WO2011071365A1 - Composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide adaptée à l'alimentation entérale - Google Patents

Composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide adaptée à l'alimentation entérale Download PDF

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Publication number
WO2011071365A1
WO2011071365A1 PCT/NL2009/050741 NL2009050741W WO2011071365A1 WO 2011071365 A1 WO2011071365 A1 WO 2011071365A1 NL 2009050741 W NL2009050741 W NL 2009050741W WO 2011071365 A1 WO2011071365 A1 WO 2011071365A1
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Prior art keywords
acid
fat composition
composition according
dha
epa
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PCT/NL2009/050741
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English (en)
Inventor
Rogier Daniël VAN ANHOLT
Zandrie Hofman
Wynette Hermina Agnes Kiers
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N.V. Nutricia
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42543137&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2011071365(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by N.V. Nutricia filed Critical N.V. Nutricia
Priority to PCT/NL2009/050741 priority Critical patent/WO2011071365A1/fr
Priority to ES10798405.6T priority patent/ES2464045T3/es
Priority to RU2012128503/13A priority patent/RU2546865C2/ru
Priority to CN201080063293.8A priority patent/CN102753027B/zh
Priority to PL10798405T priority patent/PL2509431T3/pl
Priority to PCT/NL2010/050825 priority patent/WO2011071376A1/fr
Priority to BR112012013541-4A priority patent/BR112012013541B1/pt
Priority to US13/514,275 priority patent/US9044043B2/en
Priority to MX2012006463A priority patent/MX2012006463A/es
Priority to EP10798405.6A priority patent/EP2509431B1/fr
Publication of WO2011071365A1 publication Critical patent/WO2011071365A1/fr

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    • 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
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D7/00—Edible oil or fat compositions containing an aqueous phase, e.g. margarines
    • A23D7/003—Compositions other than spreads
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings, cooking 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
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • This invention relates to a balanced fat composition and use thereof in a liquid nutritional composition, in particular suitable for tube feeding.
  • This invention further relates to said liquid nutritional composition for providing enteral nutrition to patients in need thereof, in particular for providing a complete enteral nutrition, in particular for providing a long-term enteral nutrition.
  • the balanced fat composi- tion and the liquid nutritional composition comprising said balanced fat composition comprises specific amounts of linoleic acid (LA), alpha-linolenic acid (ALA), docosa- hexaenoic acid (DHA), eicosapentaenoic acid (EPA), at least one medium chain fatty acid (MCFA) and at least one mono -unsaturated fatty acid (MUFA).
  • the invention relates further to a method for providing enteral nutrition to a person in need thereof, comprising administering to said person an effective amount of said liquid nutritional composition comprising the balanced fat composition according to the invention.
  • Tube feeding is provided primarily using a device such as a nasogastric feeding tube or a naso-jejunal feeding tube, or by using a percutaneous endoscopic gastrostomy (PEG) or PEG - jejuno-feeding system.
  • a device such as a nasogastric feeding tube or a naso-jejunal feeding tube, or by using a percutaneous endoscopic gastrostomy (PEG) or PEG - jejuno-feeding system.
  • PEG percutaneous endoscopic gastrostomy
  • enteral feeding the state of being fed orally by nutritional supplements or a by a feeding tube
  • enteral nutrition the nutrition used in such feeding
  • Use of such enteral nutrition may be temporary for the treatment of acute conditions, or lifelong in the case of chronic disabilities. In the latter case, it is primordial that the enteral nutrition is designed for long- term administration containing all necessary components. With advances in medicine resulting in increased life expectancy and better disease treatment, a large number of patients would benefit from such enteral nutrition designed to provide long-term enteral nutrition.
  • the aim of the invention to provide a balanced fat composition which is suitable to be used in an enteral nutritional composition and which is in accordance with the general recommendations for a healthy and balanced diet.
  • the balanced fat composition comprised in the enteral nutritional composition should be well-tolerated.
  • the enteral nutritional composition comprising said balanced fat composition according to the invention should be easy to administer by tube, i.e. it should have a low viscosity and a low density, it should be pH neutral, have a good shelf stability, not segregate, agglomerate or sedimentate. It should be suitable for heat treatments (such as sterilization and pasteurization) without a substantial change in structure, pal- atability (especially for oral nutritional compositions), viscosity, etc.
