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WO2009072869A1 - Composition nutritionnelle entérale liquide à haute énergie - Google Patents

Composition nutritionnelle entérale liquide à haute énergie Download PDF

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Publication number
WO2009072869A1
WO2009072869A1 PCT/NL2007/050626 NL2007050626W WO2009072869A1 WO 2009072869 A1 WO2009072869 A1 WO 2009072869A1 NL 2007050626 W NL2007050626 W NL 2007050626W WO 2009072869 A1 WO2009072869 A1 WO 2009072869A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
composition according
nutritional composition
liquid enteral
enteral nutritional
Prior art date
Application number
PCT/NL2007/050626
Other languages
English (en)
Inventor
Wynette Hermina Agnes Kiers
Natalie Elizabeth Hotrum
Edward Lucian Sliwinski
Original Assignee
N.V. Nutricia
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 N.V. Nutricia filed Critical N.V. Nutricia
Priority to PCT/NL2007/050626 priority Critical patent/WO2009072869A1/fr
Priority to DK08858188.9T priority patent/DK2230940T3/da
Priority to EP08857136.9A priority patent/EP2249666B1/fr
Priority to EP08858245A priority patent/EP2230941A1/fr
Priority to CN2008801253397A priority patent/CN101925307B/zh
Priority to EP08858188.9A priority patent/EP2230940B1/fr
Priority to MX2010006199A priority patent/MX2010006199A/es
Priority to EP14181438.4A priority patent/EP2818055B1/fr
Priority to RU2010127252/13A priority patent/RU2471370C2/ru
Priority to PCT/NL2008/050776 priority patent/WO2009072884A1/fr
Priority to ES13189113.7T priority patent/ES2679346T3/es
Priority to EP17167341.1A priority patent/EP3216349B1/fr
Priority to PCT/NL2008/050778 priority patent/WO2009072886A1/fr
Priority to BRPI0820951-0A2A priority patent/BRPI0820951A2/pt
Priority to CN201210570751.8A priority patent/CN103054046B/zh
Priority to PL08858188T priority patent/PL2230940T3/pl
Priority to EP13189113.7A priority patent/EP2687106B1/fr
Priority to BRPI0820956A priority patent/BRPI0820956B8/pt
Priority to ES08858188.9T priority patent/ES2523198T3/es
Priority to PCT/NL2008/050777 priority patent/WO2009072885A1/fr
Priority to ES08857136.9T priority patent/ES2640728T3/es
Priority to DK08857136.9T priority patent/DK2249666T3/en
Priority to MX2010006195A priority patent/MX2010006195A/es
Priority to US12/746,489 priority patent/US20110008485A1/en
Priority to MX2010006197A priority patent/MX2010006197A/es
Priority to RU2010127237/13A priority patent/RU2471371C2/ru
Priority to BRPI0820952-9A priority patent/BRPI0820952B1/pt
Priority to US12/746,135 priority patent/US20110021421A1/en
Priority to US12/746,490 priority patent/US8409651B2/en
Priority to CN2008801249546A priority patent/CN101909468A/zh
Priority to CN200880126292.6A priority patent/CN101938911B/zh
Priority to RU2010127236/13A priority patent/RU2482705C2/ru
Publication of WO2009072869A1 publication Critical patent/WO2009072869A1/fr
Priority to US13/843,330 priority patent/US8999423B2/en
Priority to US14/632,918 priority patent/US9345256B2/en
Priority to US15/136,036 priority patent/US20160309765A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • A23L33/19Dairy proteins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention is in the field of liquid enteral nutritional compositions.
  • the present invention relates in general to a liquid enteral composition for providing nutrition, either as a supplement, or as a complete nutrition, with a high energy content.
  • the human body requires energy to perform its vital functions, such as blood circulation, immune processes, respiration processes, etc. Energy can be supplied in the form of calories.
  • Calories are typically supplied by the consumption of food. Calorie sources can be classified into three categories: proteins, fats, and carbohydrates. Proteins can provide the body with support for muscular activity, fats can provide the body with stored energy, and carbohydrates can supply the body with immediate energy. Essential vitamins and minerals are necessary to help regulate the processes of the human body.
  • Nutritional needs can also change with a person's age. For example, elderly persons show a decrease in the amount of energy their body requires from fat sources.
  • an elderly person is a person of the age of 50 or more, in particular of the age of 55 or more, more in particular of the age of 60 or more, more in particular of the age of 65 or more.
  • This rather broad definition takes into account the fact that the average age varies between different populations, on different continents, etc.
  • Most developed world countries have accepted the chronological age of 65 years as a definition of 'elderly' or older person (associated with the age at which one may begin to receive pension benefits), but like many westernized concepts, this does not adapt well to e.g. the situation in Africa.
  • U United Nations
  • the more traditional African definitions of an elder or 'elderly' person correlate with the chronological ages of 50 to 65 years, depending on the setting, the region and the country.
  • the decrease in the amount of energy is attributed to a decrease in the number of functioning cells in said elderly person. This is also attributed to a decrease in activity. Accordingly, an elderly person's nutritional requirements may be different than a young or middle aged person.
