Method for preparing of nutritional compositions

Abstract

The present invention relates to a method for preparing ready-to-drink liquid nutrition compositions. In this method, water-soluble / dispersible powder ingredients of the composition, vitamins and minerals, flavoring and / or coloring agents, fat and other ingredients are added at different stages of production and the sterilization process is carried out using the UHT system. Said nutritional compositions are preferably clinical nutritional compositions.

Description

[0001] METHOD FOR PREPARING OF NUTRITIONAL COMPOSITIONS

[0002] Technical Field of Invention

[0003] The present invention relates to a method for preparing ready-to-drink liquid nutrition compositions. In this method, water-soluble / dispersible powder ingredients of the composition, vitamins and minerals, flavoring and / or coloring agents, fat and other ingredients are added at different stages of production and the sterilization process is carried out using the UHT system. Said nutritional compositions are preferably clinical nutritional compositions.

[0004] State of the Art

[0005] Food compositions are dietary supplements, that is, they intend to meet a certain part or whole of the daily nutritional requirements. Clinical nutrition products, on the other hand, refer to compositions developed specifically for a particular disease or a particular age group as well as supporting the diet. Clinical nutrition primarily focuses on the prevention of dietary changes in patients with chronic diseases and conditions and the diagnosis and management of such diseases. Normally, individuals take the necessary nutrients into their bodies through regular daily diets. However, illness, disorder, stress and similar conditions may block the body from getting sufficient nutrients through diets alone. In such cases, a specifically formulated dietary supplement may be required. This supplement may be in the form of clinical nutrition. Clinical nutrition not only aims to maintain a healthy energy balance, but also provide patients with sufficient amounts of nutrients, such as protein, fat, carbohydrates, water, vitamins and minerals.

[0006] Clinical nutrition and nutrition-supported care have gained wide clinical and scientific interest, especially in recent years. Increasing knowledge on the relationship between nutrition and metabolic disorders in chronic and acute diseases has spurred rapid developments in the design, development and clinical application of dietary supplements.The contents of these food compositions and / or clinical nutrition products may vary depending on the target patient group.

[0007] Clinical nutrition products can be administered enterally or parenterally depending on patient needs. Enteral and parenteral nutrition are special nutrition methods. While enteral nutrition takes place in the digestive system, parenteral nutrition is given through the vein. Both methods are preferred in clinical settings. Enteral and parenteral nutrition are specific to the patient condition.

[0008] A patient who has decreased appetite, difficulty swallowing, or has undergone any operation that prevents eating, or a person with a chronic disease may not be able to meet their daily nutritional needs naturally. In this case, the person needs to be provided with external nutritional support This method is called "enteral nutrition”.

[0009] Enteral nutrition is a standard intensive care support treatment Effective and complete nutrition can be provided in patients whose gastrointestinal system is fully or at least partially functional. Examples of diseases for which enteral nutrition is indicated include neurological problems, tracheoesophageal fistula, oral malignancy, mucositis, oral or esophageal burns, and severe reflux. In addition, inflammatory bowel disease, cystic fibrosis, short bowel syndrome, intestinal malignancy, enteritis, intestinal fistula, chronic diarrhea and malabsorption, and digestive or absorption disorders seen in AIDS patients are also indications for enteral nutrition.

[0010] It is also used in the dietary management of children with malnutrition and those at risk of malnutrition. The most common indications for enteral nutrition in childhood are growth retardation due to chronic diseases. These diseases are heart, liver disease, cancer, coronary diseases and chronic lung disease.

[0011] Enteral nutrition product is a food product produced for tube or oral feeding to meet a specific medical purpose. It can be available in powder form to make ready-to-drink liquids, beverages, or to mix into other foods. The ingredients of the product used under the supervision of a physician or dietitian may be full or partial.

[0012] WO 2023 / 080857 Al relates to a method for preparing high viscosity liquid nutritional compositions and describes the steps of adding the oil ingredients of the composition to the mixture by the direct oil injection method and performing the sterilization process using the UHT system.

