or equal to 150 kcal per 100 mL of composition.

[0020] Pea protein isolate exhibits an essential amino acid composition exceeding the 2013 FAO recommendations (FAO of the United Nations, 2013), except for sulfur-containing amino acids (ASAs, cysteine ​​and methionine). Therefore, simple enrichment with these amino acids is sufficient to equal, or even surpass, the amino acid content of a dairy protein-based composition, and to comply with FAO recommendations. The nutritional composition according to the invention is thus advantageous from an amino acid perspective.

[0021] The composition according to the invention has the advantage of being stable over time and remaining liquid, despite a pea protein content of between 6 and 10 g per 100 mL. Indeed, one of the difficulties in formulating products rich in vegetable protein is achieving a stable product. This problem has been solved by the process according to the invention. It appears that the combination of steps as described herein, in particular (i) the association of a pea protein hydration step prior to mixing with the other ingredients, with (ii) sterilization by direct steam injection, and (iii) the addition of calcium consisting of at least 65% calcium in an insoluble form, makes it possible to produce a stable composition with controlled viscosity that is maintained over time. Thus, the compositions are stable for at least 6 months at room temperature (between 4 and 25°C), which is compatible with a best-before date of 9 months.

[0022] Another interesting property of the composition according to the invention is that it has no pronounced vegetal aftertaste or astringency. Surprisingly, the inventor has demonstrated that this property is attributable, at least in part, to the nature of the added calcium form. This composition, combined with flavorings, allows for a variety of tastes. Furthermore, its smooth texture and liquid consistency make it pleasant for even weakened patients to consume. The organoleptic properties are therefore satisfactory.

[0023] Finally, the resulting product is suitable for people with milk protein allergies. No other nutritional composition on the market offers a protein content of at least 6g per 100ml that is also milk-free. Furthermore, the product can be formulated without any other dairy ingredients to meet the needs of people allergic to various components of milk, particularly lactose. This product therefore addresses an unmet medical need.

[0024] The process according to the invention is also innovative in that it combines key steps for obtaining a composition exhibiting the properties described, namely, hydration of the pea protein isolate before mixing with the other ingredients, a supply of calcium consisting of at least 65% calcium in an insoluble form and sterilization by direct steam injection. DETAILED DESCRIPTION OF THE INVENTION

[0025] A first object of the invention relates to a liquid nutritional composition based on vegetable proteins. comprising per 100 mL of composition: ∘ between 6 and 10 g of protein ∘ between 5 and 10 g of lipids ∘ an energy value between 150 and 250 kcal with a viscosity less than 120 mPas⁻¹ at 20°C measured on a cup and bob rotary viscometer with a pH between 7.1 and 7.4 characterized in that the protein consists solely of whole vegetable proteins from yellow pea and in that it contains at least 53 mg of calcium / 100ml for a composition of 150 kcal (per 100 mL), with at least 65% of the calcium being supplied in insoluble form.

[0026] This composition is formulated using proteins exclusively from whole yellow pea proteins.

[0027] By "yellow peas" we mean the variety Pisum sativum.

[0028] By "whole protein" we mean an unhydrolyzed protein, and more specifically a pea protein isolate.

[0029] In a preferred embodiment of the invention, the ingredients other than proteins are also of plant origin. In particular, the lipids can be vegetable oils such as rapeseed oil, sunflower oil, soybean oil, palm oil, olive oil, coconut oil, etc., alone or in mixtures. Thus, the product offered for consumption can be suitable for people who do not consume products of animal origin, as well as for people who are allergic or intolerant to dairy products.

[0030] In another preferred embodiment, the carbohydrates consist of sucrose, glucose syrup and / or maltodextrins.

[0031] The compositions present a complete mineral and vitamin profile in accordance with the DADFMS regulation.

[0032] The compositions may contain flavorings and emulsifiers such as soy or sunflower lecithin, or mono- and diglycerides of fatty acids, sucrose ester, etc., to improve the palatability and texture of the product.

[0033] The compositions according to the invention are energy-rich, with an energy value between 150 and 250 kcal / 100 mL of composition. They can be described as "hypercaloric" due to their energy content exceeding 150 kcal per 100 mL and can be used as medical nutrition products.

[0034] Pea proteins generally have a low calcium content, less than 100 mg per 100 g of powdered ingredient, compared to values ​​typically exceeding 1500 mg of calcium per 100 g of ingredient for powdered dairy protein isolates. Therefore, since pea proteins are naturally low in calcium, it is necessary to add calcium during formulation to reach a minimum of 53 mg / 100 mL for a 150 kcal nutritional composition, and to meet the requirements of the DADFMS regulation (see below). To obtain the desired properties (stability, viscosity), the inventor has determined that at least 65% of the added calcium must be in an insoluble form. Examples of insoluble forms include calcium citrate, calcium oxide, calcium carbonate, calcium phosphate, etc. Examples of soluble forms include calcium dihydroxide and calcium chloride.

[0035] Insoluble forms of calcium can be provided either from a single calcium source or from a mixture of two or more insoluble calcium forms. When insoluble forms represent less than 100% of the calcium, they consist of a mixture of one or more insoluble and soluble calcium forms.

[0036] In one particular embodiment, the insoluble forms are a mixture of tricalcium phosphate and calcium carbonate.

[0037] The compositions are liquid and have a viscosity of less than 120 mPas⁻¹ at 20°C measured on a cup and bob type rotary viscometer. Preferably, their viscosity is less than 100 mPas⁻¹.

[0038] The pH of these compositions is between 7.1 and 7.5.

[0039] The compositions according to the invention are both thermally stable during their preparation and stable over time, at least 6 months.