  • nutritional compositions such as nutritional supplements and complete nutrition have been designed to provide nutritional support to persons in need thereof. This nutrition can be directed towards a particular type of nutritional support. For example, a supplement may provide a person with additional calories for increased energy. Although these supplements provide a certain amount of nutritional support, it is in the best interests to provide a nutritional composition having increased nutritional value for a specific nutritional requirement. In the above examples of elderly persons and ill patients, it is desired to provide nutritional liquid compositions having increased energy as well as increased protein per unit dosage.
  • an elderly person's energy needs may be reduced, their ability to consume products may also be diminished. For example, they may have difficulty consuming a product due to, e.g., swallowing difficulties, or due the too large amount of product they need to consume to meet the daily intake of nutrients. Hence, compliance is not optimal, and often, the intake is suboptimal, leading to suboptimal nourishment.
  • certain disease states or conditions may require restrictions on the diet a patient consumes.
  • renal patients may have fluid restrictive diets.
  • a number of patients need nutrition in the smallest volume of liquid.
  • These patients may be cachectic patients or persons suffering from end-stage AIDS, cancer or cancer treatment, severe pulmonary diseases like COPD (Chronic Obstructive Pulmonary Disease), tuberculosis and other infection diseases or persons that experience severe surgery or trauma like burns.
  • COPD Chironic Obstructive Pulmonary Disease
  • tuberculosis and other infection diseases or persons that experience severe surgery or trauma like burns.
  • persons suffering from disorders in the throat or mouth such as oesophageal cancer or stomatitis and persons having problems with swallowing like dysphagic persons, require special liquid, low- volume nutrition.
  • persons suffering from reduced appetite and/or loss of taste will benefit from a low- volume liquid nutritional composition.
  • increasing calories and/or proteins in a nutritional liquid composition may increase the overall viscosity of the composition. This can make the liquid nutritional composition difficult to consume or administer, and can also diminish the taste of the nutritional composition.
  • the problem of the present invention is therefore to provide a stable, attractive, liquid enteral composition for providing nutrition, either as a supplement, or as a complete nutrition, with a high energy content, to a person, in particular to an elderly person or an ill patient.
  • WO 02/098242 Al discloses a calorically dense liquid oral supplement (2.25 kcal/ml) based on a (60:40) soy protein isolate/caseinate mixture with a protein level of 9 g/100 ml (16 En%), 12,25 g/100 ml of fat (49 En%), and 19.7 g/100 ml of carbohydrates (35 En%).
  • the commercially available product Resource 2.0 is a high calorie product from Novartis (2 kcal/ml), based on a mixture of calcium and sodium caseinate as protein source, comprising 9 g/100 ml of proteins, 9 g/100 ml of fat, and 22 g/100 ml of carbohydrates, and provided in a 237 ml unit dosage.
  • the commercially available product VHC 2.25 is a high calorie product from Nestle (2.25 kcal/ml), based on a mixture of calcium- and potassium caseinate and isolated soy protein as protein source, comprising 9 g/100 ml of proteins, and provided in a 250 ml unit dosage.
  • the present invention provides a liquid enteral nutritional composition with a high energy content, designed to meet the nutritional needs of persons in need thereof, in particular elderly and patients with certain disease states.
  • the composition provides an increased amount of energy per unit volume while providing a sufficiently low viscosity to allow the composition to be easily consumed orally or be administered by tube. In addition, the taste of the composition is not diminished.
  • a liquid enteral nutritional composition comprising 6 to 14 g of protein per 100 ml of the composition, said protein including micellar casein and caseinate, the composition having an energy density of at least 2.0 kcal/ml.
  • a liquid enteral nutritional composition comprising protein that provides 10 % to 30 % of the total energy content of the composition, said protein including micellar casein and caseinate, the composition having an energy density of at least 2.0 kcal/ml.
  • Micellar Casein also named Micellar Casein Isolate (abbreviated as MCI) is a high quality milk protein, produced by a proprietary process that does not denature the proteins. Fresh skim milk is ultra filtered, in much the same process used to make whey protein, to produce a pure, undenaturated and easily soluble milk protein with its native structure. The resulting material contains more than 95 % casein, the rest mainly being whey and other non-protein nitrogen and other constituents, such as lactose. This milk protein is probably the least processed of all milk proteins. It has an intrinsic low viscosity and a liquid composition comprising said MCI is therefore easy to drink.
  • MCI Micellar Casein Isolate
  • casein refers to the curd form of casein, having lost its native micellar structure.
  • MCI may also be provided in the form of other materials, such as, for instance, Milk Protein Concentrate (MPC), which is a product comprising micellar casein and whey, typically in a ratio of 80:20.
  • MCI Milk Protein Concentrate
  • the composition of the present invention should not contain large amounts of proteins other than MCI and caseinate, the composition of the present invention may comprise up to about 15 weight% of whey.
  • micellar casein in the production of liquid enteral nutritional compositions with a high protein content and further containing acids, in particular citric acid, is the formation of calcium-acid complexes, such as calcium citrate.
  • citric acid is added to the composition to adjust the pH and also to adjust Ca-ion activity.
  • a certain Ca-ion activity is beneficial to maintain a desired viscosity of the composition during processing of the composition, e.g. during pasteurisation and/or sterilisation.