[0013] Ultra-high temperature processing (UHT), ultra-high heat treatment, or ultra-pasteurization is a food processing technology that sterilizes liquid foods by heating them to temperatures above 135°C (275°F), the temperature required to kill bacterial endospores within 2 to 5 seconds. Although UHT is most commonly used in milk production, it is also used in the sterilization of nutritional compositions, fruit juices, cream, soy milk, yoghurt, wine, soup, honey and stews. UHT principles are divided into two categories as direct and indirect In direct UHT systems, culinary steam is applied directly to the product, and the product is cooled in a flash cooler. Conventional direct UHT is performed using an injector to apply steam to the product. Today, however, the infusion chamber is preferred to strongly reduces turbulence and contamination. In indirect systems, a heating surface is positioned between steam and product. In the indirect UHT systems, conventional system based on plate heat exchangers is used for milk and low viscosity products. Modern indirect UHT systems, on the other hand, use tubes placed in a steam chamber. Depending on the composition to be produced, it is important to select the appropriate system.

[0014] It is known that one of the biggest difficulties in the preparation of nutritional compositions in the state of the art is obtaining a stable composition with the desired shelf life, since the sensitive vitamin contents in the composition tend to degrade during the process. In the light of this information, there is a need for improvements in the preparation and production of a stable nutritional composition. The present invention provides a new method with optimized steps for preparing of clinical nutritional compositions.

[0015] Brief Description of the Invention

[0016] The present invention provides a method for preparing of nutritional compositions. The said method comprises the following steps: a) obtaining a solution by mixing water-soluble / dispersible powder ingredients with water, b) obtaining vitamin solution in a separate mixing tank, c) mixing the vitamin solution with the solution prepared in step (a), d) mixing the flavoring and / or coloring agent with water and adding it to the mixture obtained in step (c), e) obtaining an fat mixture in a separate mixing tank and adding it to the mixture obtained in step (d) and homogenizing the mixture, f) carrying out the sterilization process using the UHT system, g) obtaining the nutritional composition and filling it into bottles.

[0017] According to the method of the present invention, preferably, the mixing of said water- soluble / dispersible powder ingredients with water is carried out by transferring them under vacuum. Using a vacuum mixer to dissolve / disperse powder ingredients has many advantages, such as eliminating the risk of severe foaming, which is a major risk in milk proteins, providing rapid homogeneous mixing, and eliminating the need for additional powder removal systems, as the vacuum mixer draws the powder.

[0018] According to the method of the present invention, preferably, said water-soluble / dispersible powder ingredients are selected from the group comprising at least one carbohydrate source, at least one fat source, at least one protein source, at least one fiber source, at least one mineral source, pH regulator, emulsifier and / or stabilizer, flavoring and / or coloring agent or mixtures thereof.

[0019] Since clinical nutrition products are specially prepared for people who cannot eat a complete or adequate / balanced diet for any reason, they reflect the reference values of macronutrients (carbohydrates, proteins, fats and fiber) and micronutrients (vitamins, minerals and trace elements) that the person needs. Carbohydrates constitute a large part of the daily diet and are the main energy sources that can be used in almost every cell of the body.

[0020] According to the method of the present invention, preferably, said carbohydrate source is selected from the group comprising maltodextrin, sucrose, fructose, corn syrup solids, sugar alcohols, or mixtures thereof.

[0021] According to the method of the present invention, preferably, said carbohydrate source is maltodextrin and sucrose.

[0022] Maltodextrin is a white-slightly yellowish powder with a slightly sweet taste that dissolves easily in water and forms a transparent solution. Due to its vague taste, it preserves the unique aroma of the product, making it an ideal additive.

[0023] Maltodextrin, used as a crystallization inhibitor, is added to candies and semi-soft desserts, preventing the sandy appearance of these products and increasing their shelflife. It prevents the agglomeration of other dry substances in powder mixtures.

[0024] According to the method of the present invention, preferably, said powdered fat source is encapsulated fish oil. Fish oil is extremely sensitive to oxidation because it contains long-chain and polyunsaturated fatty acids. Therefore, preserving the chemical structure of fish oil and making it resistant to oxidation is very important in the production processes for nutritional compositions. Therefore, the encapsulation process is particularly advantageous when using fat ingredients with a fishy flavor and odor, such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The inventors observed that since the encapsulated fish oil does not react with oxygen, oxidation and odor formation are prevented during its shelflife.

