MXPA01006267A - Fibre blend for enteral composition - Google Patents

Abstract

An enteral composition which contains a protein source, a lipid source, a carbohydrate source, and a fibre blend. The fibre blend contains inulin and fructo-oligosaccharides and has 45 to 55%by weight of the blend of soluble fibre and 45 to 55%by weight of the blend of insoluble fibre. The fibre blend may also contain pea inner fibres and pea outer enveloppe fibres.

Description

FIBER MIX FOR ENTERAL COMPOSITION DESCRIPTION OF THE INVENTION This invention relates to a fiber mixture for inorganic compositions. The invention also relates to the enteric compositions containing the fiber mixture. It is now well accepted that dietary fibers should be part of the daily food intake. For example, Pilch S.M. (1987, MD Federation of American Societies for Experimental Biol., 223, 84, 2059) recommends that the amount of dietary fiber in the daily food intake of healthy persons should be in the order of 27 to 40 gr. Dietary fibers can be classified according to their properties, their chemical and physical structures, their digestibility during gastrointestinal transit, or their physiological properties during gastrointestinal transit. Chemically, dietary fibers are considered to comprise polysaccharides or lignin. These compounds are not hydrolyzed by endogenous secretions during gastrointestinal transit (T. Schweizer et al., 1991; Experimentia, 44, p 182-186). The constituent polysaccharides of dietary fibers can be polysaccharides of plant membranes, in particular cellulose, hemicellulose or pectin, or other intracellular polysaccharides which are not hydrolyzed by digestive enzymes, such as resistant starch, galactomannans or inulin (Quemener et al., 1994, Lebensm, Wiss, u Technol., 27 p.125-132). Ordinarily, dietary fibers are classified into two categories depending on their biological and physicochemical properties. These categories are insoluble fibers and soluble fibers. Insoluble fibers, such as cellulose, corn fibers or insoluble soy fibers, essentially have a mechanical role in the gastrointestinal tract. These are in general only very slightly fermented by the intestinal flora and contribute to reduce the duration of intestinal transit (Scheppach et al., 1990, JPEN, 14, pp. 202-209). Soluble fibers, such as pectin, inulin or resistant starch, are a very good substrate for fermentation, for the intestinal flora. The result of this fermentation is a release of fatty acids, in particular short-chain fatty acids in the colon. This has the effect of reducing the pH value in the colon. The result is a reduction in the development and growth of pathogenic bacteria in the colon. In general, most humans in industrialized societies do not consume enough dietary fiber. However, from a clinical point of view, the problem becomes acute. For example, the administration of an enteral composition free of dietary fibers frequently causes intestinal disorders such as diarrhea or constipation in patients (Palacio et al., 1990; Nutri tion in clinical practice, 5, pp. 99-106). Therefore, it has been proposed to include dietary fibers in oral compositions for clinical nutrition. For example, European patent application 0591267 describes a fiber system for the inorganic compositions comprising, by weight, 5 to 50% gum arabic, 5-25% sodium carboxymethylcellulose and 45-80% envelope fiber. oats. In addition, European patent application 0756828 describes inert compositions containing dietary fibers to maintain good intestinal function. This composition, which is in liquid form or in dehydrated form, contains, for 2000 kcal, 15-50% of soluble dietary fibers, 15-45% of insoluble dietary fibers and 8-70% of oligosaccharides or resistant starch.

