EP4110086A2 - Nutritional compositions for promoting pediatric health maintenance - Google Patents

Nutritional compositions for promoting pediatric health maintenance

Info

Publication number
EP4110086A2
EP4110086A2 EP21760308.3A EP21760308A EP4110086A2 EP 4110086 A2 EP4110086 A2 EP 4110086A2 EP 21760308 A EP21760308 A EP 21760308A EP 4110086 A2 EP4110086 A2 EP 4110086A2
Authority
EP
European Patent Office
Prior art keywords
vitamin
composition according
oil
mcg
acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21760308.3A
Other languages
German (de)
French (fr)
Other versions
EP4110086A4 (en
Inventor
Zafer Toksoz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Montero Gida Sanayi Ve Ticaret AS
Original Assignee
Montero Gida Sanayi Ve Ticaret AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Montero Gida Sanayi Ve Ticaret AS filed Critical Montero Gida Sanayi Ve Ticaret AS
Publication of EP4110086A2 publication Critical patent/EP4110086A2/en
Publication of EP4110086A4 publication Critical patent/EP4110086A4/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres

Definitions

  • the present invention relates to liquid compositions providing complete and balanced nutrition helping with the daily energy need in pediatric patients over one year of old with malnutrition and growth retardation.
  • Nutritional supplements are usually not intended to provide all the nutrients necessary for a nutritionally complete diet; instead they are generally intended to supplement the diet such that it becomes more nutritionally complete. However, in some instances they may provide complete nutrition.
  • the World Health Organization defines malnutrition as “the cellular imbalance between the supply of nutrients and energy and the body’s demand for them to ensure growth, maintenance, and specific functions.” This dynamic imbalance of nutrients affects children differently than adults and can have profound implications for the developing child.
  • Wasted children have a low lean body mass in relation to their height, usually related to a low muscle mass and low fat stores. In their case, recovering a normal body composition will require the intake of larger quantities of energy, proteins and of all nutrients needed for the synthesis of muscle and fat tissue.
  • Children with stunting but no wasting have muscle and fat mass in relation to their height that is close to normal, but they have delayed bone growth. Providing extra energy is likely to be of little help, as bone growth is not an energy consuming process. Also, excess energy may unnecessarily increase fat mass.
  • these children should receive additional quantities of nutrients needed for both bone growth and lean tissue accretion, not always available in the typical diet of poor children. Needs of children over one year old having a disease related malnutrition in terms of energy, carbohydrate, protein, fat, minerals, vitamins and essential fatty acids should be estimated before formulating any recommendation for feeding malnutrition.
  • PUFAs polyunsaturated chain fatty acids
  • long-chain PUFAs have been shown beneficial in the prevention and management of immune deficiency and growth retardation in children.
  • long-chain PUFAs tend to be more sensitive to oxidation than many other ingredients commonly found in nutritional compositions. Due to their chemical structure, exposure to heat and atmospheric levels of oxygen can cause a series of chemical reactions about their carbomcarbon double bonds resulting in free radical formation. These free radicals can continue to break down the polyunsaturated fatty acids in an auto-oxidative process. The result is the development of undesirable off-flavors and odors and the eventual degradation of the beneficial polyunsaturated fatty acids. These long-chain PUFAs are especially susceptible to oxidation during high-heat processing, spray drying processing, or even during relatively short storage periods after the formula has been sealed and packaged.
  • Oxidative stability has become especially challenging with recent children compositions that contain relatively high concentrations of long chain-polyunsaturated fatty acids to boost the immune system and enhance brain development.
  • the high concentrations of DHA will strongly complicate that challenge in respect to remove the fishy flavor during production and prevent development of this flavor during shelf life.
  • One method of controlling the undesirable oxidation of polyunsaturated fatty acids in powder nutritional compositions is the addition of antioxidants including ascorbyl palmitate, beta- carotene, mixed tocopherols, and others as described in U.S. Pat. No. 5,234,702 (Katz et al.).
  • U.S. 7,090,879 discloses the powder infant formula comprising carbohydrate, protein and a lipid component containing a polyunsaturated fatty acid; and a combination of lutein, lycopene, and beta-carotene.
  • oils are prone to oxidation. This fact especially applies for fish oils with a high level of DHA. Oxidation happens as a result of reactions between the polyunsaturated fatty acids in the oil and oxygen. These reactions are accelerated by the presence of oxygen and pro-oxidants. This challenge is being more complicated as the formulas contain high levels of pro-oxidants (Ferrous, Cobber and Zink).
  • the main object of the present invention is to obtain liquid nutritional compositions for providing complete and balanced nutrition helping with the energy need in pediatric patients over one year of old with malnutrition and growth retardation.
  • the present invention is also directed to the process for obtaining the compositions subjected to the invention and the administration of them.