[0025] According to the method of the present invention, preferably, said protein source is selected from the group comprising calcium caseinate, sodium caseinate, potassium caseinate, milk protein, soy protein, whey protein, egg ovalbumin, gelatin, soybean or mixtures thereof.

[0026] In cases where oral nutrition is not possible or inadequate, clinical nutrition products consisting of a mixture of macro and micro nutrients are used to provide the necessary nutritional support. The protein source to be chosen is important in terms of compatibility with other ingredients in the formulation and stability of the finished product

[0027] According to the method of the present invention, preferably, said protein source is calcium caseinate and sodium caseinate.

[0028] Sodium caseinate is a milk protein and in addition to being used as a protein source, it is also used as an emulsifier and stabilizer. It binds water and fat molecules together and positively affects the appearance of foods by shrinking fat particles. It can easily dissolve in water and form gel. It has better solubility than calcium caseinate and can coagulate at lower pH levels.

[0029] Calcium caseinate is a salt obtained from the extraction of milk proteins. It is soluble in water and has the ability to form gels and can coagulate at low pH values.

[0030] According to the method of the present invention, preferably, said fiber source is selected from the group comprising oligofructose, inulin starch, fructooligosaccharides, guar gum, xanthan gum, xylo-oligosaccharides, gum arabic, pectin, acacia gum, dextrans, hemicellulose, gum, mucilage or mixtures thereof.

[0031] According to the method of the present invention, preferably, said fiber source is oligofructose and inulin. A daily fiber intake of 15-30 g is recommended for healthy individuals with normal daily diets. Fiber consumption is provided through clinical nutrition products for individuals who cannot eat a balanced diet with normal daily diets for any reason. Thus, when fiber-rich foods are consumed in sufficient quantities, intestinal physiology is preserved, the intestines work more smoothly, cholesterol levels are kept at normal levels, blood sugar levels are regulated and people are prevented from gaining weight. (Baysoy, 2013)

[0032] Oligofructose delays gastric emptying by increasing the viscosity of the stomach content due to its low energy value and water-attracting properties. Thus, by creating a feeling of fullness, the individual's desire to eat decreases. It is known that a diet high in oligofructose, supported by drinking plenty of water, will create a feeling of fullness for a longer time. (Thompson ve Manore, 2005)

[0033] Inulin is known to slow down digestion and keep blood sugar levels balanced. Textural properties have been improved by using inulin in clinical nutrition products. Additionally, inulin as a fat replacer has been observed to improve the desired creamy texture in the finished product.

[0034] Minerals are inorganic nutrients that are necessary for the body to function in a healthy way. They must be taken by the body in sufficient amounts to perform various biological functions.

[0035] According to the method of the present invention, preferably, said mineral source is called mineral premix.

[0036] According to the method of the present invention, preferably, said mineral premix comprising sodium, potassium, chloride, calcium, phosphorus, magnesium, iron, zinc, copper, manganese, fluoride, molybdenum, selenium, chromium, phosphate, iodine and / or their pharmaceutically acceptable salts, polymorphs, solvates, hydrates or esters.

[0037] According to the method of the present invention, preferably, the amount of said mineral premix is between 0.5-2.0%, preferably 0.7-1.5%, more preferably 0.8-1.0% by weight of the total composition.

[0038] For the product subject to the present invention, each mineral was quantified according to the required daily intake dose and was prepared as a mixture that would meet these values. Thus, consumption in excess of permitted amounts is prevented and undesirable side effects are eliminated. As used herein, "particle size” means the cumulative volume size distribution tested by any conventionally accepted method, such as the laser diffraction method (i.e., Malvern Mastersizer 2000 analysis). The term d (0.9) particle size means the size at which 90% of the particles by volume are finer, and the term d (0.5) particle size means the size at which 50% of the particles by volume are finer.

[0039] The d(0.9) particle size of calcium carbonate in the mineral premix is less than 20 pm, and the d(0.9) particle size of tricalcium phosphate is less than 13 pm. By selecting these ingredients as micronized, the mineral premix was prevented from precipitating in the production vessels. In this way, each mineral in the product is ensured to be distributed homogeneously.

[0040] According to the method of the present invention, preferably, said pH regulator is selected from the group comprising citric acid, potassium hydroxide, trisodium citrate, sodium bicarbonate, tartaric acid, maleic acid or mixtures thereof.

