MXPA98005035A - Composition and method for providing nutrition to diabeti - Google Patents

Abstract

A nutritional composition for diabetics is provided. The composition contains a protein source, a lipid source and a carbohydrate source. The composition includes a fiber mixture containing a viscous soluble fiber and inulin, an inulin hydrolyzate or both. The fiber mixture may also contain insoluble fiber. When in liquid form, the nutritional composition has a low viscosity and excellent flow rates in your

Description

COMPOSITION AND METHOD TO PROVIDE NUTRITION TO DIABETICS.

FIELD OF THE INVENTION This invention relates to a nutritional composition suitable for providing nutrition to diabetic patients. The invention also relates to a method for providing nutrition to diabetic patients and to a method for the nutritional control of diabetic symptoms in patients.

BACKGROUND OF THE INVENTION Diabetes is a general term for a group of metabolic disorders which are characterized by the inability to adequately metabolize glucose. This disability is due to an inefficiency in the hormone insulin or a resistance to the action of insulin. In any case, when left untreated, this disability leads to hyperglycemia and its complications of morbidity and mortality. Diabetes is usually classified into three clinical classes; diabetes mellitus, gestational diabetes and impaired tolerance to glucose or glucose intolerance. Diabetes Mellitus is generally divided into two types; type I diabetes mellitus and type II diabetes mellitus. Type I diabetes mellitus occurs in individuals who produce little or no insulin and make up less than about 10% of the diabetic population. The access of diabetes mellitus type I usually manifests itself during youth. Type II diabetes mellitus or non-insulin dependent diabetes mellitus usually develops after the age of approximately 30 years and constitutes more than approximately 90% of the diabetic population. Impaired tolerance to glucose, at the clinical onset, often presents as hyperglicemia induced by stress. Frequently, especially in severe cases, diabetes is treated by administration of exogenous insulin, or antihyperglycemic agents. However, nutritional control of diabetes is possible and the American Diabetes Association has published guidelines for the nutritional therapy of diabetes. These guidelines suggest that diabetic patients should consume approximately 20 to 25 g of dietary fiber daily. Dietary fibers can be classified as soluble and insoluble. Insoluble fibers appear to have little influence on glycemic levels. However, the incorporation of soluble fibers in foods is known to reduce postprandial glycemia in diabetics (Anderson, J.W. and Akanji, A. O .; 1993; "Treatment of Diabetes with High Fiber Diets", CRC Handbook of Dietary Fiber in Human Nutrition, CRC Press Inc., 2nd Edition, pages 443-470). Examples of soluble fibers which are believed to have this property are guar gum, pectin, xanthan gum and β-glucan. This property makes soluble fibers ideal candidates for incorporation into diabetic foods. However, to date, soluble fibers have not been used so widely in diabetic foods. A common problem is that many soluble fibers are not very palatable. Furthermore, in the field of clinical nutrition, the incorporation of soluble fibers in compositions administered enterally is extremely difficult since the soluble fibers are thickening agents and greatly increase the viscosity. Accordingly, compositions which contain sufficient soluble fiber to significantly reduce postprandial glycemia are usually too thick and viscous for enteral feeding; especially for patients who require tube feeding. A nutritional composition which provides a solution to the problem is described in the North American patent No. ,292,723. The nutritional composition described in this patent has a carbohydrate component consisting of glucose polymers, modified starch and soluble fiber. It is suggested that pectin as a suitable soluble fiber. The nutritional composition has a viscosity of at least 0.05 kg / s when measured at approximately 20 ° C. In addition, the nutrition composition, when consumed, results in a lower glycemic response in patients compared to glucose, with the same energy content. However, there is still a need for a nutritional composition which is suitable for diabetic patients and which has good flow characteristics.

