HIGH PROTEIN NUTRITIONAL COMPOSITION, THE PROTEIN SOURCE OF WHICH IS 100% HYDROLYZED PROTEIN

A high-protein, fluid nutritional composition with balanced minerals addresses the mineral deficiencies of existing products by using hydrolyzed whey and collagen proteins, ensuring compliance with regulatory standards and ease of consumption for malnourished patients.

FR3134292B1Active Publication Date: 2025-11-07EVEN SANTE IND
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Patent Information

Application Number
FR2022003249
Authority / Receiving Office
FR · FR
Patent Type
Patents
Current Assignee / Owner
Filing Date
2022-04-08
Publication Date
2025-11-07
Estimated Expiration
2042-04-08
Patent Text Reader

Abstract

The invention relates to the field of high-protein liquid nutritional compositions. More particularly, the invention concerns 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 the sole source of nutrition in malnourished patients.
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Description

Title of the invention: HIGH PROTEIN NUTRITIONAL COMPOSITION WHICH HAS A SOURCE PROTEIC IS CONSISTED OF 100% HYDROLYZED PROTEINS

[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 the sole source of nutrition in malnourished patients. Scope of the invention

[0002] The human body is a complex organism. Its proper functioning, particularly the maintenance of vital functions, requires energy supplied by food, which must be sufficient and balanced. Energy must be provided by proteins, sugars, and fats. Proteins are essential for muscle activity, fats allow for the storage of energy that can be 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 vitamins and minerals, which play a role in the physiological balance of the body's various vital functions.

[0003]

[0004] This balance can be disrupted in the event of malnutrition due, for example, to an eating disorder (anorexia...), or undernutrition resulting from a pathological situation or in elderly people who no longer feed themselves properly on their own.

[0005] Nutritional needs change throughout life. For example, older people have reduced lipid requirements due to decreased activity and a slowing of cell renewal.

[0006] Most drinkable nutritional compositions currently available on the market have a protein content of 14.5 g / 100 ml or less. 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 from the point of view of their mineral profile beyond 20g of protein per 100mL.

[0008]

[0009]

[0010]

[0011]

[0012]

[0013] No beverage with a higher protein content that is also fluid and has a complete mineral profile is currently available. 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. There is therefore a need for a drink with a higher protein content for malnourished patients that is also mineral-complete so that it can be consumed as the sole source of nutrition. Description of the invention The inventors have developed an innovative formula thanks to its protein pool, which consists of 100% hydrolyzed proteins. These hydrolyzed proteins are a blend of whey proteins and collagen. Despite a high protein content of between 14 and 30g per 100ml, the formula remains fluid and is comprehensive in terms of mineral intake. Thus, the invention relates to a complete liquid nutritional composition comprising: - between 14g and 30g of protein per 100ml - carbohydrates which provide between 17% and 45% of the total energy content of the composition - lipids that provide between 30% and 65% of the total energy content of the composition - an energy content greater than or equal to 2.4 kcal per 100 ml - a viscosity less than or equal to 600 mPa.s measured at 20°C at 100 s using of 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 protein between 9 and 14g - a ratio between hydrolyzed serum proteins and hydrolyzed collagen between 40:60 and 70:30. The invention also relates to a method for preparing a composition according to the invention comprising the steps of: a. Mixing of proteins, carbohydrates, minerals, and vitamins in an aqueous phase; b. Addition of lipids and emulsifiers. c. Adjusting the pH between 7 and 8 d. Cooling and balancing of the composition e. Sterilization or pasteurization. Advantages of the invention

[0014] The composition addresses an unmet need for high-protein drinks, particularly those containing more than 14g of protein per 100ml, which can serve as the sole source of nutrition for malnourished patients. This type of product can be offered in hospitals or pharmacies.

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

[0016] The original mineral protein pool of these compositions is obtained through the complementary properties of whey proteins and hydrolyzed collagen. The partially hydrolyzed whey proteins have a low phosphorus content, a relatively high magnesium content, and are rich in sodium and potassium, two minerals for which it is difficult to achieve the targets recommended by the DADFMS regulation (Regulation 2016 / 128). These whey proteins contribute little or no viscosity. Hydrolyzed collagen is relatively insensitive to its environment and contains few minerals.

[0017] Very interestingly, hydrolyzed whey proteins provide sufficient sodium and potassium to meet 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 ​​without the constraints related to citrate intake, particularly when sodium and / or potassium are supplied in the form of sodium citrate or potassium citrate; citrate forms being known to cause an increase in viscosity. Thus, the (very) high protein compositions according to the invention are liquid. DETAILED DESCRIPTION OF THE INVENTION

[0018] A first object of the invention relates to a complete liquid nutritional composition comprising: - between 14g and 30g of protein per 100ml - carbohydrates which provide between 17% and 45% of the total energy content of the composition - lipids that provide between 30% and 65% of the total energy content of the composition - an energy content greater than or equal to 2.4 kcal per 100 ml - a viscosity less than or equal to 600 mPa.s measured at 20°C at 100 s using of 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 collagen - a total amount of serum protein between 9 and 14g - a ratio between hydrolyzed serum protein and hydrolyzed collagen between 40:60 and 70:30.

[0020] By "complete nutritional composition" is meant a composition which can be used as a sole source of nutrition. It includes a complete mineral and vitamin profile in accordance with Regulation 2016 / 128.