  • Another object of the present invention is to obtain nutritional composition comprising at least one source of antioxidant to enhance stability by reducing sedimentation and oxidation at the same time.
  • Another object of the present invention is to obtain nutritional compositions comprising biocompatible components with no redundancy or competitive absorption.
  • Another object of the present invention is to obtain nutritional compositions essentially comprising water, at least one source of protein, at least one source of carbohydrate, at least one source of fat, at least one source of fiber, vitamins and minerals.
  • Another object of the present invention is to obtain nutritional compositions comprising taurine and L-carnitine, which increase the absorption of each other.
  • Another object of the present invention is to obtain nutritional compositions with enhanced fiber range to support gastrointestinal system.
  • Another object of the present invention is to obtain nutritional compositions comprising caseinates in specific ranges as protein sources to provide reduced osmolarity and sedimentation.
  • Another object of the present invention is to obtain nutritional compositions comprising docosahexaenoic acid and eicosapentaenoic acid in encapsulated form to reduce oxidation and provide deodorization.
  • Another object of the present invention is to develop a process for preparing such compositions to enhance homogenization and reduce oxidation.
  • Another object of the present invention is also providing a process eliminating the risk of severe foaming which is a great risk with dairy proteins and ensuring fast homogeneous mixing.
  • Another object of the present invention is also a process comprising the application of a high temperature for a shorter period of time, thereby reducing the thermal damage for the liquid nutritional composition.
  • the present invention relates to a liquid composition useful for providing complete and balanced nutrition and helping with the energy need of pediatric patients over one year old having a disease related malnutrition, comprising;
  • At least one source of antioxidant which is selected from the group carotenoids, ascorbic acid, ascorbyl palmitate, retinyl palmitate, tocopherols, ascorbate salts, oil-soluble rosemary extract, and mixtures thereof,
  • child and children refers to children not more than 36 months and includes children from about 12 months to about 36 months.
  • Ultra-high temperature processing UHT
  • ultra-heat treatment or ultra-pasteurization is a food processing technology that sterilizes liquid food by heating it above 135°C (275 °F), the temperature required to kill bacterial endospores for 2 to 5 seconds.
  • UHT is most commonly used in milk production, but the process is also used for nutritions, fruit juices, cream, soy milk, yogurt, wine, soups, honey, and stews.
  • UHT principles eliminates the risk of high viscosity and protein and protein fouling.
  • the Infusions and Steam injections systems are most suitable for high viscous products and will ensure longer production time between cleanings.
  • Using vacuum mixer to dissolve the powdered ingredients provides several benefits such as eliminates the risk of severe foaming which is a great risk with dairy proteins and ensures fast homogeneous mixing.
  • the mixture is usually pasteurized at a temperature of less than 100°C (212°F) to eliminate pathogens and prolong shelf life.
  • the composition comprises the combination of beta-carotene, lutein and lycopene as antioxidants.
  • said source of long chain-polyunsaturated fatty acid is selected from the group comprising arachidonic acid, linoleic acid, linolenic acid, eicosapentaenoic acid (EPA), decosahexaenoic acid (DHA) or mixtures thereof.
  • EPA eicosapentaenoic acid
  • DHA decosahexaenoic acid
  • at least two long chain-polyunsaturated fatty acids are included in the composition in encapsulated form to assure deodorization of the fishy flavor and odor. Additionally, encapsulation reduces oxidation during the production process and the shelf-life.
  • the composition comprises docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as long chain-polyunsaturated fatty acids.
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • the weight ratio of total amount of beta-carotene, lutein and lycopene to total amount of long chain-polyunsaturated fatty acids is in the range of 1:50 to 1 :1000, preferably 1:100 to 1 :800, more preferably 1:300 to 1:600. This selection of specific ranges has been observed to reduce oxidation.
  • the composition further comprises at least one component selected from L-carnitine, taurine, b-alanine, glutamine, creatinine or mixtures thereof.
  • Carnitine is a quaternary amine, b-hydroxy, g-N-tri-methylaminobutyric acid, which is an important metabolite in mammalian tissues for the utilization of long chain fatty acids as a source of energy.
  • L-carnitine is a vitamin-like antioxidant and has greatly positive effects on the body's energy production and normal functions of the brain. L-carnitine facilitates the transport of free fatty acids across the mitochondrial membrane and hence plays a role in fatty acid oxidation and ketogenesis.
  • L-carnitine is present in an amount of at least 1 g, particularly 1 to 5 mg, per 100 ml.
  • Taurine is one of the major constituents of the free amino acid pool in all mammalian central nervous system tissues.
  • the major physiological functions of taurine are participation in bile conjugation, osmoregulation, neurotransmission and neuroregulation and membrane stabilization.