BRIEF DESCRIPTION OF THE INVENTION Accordingly, in one aspect, this invention provides a nutritional composition for diabetic patients, the composition contains a source of protein, a source of lipids, a source of carbohydrates, the source of carbohydrates includes a mixture of fibers comprising a soluble viscous fiber of inulin or an inulin hydrolyzate, or both. Surprisingly it has been found that the use of a mixture of fiber or soluble viscous fiber and inulin, an inulin hydrolyzate or both, results in a suitable reduced glycemic response and at the same time retains a reasonably low viscosity. Therefore, due to the excellent flow properties, the nutritional composition is ideally suited to be supplied as probe food to patients. In addition, the use of inulin or its hydrolysates provides a substrate for the lactic acid bacteria in the gastrointestinal tract; which induces a beneficial effect on the general health of the patient. The nutritional composition may be in liquid form or in the form of a soluble powder which is reconstitutable in an aqueous liquid to provide a liquid nutritional composition. Preferably, the protein source provides from about 10% to about 20% energy, the lipid source provides from about 30% to about 50% energy, and the carbohydrate provides from about 35% to about 55% energy In another aspect, this invention provides a method for the nutritional control of the diabetes symptom, the method comprises orally administering to a patient an effective amount of a liquid nutritional composition for diabetic patients, the composition comprising a source of proteins, a source of lipids , a source of carbohydrates and a fiber mixture that includes a viscous soluble fiber and inulin, an inulin hydrolyzate or both.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Now embodiments of the invention will be described by way of example only. This invention provides a nutritional composition for diabetic patients. The composition contains a protein source, a lipid source and a carbohydrate source. The carbohydrate source includes a fiber mixture comprising a viscous soluble fiber and inulin. In this specification, the term "soluble fiber" means those food fibers which 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 Chemist. The term "viscous soluble fiber" means a soluble fiber which is capable of increasing the viscosity of the contents of the stomach and small intestine and decreasing the rates of gastric emptying. The viscous soluble fiber can be any suitable soluble fiber which is capable of increasing the capacity of the contents of the stomach and small intestine. Examples of suitable soluble fibers are gums such as guar gum, xanthan gum and gum arabic, pectin and jS-glucan or mixtures thereof. Pectin and gum arabic are particularly preferred. Inulin can be provided in the form of a natural extract which is suitable for human consumption. They are particularly suitable extracts of achichoria. The extract preferably contains at least 80% by weight of inulin or an inulin hydrolyzate. More preferably, at least 90% by weight of inulin or an inulin hydrolyzate. The inulin preferably has a degree of polymerization of at least about 8; for example from about 10 to about 25. Suitable inulin extracts can be obtained from Orafti SA or Tirlemont 3300, Belgium, under the trademark "Raftiline". For example, this may provide the inulin in the form of Raftiline ™ ST which is a fine white powder which contains from about 90 to about 94% by weight of inulin, up to about 4% by weight of glucose and fructose, and from about 4 to 9% by weight of sucrose. The average degree of polymerization of the inulin is from about 10 to about 12. The inulin may also be in the form of inulin hydrolysates or mixtures of: inulin and inulin hydrolysates. Inulin hydrolysates are commonly known as fruc or oligosaccharides or FOS. It is reported that inulin and its hydrolysates promote the growth of bifid bacteria in the gastrointestinal tract and, under certain circumstances, prevent or decrease the growth of pathogens such as Clostridiae. In addition, it has been reported that the promotion of the growth of bifid bacteria has several other beneficial effects. In addition, inulin and its hydrolysates They can reduce blood glucose levels. The fiber mixture may also contain a source of insoluble food fiber. Suitable sources of insoluble food fibers are legume and grain husk fibers; for example pea husk fiber, oat husk fiber, barley husk fiber and soybean husk fiber. Especially preferred is pea husk fiber. However, any other suitable source of insoluble food fiber can be used. These sources may also contain part of soluble fiber. The ratio of soluble fiber, which includes inulin, to the insoluble fiber preferably is from 1: 3 to about 3: 1; more preferably from about 1: 1 to about 2: 1. For example, the proportion of soluble fiber, including inulin, with respect to the insoluble fiber is preferably about 2: 1. In addition, the fiber mixture may be present in an amount from about 1.0 g / 100 ml to about 2.0 g / 100 ml; for example from 1.3 g / 100 ml to approximately 1.7 g / 100 ml; for example from approximately 1.5 g / 100 ml. In a preferred embodiment, the fiber mixture comprises approximately 0.5 g / 100 ml inulin, approximately 0.5 g / 100 ml pectin or gum arabic and approximately 0.5 g / 100 ml outer pea fiber.