[0041] According to the method of the present invention, preferably, said pH regulator is citric acid and potassium hydroxide.

[0042] According to the method of the present invention, preferably, said emulsifier and / or stabilizer is selected from the group comprising guar gum, carrageenan, mono- and diglyceride fatty acids or mixtures thereof.

[0043] Due to its non- ionic nature, guar gum is stable over a wide pH range and compatible with a variety of electrolytes. It is used as an additive in various foods because it changes the behavior of water, which is a common ingredient of many foods. It is used as a thickener, stabilizer and emulsifier in many dairy products. It is very suitable for use in short-term heat treatments at high temperatures.

[0044] Carrageenans consist of large and highly elastic molecules with a coiled helical structure. This flexible structure of carrageenan molecules allows them to form gel forms with different properties at room temperature. Thanks to their thixotropic properties (the thinning of the viscous structure under applied stress is regained when the stress is removed), which is the biggest advantage of carrageenans, they can be easily transferred between processes by pressure and easily regain their structural properties. Mono and diglyceride fatty acids are preferred due to their advantages such as facilitating mixing (emulsion), widespread compatibility (homogeneity), and keeping them balanced (stabilization).

[0045] This stabilizing agent mixture used in the product formulation was used in the most appropriate proportions to ensure that the water and oil phases mixed homogeneously and the product was stable.

[0046] According to the method of the present invention, preferably, the solution prepared in step (a) is kept in the Mix Stock Tank for 8 to 24 hours.

[0047] Due to the caseinates contained in these ready-to-drink liquid nutrition compositions, the water retention capacity of the powder components increases. For this reason, the powder components are kept in the process until the water retention amounts stabilize. Before adding vitamin premix, flavoring and fat to the solution prepared in step (a), the solution prepared in step (a) is kept in the Mix Stock Tank for 8 to 24 hours, thus aiming for a stable finished product

[0048] Vitamins are vital nutrients necessary for the body to function healthily. They can be used to meet a specific nutritional need.

[0049] According to the method of the present invention, preferably, said vitamin premix comprising vitamin A, vitamin D, vitamin E, vitamin C, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin B7, vitamin B9 and / or their pharmaceutically acceptable salts, polymorphs, solvates, hydrates or esters.

[0050] According to the method of the present invention, preferably, the amount of said vitamin premix is between 0.25-0.40%, preferably 0.20-0.35%, more preferably 0.15-0.30% by weight of the total composition.

[0051] For the product subject to the present invention, each vitamin was quantified according to the required daily intake dose and prepared as a mixture that would meet these values. Thus, consumption in excess of permitted amounts is prevented and undesirable side effects are eliminated.

[0052] During the process, chemical degradation may occur in the structures of sensitive vitamin contents due to the effect of heat, or vitamins may oxidize with other ingredients in the product The inventors surprisingly have noticed that the stability of the finished product increased when they apply process steps in this order that minimizes the contact time between the vitamin premix and other ingredients.

[0053] According to the method of the present invention, preferably, said flavoring and / or coloring agent is selected from the group comprising cocoa powder, hazelnut flavor, vanilla flavor, strawberry flavor, chocolate-banana flavor, white chocolate-strawberry flavor, chocolate-cookie flavor and watermelon flavor or mixtures thereof.

[0054] It is well known in the state of the art that high protein content in liquid, semi-liquid or powder products causes undesirable taste and odor. To increase patient compliance, there is a need to mask undesirable taste and odor caused by high protein and fat contents in the oral composition. Appropriate flavors are used for this purpose. By using cocoa powder instead of cocoa flavor in the present invention, the product is made easier to drink and its taste is increased. In order to prevent the precipitation of cocoa powder in the cocoa-hazelnut flavored product and to keep it suspended in the product, the d (0.5) particle size of the cocoa was chosen to be less than 20 pm.

[0055] According to the method of the present invention, preferably, said fat ingredients are stored under nitrogen before being added to the mixture obtained in step (d).