[0040] By "stable" composition, we mean a composition that remains homogeneous, without phase shift or the appearance of deposits.

[0041] In a particular embodiment of the invention, the composition comprises 6 g of yellow pea protein per 100 mL.

[0042] In another particular embodiment, the composition comprises 9 g of yellow pea protein per 100 mL.

[0043] The compositions according to the invention constitute clinical nutrition products intended for malnourished patients and to be distributed by hospitals or pharmacies for home use.

[0044] A second object of the invention relates to a method for preparing a composition as defined above, comprising the steps of: Hydration of a whole yellow pea protein isolate. Mixing of said isolate with the other ingredients, including calcium of which at least 65% is in an insoluble form. Adjustment of the pH between 7.1 and 7.5. Sterilization of the mixture obtained by direct steam injection.

[0045] The yellow pea protein isolate used in this process is in powder form, containing at least 80% protein, and preferably at least 85% protein. Such isolates are commercially available. However, they are not widely used today because their formulation is more complex than that of dairy proteins, as plant proteins are less thermally stable.

[0046] The protein isolate is first hydrated in an aqueous solution, preferably water. Preferably, this step is carried out by hydrating the proteins in the solution heated between 35°C and 65°C, preferably between 45°C and 60°C, for a period of 20 minutes to 3 hours.

[0047] Other ingredients that make up the composition include lipids, carbohydrates, minerals, and vitamins. It may also include flavorings, stabilizers, texturizers, and thickeners.

[0048] The ingredients are mixed in the proportions described above, namely between 6 and 10 g of whole yellow pea protein, between 5 and 10 g of lipids, between 15 and 25 g of carbohydrates.

[0049] Regarding calcium intake, the amount provided depends on the formulation and is determined to comply with the DADFMS Regulation. For example, the minimum amount of calcium is between 53 mg / 100 ml for a 150 kcal composition and 88 mg / 100 ml for a 250 kcal / 100 ml composition, in accordance with the DADFMS Regulation. Regardless of the composition, at least 65% by weight of the total calcium provided must be in an insoluble calcium form. In a preferred embodiment, at least 70% of the calcium provided is in an insoluble form. In a particular embodiment, between 70% and 80% of the added calcium is in an insoluble form.

[0050] The pH is adjusted to a value between 7.1 and 7.4.

[0051] The composition is then sterilized by applying UHT heat treatment, for example by direct steam injection / with a sterilizing value > 15.

[0052] The product resulting from this process is liquid and stable over time, allowing a shelf life of at least 6 months. EXAMPLES EXAMPLE 1: Preparation of a liquid nutritional composition comprising whole yellow pea protein as the sole protein source

[0053] The preparation steps are summarized in the following diagram:

[0054] A homogenization step may be necessary at the end of the process.

[0055] Examples of compositions according to the invention are described in Table 1 Table 1: Compositions according to the invention (per 100 mL) Ingredients Composition A Composition B Yellow pea protein 6g / 100ml 9g / 100ml Lipids 6g / 100ml 8.3g / 100ml carbohydrates 18g / 100ml 22.3g / 100ml Viscosity (20°C - 50s-1) <100 mPas <100 mPas Energy value 150 kcal / 100ml 200 kcal / 100ml Quantity of Ca 60mg / 100ml 90 mg / 100ml which is insoluble 70% 70% EXAMPLE 2: Characteristics of compositions according to the invention as a function of the calcium form used

[0056] Compositions containing 9g / 100mL of whole yellow pea protein were prepared by varying the form of the added calcium. In this example, the insoluble calcium is in the form of a mixture of tricalcium phosphate and calcium carbonate. All three compositions comply with the DADFMS Regulation. Table 2 : Viscosity and stability of nutritional compositions based on yellow pea protein depending on the form of calcium added. Formula B1 B2 B3 protein (g / 100ml) (yellow peas) 9 9 9 lipids (g / 100ml) 8,3 8,3 8,3 carbohydrates (g / 100ml) 22,3 22,3 22,3 Energy value (kcal / 100ml) 200 200 200 Ca (mg / 100ml) 90 90 90 Form of added calcium 100% in the form of soluble salts 100% in the form of insoluble salts 50% soluble forms / 50% insoluble forms viscosity in mPas at J+7 (100s-1 / 20°C) 65 54 46 observation of finished product stability at day 7 Phase separation, surface creaming, white spots stable product with a very vegetal taste Phase separation, surface creaming, white spots

Claims

1. A liquid nutritional composition based on plant proteins - comprising for 100 ml of composition: ∘ between 6 and 10 g of protein ∘ between 5 and 10 g of fats ∘ between 15 and 25 g of carbohydrates ∘ an energy value between 150 and 250 kcal - having a viscosity lower than 120 mPas-1 at 20°C measured on a "cup and bob" type rotary viscometer - having a pH between 7.1 and 7.4 characterised in that: - the protein is made up solely of whole plant proteins derived from Pisum sativum yellow pea - it contains at least 53 mg of calcium / 100 ml for a 150 kcal composition, and - at least 65 % of the calcium provided is in insoluble form.

2. The composition according to claim 1, characterised in that said fats are vegetable oils.

3. A method for preparing a composition as defined in one of claims 1 to 2 comprising the steps of: - Hydrating a whole Pisum sativum yellow pea protein isolate - Mixing said isolate with the other ingredients and in particular the fats, the carbohydrates, the minerals and the vitamins, the calcium provided being at least 65% in insoluble form - Adjusting the pH to between 7.1 and 7.5 - Sterilising the obtained mixture by direct steam injection.

4. The method according to claim 3 characterised in that said hydration step is carried out by heating to a temperature between 35°C and 65°C.