  • Taurine is highly found in the brain, bones, heart muscle, and blood cells. It plays a role in the regulation of calcium and potassium balance in the brain and nervous system. Taurine is involved in many processes including cell membrane function and bile acid conjugation and, since the children's ability to synthesise this amino acid is limited, an external supply of taurine is thought to be desirable.
  • Taurine is present in an amount of at least 2.5 mg, particularly 2.5 to 10 mg, per 100 ml.
  • the weight ratio of L-carnitine to taurine is in the range of 1:0.1 to 1:20, preferably 1:1 to 1:10, more preferably 1 :3 to 1 :5. These ratios of combination provide the most effective results as absorptions of taurine and L-carnitine simultaneously increase. It shows that this combination plays an important role in brain development in children.
  • said source of carbohydrate is selected from the group comprising sucrose, maltodextrin, fructose, hydrolyzed corn starch, corn syrup solids, high fructose corn syrup or mixtures thereof.
  • the composition comprises maltodextrin and sucrose.
  • the weight ratio of maltodextrin to sucrose is in the range of 1 :0.05 to 1 :2, preferably 1:01 to 1:1, more preferably 1:0.3 to 1:0.7. It has been surprisingly seen that osmolality of the composition can be reduced by using specifically these ranges.
  • osmolality of the composition is in the range of 100-1000 mOsm/kg water, preferably 200-800 mOsm/kg water.
  • osmolarity of the composition is in the range of 100-800 mOsm/L, preferably 200-600 mOsm/L.
  • said source of protein is selected from the group comprising casein, soy, rice, pea, carob, oat, whey, caseino-glyco-macropeptides or mixtures thereof.
  • the composition is free of whey to provide a balanced solid content and to achieve good heat stability and flowability on a tubular plant production.
  • the composition comprises sodium caseinate and calcium caseinate as protein sources.
  • the weight ratio of sodium caseinate to calcium caseinate is in the range of 1 :0.01 to 1:2, preferably 1:0.05 to 1:1, more preferably 1:0.2 to 1 :0.6. Specifically these ratios provide enhanced stability by reducing sedimentation over time and increase shelf-life accordingly. It has been also observed that the use of sodium caseinate and calcium caseinate as protein sources supports the reduction of osmolality.
  • said source of fat is selected from the group comprising fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil, safflower oil, rapeseed oil, soy oil, olive oil, canola oil, corn oil, peanut oil, rice bran oil, butter fat, hazelnut oil, structured lipids or mixtures thereof.
  • said source of fat is selected from the fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil or mixtures thereof. This selection of fat source has been shown to reduce oxidation and prolong shelf life of the composition.
  • said source of fiber is selected from the group comprising fructooligosaccharides, inulin, guar gum, xanthan gum, xylo-oligosaccharides, gum arabic, pectin, acacia gum, resistant starch, dextrans or mixtures thereof.
  • the composition comprises fructooligosaccharides and inulin.
  • the total amount of fructooligosaccharides and inulin is 0.5-3 g/100ml_, most preferably 0.75-2 g/100ml_. It is aimed to improve the bowel functions of children patients by the specific selection of these water-soluble fibers and their amounts which are relatively high considering the prior art.
  • said vitamins are selected from the group comprising vitamin A, vitamin D3, vitamin E, vitamin K1 , vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B8, vitamin B12, choline or mixtures thereof.
  • said minerals are selected from the group comprising sodium, potassium, chloride, calcium, phosphorus, magnesium, floride, iron, zinc, manganese, copper, iodine, selenium, chromium, molybdenum, phosphate or mixtures thereof.
  • the energy value of the composition is in the range of 140- 170 kcal/100 mL to ensure daily energy need of children patients.
  • the composition comprises;
  • composition further comprises;
  • Example 1 Liquid composition providing complete and balanced nutrition for pediatric patients
  • Example 2 Liquid composition providing complete and balanced nutrition for pediatric patients
  • the preparation method of the above-mentioned liquid compositions given in examples 1 and 2 is prepared by following these steps: a. Blending water soluble components in water b. Pasteurizing the mixture c. Adding fat sources to the mixture d. UHT processing the total mixture

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Polymers & Plastics (AREA)
  • Pediatric Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to liquid compositions providing complete and balanced nutrition helping with the daily energy needs in pediatric patients over one year of old with malnutrition and growth retardation.

Description

NUTRITIONAL COMPOSITIONS FOR PROMOTING PEDIATRIC HEALTH
MAINTENANCE
Field of Invention
The present invention relates to liquid compositions providing complete and balanced nutrition helping with the daily energy need in pediatric patients over one year of old with malnutrition and growth retardation.