[0056] Fat ingredients are more susceptible to oxidation than other ingredients frequently found in nutritional compositions. Due to their chemical structure, a series of reactions related to carbomcarbon double bonds may occur under the influence of heat and atmospheric oxygen, resulting in the formation of free radicals. These reactions are accelerated in the presence of oxygen and oxidation accelerators. The resulting free radicals can then continue to break down polyunsaturated fatty acids in an auto-oxidative process. As a result, fatty acids deteriorate and undesirable bad tastes and odors occur. Oxidation of fat ingredients stored under nitrogen is prevented during production and shelflife. Reducing oxidation is one of the factors that increase the stability of the compositions.

[0057] According to the method of the present invention, preferably, said fat ingredients are selected from the group comprising rapeseed oil, oleic acid-rich sunflower oil, corn oil, canola oil, saffron oil, soybean oil, medium chain triglycerides or mixtures thereof.

[0058] According to the method of the present invention, preferably, said fat ingredients are rapeseed oil, oleic acid-rich sunflower oil and medium chain triglycerides. All these fats used in the product of the present invention provide the body with the healthiest fat source necessary to prevent weight loss.

[0059] Rapeseed oil is preferred because its saturated fat and monounsaturated fat rates are very low. In this way, it reduces bad cholesterol in the blood. Additionally, it has positive effects on the skin because it is rich in vitamin E.

[0060] Sunflower oil, rich in oleic acid, has an advantage over other fats as it has a medium chain and is quickly absorbed. Since it shows high stability, the shelflife of the product it is used in is longer. It does not need hydrogenation and does not contain trans fat

[0061] Medium-chain triglycerides are vegetable fats in which triglyceride molecules are composed of medium-chain fatty acids. Since they are medium chain, they are metabolized and converted into energy faster than other fats. Since they are completely saturated, they are very resistant to oxidation.

[0062] In order to prevent the oxidation of fat ingredients with high oxidation potential, such as polyunsaturated fatty acids, which are commonly contained in in nutritional compositions, the step of adding fat ingredients is carried out by adding fats to the mixture by injection. According to the step called "Direct Oil Injection” of the method, fats are stored under nitrogen to prevent a long-term contact between the fat ingredients of the composition and the air (oxygen) and added directly to the mixture by injection before the UHT process. Adding fats to the mixture by injection not only prevents oxidation that may occur during production but also extends the shelflife. Additionally, it is important to add each ingredients in the appropriate order during the process to obtain the compositions. In this context, the inventors have realized that it is advantageous to add the fat ingredients just before the UHT process. This is especially true for ingredients with a high risk of oxidation and developing odors and aromas during their shelflife.

[0063] According to the method of the present invention, preferably, said fat mixture further comprising antioxidant, emulsifier and / or stabilizer substances.

[0064] According to the method of the present invention, preferably, said antioxidant is selected from the group comprising zeaxanthin, lutein, lycopene, tocopherol, ascorbyl palmitate or mixtures thereof. Oxygen is a highly reactive atom that can become part of potentially damaging molecules often called "free radicals." Free radicals can attack the body's healthy cells, causing them to lose their structure and function. Free radical formation is naturally controlled by a variety of useful reactive molecules known as antioxidants and are therefore critical to this invention.

[0065] According to the method of the present invention, preferably, said emulsifier is lecithin.

[0066] Lecithin (Sunflower lecithin) is a natural compound in oil form obtained from sunflower seeds. It has a dense consistency that mixes with water and forms an emulsion easily. It provides a better texture and consistency by stabilizing the mixture of oil and water phases. It functions as an emulsifier, increasing the dispersion of oils in water and helping the ingredients stay together.

[0067] According to the method of the present invention, preferably, the process of adding said fat mixture to the mixture obtained in step (d) is carried out in a high shear mixer. In this way, homogeneous mixing of water-soluble / dispersible powder components, vitamin premix and fats is ensured. Thus, the product remains stable for a long time without any phase separation occurring.

[0068] The selection and design of the UHT system / facility is of great importance in order to produce said compositions by using the production line efficiently and in such a way that the resulting product has a shelf life of 12 months. In order to ensure a shelf life of at least 12 months, the development of flavor loss, oil separation, sedimentation and viscosity increase must be minimized. This is possible, among other parameters, by choosing the right UHT system during production.

[0069] The selected UHT system and the order in which the UHT treatment is applied within the process are also important for efficient production (long run time between cleanings), as mentioned above. This is possible by minimizing the increase in contamination during production.