  • Calcium, originating from the micellar casein tends to react with acid, in particular the citric acid, thus forming calcium citrate crystals, which precipitate when the acidity of the composition increases over time (pH lowering), giving rise to a poor shelf stability.
  • the viscosity of the final composition is not increased as much as could be expected by the substitution of an amount of micellar casein by the same amount of caseinate, such that a composition is obtained with still a low viscosity, which is still very easy to drink or to administer by tubing, while at the same time no undesired Ca-acid precipitates are observed.
  • a liquid enteral nutritional composition consisting essentially of native micellar casein is exemplified in EP 0 686 396 Bl.
  • the problem as described in the present application has not been disclosed, nor the compositions with a high protein content according to the present invention are disclosed.
  • the present invention concerns a method of providing nutrition to a person in need thereof, comprising the steps of administering to said person the nutritional composition according to the present invention.
  • the present invention concerns the use of a mixture of micellar casein and caseinate in the manufacture of a liquid nutritional composition according to the present invention for providing nutrition to a person.
  • a liquid enteral nutritional composition comprising 6 to 14 g of protein per 100 ml of the composition, preferably 8 to 12 g/100 ml of the composition, more preferably at least 9 g/100 ml of the composition, said protein including micellar casein and caseinate, the composition having an energy density of at least 2.0 kcal/ml.
  • the protein provides 10 % to 30
  • the protein provides at least 16 % of the total energy content.
  • the high levels of protein are beneficial for patients who may not be physically capable of receiving a large volume, for example, fluid restricted patients. Such patients can be given a reduced level of fluid while still receiving a required amount of nutritional support per day.
  • the term "at least” also includes the starting point of the open range.
  • an amount of "at least 95 weight%” means any amount equal to 95 weight % or above.
  • enteral means orally or by tube.
  • the composition has an energy density of at least 2.0 kcal/ml, preferably at least 2.2 kcal/ml, more preferably at least 2.3 kcal/ml, even more preferably at least 2.4 kcal/ml.
  • the composition has a high energy density, it also has a sufficiently low viscosity to allow it to be consumed by persons that may have difficulty swallowing products or those that are tube fed.
  • the combined amount of micellar casein and caseinate in the liquid nutritional composition according to the invention is at least 85 weight%, more preferably at least 90 weight %, more preferably at least 95 weight% of the total protein present in the liquid nutritional composition.
  • the composition of the present invention should not contain large amounts of proteins other than MCI and caseinate.
  • the composition may comprise up to about 15 weight% of whey, preferably less than or equal to 10 weight% of whey, more preferably, less than or equal to 5 weight% of whey of the total protein present in the liquid nutritional composition.
  • Na-caseinate, Mg-caseinate, K-caseinate or any mixture thereof or combinations thereof such as Na/K-caseinate and Na/Mg caseinate are used as the source of caseinate.
  • Ca-caseinate, or a caseinate comprising Ca is not used, as the micellar casein already contains a sufficient amount of calcium, and the formation of further calcium crystals should be avoided.
  • the weight ratio of micellar casein to caseinate ranges from 90:10 to 55:45. Preferably, the weight ratio of micellar casein to caseinate is equal to 65:35.
  • composition according to the invention is designed to either supplement a person's diet or to provide complete nutritional support.
  • the composition according to the invention may further comprise at least fat and/or carbohydrate and/or a source of vitamins and minerals and/or a source of prebiotics.
  • the composition according the invention is a nutritionally complete composition.
  • the liquid nutritional composition according to the invention further comprises fat, said fat providing between 20 to 40 % of the total energy content of the composition. For a 2.0 kcal/ml composition, this amounts to 40 to 80 kcal per 100 ml.
  • the fat may include medium chain triglycerides (MCT, mainly 8 to 10 carbon atoms long), long chain triglycerides (LCT) or any combination of the two types.
  • MCTs are beneficial because they are easily absorbed and metabolized in a metabolically- stressed patient. Moreover, the use of MCTs will reduce the risk of nutrient malabsorption.
  • LCT sources such as canola oil, rapeseed oil, or corn oil are preferred because they can reduce immune suppression associated with certain types of fatty acids concentrated in the body.
  • the fat comprises 30 to 60 weight% of animal or algal fat, 40 to 70 weight% of vegetable fat and optionally 0 to 20 weight% of MCTs based on total fat of the composition.
  • the animal fat preferably comprises a low amount of milk fat, i.e. lower than 6 weight%, especially lower than 3 weight%.
  • a mixture of corn oil, egg oil, and/or canola oil and specific amounts of marine oil are used.
  • Egg oils, fish oils and algal oils are a preferred source of non-vegetable fats.
  • compositions that are to be consumed orally in order to prevent formation of off-flavours and to decrease a fishy after-taste, it is recommended to select ingredients that are relatively low in docosahexanoic acid (DHA), i.e. less than 6 weight%, preferably less than 4 weight% of the fat.
  • DHA docosahexanoic acid
  • Marine oils containing DHA are preferably present in the composition according to the invention in an amount lower than 25 weight%, preferably lower than 15 weight% of the fat.
  • inclusion of eicosapentanoic acid (EPA) is highly desirable for obtaining the maximum health effect.