The background of the invention
Many children do not take in sufficient nutrients for a nutritionally complete diet. In order to assist these children, nutritional supplements have been developed. Nutritional supplements are usually not intended to provide all the nutrients necessary for a nutritionally complete diet; instead they are generally intended to supplement the diet such that it becomes more nutritionally complete. However, in some instances they may provide complete nutrition.
Childhood malnutrition is a major global health problem, contributing to childhood morbidity, mortality, impaired intellectual development, suboptimal adult work capacity, and increased risk of diseases in adulthood. Children are particularly susceptible to malnutrition if complementary foods are of low nutrient density and have low bioavailability of micronutrients.
The World Health Organization (WHO) defines malnutrition as “the cellular imbalance between the supply of nutrients and energy and the body’s demand for them to ensure growth, maintenance, and specific functions.” This dynamic imbalance of nutrients affects children differently than adults and can have profound implications for the developing child.
Nutritional needs of wasted and stunted children are likely to be different. Wasted children have a low lean body mass in relation to their height, usually related to a low muscle mass and low fat stores. In their case, recovering a normal body composition will require the intake of larger quantities of energy, proteins and of all nutrients needed for the synthesis of muscle and fat tissue. Children with stunting but no wasting have muscle and fat mass in relation to their height that is close to normal, but they have delayed bone growth. Providing extra energy is likely to be of little help, as bone growth is not an energy consuming process. Also, excess energy may unnecessarily increase fat mass. On the other hand, these children should receive additional quantities of nutrients needed for both bone growth and lean tissue accretion, not always available in the typical diet of poor children. Needs of children over one year old having a disease related malnutrition in terms of energy, carbohydrate, protein, fat, minerals, vitamins and essential fatty acids should be estimated before formulating any recommendation for feeding malnutrition.
Lack of adequate micronutrients such as minerals, vitamins, L-carnitine, taurine, b-alanine, glutamine and creatinine or macronutrients such as protein, carbohydrate, fat, long chain- polyunsaturated fatty acid can lead to clinically significant immune deficiency and growth retardation in children.
Besides the lack of micronutrients or macronutrients intake, many children also have inadequate vitamin and supplement intake. Supplement deficiencies have been correlated with disorders that are frequent among the children, such as disease related malnutrition, short bowel syndrome, intractable malabsorption, proven inflammatory bowel disease, following total gastrectomy, bowel fistulae and dysphagia.
Many nutritional compositions, especially pediatric compositions, commonly contain a variety of polyunsaturated chain fatty acids (PUFAs) as part of the lipid component of the overall nutrient system. For example, long-chain PUFAs have been shown beneficial in the prevention and management of immune deficiency and growth retardation in children.
These long-chain PUFAs, however, tend to be more sensitive to oxidation than many other ingredients commonly found in nutritional compositions. Due to their chemical structure, exposure to heat and atmospheric levels of oxygen can cause a series of chemical reactions about their carbomcarbon double bonds resulting in free radical formation. These free radicals can continue to break down the polyunsaturated fatty acids in an auto-oxidative process. The result is the development of undesirable off-flavors and odors and the eventual degradation of the beneficial polyunsaturated fatty acids. These long-chain PUFAs are especially susceptible to oxidation during high-heat processing, spray drying processing, or even during relatively short storage periods after the formula has been sealed and packaged.
Oxidative stability has become especially challenging with recent children compositions that contain relatively high concentrations of long chain-polyunsaturated fatty acids to boost the immune system and enhance brain development. The high concentrations of DHA will strongly complicate that challenge in respect to remove the fishy flavor during production and prevent development of this flavor during shelf life. One method of controlling the undesirable oxidation of polyunsaturated fatty acids in powder nutritional compositions, is the addition of antioxidants including ascorbyl palmitate, beta- carotene, mixed tocopherols, and others as described in U.S. Pat. No. 5,234,702 (Katz et al.).
Another patent document numbered U.S. 7,090,879 discloses the powder infant formula comprising carbohydrate, protein and a lipid component containing a polyunsaturated fatty acid; and a combination of lutein, lycopene, and beta-carotene.
In the patent literature also, there are nutritional compositions which are specifically formulated for different age ranges and for different objectives. They can be supplementary to a malnourishment or they can provide a complete nutrition for patients with disabilities.
As mentioned above oils are prone to oxidation. This fact especially applies for fish oils with a high level of DHA. Oxidation happens as a result of reactions between the polyunsaturated fatty acids in the oil and oxygen. These reactions are accelerated by the presence of oxygen and pro-oxidants. This challenge is being more complicated as the formulas contain high levels of pro-oxidants (Ferrous, Cobber and Zink).
However, the state of art is insufficient for a specific process to minimise contact time between oxygen and oils.
Objects and Brief Description of the Invention
The main object of the present invention is to obtain liquid nutritional compositions for providing complete and balanced nutrition helping with the energy need in pediatric patients over one year of old with malnutrition and growth retardation.