[0070] According to the method of the present invention, preferably, the direct UHT system is preferred for the UHT process for the above reasons. Said system is advantageous in that it is useful in the sterilization of products with high viscosity, such as high protein concentration, and minimizes the risk of protein contamination, and when this system is used, the production lines of the products in question can be used for a longer time without requiring cleaning.

[0071] Under direct UHT methods, the liquid product is heat treated at Ultra High Temperature (up to 138 to 145°C) for a very short period of time (1-10 seconds). The goal is to kill all vegetative cells and destroy any existing spores that may begin to grow during shelflife. Additionally, by reducing the time the product is exposed to high temperatures, bad tastes and odors that may occur in the product are prevented.

[0072] In particular, direct UHT systems are preferred because they eliminate the risk of protein contamination in compositions with high viscosity. Steam Injection and Infusion systems, which are direct UHT methods, are also advantageous in that they allow the time between cleaning processes of production lines used for high viscosity products to be extended.

[0073] The method of the present invention, preferably, further comprises performing the homogenization between the steps of adding said fat mixture to the mixture obtained in step (d) and performing the sterilization process using the UHT system. This method step is advantageous in that it ensures that the fat ingredients added before the heat treatment are well incorporated into the mixture.

[0074] The method of the present invention, preferably, further comprises performing flash cooling after the step of performing the sterilization process using the UHT system. Flash cooling removes all oxygen from the product and reduces the risk of oils oxidizing during storage. Flash cooling is also advantageous in that it removes oxidative flavors / off- flavors that form in the mixture prior to UHT.

[0075] The method of the present invention, preferably, further comprises the step of performing a second homogenization after the flash cooling step. Some fat separation may occur in the mixture due to flash cooling. Therefore, the second homogenization step of the method according to the invention is advantageous in that it re-homogenizes and stabilizes the fat droplets.

[0076] Nutritional compositions suitable for production by the method of the present invention are in liquid form that can be administered orally or via a feeding tube.

[0077] According to the method of the present invention, preferably, the nutritional compositions can be administered enterally.

[0078] According to the method of the present invention, preferably, the nutritional compositions can be administered parenterally. The term "enterally" as used herein includes tube feeding (insertion of a tube that allows a nutritional product to be delivered into the person's gastrointestinal tract without entering the person's mouth).

[0079] The amount of solids contained in the product is important in order to ensure the osmolarity and osmolality balance of the product and thus maximize patient compliance. According to the method of the present invention, preferably, the amount of said solids are between 10-50%, preferably 20-45%, more preferably 25-40% by weight of the total composition.

[0080] The method of the present invention, preferably, comprises filling the obtained nutrition composition into bottles under nitrogen in a sterile environment and treating the bottles to be used during filling with peroxide for no longer than 20 seconds before filling. In this way, possible contamination is prevented and microbial and chemical stabilization of the product is ensured throughout its shelflife.

[0081] According to the method of the present invention, preferably, the obtained nutrition composition is the clinical nutrition composition.

[0082] The present inventors have found that the above method steps and their ordering are effective and advantageous in the production of nutritional compositions. The method steps of the invention are effective both in terms of efficient use of the production facility and in obtaining products with the desired viscosity and shelflife. In addition, the method of the invention ensures sufficient homogenization of fat ingredients and prevents oxidation during production and shelf life. Reducing sedimentation and oxidation are factors that increase the stability of the compositions.

[0083] The method of the present invention is also advantageous in that it allows obtaining high nutritional compositions with optimal osmolarity and osmolality balance, thus being compatible with the patient

[0084] Detailed Description of the Invention

[0085] An embodiment of the method of obtaining a ready-to-drink liquid nutritional composition of the present invention is described in detail in the Examples below. EXAMPLES

[0086] Formulation 1:

[0087] q.s.: quantum sufficit

[0088] * The amount of KOH is determined according to the desired pH value.

[0089] Formulation 2: q.s.: quantum sufficit

[0090] * The amount of KOH is determined according to the desired pH value.