  • the amount of EPA ranges preferably between 4 weight% and 15 weight%, more preferably between 8 weight% and 13 weight% of the fat.
  • the weight ratio EPA:DHA is advantageously at least 6:4, for example between 2: 1 and 10:1.
  • liquid nutritional composition according to the invention may beneficially comprise an emulsif ⁇ er.
  • emulsifiers may be used and generally the emulsifier contributes to the energy content of the fat in said composition.
  • the liquid nutritional composition according to the invention further comprises carbohydrate, said carbohydrate providing between 30 to 60 % of the total energy content of the composition.
  • carbohydrate provides at least 40 % of the total energy content of the composition according to the invention.
  • the composition of the carbohydrate preferably is such that high viscosities, excessive sweetness, excessive browning (Maillard reactions) and excessive osmolarities are avoided. Acceptable viscosities and osmolarities may be achieved by adjusting the average chain length (average degree of polymerisation, DP) of the carbohydrates between 1.5 and 6, preferably between 1.8 and 4. In order to avoid excessive sweetness, the total level of sucrose and fructose is less than 52 % and preferably less than 40 % of the weight of the carbohydrate, especially of the digestible carbohydrate.
  • Long-chain digestible carbohydrates such as starch, starch fractions and mild starch hydrolysates (DP > 6, DE ⁇ 20), may also be present, preferably in an amount of less than 25 weight%, especially less than 15 weight% of the carbohydrate, and less than 6 g/100 ml, preferably less than 4 g/100 ml of the total liquid enteral composition according to the invention.
  • the carbohydrate includes maltodextrose with a high DE (dextrose equivalent). In one embodiment the carbohydrate includes maltodextrose with a DE of > 20, preferably > 30 or even > 40, such as a DE of about 47.
  • maltodextrose leads to few or no Maillard reaction products upon heating. Without being bound to any explanation, this effect might be attributed to the fact that the compact micellar structure of the micellar casein offers few lysine reaction sites for a Maillard reaction.
  • the carbohydrate includes maltodextrose with a high DE in an amount of at least 35 weight%, preferably at least 50 weight%, preferably at least 65 weight%, preferably at least 90 weight% of the total weight of carbohydrate.
  • the carbohydrate includes maltodextrose with a low DE of 2 to 20.
  • the carbohydrate includes maltodextrose with a low DE of 2 to 10, preferably with a low DE of about 2.
  • the carbohydrate includes maltodextrose with a low DE in an amount of less than 35 weight%, preferably less than 20 weight%, preferably less than 10 weight% of the carbohydrate.
  • Maltodextrose with a low DE may also be referred to as maltodextrine.
  • the carbohydrate includes maltodextrose with a high DE, preferably a DE of > 20, preferably > 30 or even > 40, most preferably a DE of about 47 in combination with maltodextrose with a low DE, preferably a low DE of 2 to 20, more preferably a low DE of 2 to 10, most preferably with a low DE of about 2.
  • maltodextrose with a low DE such as of about 2 gives rise to a high viscosity.
  • Maltodextrose with a high DE such as of about 47 gives rise to a low viscosity, but is very sweet.
  • the carbohydrate includes at least 65 weight%, preferably at least 90 weight%, based on total weight of carbohydrate of maltodextrose with a DE >40, preferably with a DE of about 47 and 0 to 10 weight% of maltodextrose with a DE 2 to 10, preferably with a DE of about 2.
  • the carbohydrate includes trehalose.
  • trehalose As was indicated, it is one of the main objects of the invention to provide a nutritional composition with a low viscosity. Sucrose is very well suited for such purpose, but gives rise to very sweet compositions, which are in general disliked by the consumer. Maltodextrose with a low DE, such as of about 2, does not suffer from the latter drawback, but gives rise to a high viscosity. Maltodextrose with a high DE, such as of about 47 gives rise to a low viscosity, but is again very sweet, and gives further rise to the undesired Maillard reactions.
  • Trehalose is a preferred choice of carbohydrate, as it gives rise to a low viscosity, no undesired Maillard reactions and it has a sweetness about half of that of sucrose.
  • the carbohydrate includes trehalose in an amount of 20 % to 60 % of the weight of the carbohydrate, in an amount of 20 % to 45 %, more preferably in an amount of 25 % to 45 % of the weight of the carbohydrate.
  • composition according to the invention may contain a variety of vitamins and minerals. Overall, the composition according to the invention preferably includes at least 100 % of the United States Recommended Daily Allowance (USRDA) of vitamins and minerals in a one litre portion.
  • USRDA United States Recommended Daily Allowance
  • the composition according to the invention provides all necessary vitamins and minerals.
  • the composition according to the invention preferably provides 6 mg of zinc per 100 ml of the composition which is beneficial for tissue repair in a healing patient.
  • the composition according to the invention (also) provides 25 mg of vitamin C per 100 ml of the composition to aid patients with more severe healing requirements.
  • the composition according to the invention (also) provides 2.25 mg iron per 100 ml of the composition. Iron is beneficial in maintaining bodily fluids as well as circulatory system functions in an elderly patient.
  • the amount of divalent ions ranges between 170 mg/100 ml and 230 mg/100 ml and preferably between 180 mg/100 ml and 220 mg/100 ml.
