Nutritional composition having a high protein content, the protein source of which consists of 100% hydrolysed proteins

EP4503957A1Pending Publication Date: 2025-02-12EVEN SANTE IND
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Patent Information

Application Number
EP2023717922
Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-04-08
Filing Date
2023-04-07
Publication Date
2025-02-12

AI Technical Summary

Technical Problem

Current liquid nutritional compositions with high protein content lack a complete mineral profile, particularly failing to meet the sodium, potassium, and phosphorus requirements as per Delegated Regulation (EU) 2016/128, and existing high-protein drinks are not fluid enough for malnourished patients.

Method used

A nutritional composition with 100% hydrolyzed proteins, comprising a mixture of partially hydrolyzed serum proteins and hydrolyzed collagen, providing between 14-30g of protein per 100ml, along with a balanced mineral and energy content, ensuring a complete nutritional profile and fluidity by optimizing the ratio of serum proteins to collagen and adjusting pH between 7 and 8.

Benefits of technology

The composition meets the nutritional needs of malnourished patients as a sole source of nutrition, maintaining fluidity and achieving the required mineral content targets without increasing viscosity, thus addressing the unmet need for a high-protein, complete mineral profile drink.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the field of liquid nutritional compositions having a high protein content. More particularly, the invention relates to a nutritional composition comprising between 14 and 30 g of proteins per 100 ml, wherein the proteins are hydrolysed. This composition has a complete mineral profile and a suitable energy content for use as the sole source of food for malnourished patients.
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Description

HIGH PROTEIN NUTRITIONAL COMPOSITION WITH A PROTEIN SOURCE OF 100% HYDROLYZED PROTEIN

[0001] The invention relates to the field of high protein liquid nutritional compositions. More particularly, the invention relates to a nutritional composition comprising between 14 and 30 g of protein per 100 ml in which the proteins are hydrolyzed. This composition has a complete mineral profile and an energy content suitable for use as a sole source of nutrition in malnourished patients. Field of invention

[0002] The human body is a complex organism. Its proper functioning, particularly the maintenance of vital functions, requires energy provided by food, which must be sufficient and balanced. Energy must be provided by proteins, sugars, and fats. Proteins are essential for muscular activity, fats allow energy to be stored and released according to the body's needs, and sugars provide an immediately available source of energy. These caloric sources are therefore complementary. They must be supplemented by vitamin and mineral intakes that play a role in the physiological balance of the body's various vital functions.

[0003]

[0004] This balance can be disrupted in cases of malnutrition due, for example, to an eating disorder (anorexia, etc.), or malnutrition resulting from a pathological situation or in elderly people who no longer eat properly independently.

[0005] Nutritional needs change throughout life. For example, older adults have reduced lipid requirements due to decreased activity and slower cell turnover.

[0006] Most of the drinkable nutritional compositions available on the market today have a protein content of less than or equal to 14.5 g / 100 ml. Their energy value is between 225 and 240 kcal / 100 ml.

[0007] Patent EP3411057 describes high-protein nutritional compositions, the protein source of which includes hydrolyzed collagen. However, these compositions are not complete in terms of their mineral profile beyond 20g of protein per 100mL.

[0008] There is no drink with a higher protein content, which is fluid and has a complete mineral profile. In particular, the phosphorus content is generally too high and the sodium, potassium and / or magnesium content is too low compared to Delegated Regulation (EU) 2016 / 128 of 25 September 2015.

[0009] There is therefore a need for a drink with a higher protein content for malnourished patients that is mineral-complete so that it can be consumed as the sole source of nutrition.

[0010] The inventors propose an innovative composition due to its protein pool consisting of 100% hydrolyzed proteins. These hydrolyzed proteins are a mixture of whey proteins and collagen. The composition is fluid despite a high protein content of between 14 and 30g per 100 ml and complete in terms of mineral intake.