The present invention is also directed to the process for obtaining the compositions subjected to the invention and the administration of them.
Another object of the present invention is to obtain nutritional composition comprising at least one source of antioxidant to enhance stability by reducing sedimentation and oxidation at the same time.
Another object of the present invention is to obtain nutritional compositions having reduced osmolarity and osmolality, and accordingly enhanced patient compliance. Another object of the present invention is to obtain nutritional compositions having balanced carbohydrate content ensuring patient’s daily energy need.
Another object of the present invention is to obtain nutritional compositions comprising biocompatible components with no redundancy or competitive absorption.
Another object of the present invention is to obtain nutritional compositions essentially comprising water, at least one source of protein, at least one source of carbohydrate, at least one source of fat, at least one source of fiber, vitamins and minerals.
Another object of the present invention is to obtain nutritional compositions comprising taurine and L-carnitine, which increase the absorption of each other.
Another object of the present invention is to obtain nutritional compositions with enhanced fiber range to support gastrointestinal system.
Another object of the present invention is to obtain nutritional compositions comprising caseinates in specific ranges as protein sources to provide reduced osmolarity and sedimentation.
Another object of the present invention is to obtain nutritional compositions comprising docosahexaenoic acid and eicosapentaenoic acid in encapsulated form to reduce oxidation and provide deodorization.
Another object of the present invention is to develop a process for preparing such compositions to enhance homogenization and reduce oxidation.
Another object of the present invention is also providing a process eliminating the risk of severe foaming which is a great risk with dairy proteins and ensuring fast homogeneous mixing.
Another object of the present invention is also a process comprising the application of a high temperature for a shorter period of time, thereby reducing the thermal damage for the liquid nutritional composition.
Detailed description of the invention
In accordance with the objects outlined above, detailed features of the present invention are given herein. The present invention relates to a liquid composition useful for providing complete and balanced nutrition and helping with the energy need of pediatric patients over one year old having a disease related malnutrition, comprising;
- water
- at least one source of protein,
- at least one source of carbohydrate,
- at least one source of fat,
- at least one long chain-polyunsaturated fatty acid,
- at least one source of fiber,
- at least one source of antioxidant which is selected from the group carotenoids, ascorbic acid, ascorbyl palmitate, retinyl palmitate, tocopherols, ascorbate salts, oil-soluble rosemary extract, and mixtures thereof,
- vitamins,
- minerals, wherein the composition obtained by a process comprising the steps of:
- blending water soluble components in water
- pasteurizing the mixture
- adding fat sources to the mixture
- UHT processing the total mixture
The term "child" and "children" as used herein refers to children not more than 36 months and includes children from about 12 months to about 36 months.
Making sterilized liquid compositions is an advanced processing technology that has been optimised for liquid milk.
Ultra-high temperature processing (UHT), ultra-heat treatment, or ultra-pasteurization is a food processing technology that sterilizes liquid food by heating it above 135°C (275 °F), the temperature required to kill bacterial endospores for 2 to 5 seconds. UHT is most commonly used in milk production, but the process is also used for nutritions, fruit juices, cream, soy milk, yogurt, wine, soups, honey, and stews.
Using UHT principles eliminates the risk of high viscosity and protein and protein fouling. The Infusions and Steam injections systems are most suitable for high viscous products and will ensure longer production time between cleanings. Using vacuum mixer to dissolve the powdered ingredients provides several benefits such as eliminates the risk of severe foaming which is a great risk with dairy proteins and ensures fast homogeneous mixing.
The mixture is usually pasteurized at a temperature of less than 100°C (212°F) to eliminate pathogens and prolong shelf life.
It has been surprisingly seen that oxidation is reduced by successively applying the process steps in this way.
In the preferred embodiment; the composition comprises the combination of beta-carotene, lutein and lycopene as antioxidants.
According the preferred embodiment, said source of long chain-polyunsaturated fatty acid is selected from the group comprising arachidonic acid, linoleic acid, linolenic acid, eicosapentaenoic acid (EPA), decosahexaenoic acid (DHA) or mixtures thereof. Most preferably, at least two long chain-polyunsaturated fatty acids are included in the composition in encapsulated form to assure deodorization of the fishy flavor and odor. Additionally, encapsulation reduces oxidation during the production process and the shelf-life.
In the preferred embodiment; the composition comprises docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as long chain-polyunsaturated fatty acids.
In the preferred embodiment; the weight ratio of total amount of beta-carotene, lutein and lycopene to total amount of long chain-polyunsaturated fatty acids is in the range of 1:50 to 1 :1000, preferably 1:100 to 1 :800, more preferably 1:300 to 1:600. This selection of specific ranges has been observed to reduce oxidation.