  • the balanced fat composition should be easily mixable with other components, such as a protein fraction, a carbohydrate fraction, a digestible fibre fraction, and other components, e.g. to provide a complete nutritional composition.
  • the inventors have first established that there are no recommendations for a balanced fat composition for patients in need of enteral medical nutrition. To overcome this problem, the inventors have collected a substantial number of recommendations and/or guidelines for a healthy and balanced dietary fat intake of national and international organizations. From this, the inventors defined a range which is defined by the lowest maximum and the highest minimum of those recommendations. Subsequently, the recommendations (in En%) were redefined in terms of weight% and a suitable fat source was researched, however, not a single fat source was able to fulfil the recommendations. Hence, a composition of fat sources was designed to yield the desired balanced fat composition.
  • such balanced fat composition should comprise at least specific amounts of linoleic acid (LA, 18:2n-6), alpha- linolenic acid (ALA, 18:3n-3), docosahexaenoic acid (DHA, 22:6n-3), eicosapen- taenoic acid (EPA, 20:5n-3), at least one medium chain fatty acid (MCFA, e.g. 8:0 and/or 10:0), and at least one mono -unsaturated fatty acid (MUFA, e.g. 16: 1, 18: 1, 20: 1, 22: 1 and/or 24: 1). More in particular, the balanced fat composition contains lower amounts of LA than found in the prior art, in particular in commercial products available from, for example, Abbott, Fresenius, Nestle, and Nutricia.
  • LA linoleic acid
  • ALA alpha- linolenic acid
  • DHA docosahexaenoic acid
  • EPA eicosa
  • said balanced fat composition could be designed based on common fat sources, could be easily manufactured and could be used for the manufacture of a liquid nutritional composition.
  • EP 1 964 554 Al discloses a balanced fat composition suit- able for an enteral nutritional composition with a specific lipid profile, to be used in enteral nutrition products.
  • the fat composition differs from our invention in the fact that is comprises 17.2 to 22.8 weight% (target value 19.95 weight%) of LA and 1.7 to 2.4 weight% of ALA (target value 2.28 weight%).
  • WO 2008/046871 A2 discloses long term tube nutrition for specific patient populations, such as elderly.
  • the fat composition disclosed in the examples differs from our invention in several ways (either lower or higher in LA, no EPA and DHA, or higher in EPA and DHA, and lower in ALA, in comparison with the composi- tion according to the present invention).
  • the present invention relates to a fat composition, in particu- lar for use in a nutritional composition suitable for tube feeding, comprising
  • ⁇ -3 poly-unsaturated fatty acids alpha-linolenic acid ALA, 18:3n-3
  • docosahexaenoic acid DHA, 22:6n-3
  • eicosapentaenoic acid ⁇ -3 poly-unsaturated fatty acids alpha-linolenic acid (ALA, 18:3n-3)
  • DHA docosahexaenoic acid
  • MCFA medium-chain fatty acid
  • the balanced fat composition according to the invention should not substantially contain other components which cannot be classified as fats according to the skilled person.
  • the present invention relates to a liquid nutritional com- position, in particular a complete liquid nutritional composition comprising the balanced fat composition according to the invention.
  • Said liquid nutritional composition is particularly suitable for enteral feeding, in particular for long-term feeding.
  • the present invention relates to a liquid nutritional composition wherein the fat composition comprises between 30 and 50 En%, preferably between 30 and 40 En% of the total energy of the composition.
  • Said liquid nutritional composition is particularly suitable for enteral feeding, in particular for long-term feeding.
  • the % of total energy is also abbreviated as En%; En% is thus short for energy percentage and represents the relative amount that a constituent contributes to the total caloric value of the composition.
  • 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.
  • polyunsaturated fatty acids linoleic acid (18:2n-6, abbreviated as LA, an omega-6 fatty acid) and a-linolenic acid (18:3n-3, abbreviated as ALA, an omega-3 fatty acid) are the only essential fatty acids for humans; all other physiologically and structurally important fatty acids can be derived from these two fatty acids.
  • ARA, EPA, DHA fatty acids
  • EPA, DHA fatty acids
  • LCPs long-chain PUFAs
  • ARA belonging to the omega-6 LCPUFAs
  • EPA and DHA belonging to the omega-3 LCPUFAs.
  • the composition of a diet largely determines the incorporation of these fatty acids into various cells and tissues in a complex way.