[0011] Thus, the invention relates to a nutritionally complete liquid nutritional composition comprising a high protein content and which is adapted to the needs of malnourished patients; this composition can be consumed as the sole source of nutrition by malnourished patients in accordance with the nutritional profile established by Regulation 2016 / 128. This composition comprises:between 14g and 30g of protein per 100 ml carbohydrates which provide between 17% and 45% of the total energy content of the composition lipids which provide between 30% and 65% of the total energy content of the composition a sodium content greater than or equal to 72 mg and a potassium content greater than or equal to 192 mg per 100 ml an energy content greater than or equal to 240 kcal per 100 ml a viscosity less than or equal to 600 mPa.s measured at 20°C at 100 s -1 using a rotary viscometer a pH between 7 and 8

[0012] in which said proteins are characterized by:a protein intake consisting of partially hydrolyzed serum proteins and hydrolyzed collagena total quantity of serum proteins of between 9 and 14g per 100 mla ratio between hydrolyzed serum proteins and hydrolyzed collagen of between 40:60 and 70:30.

[0013] The invention also relates to a process for preparing a composition according to the invention comprising the steps of: Mixing in aqueous phase of proteins, carbohydrates, minerals, vitamins, Adding lipids and emulsifiers Adjusting the pH between 7 and 8 Cooling and balancing the composition Sterilization or pasteurization. Advantages of the invention

[0014] The composition addresses an unmet need for high-protein drinks, particularly those with more than 14g of protein per 100ml, which may be the sole source of nutrition for malnourished patients. This type of product can be offered in hospitals or pharmacies; it meets current regulations establishing the nutritional needs of malnourished patients (Regulation 2016 / 128).

[0015] The challenge addressed by the present invention is to provide a composition very rich in proteins which remains fluid and which presents a complete mineral profile with regard to current regulations.

[0016] The original mineral protein pool of these compositions is obtained thanks to the complementary properties of hydrolyzed whey proteins and hydrolyzed collagen. Partially hydrolyzed whey proteins have a low phosphorus content, a fairly interesting magnesium content and are rich in sodium and potassium, two minerals whose targets recommended by the DADFMS regulation (regulation 2016 / 128) are difficult to achieve. Compositions prepared from this protein mixture have a low viscosity because hydrolyzed whey proteins do not provide or provide very little viscosity and hydrolyzed collagen is not very sensitive to its environment and contains few minerals.

[0017] Interestingly, hydrolyzed whey proteins provide sufficient sodium and potassium to achieve the target values ​​of the DADFMS regulation (regulation 2016 / 128). Therefore, from such a protein pool, it is possible to comply with these target values ​​while avoiding the constraints linked to the citrate intake encountered in particular when sodium and / or potassium are provided in the form of sodium citrate or potassium citrate; citrate forms being known to cause an increase in viscosity. Thus, the compositions with a (very) high protein content according to the invention are liquid. DETAILED DESCRIPTION OF THE INVENTION

[0018] A first subject of the invention relates to a nutritionally complete liquid nutritional composition so that it can constitute the sole source of nutrition for malnourished patients, comprising: between 14g and 30g of proteins per 100 ml carbohydrates which provide between 17% and 45% of the total energy content of the composition lipids which provide between 30% and 65% of the total energy content of the composition a sodium content greater than or equal to 72 mg and a potassium content greater than or equal to 192 mg per 100 ml an energy content greater than or equal to 240 kcal per 100 ml a viscosity less than or equal to 600 mPa.s measured at 20°C at 100 s -1 using a rotary viscometer a pH between 7 and 8

[0019] in which said proteins are characterized by:a protein intake consisting of partially hydrolyzed serum proteins and hydrolyzed collagena total quantity of serum proteins of between 9 and 14g per 100 mla ratio between hydrolyzed serum proteins and hydrolyzed collagen of between 40:60 and 70:30.

[0020] A “complete nutritional composition” means a composition that can be used as the sole source of nutrition. In particular, it includes a complete mineral and vitamin profile in accordance with Regulation 2016 / 128.