However, most of the known compositions of the invention do not contain a balance of soluble and insoluble dietary fibers. In addition, those compositions that contain higher proportions of soluble fibers are often too viscous for tube feeding. Problems with stability also arise. In consecuense, this invention provides a mixture of fibers for an enteral composition, comprising the mixture of fibers, internal pea fibers, fibers of the outer shell of the pea, inulin, and fructo-oligosaccharides. The fiber mixture provides the enteral composition with good mechanical properties and good nutritional and biological properties. Mechanical properties include decrease and duration of gastrointestinal transit. The nutritional and biological properties include the release of short-chain fatty acids to maintain the bacterial balance in the intestinal mucosa and to prevent the development and growth of pathogenic bacteria. The mixture of fibers can act on the entire gastrointestinal system, at the level of the stomach, the small intestine and the colon. In addition, a balance between soluble and insoluble fibers can be obtained without the enteral composition becoming too viscous. The fiber blend may contain about 20 to about 50% by weight of domestic pea fibers, about 20 to about 50% by weight of pea outer wrap fibers, about 5% to about 30% by weight of inulin, and about 10% to about 40% by weight of fructo-oligosaccharides. The invention also provides an enteral composition which contains the fiber mixture defined above. The enteral composition may also contain a protein source, a carbohydrate source and a lipid source. Preferably, the protein source provides about 10% to about 20% energy, the lipid source provides about 30% at "about 50% energy, and the carbohydrate source provides about 35% to about 55% energy. Yet another aspect, this invention provides an enteral composition which comprises a protein source, a lipid source, a carbohydrate source, and a fiber mixture comprising inulin and fructo-oligosaccharides and having 45 to 55% by weight of the mixture of soluble fiber and 45 to 55% by weight of the insoluble fiber mixture In a further aspect, this invention provides an enteral composition which comprises a source of proteins, a source of lipids, a source of carbohydrates, and a fiber mixture comprising about 20% to about 40% by weight of inulin and about 60% to about 80% by weight of fructo-oligosaccharides. ~ " The enteral composition may be in the liquid form or in the form of a soluble powder which is reconstitutable in an aqueous liquid to provide a liquid nutritional composition. The enteral composition may also be in other enterally administrable forms such as desserts, cereals, sandwich bars, and the like. The embodiments of the invention are now described by way of example only. In this specification, the term "soluble fiber" means those dietary fibers that are characterized as soluble using the method of Prosky et al.; 1988; J. Assoc. Off. Anal Chem, 70, 5, 1017. This is the official method of the Association of Official Analytical Chemists. The term "insoluble fiber" means those dietary fibers that are characterized as insoluble using the method of Prosky et al. The invention provides a fiber mixture containing inulin and fructo-oligosaccharides. This mixture has an optimal bifidogenic effect and production of short chain fatty acids in the colon. The fiber mixture can have almost equivalent amounts of soluble fiber and insoluble fiber. The fiber mixture may also contain internal pea fibers and fibers from the outer shell of the pea. Within the context of this specification the term "internal pea fibers" means the fibers of the internal part of the outer shell of the pea or the testa. These comprise cellulose, hemicellulose and pectin; for example about 15% by weight of cellulose, about 45% by weight of hemicellulose and about 40% by weight of pectin. With this fiber distribution, approximately 66% by weight of the fibers are insoluble fibers. Therefore, the internal fibers of pea contribute mechanically to the gastrointestinal transit by reducing the transit time. In addition, the components of the internal pea fibers are fermented by the intestinal fiber to release short chain fatty acids. This release causes a reduction in the pH in the colon and, as a result, a decrease in the growth and development of the pathogenic bacteria in the colon. Suitable internal pea fibers are commercially available. The release of fatty acids is of greater importance for patients who are treated with antibiotics because, during treatment with antibiotics, the identity and function of the intestinal flora is compromised. A diet high in soluble fibers reduces these effects. In addition, the release of short chain fatty acids, such as butyrate, causes the absorption of water together with the absorption of sodium ions in the colon. This one has the effect of diarrhea. Also, butyrate is a high-energy substrate for the colonocytes. Within the context of this specification the term "fibers of the outer shell of the pea" means the fibers coming from the outer shell of the pea or testa. These comprise cellulose, hemicellulose and lignin; for example about 68% by weight of cellulose, about 25% by weight of hemicellulose and about 7% by weight of lignin. With this fiber distribution, about 10% by weight of the fibers are insoluble fibers and about 90% by weight are insoluble fibers. Therefore, the outer wrap fibers of the pea contribute mechanically to gastrointestinal