  • the amount of calcium ranges between 155 mg/100 ml and 185 mg/100 ml and preferably between 160 mg/100 ml and 180 mg/100 ml.
  • the phosphorus content can be above
  • Carnitin may advantageously be present in an amount of 8 mg/100 ml to 1000 mg/100 ml, preferably 10 mg/100 ml to 100 mg/100 ml of composition; it may have the form of carnitin, alkyl camitin, acyl carnation or mixtures thereof.
  • Organic acids are preferably present at a level of between 0.1 g/100 ml to 0.6 g/100 ml, especially 0.25 g/100 ml to 0.5 g/100 ml.
  • these acids include short fatty acids such as acetic acid, hydroxy acids such as lactic acid, gluconic acid, and preferably polyvalent hydroxy acids, such as malic acid and citric acid.
  • the present composition also comprises citric acid.
  • the liquid enteral nutritional composition according to the invention may be fortified with a prebiotic, for example, with non-digestible carbohydrates (dietary fibres), such as fructo- oligosaccharides or inulin.
  • dietary fibres such as fructo- oligosaccharides or inulin.
  • the composition according to the invention comprises 0.5 g/100 ml to 6 g/100 ml of non-digestible carbohydrates.
  • the dietary fibres include non-digestible oligosaccharides having a DP of 2 to 20, preferably 2 to 10. More preferably, these oligosaccharides do not contain substantial amounts (less than 5 weight%) of saccharides outside these DP ranges, and they are soluble.
  • oligosaccharides may comprise fructo-oligosaccharides (FOS), trans-galacto- oligosaccharides (TOS), xylo-oligosaccharides (XOS), soy oligosaccharides, and the like.
  • FOS fructo-oligosaccharides
  • TOS trans-galacto- oligosaccharides
  • XOS xylo-oligosaccharides
  • soy oligosaccharides and the like.
  • higher molecular weight compounds such as inulin, cellulose, resistant starch and the like may be incorporated in the composition according to the invention.
  • the amount of insoluble fibre such as cellulose is preferably lower than 20 weight% of the dietary fibre fraction of the composition according to the invention, and/or below 0.4 g/100 ml.
  • the amount of thickening polysaccharides such as carrageenans, xanthans, pectins, galactomannans and other high molecular weight (DP > 50) indigestible polysaccharides is preferably low, i.e. less than 20 % of the weight of the fibre fraction, or less than 1 g/100 ml.
  • hydrolysed polysaccharides such as hydrolysed pectins and galactomannans can advantageously be included.
  • a preferred fibre component is an indigestible oligosaccharide with a chain length (DP) of 2 to 10, for example Fibersol® (resistant oligoglucose), in particular hydrogenated Fibersol®, or a mixture of oligosaccharides having a DP of 2 to 10, such as fructo-oligosaccharides or galacto-oligosaccharides, which may also contain a small amount of higher saccharides (e.g. with a DP of 11 to 20).
  • Such oligosaccharides preferably comprise 50 weight% to 90 weight% of the fibre fraction, or 0.5 g/100 ml to 3 g/100 ml of the composition according to the invention.
  • Other suitable fibre components include saccharides that have only partial digestibility.
  • the viscosity of the liquid enteral nutritional composition is lower than 50 mPa.s at 20 0 C at a shear rate of 100 s "1 , preferably between 20 and 45 mPa.s.
  • the viscosity may be determined using a rotational viscosity meter using a cone/plate geometry.
  • the protein consists of a blend of micellar casein and caseinate in a ratio of 65:35. The latter embodiment of the present invention has a viscosity of approximately about 40 mPa.s.
  • the osmolality of the composition is preferably lower than 900 mOsm/1, more preferably lower than 800 mOsm/1, most preferable lower than 700 mOsm/l,.
  • the density of the composition ranges between 1.05 g/ml and 1.20 g/ml, especially between 1.10 g/ml and 1.18 g/ml.
  • the liquid enteral nutritional composition according to the invention may have the form of a complete food, i.e. it can meet all nutritional needs of the user. As such, it preferably contains 1200 to 2500 kcal per daily dosage.
  • the daily dosage amounts are given with respect to a daily energy supply of 2000 kcal to a healthy adult having a body weight of 70 kg. For persons of different condition and different body weight, the levels should be adapted accordingly. It is understood that the average daily energy intake preferably is about 2000 kcal.
  • the complete food can be in the form of multiple dosage units, e.g. from 4 (250 ml/unit) to 20 (50 ml/unit) per day for an energy supply of 2000 kcal/day using a liquid enteral nutritional composition according to the invention of 2.0 kcal/ml.
  • the liquid enteral nutritional composition can also be a food supplement, for example to be used in addition to a non-medical food.
  • the liquid enteral nutritional composition contains per daily dosage less than 1500 kcal, in particular as a supplement, the liquid enteral nutritional composition contains 400 to 1000 kcal per daily dose.
  • the food supplement can be in the form of multiple dosage units, e.g. from 2 (250 ml/unit) to 10 (50 ml/unit) per day for an energy supply of 1000 kcal/day using a liquid enteral nutritional composition according to the invention of 2.0 kcal/ml.