[0021] The term "hydrolyzed whey proteins" refers to a solution of partially or fully hydrolyzed whey proteins. Hydrolyzed whey proteins are characterized by their high sodium and potassium content, with at least 650 mg of Na and 2445 mg of K per 100 g of protein, respectively. These mineral levels ensure that 100% of these two minerals are supplied via the whey proteins. 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] By "hydrolyzed collagen" is meant 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 bovine or fish collagen.

[0023] Carbohydrates provide between 17% and 45% of the total energy content of the composition. They can be supplied by any type of sugar. In a preferred embodiment, they are mainly supplied by glucose syrup.

[0024] Lipids provide between 30% and 65% of the total energy content of the composition. They can be supplied by any type of lipid source, such as vegetable oils.

[0025] The composition is described as a liquid, meaning that it is drinkable. It has a viscosity of 600 mPa·s or less, measured at 20°C at 100 s⁻¹ using a rotary 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.

[0026] The energy content of the composition is greater than or equal to 2.4 kcal / 100ml. It is generally between 2.4 and 3 kcal / 100ml depending on the embodiment, preferably between 2.4 and 2.6 kcal / 100ml.

[0027] The composition presents a complete mineral profile in accordance with regulations. Mineral adjustment does not pose any particular difficulty and can be carried out by a person skilled in the art. In particular, sodium and potassium adjustment is not necessary due to the quantities provided by serum proteins. The other minerals, in particular magnesium and calcium, can be provided by different means. various mineral sources.

[0028] 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 adjust the amount of whey protein, which constitutes the lactose source, by adjusting the whey protein:collagen ratio when necessary, while remaining within the ranges defined in the present invention.

[0029] The pH of the composition is adjusted between 7 and 8 so as to stabilize the composition and maintain fluidity with regard to the presence of serum proteins.

[0030] A second object of the invention relates to a method for preparing a composition according to the invention comprising the steps of: a. Mixing of proteins, carbohydrates, minerals and vitamins in an aqueous phase. Addition of lipids and emulsifiers. c. Adjusting the pH between 7 and 8 d. Cooling and balancing of the composition e. Sterilization or pasteurization.

[0031] Flavors and colors may also be added in step a.

[0032] The present invention will be better understood by reading the following examples, which are provided by way of illustration and should in no way be considered as limiting the scope of the present invention. EXAMPLES

[0033] EXAMPLE 1: Preparation and characterization of a composition according to the invention

[0034] 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 steps. The water and proteins can be preheated to between 30 and 60°C. The fat and emulsifiers can be added directly 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 equilibration 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 standard Ultra High Temperature processes.

[0035] The characteristics of such a composition with 18g of protein per 100ml are presented in Table 1. Vitamins are also added to comply with Regulation 2016 / 128.

[0036] [Tables 1] Nutrients Unit Value per 100ml %AET Density g / L 1140 Energy kcal 260 kJ 1092 Fat g 9.3 32.2 of which saturates g 1.3 of which unsaturated fatty acids g 7.5 Carbohydrate (excluding fiber) g 26.14 40.1 of which sugars (mono- and di-) g 7.7 Fiber g 0 0 Protein g 18 27.7 Salt g 0.3675 Dry extract g 55.9 Na mg 147 K mg 289 Ca mg 145 P mg 105 Mg mg 25.8 Cl mg 93

[0037] Table 1: Nutritional profile of a composition at 18g / 100ml.

[0038] EXAMPLE 2: Characteristics of different compositions according to the invention

[0039] [Tables2] Nutrients Unit 250 kcal Formula FSMP Min FSMP Max Protein g 16 18 20 24 28 NA ES g 55.09 55.92 56.09 56.32 57.54 Na mg 125 147 162 183 202 78 455 K mg 300 289 319 335 335 208 767 Ca mg 216 145 152 157 158 91 455 P mg 112 105 114 119 119 78 208 Mg mg 25.3 25.8 26.6 27.0 27.0 19.5 65 Cl mg 92 93 95 95 95 78 455 Viscosity at day 7 cP 120 154 185 365* 329* NA Viscosity at month 3 cP 134 166 245 427* 472*

[0040] *The differences in values ​​of the compositions at 24 and 28g of protein are not significantly different.

[0041] Table 2: Viscosity of the compositions according to the invention as a function of the amount of protein

Claims

Demands

1. Liquid nutritional composition that can constitute the sole source of nutrition for malnourished patients comprising: • between 14g and 30g of protein per 100 ml • carbohydrates that provide between 17% and 45% of the total energy content of the composition • lipids that provide between 30% and 65% of the total energy content of the composition • 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 in which said proteins are characterized by: - ​​a protein intake consisting of partially hydrolyzed serum proteins and hydrolyzed collagen in which the proteins have an average molecular weight between 2 and 5 kDa - a total quantity 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.

2. Composition according to claim 1 wherein said energy content of the composition is between 240 and 300 kcal / 100 ml.

3. Composition according to any one of the preceding claims wherein the amount of lactose is less than 0.5 mg / 100 ml.

4. Composition according to any one of the preceding claims wherein the viscosity is less than 400 mPa.s.

5. Composition according to any one of the preceding claims wherein the viscosity is less than 200 mPa.s.

6. A method for preparing a composition according to any one of claims 1 to 5 comprising the steps of: a. Mixing in aqueous phase of proteins, carbohydrates, minerals and vitamins b. Addition of lipids and emulsifiers c. Adjusting the pH between 7 and 8 d. Cooling and balancing of the composition e. Sterilization or pasteurization.