[0091] 1. Mixing Water Soluble / Dispersible Ingredients Some of the water is taken into the mixing tank. (Mix Tank-1) Water-soluble / dispersible ingredients are sequentially transferred to the powder loading bunkers and circulated between the vacuum mixer and Mix Tank-1. The pH of the aqueous mixture is controlled and undergoes a cooling process. The final mixture obtained is transferred to a different mixing tank. (Mix Tank-2) 2. Heat Treatmen t and Stabilization Processes

[0092] The product in Mix Tank- 2 is pasteurized and cooled. The cooled mixture is transferred to the Mix Stock Tank and kept for stabilization for 8-24 hours.

[0093] 3. Preparation of Vitamin and Flavor Solutions Water at room temperature is taken into the Vitamin Mix Tank. Vitamin premix in powder form is transferred to the vitamin mix tank and mixed. After mixing, the pH value of the solution is adjusted with potassium hydroxide solution to be between 6.2-9.0. The prepared Vitamin Premix mixture is sent to the stock tank and mixed. Then, water at room temperature is transferred into the Vitamin Mix Tank. Flavor is added and mixed, and the mixture is sent into the Mix Stock Tank.

[0094] 3. Preparation of Fat Ingredients

[0095] The fats to be added to the product (sunflower oil rich in oleic acid, rapeseed oil, medium chain triglycerides) are taken into the Oil Balance Tank and heated and transferred into the Oil Stock Tank. Lecithin is mixed with some fat taken from the Oil Stock Tank and this mixture is added into the Oil Stock Tank. Zeaxanthin, lutein, lycopene, tocopherol and ascorbyl palmitate are mixed with some fat taken from the Oil Stock Tank, respectively, and these mixtures are added into the Oil Stock Tank. The product in the Mix Stock Tank is heated to 60°C and mixed with the prepared fat mixture in the Mixer unit.

[0096] 4. Non-Aseptic Homogenization, Sterilization and Aseptic Homogenization

[0097] The final mixture is heated to 70°C and sent to the non-aseptic homogenizer and subjected to homogenization at 250 - 350 bar. The product resulting from the non-aseptic homogenization process is heated and transferred to the UHT system and kept at 138- 145 °C for 1-10 seconds. The product is then cooled back to the homogenization temperature and sent to the aseptic homogenizer and subjected to homogenization at 250 - 350 bar. After the aseptic homogenization process, the product is gradually cooled to 15-20°C and then sent to the Aseptic Tank.

[0098] 5. Filling process

[0099] The product in the Aseptic Tank is filled into bottles and packaged by an Aseptic Filling Machine under sterile conditions and nitrogen. The bottles used during filling are sterilized by treating them with hydrogen peroxide for no longer than 20 seconds before the filling process.

Claims

CLAIMS1. A method for preparing of nutritional compositions comprises the following steps: a) obtaining a solution by mixing water-soluble / dispersible powder ingredients with water, b) obtaining vitamin solution in a separate mixing tank, c) mixing the vitamin solution with the solution prepared in step (a), d) mixing the flavoring and / or coloring agent with water and adding it to the mixture obtained in step (c), e) obtaining an fat mixture in a separate mixing tank and adding it to the mixture obtained in step (d) and homogenizing the mixture, f) carrying out the sterilization process using the UHT system, g) obtaining the nutritional composition and filling it into bottles.

2. The method according to claim 1, wherein the mixing of said water-soluble / dispersible powder ingredients with water is carried out by transferring them under vacuum.

3. The method according to claim 1 or 2, wherein the water-soluble / dispersible powder ingredients are selected from the group comprising at least one carbohydrate source, at least one fat source, at least one protein source, at least one fiber source, at least one mineral source, pH regulator, emulsifier and / or stabilizer, flavoring and / or coloring agent or mixtures thereof.

4. The method according to claim 3, wherein the carbohydrate source is selected from the group comprising maltodextrin, sucrose, fructose, corn syrup solids, sugar alcohols, or mixtures thereof.

5. The method according to claim 3 or 4, wherein the carbohydrate source is maltodextrin and sucrose.

6. The method according to claim 3, wherein the water-soluble / dispersible powder ingredients comprise powder encapsulated fish oil.

7. The method according to claim 3, wherein the protein source is selected from the group comprising calcium caseinate, sodium caseinate, potassium caseinate, milk protein, soy protein, whey protein, egg ovalbumin, gelatin, soybean or mixtures thereof.