  • the fatty acids either derived from the diet or synthesised from precursors, compete on various levels for the same enzymes that determine the incorporation into tissues and/or conversion into bio- logically active metabolites: for enzymes that determine (1) incorporation into phospholipids and tissues, (2) the release from membranes and other stores, (3) the conversion into other fatty acids, and (4) the conversion into various metabolites (eicosanoids, resolvins).
  • enzymes that determine (1) incorporation into phospholipids and tissues, (2) the release from membranes and other stores, (3) the conversion into other fatty acids, and (4) the conversion into various metabolites (eicosanoids, resolvins).
  • eicosanoids and resolvins are involved in a wide variety of physio- logical and immunological processes, regulate the release of a range of hormones and have an effect on nervous system function.
  • Pocesaftexaefloic acid Table 1 gives a Schematic representation of the metabolism of fatty acids in humans that starts with the two essential fatty acids linoleic acid and a-linolenic acid from dietary (plant) sources. From these fatty acids all other important fatty acids can (theo- retically) be derived by enzymatic conversion: desaturation enzymes ( ⁇ 5, ⁇ 6) insert new double bounds between carbon atoms and the enzyme elongase adds carbon atoms to the carbon chain.
  • trans fats mainly derived from processed foods
  • LA omega-6 fatty acids
  • LA linoleic acid
  • MCFA medium-chain fatty acids
  • the wording "balanced”, “better balanced” and the like is used to indicate that the fat composition according to the invention is a better solution to the recommendations for a healthy and balanced fat intake than the existing, commercially available fat compositions. 1. Inclusion of a source of EPA and/or DHA
  • EPA and DHA Increasing the consumption of fish oil, high in the omega-3 fatty acids EPA and DHA, has an effect on a range of physiological and immunological processes, including membrane fluidity and functioning and signal transduction pathways. Most impor- tantly, increasing the intake of EPA and DHA reduces the production of proinflammatory mediators such as cytokines, interleukins and tumor necrosis factor (TNF).
  • proinflammatory mediators such as cytokines, interleukins and tumor necrosis factor (TNF).
  • n-3 PUFA A large number of interventions with elevated intakes of n-3 PUFA have been published with the objective to reduce symptoms of (and sometimes to treat) diseases related to chronic inflammation, including rheumatoid arthritis, asthma, cancer-associated cachexia, and inflammatory bowel disease.
  • diseases related to chronic inflammation including rheumatoid arthritis, asthma, cancer-associated cachexia, and inflammatory bowel disease.
  • Other diseases that have been found to be influenced by consumption of fish oil fatty acids are, among others, cardiovascular diseases (CVD), macular degeneration, osteoporosis, depression, schizophrenia, Attention Deficit/Hyperactivity Disorder (ADHD), eating disorders, cancer, burns, and skin disorders (Calder 2006).
  • CVD cardiovascular diseases
  • ADHD Attention Deficit/Hyperactivity Disorder
  • eating disorders cancer, burns, and skin disorders
  • composition and purity of the available fish oils vary considerably. Not only are these oils different in the total amount of EPA and DHA, but also the ratio of EPA to DHA is subject to variation (see Table 3).
  • EPA and DHA have different functions in the human body; beneficial effects of EPA are principally contributed to the competitive inhibition of eicosanoid synthesis from ARA, attributes of DHA are often linked to membrane functioning. Despite these differences in functionality, many intervention studies provide very little information on the exact intake of these fatty acids, not in the least because these levels can be difficult to determine in the diet.
  • EPA and DHA can also be provided as purified ethyl-esters.
  • Dietary LCPUFAs can also be administered in the form of phospholipids, for example derived from eggs. While some studies reported a superior intestinal absorption of omega-3 LCPUFAs from phospholipids compared to triglycerides (Carnielli et al. 1998), others reported similar appearances of LCPUFAs in the plasma lipid fraction and virtually equal rates of incorporation of ARA and DHA in red blood cells from ei- ther phospholipids or triglycerides in infants (Sala-Vila et al. 2004; Sala-Vila et al. 2006).
  • dietary a-linolenic acid can be converted into long- chain omega-3 fatty acids EPA and DHA via enzymatic conversion.
  • Rich sources of ALA are plant oils such as linseed oil (about 60% ALA), perilla oil (about 50% ALA), and canola oil (about 10%).
  • ALA a-linolenic acid
  • DHA DHA
  • high intakes of ALA will be required to reach the equivalent of the recommended EPA+DHA intakes per.