According the preferred embodiment, the composition further comprises at least one component selected from L-carnitine, taurine, b-alanine, glutamine, creatinine or mixtures thereof.
Carnitine is a quaternary amine, b-hydroxy, g-N-tri-methylaminobutyric acid, which is an important metabolite in mammalian tissues for the utilization of long chain fatty acids as a source of energy. L-carnitine is a vitamin-like antioxidant and has greatly positive effects on the body's energy production and normal functions of the brain. L-carnitine facilitates the transport of free fatty acids across the mitochondrial membrane and hence plays a role in fatty acid oxidation and ketogenesis. L-carnitine is present in an amount of at least 1 g, particularly 1 to 5 mg, per 100 ml.
Taurine is one of the major constituents of the free amino acid pool in all mammalian central nervous system tissues. The major physiological functions of taurine are participation in bile conjugation, osmoregulation, neurotransmission and neuroregulation and membrane stabilization. Taurine is highly found in the brain, bones, heart muscle, and blood cells. It plays a role in the regulation of calcium and potassium balance in the brain and nervous system. Taurine is involved in many processes including cell membrane function and bile acid conjugation and, since the children's ability to synthesise this amino acid is limited, an external supply of taurine is thought to be desirable. Taurine is present in an amount of at least 2.5 mg, particularly 2.5 to 10 mg, per 100 ml.
In the preferred embodiment; the weight ratio of L-carnitine to taurine is in the range of 1:0.1 to 1:20, preferably 1:1 to 1:10, more preferably 1 :3 to 1 :5. These ratios of combination provide the most effective results as absorptions of taurine and L-carnitine simultaneously increase. It shows that this combination plays an important role in brain development in children.
According to one embodiment, said source of carbohydrate is selected from the group comprising sucrose, maltodextrin, fructose, hydrolyzed corn starch, corn syrup solids, high fructose corn syrup or mixtures thereof.
In the preferred embodiment; the composition comprises maltodextrin and sucrose. The weight ratio of maltodextrin to sucrose is in the range of 1 :0.05 to 1 :2, preferably 1:01 to 1:1, more preferably 1:0.3 to 1:0.7. It has been surprisingly seen that osmolality of the composition can be reduced by using specifically these ranges.
Accordingly, osmolality of the composition is in the range of 100-1000 mOsm/kg water, preferably 200-800 mOsm/kg water. Besides, osmolarity of the composition is in the range of 100-800 mOsm/L, preferably 200-600 mOsm/L.
According to one embodiment, said source of protein is selected from the group comprising casein, soy, rice, pea, carob, oat, whey, caseino-glyco-macropeptides or mixtures thereof.
Preferably, the composition is free of whey to provide a balanced solid content and to achieve good heat stability and flowability on a tubular plant production. According to the preferred embodiment, the composition comprises sodium caseinate and calcium caseinate as protein sources. The weight ratio of sodium caseinate to calcium caseinate is in the range of 1 :0.01 to 1:2, preferably 1:0.05 to 1:1, more preferably 1:0.2 to 1 :0.6. Specifically these ratios provide enhanced stability by reducing sedimentation over time and increase shelf-life accordingly. It has been also observed that the use of sodium caseinate and calcium caseinate as protein sources supports the reduction of osmolality.
According to one embodiment, said source of fat is selected from the group comprising fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil, safflower oil, rapeseed oil, soy oil, olive oil, canola oil, corn oil, peanut oil, rice bran oil, butter fat, hazelnut oil, structured lipids or mixtures thereof.
According to the preferred embodiment, said source of fat is selected from the fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil or mixtures thereof. This selection of fat source has been shown to reduce oxidation and prolong shelf life of the composition.
According the one embodiment, said source of fiber is selected from the group comprising fructooligosaccharides, inulin, guar gum, xanthan gum, xylo-oligosaccharides, gum arabic, pectin, acacia gum, resistant starch, dextrans or mixtures thereof.
According the preferred embodiment, the composition comprises fructooligosaccharides and inulin. Preferably, the total amount of fructooligosaccharides and inulin is 0.5-3 g/100ml_, most preferably 0.75-2 g/100ml_. It is aimed to improve the bowel functions of children patients by the specific selection of these water-soluble fibers and their amounts which are relatively high considering the prior art.
According the one embodiment, said vitamins are selected from the group comprising vitamin A, vitamin D3, vitamin E, vitamin K1 , vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B8, vitamin B12, choline or mixtures thereof.
According the one embodiment, said minerals are selected from the group comprising sodium, potassium, chloride, calcium, phosphorus, magnesium, floride, iron, zinc, manganese, copper, iodine, selenium, chromium, molybdenum, phosphate or mixtures thereof.