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, peas and oat protein, or mixtures thereof, can also be used. In addition, if desired, the protein source can include free amino acids. The protein source preferably provides from about 10 to about 20% of the energy of the composition. For example, the protein source can provide from about 12% to about 18% of the energy of the composition; preferably, about 15% of the energy of the composition. The source of carbohydrates can be any carbohydrate or mixture of suitable carbohydrates. For example, the carbohydrate source can be maltodextrin, modified starch, starch amylose, tapioca starch, corn starch or fructose, or mixtures thereof. The modified starch is preferred; especially modified tapioca and corn starches. If the carbohydrate source includes maltodextrin, maltodextrin with a low ED is preferred; for example, maltodextrin with an ED of 3 or less. Preferably, the composition is low in or free of free mono- and di-saccharides such as fructose or other sugars exchange, and lactose. For example, the composition contains less than about 3 g / 1 of lactose. The carbohydrate source which includes the viscous soluble fiber and inulin, provides about 35% to about 55% of the energy of the composition; preferably from about 40% to about 50% of the energy. For example, the carbohydrate source can provide approximately 45% of the energy of the composition. The amount of energy provided to the patient by soluble viscous fiber and inulin is very small. Preferably, the lipid source is rich in monounsaturated fatty acids; for example, monounsaturated fatty acids can provide at least 50% of the energy of the lipid source. Preferably, the monounsaturated fatty acids provide about 25% to about 35% of the energy of the composition; for example, approximately 29 to 30%. The source of lipids may contain polyunsaturated fatty acids (omega-3 and omega-6 fatty acids); preferably, these polyunsaturated fatty acids provide up to about 10% of the energy of the composition. For example, these polyunsaturated fatty acids can provide from about 3% to about 10% of the energy of the composition. Preferably, the lipid profile of the enteral composition is designed to have an acid ratio polyunsaturated omega-6 (n-6) with respect to omega-3 (n-3) from about 4: 1 to about 10: 1. The saturated fatty acids preferably provide less than 10% of the energy of the composition; for example, less than about 7%. The lipid source can provide from about 30% to about 50% of the energy of the composition; preferably from about 35% to about 45%. For example, the lipid source can provide approximately 40% of the energy of the composition. If desired, the lipid source may include medium chain triglycerides. For example, medium chain triglycerides can constitute from about 10% to about 50% by weight of the lipid source. Suitable sources of monounsaturated fatty acids are olive oil, sunflower oil rich in oleic acid, rapeseed oil rich in oleic acid, hazelnut oil, saffron oil, and the like. If medium chain triglycerides are included in the lipid source, fractionated coconut oils are an adequate source of medium chain triglycerides. A mixture of sunflower oil, rapeseed oil and olive oil is preferred. Preferably, the enteral composition includes a complete profile of vitamins and minerals. For example, sufficient vitamins and minerals can be provided to supply from approximately 75% to approximately 250% of the recommended daily doses of vitamins and minerals per 1000 calories of the nutritional composition. Conveniently, the nutritional composition has an osmolarity of about 180 mOsm / 1 to about 300 mOsm / 1; for example from about 190 mOsm / 1 to about 210 mOsm / 1. The viscosity of the nutritional composition, when measured at room temperature, is preferably less than about 0.04 kg / ms; especially less than about 0.035 kg / ms. For example, the viscosity of the nutritional composition, when measured at room temperature, may be from about 0.015 to about 0.03 kg / ms. In addition, the flow rate of the nutritional composition through a standard feed tube is preferably less than about 150 minutes / 1; for example less than about 100 minutes / 1. The energy density of the nutritional composition is preferably from about 700 kcal / to about 1500 kcal / 1; for example of approximately 1000 kcal / 1. The nutritional composition is preferably in the form of a ready-to-use formulation. In this form, the composition can be delivered to a patient via a nasogastric tube, an intestinal tube or the patient can ingest it. As such, the nutritional composition can be diverse shapes; for example as a fruit juice type drink, a milk malted beverage type and the like. However, the nutritional 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 aspartame. The nutritional composition can be produced as is conventional; for example, by mixing together the source of protein, the source of carbohydrates and the source of lipids. If used, emulsifiers can be included in the mixture. Vitamins and minerals can be added at this point, but are usually added later to avoid thermal degradation. Any lipophilic vitamin, emulsifiers and the like can be dissolved in the lipid source prior to mixing. It can then be mixed with water, preferably water which has been subjected to reverse osmosis, to form a liquid mixture. The water temperature is conveniently from about 50 ° C to about 80 ° C to aid in the dispersion of the other ingredients. Commercially available diluents can be used to form the liquor mix. The liquid mixture can subsequently be heat treated to reduce bacterial loads. For example, the The liquid mixture can be rapidly heated to a temperature in the range from 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 in a plate heat exchanger. Subsequently the liquid mixture can be cooled to about 60 ° C to about 85 ° C; for example by instantaneous cooling. Subsequently, the liquid mixture is homogenized; for example, in two stages at about 7 MPa to about 40 MPa in the first stage, and from about 2 MPa to about 14 MPa in the second stage. Subsequently the homogenized mixture can be further cooled to add any heat sensitive component; such as vitamins and minerals. At this point the pH and the solids content of the homogenized mixture are conveniently standardized. For a product in liquid form, the homogenized mixture is preferably aseptically packaged in suitable containers. The aseptic packaging of the containers can be carried out by preheating the homogenized mixture (eg, from about 75 to 85 ° C) and then injecting steam into the homogenized mixture to increase the temperature from about 140 to 160 ° C; for example at approximately 150 ° C. Later the mixture homogenized can be cooled, for example by instantaneous cooling to a temperature of about 75 to 85 ° C. Then, the homogenized mixture can be further homogenized, cooled to room temperature and packaged in containers. A suitable apparatus is available commercially to carry out aseptic filling of this nature. For a product in powder form, the homogenized mixture is dried to a powder; for example by spray drying. Conventional procedures can be used. The nutritional composition can be used as a nutritional support for patients who suffer from metabolic abnormalities which make them susceptible to hypoglycemia or hyperglycemia. For example, the nutritional composition can be used as a nutritional support for patients suffering from diabetes mellitus type I, diabetes mellitus type II or glucose intolerance. In addition, the nutritional composition can be used as a nutritional support for patients who are at risk of a recurrence of hypoglycemia or hyperglycemia. The nutritional composition can also be used as a nutritional support for post-operative patients. The nutritional composition is particularly useful for the nutritional control of diabetic symptoms of diabetic patients.