  • the addition of preformed EPA + DHA seems imperative.
  • omega-3 LCPUFA reduces the risk of several diseases, including cardiovascular diseases.
  • an improvement of general health might be expected from a reduction of pro-inflammatory markers, reduced serum triglycerides, and/or a reduction in blood pressure.
  • Recommended intakes of EPA+DHA vary from 0.15 to 0.5 En%. To meet the minimum recommended intake of most organizations, the daily intake of EPA+DHA should be at least 500 mg/day (based on a minimum daily food intake of 1500 kcal/day).
  • the balanced fat composition according to the invention comprises between 3.0 and 6 wt% of a combination consisting of the ⁇ -3 poly-unsaturated fatty acids alpha- linolenic acid (ALA), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), wherein the amount of ALA > 2.5 wt%, more preferably > 2.7 wt%, or preferably ranges between 2.5 and 4.0 wt%, and the combined amount of DHA and EPA ⁇ 2.5 wt%, preferably ⁇ 1.0 wt%.
  • ALA alpha- linolenic acid
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • the ⁇ -3 poly-unsaturated fatty acids may be present as triglycerides, ethyl-esters, phospholipids, sphingolipids, glycolipids or other food grade forms.
  • Recommendations for an minimum intake of LA vary from 1 to 4% of the total caloric intake per day : the French organizations AFSSA and CNERNA-CNRS provided the highest recommendation of 4 En% for adults. None of the national committees and health councils have included a safe upper limit for LA consumption. Nevertheless, the level of LA in the fat composition that is currently used in a number of commercial products is several times higher than the intake that is considered to be adequate in order to prevent a deficiency. Reasons to limit the LA content to an amount close to the highest recommended (adequate) intake of 4 En% are discussed in the following section.
  • the conversion of the fatty acids LA and ALA into their respective LCPUFAs is controlled by a complex of metabolic factors and the dietary (fatty acid) composition.
  • increasing the dietary intake of LCPUFAs reduces the conversion of LA and ALA presumably due to product downregulation of the desaturation and elongation enzymatic pathways that are responsible for the conversion of LA and ALA (Brenna 2002).
  • Emken et al. (1994) nicely demonstrated that the conversion of LA as well as ALA into their respective LCPUFAs (ARA, EPA, DHA) was reduced by 40- 54%, when the intake of LA was increased from 15 to 30 g/day in volunteers (Emken et al. 1994).
  • LA intakes corresponded to 4.7 and 9.3 En%, respectively (2800 kcal/day diets), which are in the range of normal dietary intakes and of sip and tube feeds currently on the market.
  • EPA and DHA should be supplied via the diet, which is another argument to include fish oil in the composition according to the invention.
  • LA intakes not only reduce the conversion of LA and ALA into long-chain fatty acids, but LA also competes with ALA, EPA, as well as DHA for incorporation into tissue phospholipids: the ratio between the dietary omega-6 and omega-3 fatty acids has a strong effect on the eventual tissue composition. As a consequence, high levels of LA have a marked effect on the efficiency of fish oil supplementation.
  • intakes of ARA a downstream product of LA
  • LA is the predominant PUFA in a normal (western) diet.
  • the level of LA can be regarded as adequate according to all recommendations.
  • this level of 4 En% should preferably be considered as the maximum level for nutritionally complete products.
  • the ratio ⁇ -6 : ⁇ -3 in the fat composition according to the invention is about 2.5: 1 - 3.5: 1, preferably3 : 1 , wherein the term about means a relative deviation of 10 %.
  • the balanced fat composition according to the invention comprises between 10 to
  • LA linoleic acid
  • the linoleic acid may be present as triglycerides, phospholipids, sphingolipids, gly co lipids or other food grade forms.
  • LA fatty acid
  • MUFAs i.e. oleic acid
  • available oils that are rich in MUFAs also contain LA, which means that an increase in the MUFA content results in an increase of the LA content as well.
  • the saturated fatty acid content can be increased: the current saturated fatty acid contents of most of the commercial products are well below the recommended upper intakes (see Table 2).
  • increasing the saturated fatty acid content cannot imme- diately be considered a health benefit, as it for instance increases serum cholesterol levels.
  • MCTs medium-chain fatty acids
  • MCTs medium-chain fatty acid esters of glycerol consisting of 3 medium-chain saturated fatty acids (MCFAs) each comprising 6 to 12 carbon atoms.