  • a unit dosage comprises any amount of the liquid enteral nutritional composition according to the invention between 10 ml and 250 ml, the end values of this range included, preferably any amount between 25 ml and 200 ml, the end values of this range included, more preferably any amount between 50 ml and 150 ml, the end values of this range included, most preferably about 125 ml.
  • a person receiving the liquid enteral nutritional composition according to the invention between 10 ml and 250 ml, the end values of this range included, preferably any amount between 25 ml and 200 ml, the end values of this range included, more preferably any amount between 50 ml and 150 ml, the end values of this range included, most preferably about 125 ml.
  • 50 ml unit dosages can be given 10 unit dosages per day to provide nutritional support using a liquid enteral nutritional composition according to the invention of 2.0 kcal/ml.
  • a person receiving 125 ml unit dosages can be given 4 or 5 or 6 or 7 or 8 unit dosages per day to provide nutritional support using a liquid enteral nutritional composition according to the invention of 2.0 kcal/ml.
  • Such small dosage units are preferred because of better compliance.
  • the composition is provided in a ready to use liquid form and does not require reconstitution or mixing prior to use.
  • the composition according to the invention can be tube fed or administered orally.
  • the composition according to the invention can be provided in a can, on spike, and hang bag.
  • a composition may be provided to a person in need thereof in powder form, suitable for reconstitution using an aqueous solution or water such that the composition according to the invention is produced.
  • the present composition is in the form of a powder, accompanied with instructions to dissolve or reconstitute in an aqueous composition or water to arrive at the liquid nutritional enteral composition according to the present invention.
  • the present liquid nutritional enteral composition may thus be obtained by dissolving or reconstituting a powder, preferably in an aqueous composition, in particular water.
  • the composition according to the invention is packaged.
  • the packaging may have any suitable form, for example a block-shaped carton, e.g. to be emptied with a straw ; a carton or plastic beaker with removable cover ; a small- sized bottle for example for the 80 ml to 200 ml range, and small cups for example for the 10 ml to 30 ml range.
  • Another suitable packaging mode is inclusion of small volumes of liquid (e.g.
  • Another suitable packaging mode is a powder in a container, e.g. a sachet, preferably with instructions to dissolve or reconstitute in an aqueous composition or water.
  • the liquid enteral nutritional composition according to the invention may be prepared by first preparing the liquid protein composition. This may be done by sequentially or simultaneously dissolving micellar casein in powder form and caseinate in powder form in water. It is also possible to use micellar casein in a wet form, directly prepared from milk. It may even be advantageous to prepare the micellar casein as a part of a continuous process to prepare the composition according to the invention. The latter may be done in the same production facility to prepare the composition according to the invention.
  • a nutritional product may be prepared by subsequently adding the carbohydrates to the protein composition, followed by adding the water-soluble vitamins and other components in one or two stages, mixing, adjusting the resulting composition to the desired viscosity, adding the fat, including fat-soluble vitamins, homogenizing, subjecting the resulting solution to a heat- treatment (pasteurization, sterilisation) and packaging the resulting product.
  • a heat- treatment pasteurization, sterilisation
  • the acidity of the composition is very important during the heat-treatment.
  • the pH should be between about 6.6 and 7.2 for the pasteurisation and sterilisation. Typical pasteurisation times are 30 sec at 85 0 C. Typical sterilisation times are 4 minutes at 124 0 C.
  • the present invention also concerns a method of providing nutrition to a person in need thereof, comprising the steps of administering to said person the nutritional composition according to the present invention.
  • Said person may be an elderly person, a person that is in a disease state, a person that is recovering from a disease state, or a person that is malnourished.
  • the present invention also concerns the simultaneous or sequential use of micellar casein and casemate in the manufacture of a liquid nutritional composition according to the present invention for providing enteral nutrition to a person in need thereof.
  • said composition provides 6 to 14 g of protein per 100 ml of composition, said protein including micellar casein and caseinate, the composition having an energy density of at least 2.0 kcal/ml.
  • said protein provides 10 % to 30 % of the total energy content of the composition, the composition having an energy density of at least 2.0 kcal/ml.
  • the present invention concerns a liquid enteral nutritional composition
  • a liquid enteral nutritional composition comprising : a) about 9.6 g of protein per 100 ml of the composition of a mixture of micellar casein and caseinate with a weight ratio of about 65:35, said protein providing about 16 % of the total energy content of the composition; b) fat providing about 35 % of the total energy content of the composition; c) carbohydrate providing about 49 % of the total energy content of the composition, said composition having an energy density of about 2.4 kcal/ml EXAMPLES
  • composition according to the invention has been prepared (Table 1).
  • Table 1 The composition is produced in a manner known per se, e.g. by mixing the ingredients, without difficulties, is shelf-stable, has desirable organoleptic properties, has a very high nutrient density and is effective for a person in need thereof.

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Abstract

L'invention porte sur des compositions entérales nutritionnelles liquides à haute énergie et à haute teneur en protéine, qui contiennent de la caséine micellaire et du caséinate.