transit by reducing transit time and have a positive effect on the ability to retain water in the intestine. Suitable outer pea wrap fibers are commercially available. Inulin is a soluble fiber that is present in numerous plants, such as asparagus, artichokes, onions, wheat or chicory, for example. Inulin is not digested in the small intestine; rather, it is fermented in the colon. The main effects of inulin fibers on the digestive system are a decrease in the duration of intestinal transit, a decrease in the level of glycemia, a decrease in the content of lipids in the blood, a decrease in the pH in the colon, they reduce constipation and a bifidogenic effect. In this way, inulin can be fermented by bifidobacteria, which has the consequence of increasing the concentration of these bacteria at the level of the intestinal flora and decreasing the concentration of enterobacteria, in particular Clostridiae, at the level of the intestinal flora. Inulin can be provided in the form of a natural extract that is suitable for human consumption. The chicory extracts are particularly suitable. The extract preferably contains at least 80% by weight of inulin; more preferably at least 90% by weight of inulin. The inulin preferably has a degree of polymerization of at least about 8; for example about 10 to about 25. Suitable inulin extracts can be obtained from Orafti SA of Tirlemont 3300, Belgium under the tradename "Raftiline". For example, inulin can be provided in the form Raftiline®ST which is a fine white powder containing about 90 to about 94% by weight of inulin, up to about 4% by weight of glucose and fructose, and about 4 to 9% by weight. sucrose weight. The average degree of polymerization of inulin is from about 10 to about 12. Fruit-oligosaccharides are soluble fibers that are in the form of fructose oligomers containing 1-cestose (GF2), nystase (GF3), and lF. -fructofuranosyl-nistose (GF4), in which the furctosyl units (F) are linked in the β-2,1 position of sucrose (GF) respectively. In general, amounts of sucrose, and glucose may also be present. The fructo-oligosaccharides can be obtained by the hydrolysis of inulin, by enzymatic means, or by the use of micro-organisms. The fructo-oligosaccharides can be obtained commercially, for example from Orafti SA of Tirlemont 3300, Belgium under the tradename "Raftilose", or from Meiji Seika CO, of Japan. For example, inulin can be provided in the form of Raftilose®P95. Inulin and fructo-oligosaccharides are reported as promoters of the growth of bifidobacteria in the gastrointestinal tract and, in certain circumstances, prevent or decrease the growth of pathogens such as Clostridiae. In addition, the promotion of the development of bifidobacteria is reported to have several other beneficial effects. In addition, inulin and fructo-oligosaccharides can reduce blood glucose levels. The mixture has the particular advantage of providing optimal bifidogenic effect and production of short chain fatty acids in the colon. It was found that fructo-oligosaccharides have a greater bifidogenic effect than inulin, but that inulin has delayed fermentation such that it is preferably fermented in the colon. By selecting a mixture of inulin and fructo-oligosaccharides, the bifidogenic effect and the production of short-chain fatty acids in the colon can be maximized. The fiber mixture may also contain other oligosaccharides, if desired. Suitable examples are galacto-oligosaccharides, xylo-oligosaccharides or oligo starch derivatives. The amounts of the components of the fiber blend are preferably selected such that the fiber blend comprises about 45% to about 55% by weight of soluble fibers and about 45% to about 55% by weight of insoluble fibers. This ratio makes it possible to exploit better the advantages of each of these two types of fiber. Preferably, the weight ratio of the soluble fibers to the insoluble fibers is about 1: 1. In addition, the amounts of the components of the fiber mixture are preferably selected such that the fiber mixture comprises about 20% to about 40% by weight of inulin and about 60% to about 80% by weight of fructo-oligosaccharides. For example, the fiber mixture may comprise about 30% by weight of inulin and about 70% by weight of fructo-oligosaccharides. Preferably, the fiber blend comprises about 20 to about 50% by weight of internal pea fibers, about 20 to about 50% by weight of pea outer wrap fibers, about 5% to about 30% by weight of inulin, and about 10% to about 40% by weight of fructo-oligosaccharides. For example, the fiber mixture may comprise about 30 to about 40% by weight of internal peas fibers, about 30 to about 40% by weight of fibers of the outer shell of the peas, about 5% to about 15% by weight. inulin, and about 20% to about 30% by weight of fructo-oligosaccharides. The fiber mixture can be included in an enteral composition. The enteral composition may comprise about 1% to about 5% by weight of the fiber mixture; for example about 1% to about 2% by weight. Preferably, the enteral composition includes a protein source, a carbohydrate source and a lipid source. The protein source is preferably a source of high quality protein; for example milk protein, whey protein, casein protein, or soy protein, or mixtures of these proteins. The protein source may be in the form of intact protein or it may be hydrolyzed. Other sources of protein such as rice, pea and oat protein, or mixtures thereof, may also be used. In addition, if desired, the protein source can include free amino acids.