  • Natural sources of MCFAs are coconut oils and palm kernel oils. When hydro- lyzed, these oils provide concentrated sources of MCFAs with chain lengths of primar- ily 8 (caprylic or octanoic acid) and 10 (capric or decanoic acid) carbon atoms. Hence, in practice, when MCTs or MCFAs are administered, this is often limited to fatty acids with 8- and 10-carbon chains, although (theoretically) MCFAs also include carbon chains of 6 and 12 carbon atoms.
  • the MCFAs according to the invention are preferably selected from MCTs originating from coconut oils and/or palm kernel oils.
  • the chain length of the MCFAs according to the invention is 6, 7, 8, 9, 10, 11 or 12, preferably 8, 9 or 10, most preferably 8 or 10 carbon atoms long, or any mixture thereof.
  • MCFAs are not considered essential and therefore are not considered a necessary part of the normal diet. Although MCFAs are categorized as saturated fats, they have completely different biochemical and physiological properties compared to long-chain saturated fatty acids, which will be explained below.
  • MCFAs long-chain fatty acids
  • LCFAs long-chain fatty acids
  • MCFAs absorbed from the small intestine are primarily transported via the portal vein to the liver.
  • dietary long-chain triglycerides are first hydrolyzed in the small intestine to LCFAs and re-esterified in the mucosal cells of the small intestine to long-chain triglyerides. They are then incorporated into chylomicrons and reach the circulation via the lymphatic system (Bach et al. 1996; Snook et al. 1996).
  • the digestion and absorption of MCFAs is not dependent on pancreatic enzymes or bile salts. Particularly patients with malabsorption syndromes and/or pancreatic insufficiency will benefit from a diet rich in MCTs/MCFAs and MCFAs are therefore often used as the preferred fat source for these patients (Marten et al. 2006).
  • Beta-oxidation of fatty acids results in the production of acetyl-CoA that enters the Kreb's cycle to produce energy, but acetyl-CoA can also be converted into to acetoacetate, beta-hydroxybutyrate, and acetone, collectively called ketone bodies.
  • the amount of MCFA or MCT required to reduce the LA content is relatively small: e.g. for a commercial product like Nutrison Standard (NV Nutricia) about 4 En% of MCFAs (C8+C10) is sufficient - together with a modification of other vegetable oil sources - to reduce the LA content from 8.3 to 4 En%>. This would correspond to approximately 10 to 15% of the fat composition as MCFA, or 6-8 g MCFA (C8+C10) per day (1500 kcal/day). At these levels, gastrointestinal discomfort is not likely to occur, as much higher levels have been reported to be well tolerated.
  • the overall PUFA can be lowered by increasing the amount of saturated fat: the total saturated fatty acid content of most of the current commercial products is low ( ⁇ 5 En%) and can be increased within the upper recommended levels (10-12 En%).
  • MCFAs are categorised as saturated fat, these fatty acids are easily digestible and are rapidly oxidized to yield energy, in contrast to long-chain fatty acids that are stored in adipose tissue.
  • the inclusion of MCTs/MCFAs can be used as a healthy way of reducing the LA content of the products (within limits). Only small amounts of MCT/MCFA (10-15% of the fat composition) are required to lower the LA content to the desired level of 4 En%, provided that other vegetable oils are modified as well.
  • the balanced fat composition according to the invention comprises between 10 to 20 wt% preferably 14 to 18 wt%, most preferably 15.7 to 16.2 wt% of medium-chain fatty acids (MCFA).
  • MCFA medium-chain fatty acids
  • the medium-chain fatty acids may be present as triglycerides, phospholipids, sphingo lipids, glycolipids or other food grade forms.
  • Unsaturated fatty acids are sensitive to oxidation, which leads to the production of damaging oxygen radicals and oxidative damage to surrounding molecules and cells. As the sensitivity for oxidation of fatty acids depends on the number of double bonds in the fatty acid carbon chain, mono-unsaturated fatty acids (MUFAs) are less susceptible to oxidation than polyunsaturated fatty acids.
  • MUFAs mono-unsaturated fatty acids
  • Atherosclerosis a chronic inflammatory response in the walls of arteries, is triggered by the deposition of lipoproteins (plasma proteins that carry cholesterol and triglycerides) to the arterial wall.
  • Oxidized Low-density lipoprotein (LDL) is believed to be more damaging to the arterial wall than native LDL and oxidation of LDL contributes to the development of atherosclerosis.