PCT/NL2007/050626 2007-12-05 2007-12-05 Composition nutritionnelle entérale liquide à haute énergie WO2009072869A1 (fr)

Priority Applications (35)

Application Number Priority Date Filing Date Title
PCT/NL2007/050626 WO2009072869A1 (fr) 2007-12-05 2007-12-05 Composition nutritionnelle entérale liquide à haute énergie
ES08858188.9T ES2523198T3 (es) 2007-12-05 2008-12-05 Composición nutricional enteral líquida alta en energía
BRPI0820956A BRPI0820956B8 (pt) 2007-12-05 2008-12-05 composição nutricional enteral líquida esterilizada, método para produzir a composição, uso de uma composição nutricional, e, uso simultâneo ou seqüencial de caseína micelar e, opcionalmente, caseinato
EP08858245A EP2230941A1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide présentant un faible volume spécifique de protéines
CN2008801253397A CN101925307B (zh) 2007-12-05 2008-12-05 高能量液体肠营养组合物
EP08858188.9A EP2230940B1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide riche en énergie
MX2010006199A MX2010006199A (es) 2007-12-05 2008-12-05 Composicion nutricional enterica liquida basada en caseina micelar, densa en cuanto a proteina.
EP14181438.4A EP2818055B1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide ayant une teneur énergétique élevée
RU2010127252/13A RU2471370C2 (ru) 2007-12-05 2008-12-05 Жидкая энтеральная питательная композиция с низким специфическим объемом белка
PCT/NL2008/050776 WO2009072884A1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide présentant un faible volume spécifique de protéines
ES13189113.7T ES2679346T3 (es) 2007-12-05 2008-12-05 Composición nutricional enteral líquida con un alto contenido energético
EP17167341.1A EP3216349B1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide à base de caséine micellaire dense en protéines
PCT/NL2008/050778 WO2009072886A1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide à base de caséine micellaire dense en protéines
BRPI0820951-0A2A BRPI0820951A2 (pt) 2007-12-05 2008-12-05 Composição nutricional enteral líquida, e, método para fornecer nutrição a uma pessoa em necessidade da mesma
CN201210570751.8A CN103054046B (zh) 2007-12-05 2008-12-05 高能量液体肠营养组合物
PL08858188T PL2230940T3 (pl) 2007-12-05 2008-12-05 Wysokoenergetyczna płynna dojelitowa kompozycja odżywcza
EP13189113.7A EP2687106B1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide ayant une teneur énergétique élevée
DK08858188.9T DK2230940T3 (da) 2007-12-05 2008-12-05 Flydende enteral højenergiernæringssammensætning
EP08857136.9A EP2249666B1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide à base de caséine micellaire dense en protéines
PCT/NL2008/050777 WO2009072885A1 (fr) 2007-12-05 2008-12-05 Composition nutritionnelle entérale liquide riche en énergie
ES08857136.9T ES2640728T3 (es) 2007-12-05 2008-12-05 Composición nutricional enteral líquida basada en caseína micelar densa en proteínas
DK08857136.9T DK2249666T3 (en) 2007-12-05 2008-12-05 Protein-rich liquid enteral nutritional composition on a casein basis
MX2010006195A MX2010006195A (es) 2007-12-05 2008-12-05 Composicion nutricional enterica liquida con un volumen de proteina especifico bajo.
US12/746,489 US20110008485A1 (en) 2007-12-05 2008-12-05 Protein-dense micellar casein-based liquid enteral nutritional composition
MX2010006197A MX2010006197A (es) 2007-12-05 2008-12-05 Composicion nutricional enterica liquida con alto contenido de energia.
RU2010127237/13A RU2471371C2 (ru) 2007-12-05 2008-12-05 Обогащенная белком жидкая энтеральная питательная композиция на основе мицеллярного казеина
BRPI0820952-9A BRPI0820952B1 (pt) 2007-12-05 2008-12-05 Composição nutricional enteral líquida tratada termicamente, uso da composição da mesma, e, uso simultâneo ou sequencial de caseína micelar e caseinato
US12/746,135 US20110021421A1 (en) 2007-12-05 2008-12-05 Liquid enteral nutritional composition with a low specific protein volume
US12/746,490 US8409651B2 (en) 2007-12-05 2008-12-05 High energy liquid enteral nutritional composition
CN2008801249546A CN101909468A (zh) 2007-12-05 2008-12-05 具有低蛋白比容的液体肠营养组合物
CN200880126292.6A CN101938911B (zh) 2007-12-05 2008-12-05 富含蛋白的基于胶束酪蛋白的液体肠营养组合物
RU2010127236/13A RU2482705C2 (ru) 2007-12-05 2008-12-05 Высокоэнергетическая жидкая энтеральная питательная композиция
US13/843,330 US8999423B2 (en) 2007-12-05 2013-03-15 High energy liquid enteral nutritional composition
US14/632,918 US9345256B2 (en) 2007-12-05 2015-02-26 High energy liquid enteral nutritional composition
US15/136,036 US20160309765A1 (en) 2007-12-05 2016-04-22 High energy liquid enteral nutritional composition