The protein source preferably provides about 10% to about 25% of the energy of the composition. For example, the protein source can provide about 12% to about 18% of the energy of the composition; preferably about 15% of the energy of the composition. Preferably, the carbohydrate source can be any suitable carbohydrate or mixtures of carbohydrates. For example, the carbohydrate source can be maltodextrin, modified starch, amylose starch, tapioca starch, corn starch, or fructose, or mixtures thereof. Maltodextrin is preferred if low osmolarity is required. The carbohydrate source provides about 35% to about 60% of the energy of the composition; preferably about 45% to about 55% of the energy. For example, the carbohydrate source can provide approximately 50% of the energy of the composition. The lipid source preferably contains monounsaturated fatty acids; polyunsaturated fatty acids (omega-3 and omega-6 fatty acids), and / or saturated fatty acids. Preferably, the polyunsaturated fatty acids provide up to about 30% of the weight of the lipid source. For example, polyunsaturated fatty acids can provide about 15% to about 25% of the weight of the lipid source. The lipid profile of the enteral composition is preferably designed to have a ratio of omega-6 (n-6) to omega-3 (n-3) polyunsaturated fatty acid from about 4: 1 to about 10: 1. The saturated fatty acids preferably provide about 30% to about 70% of the weight of the lipid source; for example about 50% to about 65% by weight. Most of the saturated fatty acids are preferably in the form of medium chain triglycerides. For example, medium chain triglycerides can constitute about 20% to about 70% by weight of the lipid source. Suitable sources of lipids are olive oil, corn oil, sunflower oil, rape seed oil, corn oil, hazelnut oil, safflower oil and the like. Fractionated coconut oils are a soluble source of medium chain triglycerides. A mixture of corn oil, rape seed oil, medium chain triglycerides and soybean oil can be used. The lipid source can provide about 25% to about 45% of the energy of the composition; preferably about 30% to about 45%. For example, the lipid source can provide about 35% of the energy of the composition. For clinical applications, the enteral composition preferably includes a complete profile of vitamins and minerals. For example, sufficient vitamins and minerals can be provided to supply approximately 25% to approximately 250% of the recommended daily amount of vitamins and minerals per 1000 calories of the nutritional composition. For clinical applications, the enteral composition conveniently has an osmolarity of about 200 mOsm / 1 to about 400 mOsm / 1; for example about 250 mOsm / 1 to about 350 mOsm / 1. For clinical applications, the energy density of the enteral composition is preferably from about 700 kcal / 1 to about 1500 kcal / 1; for example approximately 1000 kcal / 1. For clinical applications, the enteral composition is preferably in the form of a ready-to-use formulation. In this form, the composition can be fed to a patient via a nasogastric tube, tube in the jejunum or the patient has to drink it. As such, the enteral composition can be in a variety of forms; for example as a fruit juice type drink, a liquefied milk type drink and the like. However, the enteral composition may be in the form of soluble powder to be reconstituted before use. Various flavors, sweeteners and other additives may be present. Artificial sweeteners such as acetosulfame and L-aspartyl-based sweeteners can be used, for example, drop me. The enteral composition can be produced as is conventional; for example, by mixing together the source of protein, the source of carbohydrate and the source of lipids. If used, emulsifiers can be included in the mixture. Vitamins and minerals can also be added at this point but are usually added later to avoid thermal degradation. Any lipophilic vitamins, emulsifiers and the like can be dissolved within the source of the lipid before mixing. The water, preferably water that has been subjected to reverse osmosis, can then be mixed in the form of a liquid mixture. The temperature of the water is conveniently from about 50 ° C to about 80 ° C to aid in the dispersion of the ingredients. Commercially available blenders can be used to form the liquid mixture. The liquid mixture can then be thermally treated to reduce bacterial loads. For example, the liquid mixture can be rapidly heated to a temperature in the range of about 80 ° C to about 110 ° C for about 5 seconds to about 5 minutes. This can be carried out by steam injection or by heat exchanger; for example, a plate heat exchanger. The liquid mixture can then be cooled to about 60 ° C to about 85 ° C; for example by instantaneous cooling. The liquid mixture is then homogenized; for example in two stages at about 7 MPa up to about 40 MPa in a first stage and about 2 MPa up to about 14 MPa in the second stage. The homogenized mixture can then be further cooled to add any heat-sensitive components; such as vitamins and minerals. The pH and solids content of the homogenized mixture is conveniently standardized at this point. For a product in the liquid form, the homogenized mixture is preferably aseptically filled into suitable containers. The aseptic filling of the containers can be carried out by preheating the homogenized mixture (for example at about 75 to about 85 ° C) and then injecting steam into the homogenized mixture to raise the temperature to about 140 to 160 ° C; for example at approximately 150 ° C. The homogenized mixture can then be cooled, for example by instantaneous cooling, to a temperature of about 75 to 85 ° C. The homogenized mixture can then be further homogenized, cooled to about room temperature and filled into containers. The suitable apparatus for carrying out aseptic filling of this nature is commercially available. For a product in powder form, the homogenized mixture is dried to a powder; for example by spray drying. Conventional procedures can be used. When in a liquid form suitable for use in clinical nutrition, the enteral composition can be easily administered by tube feeding, either by gravity, or by using a pump. In this form, the enteral composition may have a viscosity of less than about 12 cp at room temperature.