  • Elevated concentrations of circulating oxidized LDL show a positive relationship with the severity of acute coronary events and are predictors for CHD both in CHD patients and in the general population (Covas, 2007).
  • the mono-unsaturated fatty acid is preferably selected from the group of palmi- toleic acid (16: 1), oleic acid (18: 1), eicosaenoic acid (20: 1), erucic acid (22: 1), nervoic acid (24: 1) or mixtures thereof. Most preferably, the mono-unsaturated fatty acid comprises oleic acid. Most preferably, at least 80 wt% of the mono-unsaturated fatty acid is oleic acid.
  • the balanced fat composition according to the invention comprises between 35 to79 wt%, preferably 50 to 70 wt%, most preferably 50 to 60 wt% of at least one mono-unsaturated fatty acid.
  • Suitable sources to increase the MUFA content are for example high oleic sunflower oil, high oleic safflower oil, and olive oil.
  • the mono-unsaturated fatty acids may be present as triglycerides, phospholipids, sphingolipids, glycolipids or other food grade forms.
  • the fat composition may be available as a combination or mixture as such, it may be available as a set of components in a defined concentration in a nutritional composition, it may be manufactured as such, or it may be manufactured by adding the different components LA, ALA, DHA, EPA, MCFA and MUFA, or sources comprising said components together with other ingredients to produce a nutritional composition comprising the fat composition according to the invention. It may also be available as a kit of parts, comprising the separate components LA, ALA, DHA, EPA, MCFA and MUFA, or sources comprising said components to be combined together in the defined amounts, optionally accompanied by instructions how to do so.
  • the fat composition according to the invention may further comprise a further fatty acid, preferably a fatty acid selected from the group of saturated fatty acids other than MCFA and poly-unsaturated fatty acids other than ALA, DHA and EPA.
  • a further fatty acid preferably a fatty acid selected from the group of saturated fatty acids other than MCFA and poly-unsaturated fatty acids other than ALA, DHA and EPA.
  • the fat composition according to the invention may be manufactured by a skilled person by combining the appropriate fat fat sources in appropriate amounts.
  • the following sources can be combined : Canola oil, high oleic sunflower oil, fish oil and MCT oil. More in particular are combined : about 37 wt% of Canola oil, about 42 wt% of high oleic sunflower oil, about 2 wt% of fish oil and about 17 wt% of MCT oil. It will be obvious to the skilled person that the amounts given above may vary to a certain extent depending on the specific composition of the fat source.
  • the balanced fat composition according to the invention makes it possible to produce a liquid enteral nutritional composition with a long shelf life and with a low viscosity.
  • the invention also pertains to a balanced fat composition according to the invention for use in the manufacture of a liquid nutritional composition, in particular for use as a tube feed, most in particular for long-term tube feeding.
  • the invention relates to a liquid nutritional composition
  • a liquid nutritional composition comprising a fat composition which comprises
  • LA linoleic acid
  • ALA alpha-linolenic acid
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • MCFA medium-chain fatty acid
  • the liquid nutritional composition according to the invention comprises the balanced fat composition according to the invention, which balanced fat composition comprises at least between 30 and 50 En%, preferably between 30 and 40 En% of the total energy of the composition.
  • the liquid nutritional composition according to the invention comprises at least 0.4 kcal/ml, preferably at least 0.7 kcal/ml, more preferably at least 0.9 kcal/ml of composition.
  • composition according to the invention is designed to either supplement a person's diet or to provide complete nutritional support.
  • the composition accord- ing to the invention may further comprise at least protein 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 viscosity of the liquid enteral nutritional composition is lower than 500 mPa.s, measured at 20 °C (i.e. room temperature) at a shear rate of 100 s "1 , preferably between 10 and 200 mPa.s, more preferably between 10 and 100 mPa.s, most preferably below 50 mPa.s.
  • the viscosity may suitably be determined using a rotational viscosity meter using a cone/plate geometry. This viscosity is ideal for orally administering the liquid enteral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity such as that displayed by the present invention. This viscosity is also ideal for unit dosages that are tube fed.
  • the density of the composition ranges between 1.00 g/ml and 1.20 g/ml, especially between 1.05 g/ml and 1.15 g/ml.
  • the liquid enteral nutritional composition according to the invention preferably has the form of a complete food, i.e. it can meet all nutritional needs of the user.