8. The method according to claim 3, wherein the protein source is calcium caseinate and sodium caseinate.

9. The method according to claim 3, wherein the fiber source is selected from the group comprising oligofructose, inulin starch, fructooligosaccharides, guar gum, xanthan gum, xylo-oligosaccharides, gum arabic, pectin, acacia gum, dextrans, hemicellulose, gum, mucilage or mixtures thereof.

10. The method according to claim 9, wherein the fiber source is oligofructose and inulin.

11. The method according to claim 3, wherein the mineral source comprises sodium, potassium, chloride, calcium, phosphorus, magnesium, iron, zinc, copper, manganese, fluoride, molybdenum, selenium, chromium, phosphate, iodine and / or their pharmaceutically acceptable salts, polymorphs, solvates, hydrates or esters.

12. The method according to claim 10 or 11, wherein the amount of mineral is between 0.5- 2.0%, preferably 0.7-1.5%, more preferably 0.8-1.0% by weight of the total composition.

13. The method according to claim 11 or 12, wherein the d(0.9) particle size of calcium carbonate in the mineral source is less than 20 pm, and the d(0.9) particle size of tricalcium phosphate is less than 13 pm.

14. The method according to claim 3, wherein the pH regulator is selected from the group comprising citric acid, potassium hydroxide, trisodium citrate, sodium bicarbonate, tartaric acid, maleic acid or mixtures thereof.

15. The method according to claim 14, wherein the pH regulator is citric acid and potassium hydroxide.

16. The method according to claim 3, wherein the emulsifier and / or stabilizer is selected from the group comprising guar gum, carrageenan, mono- and diglyceride fatty acids or mixtures thereof.

17. The method according to any of the preceding claims, wherein the solution prepared in step (a) is kept in the Mix Stock Tank for 8 to 24 hours.

18. The method according to claim 1, wherein the vitamin solution comprises vitamin A, vitamin D, vitamin E, vitamin C, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin B7, vitamin B9 and / or their pharmaceutically acceptable salts, polymorphs, solvates, hydrates or esters.

19. The method according to claim 18, wherein the amount of vitamin is between 0.25-0.40%, preferably 0.20-0.35%, more preferably 0.15-0.30% by weight of the total composition.

20. The method according to claim 1, wherein the flavoring and / or coloring agent is selected from the group comprising cocoa powder, hazelnut flavor, vanilla flavor, strawberry flavor, chocolate-banana flavor, white chocolate-strawberry flavor, chocolate-cookie flavor and watermelon flavor or mixtures thereof.

21. The method according to claim 1, wherein the fat ingredients are stored under nitrogen before being added to the mixture obtained in step (d).

22. The method according to claim 21, wherein the fat ingredients are selected from the group comprising rapeseed oil, oleic acid-rich sunflower oil, corn oil, canola oil, saffron oil, soybean oil, medium chain triglycerides or mixtures thereof.

23. The method according to claim 21 or 22, wherein the fat ingredients are rapeseed oil, oleic acid-rich sunflower oil and medium chain triglycerides.

24. The method according to any of claims 21 to 23, wherein the fat mixture further comprises antioxidant, emulsifier and / or stabilizer substances.

25. The method according to claim 24, wherein the antioxidant is selected from the group comprising zeaxanthin, lutein, lycopene, tocopherol, ascorbyl palmitate or mixtures thereof.

26. The method according to claim 25, wherein the emulsifier is lecithin.

27. The method according to any of the preceding claims, wherein the process of adding the fat mixture to the mixture obtained in step (d) is carried out in a high shear mixer.

28. The method according to any of the preceding claims, wherein the method further comprises performing flash cooling after the step of performing the sterilization process using the UHT system.

29. The method according to claim 28, wherein the method further comprises the step of performing a second homogenization after the flash cooling step.

30. The method according to any of the preceding claims, wherein the amount of solids are between 10-50%, preferably 20-45%, more preferably 25-40% by weight of the total composition.

31. The method according to any of the preceding claims, wherein the obtained nutrition composition is filled into bottles under nitrogen in a sterile environment.

32. The method according to any of the preceding claims, wherein the obtained nutrition composition is administered enterally.

33. The method according to any of the preceding claims, wherein the obtained nutrition composition is the clinical nutrition composition.

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