The enteral composition can be used as a nutritional support for human or animal patients; particularly patients who require long-term nutritional support. In addition, the enteral composition is suitable for patients with normal digestive function. It will be appreciated that the enteral composition may be in forms other than those suitable for clinical nutrition. For example, the enteral composition may be in the form of desserts, cereals, yogurts, snack bars and the like. If fed to pets, the enteral composition may be in the form of dry croquettes, meat emulsions, and formulated emulsion products. Specific examples of the fiber mixture are now described for further illustration.

Example 1 An enteral composition is prepared by mixing together internal pea fibers, pea outer wrap fibers, fructo-oligosaccharides and inulin, in demineralized water at about 65-70 ° C. The quantities of each component are selected to provide 4 g / 1 of internal pea fibers, 4 g / 1 of outer pea wrap fibers, 2.8 g / l of fructo-oligosaccharides and 1.2 g / l of inulin in the final product . The mixture is stirred for 5 minutes, homogenized and stored under agitation. A lipid phase is prepared by mixing the corn oil, rape seed oil, soybean oil and medium chain triglycerides in an amount to provide 39 g / 1 of the lipid in the final product. Approximately 1.4 g / 1 of an emulsifier, glycerol stearate, is added. The lipid phase is then mixed with the fiber mixture and homogenized. The obtained emulsion is cooled to 60 ° C. Approximately 38 g / 1 of a protein mixture comprising casein and soy protein, approximately 12.5 g / 1 carbohydrate, and mineral are added. An aqueous solution of vitamin is then added. The pH is then adjusted to 7.1. The enteral composition is heat treated at 150 ° C for 6 seconds, cooled, aseptically filled in flexible containers and stored at room temperature. The components of the enteral composition are as follows: The ratio of? -6: -? - 3 is 7 and the osmolarity is 270 mosm / 1. After a month of storage, the particle size, viscosity, texture and stability of the enteral composition are determined. In addition, a flavor evaluation of the enteral composition is carried out. The results are as follows: The results show that the enteral composition has characteristics that are highly advantageous for use in the field of enteral nutrition. For example, this composition, due to its low viscosity, can be easily fed into the tube using gravity. In addition, the composition has excellent stability.

Example 2 The enteral composition of Example 1 is administered to patients by the enteral route, using gravity. The enteral composition flows to the patient at a regular flow rate.

Claims (10)

1. A mixture of fiber for an enteral composition, the fiber mixture comprises internal pea fibers, fibers of the outer shell of the pea, inulin, and fructo-oligosaccharides.

2. A fiber mixture according to claim 1, comprising 20 to 50% by weight of internal pea fibers, 20 to 50% by weight of outer pea fiber, 5% 30% by weight of inulin, and 10% to 40% by weight of fructo-oligosaccharides.

3. A fiber mixture according to claim 2, comprising 30 to 40% by weight of internal pea fibers, 30 to 40% by weight of outer pea fiber, 5% to 15% by weight of inulin , and 20% to 30% by weight of fructo-oligosaccharides.

4. A fiber mixture according to claim 2, which contains from 45 to 55% by weight of soluble fiber and 45 to 55% by weight of insoluble fiber.

5. An enteral composition comprising a protein source, a lipid source, a carbohydrate source, and a fiber mixture comprising internal pea fibers, fibers from the outer shell of the pea, inulin and fructo-oligosaccharides.

6. An enteral composition according to claim 5, wherein the fiber mixture comprises 20 to 50% by weight of internal peas fibers, 20 to 50% by weight of fibers of the outer shell of the peas, 5% to 30% by weight of inulin, and 10% to 40% by weight of fructo-oligosaccharides.

7. An enteral composition according to claim 6, wherein the fiber mixture comprises 30 to 40% by weight of domestic peas fibers, 30 to 40% by weight of fibers of the outer shell of the peas, 5% to 15% by weight of inulin, and 20% to 30% by weight of fructo-oligosaccharides.

8. An enteral composition according to claim 6, wherein the fiber mixture contains from 45 to 55% by weight of soluble fiber and 45 to 55% by weight of insoluble fiber.

9. An enteral composition comprising a protein source, a lipid source, a carbohydrate source, and a fiber mixture comprising inulin and fructo-oligosaccharides and having 45 to 55 by weight of the soluble fiber mixture and 45 to 55 % by weight of the insoluble fiber mixture.

10. An enteral composition comprising a protein source, a lipid source, a carbohydrate source, and a fiber mixture comprising about 20% to about 40% by weight of inulin and about 60% to about 80% by weight of the fructo-oligosaccharides.