[0021] By "hydrolyzed whey proteins" is meant a solution of partially hydrolyzed or completely hydrolyzed whey proteins. Hydrolyzed whey proteins have the particularity of being rich in sodium and potassium, with respective quantities of at least 650 mg of Na and 2445 mg of K per 100 g of protein. It can be noted that the mineral contents of the whey protein make it possible to provide these 2 minerals in sufficient quantities to comply with Regulation 2016 / 128; thus it is not necessary to provide them via an exogenous mineral form. The degree of hydrolysis of these proteins is generally less than 30%, preferably less than 20% and most preferably less than 10%. When the degree of hydrolysis is less than 10%, the organoleptic properties are improved.

[0022] Hydrolyzed collagen refers to a collagen solution in which the proteins have an average molecular weight between 2 and 5 kDa. This may include collagen of animal origin such as beef or fish collagen.

[0023] By "complete mineral profile", we refer to the mineral contents mentioned in regulation 2016 / 128. These contents are not absolute values ​​because they follow regulatory developments and the person skilled in the art will know how to adapt them. However, it is accepted that to comply with this regulation, the sodium content must be greater than or equal to 30 mg and the potassium content must be greater than or equal to 80 mg per 100 kcal. These contents are achieved in the context of the present invention thanks to the protein pool implemented; as explained previously, no sodium and potassium adjustment is necessary to achieve these targets due to the quantities provided by the hydrolyzed whey proteins. However, it is not excluded to add other sources of sodium and / or potassium to meet specific nutritional needs.The adjustment of other minerals does not pose any particular difficulty and can be carried out by those skilled in the art, in particular for magnesium and calcium, which can be provided by various mineral forms. The use of citrate mineral forms will preferably be limited due to their impact on viscosity.

[0024] Thus, for example, a composition whose energy content is greater than or equal to 240 kcal per 100 ml of composition will have a sodium content greater than or equal to 72 mg and a potassium content greater than or equal to 192 mg per 100 ml. Similarly, the contents of other minerals can be calculated by a person skilled in the art. Such a composition will in particular have a calcium content greater than or equal to 84 mg and a phosphorus content greater than or equal to 72 mg per 100 ml.

[0025] For information purposes, the regulations in their current version provide for the following mineral contents:

[0026]

[0027] Table 1: Mineral contents according to regulation 2016 / 128

[0028] The vitamin profile will be adjusted by a person skilled in the art without any particular difficulty.

[0029] For information purposes, the regulations in their current version provide for the following vitamin contents:

[0030]

[0031] Table 2: Vitamin levels according to regulation 2016 / 128

[0032] Carbohydrates provide between 17% and 45% of the total energy content of the composition. They can be provided by any type of sugar. In a preferred embodiment, they are mainly provided by glucose syrup.

[0033] Lipids provide between 30% and 65% of the total energy content of the composition. They can be provided by any type of lipid source, such as vegetable oils.

[0034] The composition is described as liquid, which means that it can be drunk. It has a viscosity less than or equal to 600 mPa.s measured at 20°C at 100 s -1 using a rotational viscometer. In a preferred embodiment, the viscosity is less than 400 mPa.s, less than 300 mPa.s, or even less than 200 mPa.s.

[0035] The energy content of the composition is greater than or equal to 240 kcal / 100ml. It is generally between 240 and 300 kcal / 100ml, preferably between 240 and 260 kcal / 100ml, depending on the embodiments.

[0036] In a particular embodiment, the composition is suitable for lactose intolerant individuals because the lactose content is less than 0.5g / 100ml. Those skilled in the art will be able to adapt the amount of serum protein, which constitutes the source of lactose, by adjusting the serum protein: collagen ratio when necessary, while remaining within the ranges defined in the present invention.

[0037] The pH of the composition is adjusted between 7 and 8 in order to stabilize the composition and maintain fluidity with regard to the presence of serum proteins.

[0038] A second subject of the invention relates to a process for preparing a composition according to the invention comprising the steps of: Mixing in aqueous phase of proteins, carbohydrates, minerals and vitamins Adding lipids and emulsifiers Adjusting the pH between 7 and 8 Cooling and balancing the composition Sterilization or pasteurization.