  • the liquid enteral nutritional composition according to the invention preferably contains 1000 to 2500 kcal per daily dosage. Depending on the condition of the patient, a daily dose is about 25 to 35 kcal/kg bodyweight/day. Therefore, a typical daily dose for a 70 kg person contains about 2000 kcal.
  • the complete food can be in the form of multiple dosage units, e.g. from 8 (250 ml/unit) to 2 units (1 1/unit) per day for an energy supply of 2000 kcal/day using a liquid enteral nutritional composition according to the invention of 1.0 kcal/ml.
  • the nutritional composition is adapted for tube feeding.
  • the liquid enteral nutritional composition can also be an oral food supplement, for example to be used in addition to a non-medical food or normal diet.
  • the liquid enteral nutritional composition contains per daily dosage less than 1500 kcal, in particular as a supplement, the liquid enteral nutritional composition contains 500 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 units (50 ml/unit) per day for an energy supply of 500 kcal/day using a liquid enteral nutritional composition according to the invention of 1.0 kcal ml.
  • the nutritional composition is packaged, stored and provided in a container such as plastic bag or a pouch or the like.
  • a container such as plastic bag or a pouch or the like.
  • a variety of such containers is known, for example 500 ml, 1000 ml, and 1500 ml containers are known in the art. It should be noted that any suitable container can be used to package, store and provide the nutritional composition according to the invention.
  • 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 accord- ing 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.
  • Another suitable packaging mode is inclusion of small volumes of liquid (e.g. 10 ml to 20 ml) in edible solid or semisolid hulls or capsules, for example gelatine-like coverings and the like.
  • 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 present invention also concerns a method of providing nutrition to a person in need thereof, comprising administering to said person an effective amount of the nutritional composition according to the present invention comprising the balanced fat composition according to the 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 is also related to providing long-term tub-fed nutrition to patients in need thereof.
  • long-term means greater than one month (30 days). It is obvious that nutrition, when suitable for long-term nutrition, is also suitable for any other shorter period of nutrition, such as medium-term nutrition (10 to 30 days) and short-term nutrition (between 1 and 10 days).
  • tube nutrition is designed for maintenance patients.
  • maintenance patient refers to an patient, being any human of any age, in particular children, adults and elderly, who is unable to receive nutrition through a normal diet but who is normo-metabolic, i.e. not suffering from a metabolic disorder.
  • normo-metabolic i.e. not suffering from a metabolic disorder.
  • normal diet means to receive at least substantially all nutrition by eating, i.e.
  • enteral nutritional composition according to the invention is provided for maintenance, it is not directed to treatment of any specific dis- order, such as cancer, HIV, diabetes, e.a.
  • Patients are typically stable, normo- metabolic, healthy patients except for the fact that they require enteral nutrition in order to meet the necessary nutritional requirements.
  • these patients may suffer from a variety of disorders including swallowing disorders of a variety of etiologies, particu- larly surgical consequences of ear/nose/throat cancer, and patients suffering from a cerebral vascular accident.
  • omega-6 linoleic acid LA
  • LA omega-6 linoleic acid
  • the highest intake of LA refers to the general consumption in the United States, while the lowest level of LA corresponds to the intake in the Philippines estimated from commodities data for the domestic supply of foods for human consumption.
  • the required intakes of omega-3 LCPUFAs are calculated from an empirical formula that takes into account the competition of the various PUFAs for incorporation into tissues. The graph is based on data from Hibbeln et al. 2006.
  • the following balanced fat composition can suitably be used in an enteral composition according to the invention (Tables 4 and 5).

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  • Oil, Petroleum & Natural Gas (AREA)
  • Health & Medical Sciences (AREA)
  • Mycology (AREA)
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  • Pediatric Medicine (AREA)
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Abstract

La présente invention concerne une composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide, en particulier adaptée à l'alimentation par sonde. L'invention concerne, en outre, ladite composition nutritionnelle liquide capable d'assurer une nutrition entérale à des patients en ayant besoin, en particulier une nutrition entérale complète et, plus particulièrement encore, une nutrition entérale à long terme. Cette composition lipidique équilibrée et la composition nutritionnelle liquide contenant ladite composition lipidique équilibrée contiennent, plus précisément, des quantités déterminées d'acide linoléique (AL), d'acide alpha-linolénique (ALA), d'acide docosahexaénoïque (ADH), d'acide eicosapentaénoïque (AEP), au moins un acide gras à chaîne moyenne (AGCM) et au moins un acide gras mono-insaturé (AGMI). L'invention concerne, en outre, un procédé de nutrition entérale mis en œuvre chez des patients en ayant besoin, cela comprenant l'administration d'une quantité efficace de ladite composition nutritionnelle liquide contenant la composition lipidique équilibrée selon l'invention.