According the one embodiment, the energy value of the composition is in the range of 140- 170 kcal/100 mL to ensure daily energy need of children patients. According to one embodiment, the composition comprises;
- 2-10 g/100ml_ protein
- 15-18 g/100ml_ carbohydrate
- 5-10 g/100m L fat
- 15-300 mg/100m L docosahexaenoic acid
- 5-30 mg/100m L eicosapentaenoic acid
- 0.5-5 g/100m L fiber
- 2.5-20 mg/100ml_ taurine
- 0.8-5 mg/100ml_ L-carnitine
- 0.03-1.1 mg/100ml_ carotenoids
According to one preferred embodiment, the composition further comprises;
- 90-250 mcg/100ml_ vitamin A
- 1-5 mcg/100ml_ vitamin D3
- 1-5 mcg/100ml_ vitamin E
- 5-10 mcg/100ml_ vitamin K1
- 10-30 mg/100ml_ vitamin C
- 20-70 mcg/100ml_ folic acid
- 0.1-0.5 mg/100ml_ vitamin B1
- 0.1-0.5 mg/100ml_ vitamin B2
- 0.1-0.5 mg/100ml_ vitamin B6
- 0.2-0.5 mcg/100ml_ vitamin B12
- 0.75-3 mg/100ml_ vitamin B3
- 0.5-5 mg/100ml_ vitamin B5
- 3-10 mcg/100ml_ vitamin B7
- 10-40 mg/100ml_ cholin
- 50-100 mg/100ml_ sodium
- 150-300 mg/100ml_ potassium
- 75-200 mg/100ml_ chloride
- 100-300 mg/100ml_ calcium
- 50-200 mg/100m L phosphorus
- 10-50 mg/100ml_ magnesium
- 0.75-5 mg/100ml_ iron
- 0.75-5 mg/100ml_ zinc
- 0.1-1 mg/100ml_ manganese
- 50-100 mcg/100ml_ floride - 100-500 mcg/100ml_ copper
- 10-50 mcg/100ml_ iodine
- 1-20 mcg/100mL selenium
- 1-20 mcg/100ml_ chromium - 5-30 mcg/100ml_ molybdenum
- 100-300 mg/100ml_ phosphate
These analytically selected ratios ensure the required effective doses for the complete nutrition, toxic safety and patient compliance. Furthermore, they enhance the stability and prolonged shelf-life.
According to all these embodiments, the below given formulations can be used in the liquid composition subjected to the invention. Example 1 : Liquid composition providing complete and balanced nutrition for pediatric patients
Example 2: Liquid composition providing complete and balanced nutrition for pediatric patients
The preparation method of the above-mentioned liquid compositions given in examples 1 and 2 is prepared by following these steps: a. Blending water soluble components in water b. Pasteurizing the mixture c. Adding fat sources to the mixture d. UHT processing the total mixture

Claims

1. A liquid composition useful for providing complete and balanced nutrition and helping with the energy needs meeting in pediatric patients over one year old having a disease related malnutrition, comprising;
- water
- at least one source of protein,
- at least one source of carbohydrate,
- at least one source of fat,
- at least one long chain-polyunsaturated fatty acid,
- at least one source of fiber,
- at least one source of antioxidant is selected from the group carotenoids, ascorbic acid, ascorbyl palmitate, retinyl palmitate, tocopherols, ascorbate salts, oil-soluble rosemary extract or mixtures thereof,
- vitamins,
- minerals, wherein the composition obtained by a process comprising the steps of:
- blending water soluble components in water
- pasteurizing the mixture
- adding fat sources to the mixture
- UHT processing the total mixture
2. The composition according to claim 1, wherein said antioxidants are carotenoids.
3. The composition according to claim 2, wherein said carotenoids comprise the combination of beta-carotene, lutein and lycopene.
4. The composition according to claim 1, wherein said source of long chain- polyunsaturated fatty acid is selected from arachidonic acid, linoleic acid, linolenic acid, eicosapentaenoic acid, decosahexaenoic acid or mixtures thereof.
5. The composition according to claim 4, wherein the composition comprises docosahexaenoic acid and eicosapentaenoic acid.
6. The composition according to claim 5, wherein said docosahexaenoic acid and eicosapentaenoic acid are present in encapsulated form in the composition.
7. The composition according to claim 3, wherein the weight ratio of total amount of beta- carotene, lutein, lycopene to total amount of long chain-polyunsaturated fatty acid is in the range of 1:50 to 1:1000, preferably 1:100 to 1:800, more preferably 1:300 to 1:600.
8. The composition according to any one of the preceding claims, wherein the composition further comprises at least one component selected from L-carnitine, taurine, b-alanine, glutamine, creatinine or mixtures thereof.