[0039] Flavorings and colorings can also be added in step a.

[0040] The present invention will be better understood from the following examples, provided for illustration purposes and in no way to be considered as limiting the scope of the present invention. EXAMPLES

[0041] EXAMPLE 1: Preparation and characterization of a composition according to the invention

[0042] The composition according to the present invention can be obtained by preparing an aqueous phase into which water, proteins, carbohydrates, minerals, vitamins, flavorings and colorings, and any other additives are successively incorporated in one or more stages. The water and proteins can be preheated to between 30 and 60°C. The fat and emulsifiers can be directly added, or prepared separately (fat phase heated and incorporated into the aqueous phase). The pH is adjusted to be between 7 and 8. A cooling and balancing phase is applied and then the composition is sterilized before aseptic packaging. Homogenization is applied before or after sterilization. Sterilization is carried out by heating according to the usual Ultra High Temperature processes.

[0043] The characteristics of such a composition at 18g of protein / 100ml are presented in Table 1. Vitamins are also added to comply with Regulation 2016 / 128.

[0044] NutrientsUnitValue per 100ml%AETDensityg / l1140 Energykcal260 kJ1092 Fatg9.332.2of which saturatesg1.3 of which unsaturatesg7.5 Carbohydrates (without fiber)g26.1440.1of which sugars (mono and di sac.)g7.7 Fiberg00Proteing1827.7Selg0.3675 Dry extractg55.9 Namg147 Kmg289 Camg145 Pmg105 Mgmg25.8 Clmg93

[0045] Table 3: Nutritional profile of a composition at 18g / 100ml.

[0046] EXAMPLE 2: Characteristics of different compositions according to the invention

[0047] NutrientsUnitFormula at 250 kcalFsmp MinFsmp MaxProteing1618202428NAESg55.0955.9256.0956.3257.54Namg12514716218320278455Kmg300289319335335208767Camg21614515215715891455Pmg11210511411911978208Mgmg25.325.826.627.027.019.565Clmg929395959578455Viscosity at D+7cP120154185365*329*NAViscosity at M+3cP134166245427*472*

[0048] *The differences in values ​​of the 24 and 28g protein compositions are not significantly different.

[0049] Table 4: Nutritional profile per 100 ml and viscosity of the compositions according to the invention as a function of the quantity of proteins

Claims

A nutritionally complete liquid formula, suitable as the sole source of nutrition for malnourished patients, comprising: between 14g and 30g of protein per 100ml; carbohydrates providing between 17% and 45% of the total energy content; lipids providing between 30% and 65% of the total energy content; a sodium content greater than or equal to 72mg and a potassium content greater than or equal to 192mg per 100ml; an energy content greater than or equal to 240kcal per 100ml; and a viscosity less than or equal to 600mPa·s measured at 20°C at 100 s -1using a rotary viscometer a pH between 7 and 8 in which said proteins are characterized by: a protein intake consisting of partially hydrolyzed serum proteins and hydrolyzed collagen a total amount of serum proteins between 9 and 14g per 100 ml a ratio between hydrolyzed serum proteins and hydrolyzed collagen between 40:60 and 70:

30. Composition according to claim 1 wherein said energy content of the composition is between 240 and 300 kcal / 100 ml. Composition according to claim 1 or 2 wherein the calcium content is greater than or equal to 84 mg and the phosphorus content is greater than or equal to 72 mg per 100 ml. Composition according to any one of the preceding claims wherein the amount of lactose is less than 0.5 mg / 100 ml. Composition according to any one of the preceding claims wherein the viscosity is less than 400 mPa.s. Composition according to any one of the preceding claims wherein the viscosity is less than 200 mPa.s. A process for preparing a composition according to any one of claims 1 to 6 comprising the steps of: Mixing in aqueous phase of proteins, carbohydrates, minerals and vitamins, Addition of lipids and emulsifiers, Adjustment of pH between 7 and 8, Cooling and balancing of the composition, Sterilization or pasteurization.