PCT/NL2009/050741 2009-12-07 2009-12-07 Composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide adaptée à l'alimentation entérale WO2011071365A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
PCT/NL2009/050741 WO2011071365A1 (fr) 2009-12-07 2009-12-07 Composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide adaptée à l'alimentation entérale
EP10798405.6A EP2509431B1 (fr) 2009-12-07 2010-12-07 Composition de graisses équilibrée et son utilisation dans une composition nutritionnelle liquide appropriée à une alimentation entérale
PL10798405T PL2509431T3 (pl) 2009-12-07 2010-12-07 Zrównoważona kompozycja tłuszczowa i jej zastosowanie w płynnej kompozycji żywieniowej odpowiedniej do żywienia dojelitowego
RU2012128503/13A RU2546865C2 (ru) 2009-12-07 2010-12-07 Сбалансированные жировые композиции и их применение в жидких питательных композициях для энтерального питания
CN201080063293.8A CN102753027B (zh) 2009-12-07 2010-12-07 平衡脂肪组合物及其在适合肠饲的液体营养组合物中的用途
ES10798405.6T ES2464045T3 (es) 2009-12-07 2010-12-07 Composición equilibrada de grasas y uso de la misma en una composición nutricional líquida para alimentación enteral
PCT/NL2010/050825 WO2011071376A1 (fr) 2009-12-07 2010-12-07 Composition de graisses équilibrée et son utilisation dans une composition nutritionnelle liquide appropriée à une alimentation entérale
BR112012013541-4A BR112012013541B1 (pt) 2009-12-07 2010-12-07 composição de gordura, composição nutricional líquida, e uso da composição nutricional líquida
US13/514,275 US9044043B2 (en) 2009-12-07 2010-12-07 Balanced fat composition and use thereof in a liquid nutritional composition suitable for enteral feeding
MX2012006463A MX2012006463A (es) 2009-12-07 2010-12-07 Composicion de grasa balanceada y uso de la misma en una composicion liquida alimenticia adecuada para alimentacion enteral.

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PCT/NL2009/050741 WO2011071365A1 (fr) 2009-12-07 2009-12-07 Composition lipidique équilibrée et son utilisation dans une composition nutritionnelle liquide adaptée à l'alimentation entérale

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PCT/NL2010/050825 WO2011071376A1 (fr) 2009-12-07 2010-12-07 Composition de graisses équilibrée et son utilisation dans une composition nutritionnelle liquide appropriée à une alimentation entérale

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WO2010126353A1 (fr) 2009-04-27 2010-11-04 N.V. Nutricia Mélange de protéines à base de pois et utilisation de celui-ci dans une composition nutritionnelle liquide appropriée pour l'alimentation entérale
ES2478869T3 (es) * 2010-01-29 2014-07-23 N.V. Nutricia Composición nutricional enteral líquida adecuada para alimentación por sonda
WO2015013678A2 (fr) * 2013-07-25 2015-01-29 Iycus, Llc Compositions d'acides gras stables
CN108402467A (zh) * 2018-03-01 2018-08-17 苏州恒瑞健康科技有限公司 一种提高肿瘤患者营养需求的组合物及其应用、用于提高外源性脂肪利用率的食品及药品
EP3586640A1 (fr) 2018-06-21 2020-01-01 Nuseed Pty Ltd Compositions d'acides gras polyinsaturés enrichies en dha

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CN102753027B (zh) 2014-12-17
CN102753027A (zh) 2012-10-24
RU2012128503A (ru) 2014-01-20
EP2509431B1 (fr) 2014-02-26
BR112012013541A8 (pt) 2015-10-13
MX2012006463A (es) 2012-11-23
US9044043B2 (en) 2015-06-02
EP2509431A1 (fr) 2012-10-17
PL2509431T3 (pl) 2014-08-29
BR112012013541A2 (pt) 2015-09-15
BR112012013541B1 (pt) 2018-11-06
US20120309831A1 (en) 2012-12-06
RU2546865C2 (ru) 2015-04-10
ES2464045T3 (es) 2014-05-30

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