9. The composition according to claim 8, wherein the composition comprises L-carnitine, and taurine; and the weight ratio of L-carnitine to taurine is in the range of 1 :0.1 to 1 :20, preferably 1:1 to 1:10, more preferably 1:3 to 1:5.
10. The composition according to claim 1, wherein said source of fat is selected from the group comprising fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil, safflower oil, rapeseed oil, soy oil, olive oil, canola oil, corn oil, peanut oil, rice bran oil, butter fat, hazelnut oil, structured lipids or mixtures thereof.
11. The composition according to claim 10, wherein said source of fat is selected from the fish oil, medium chain triglycerides, rapeseed oil, sunflower oil, high oleic sunflower oil or mixtures thereof.
12. The composition according to claim 1, wherein said source of carbohydrate is selected from the group comprising sucrose, maltodextrin, fructose, hydrolyzed corn starch, corn syrup solids, high fructose corn syrup or mixtures thereof.
13. The composition according to claim 12, wherein the composition comprises maltodextrin and sucrose.
14. The composition according to claim 13, wherein the weight ratio of maltodextrin to sucrose is in the range of 1:0.05 to 1:2, preferably 1:01 to 1:1, more preferably 1:0.3 to 1:0.7.
15. The composition according to claim 1, wherein said source of protein is selected from the group comprising casein, soy, rice, pea, carob, oat, whey, caseino-glyco- macropeptides or mixtures thereof.
16. The composition according to claim 15, wherein the composition comprises sodium caseinate and calcium caseinate.
17. The composition according to claim 16, wherein the weight ratio of sodium caseinate to calcium caseinate is in the range of 11:0.01 to 1:2, preferably 1:0.05 to 1:1 , more preferably 1 :0.2 to 1:0.6.
18. The composition according to claim 1 , wherein said source of fiber is selected from the group comprising fructooligosaccharides, inulin, guar gum, xanthan gum, xylo- oligosaccharides, gum arabic, pectin, acacia gum, resistant starch, dextrans or mixtures thereof.
19. The composition according to claim 18, wherein the composition comprises fructooligosaccharides and inulin in a total amount of 3-4 g/100ml_, preferably 1.5-2 g/100ml_.
20. The composition according to claim 1, wherein said vitamins are selected from the group comprising vitamin A, vitamin D3, vitamin E, vitamin K1, vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B8, vitamin B12, choline or mixtures thereof.
21. The composition according to claim 1 , wherein said minerals are selected from the group comprising sodium, potassium, chloride, calcium, phosphorus, magnesium, iron, zinc, manganese, floride, copper, iodine, selenium, chromium, molybdenum, phosphate or mixtures thereof
22. The composition according to any one of the preceding claims, wherein the composition comprises
- 2-10 g/100ml_ protein
- 15-18 g/100ml_ carbohydrate
- 5-10 g/100m L fat
- 15-300 mg/100m L docosahexaenoic acid
- 5-30 mg/100m L eicosapentaenoic acid
- 0.5-5 g/100m L fiber
- 2.5-20 mg/100ml_ taurine
- 0.8-5 mg/100ml_ L-carnitine
- 0.03-1.1 mg/100ml_ carotenoids
- 90-250 mcg/100ml_ vitamin A
- 1-5 mcg/100ml_ vitamin D3
- 1-5 mcg/100ml_ vitamin E
- 5-10 mcg/100ml_ vitamin K1 - 10-30 mg/100ml_ vitamin C
- 20-70 mcg/100ml_ folic acid
- 0.1-0.5 mg/100ml_ vitamin B1
- 0.1-0.5 mg/100ml_ vitamin B2
- 0.1-0.5 mg/100ml_ vitamin B6
- 0.2-0.5 mcg/100ml_ vitamin B12
- 0.75-3 mg/100ml_ vitamin B3
- 0.5-5 mg/100ml_ vitamin B5
- 3-10 mcg/100ml_ vitamin B7 - 10-40 mg/100ml_ cholin
- 50-100 mg/100ml_ sodium
- 150-300 mg/100mL potassium
- 75-200 mg/100ml_ chloride
- 100-300 mg/100ml_ calcium
- 50-200 mg/100m L phosphorus
- 10-50 mg/100ml_ magnesium
- 0.75-5 mg/100ml_ iron
- 0.75-5 mg/100ml_ zinc
- 0.1-1 mg/100ml_ manganese
- 50-100 mcg/100ml_ floride
- 100-500 mcg/100ml_ copper
- 10-50 mcg/100mL iodine
- 1-20 mcg/100ml_ selenium
- 1-20 mcg/100ml_ chromium
- 5-30 mcg/100ml_ molybdenum
- 100-300 mg/100ml_ phosphate
EP21760308.3A 2020-02-25 2021-01-26 Nutritional compositions for promoting pediatric health maintenance Pending EP4110086A4 (en)

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