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/NL2007/050626 WO2009072869A1 (fr) 2007-12-05 2007-12-05 Composition nutritionnelle entérale liquide à haute énergie

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WO2012008858A1 (fr) 2010-07-16 2012-01-19 Fonterra Co-Operative Group Limited Produit laitier et procédé
WO2013129912A1 (fr) * 2012-02-28 2013-09-06 N.V. Nutricia Composition nutritionnelle liquide énergétique ayant des propriétés organoleptiques améliorées
US8815797B2 (en) 2008-03-12 2014-08-26 N.V. Nutricia High protein liquid enteral nutritional composition
US8999423B2 (en) 2007-12-05 2015-04-07 N. V. Nutricia High energy liquid enteral nutritional composition
WO2016174651A3 (fr) * 2015-10-01 2017-01-12 Frieslandcampina Nederland B.V. Composition nutritionnelle liquide comprenant de la caséine micellaire et une protéine lactosérique hydrolysée
WO2017115058A1 (fr) * 2015-12-30 2017-07-06 Even Sante Industrie Composition de nutrition enterale riche en proteines a forte proportion de caseinates
EP2575830B1 (fr) 2010-06-04 2017-08-16 N.V. Nutricia Composition nutritionnelle liquide compacte pré-épaissie pour les patients souffrant de dysphagie
EP3313191A4 (fr) * 2015-06-29 2019-02-20 Leprino Foods Company Caséine micellaire pour succédanés de crème à café et autres produits laitiers
CN111743166A (zh) * 2019-03-26 2020-10-09 株式会社明治 液态营养组合物
US12274285B2 (en) 2018-11-20 2025-04-15 Fonterra Co-Operative Group Limited Dairy product and process

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US9345256B2 (en) 2007-12-05 2016-05-24 N.V. Nutricia High energy liquid enteral nutritional composition
US8999423B2 (en) 2007-12-05 2015-04-07 N. V. Nutricia High energy liquid enteral nutritional composition
US8815797B2 (en) 2008-03-12 2014-08-26 N.V. Nutricia High protein liquid enteral nutritional composition
US9420816B2 (en) 2008-03-12 2016-08-23 N.V. Nutricia High protein liquid enteral nutritional composition
WO2011087784A2 (fr) * 2009-12-22 2011-07-21 Fmc Corporation Compositions dispersibles dans l'eau pour applications alimentaires
WO2011087784A3 (fr) * 2009-12-22 2011-10-20 Fmc Corporation Compositions dispersibles dans l'eau pour applications alimentaires
US10694765B2 (en) 2009-12-22 2020-06-30 DuPont Nutrition USA, Inc. Water-dispersible compositions for food applications
EP2575830B1 (fr) 2010-06-04 2017-08-16 N.V. Nutricia Composition nutritionnelle liquide compacte pré-épaissie pour les patients souffrant de dysphagie
EP2592938A1 (fr) 2010-07-16 2013-05-22 Fonterra Co-Operative Group Limited Produit laitier et procédé
EP2592938A4 (fr) * 2010-07-16 2015-06-17 Fonterra Co Operative Group Produit laitier et procédé
WO2012008858A1 (fr) 2010-07-16 2012-01-19 Fonterra Co-Operative Group Limited Produit laitier et procédé
EP4011212A1 (fr) * 2010-07-16 2022-06-15 Fonterra Co-Operative Group Limited Produit laitier et procédé
EP2592938B1 (fr) 2010-07-16 2021-11-24 Fonterra Co-Operative Group Limited Produit laitier et procédé
WO2013129925A1 (fr) * 2012-02-28 2013-09-06 N.V. Nutricia Composition nutritionnelle liquide énergétique ayant des propriétés organoleptiques améliorées
CN104144617A (zh) * 2012-02-28 2014-11-12 N·V·努特里奇亚 具有改进的感官性质的富含能量的液体营养组合物
WO2013129912A1 (fr) * 2012-02-28 2013-09-06 N.V. Nutricia Composition nutritionnelle liquide énergétique ayant des propriétés organoleptiques améliorées
EP2819528B1 (fr) 2012-02-28 2017-10-25 N.V. Nutricia Composition nutritionnelle liquide riche en energie ayant des proprietes organoleptiques ameliorees
EP3313191A4 (fr) * 2015-06-29 2019-02-20 Leprino Foods Company Caséine micellaire pour succédanés de crème à café et autres produits laitiers
WO2016174651A3 (fr) * 2015-10-01 2017-01-12 Frieslandcampina Nederland B.V. Composition nutritionnelle liquide comprenant de la caséine micellaire et une protéine lactosérique hydrolysée
AU2016255966B2 (en) * 2015-10-01 2020-04-16 Frieslandcampina Nederland B.V. Liquid nutritional composition comprising micellar casein and hydrolysed whey protein
FR3046354A1 (fr) * 2015-12-30 2017-07-07 Even Sante Ind Composition de nutrition enterale riche en proteines a forte proportion de caseinates.
WO2017115058A1 (fr) * 2015-12-30 2017-07-06 Even Sante Industrie Composition de nutrition enterale riche en proteines a forte proportion de caseinates
US12274285B2 (en) 2018-11-20 2025-04-15 Fonterra Co-Operative Group Limited Dairy product and process
CN111743166A (zh) * 2019-03-26 2020-10-09 株式会社明治 液态营养组合物

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