The amount of nutritional composition required to feed a patient will vary depending on factors such as the patient's condition, the patient's body weight, the patient's age and whether the nutritional composition is the sole source of nutrition. However, the amount required can be easily established by a practicing physician. In general, sufficient nutritional composition is administered to provide the patient with approximately 1 g of protein to approximately 4.0 g of protein per kg of body weight per day. For example, an adult patient may be administered approximately 1.5 g of protein to approximately 2.0 g of protein per kg of body weight per day. In addition, sufficient nutritional composition is administered to provide the patient with up to about 40 g of dietary fiber (insoluble and soluble) per day; for example, from about 25 g to about 35 g of dietary fiber per day. If the nutritional formula is used as a supplement to other foods, the amount of nutritional composition that is administered daily may decrease accordingly. The nutritional composition can be taken in multiple doses, for example 2 to 5 times, until it is the required daily amount or it can be taken in a single dose. The nutritional composition can also be supplied continuously for a desired period.

Example 1 A ready-to-use nutritional composition is prepared. The nutritional composition includes the following components: Component Conc. Energy (/ 100 ml) (%) Protein 3.8 g 15 Casein / soy protein (1: Carbohydrates 11.2 g 45 Maltodextrin (low in DE) 1.0 g Modified starch 10.2 g Soluble fiber including inulin 1.0 g Insoluble fiber 0.5 g Llpidos 4.4 g 40 Rapeseed oil, sunflower oil , olive oil, glyceryl stearate and soy lecithin Vitamins Vitamin A 150 IU Vitamin C 10 mg Vitamin D 10 IU Vitamin E 1.0 mg Vitamin K 3.0 μg Thiamin 0.1 mg Riboflavin 0.12 mg Pantothenic acid 0.50 mg Vitamin B6 0.14 mg Vitamin B12 0.30 μg Niacin 1.2 mg Folic acid 18 μg Biotin 01 μg Minerals Zinc, iron, copper, magnesium, manganese, selenium, iodine, potassium, calcium, phosphorus, chloride The composition has an osmolarity of 210 mOsm / 1 and an osmolality of 240 mOsm / kg. The viscosity is 0.023 kg / ms and the free flow rate is less than 70 minutes per 500 ml through standard enteral intubation. 2 Eight healthy volunteers of both sexes were used in the study. Volunteers are between 20 and 45 years old and have fasting blood glucose levels of approximately 70 to approximately 110 mg / dL. Any volunteer showing the symptoms of diabetes mellitus type I or II, or intolerance to fructose is excluded. The study is carried out in two stages, each stage comprising two days of study separated by an observation period of at least 7 days. The stages are also separated by a purification period of at least 7 days. Before each day of study, each volunteer consumes a meal in the evening consisting of pizza, salad and an apple. Alcohol is not ingested Subsequently, starting at 10 pm, each volunteer experiences a night of fasting. On the morning of the day of the study, a catheter is placed in each volunteer. Afterwards, a blood sample is taken. A meal is subsequently consumed in the next 10 minutes after sampling. Additional blood samples are taken at 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion of the food. Blood glucose is analyzed for each sample by the glucose oxidase method using a COBAS analyzer (Hoffman-La Roche). The level of insulin for each sample is measured by radioimmunoassay (Pharmacia). Blood glucose levels are analyzed using a two-way ANOVA. The area under the integrated curve (AUC) is calculated using the method of Wolever et al; 1986; Am. J. Clin. Nutr. , 43, 167-172. The difference between the AUC of the various curves is evaluated using paired Wilcoxon pair tests or the Hill Armitage test for cross design. The glycemic response is considered as different if the AUC curves are statistically different with p < 0.05. Three products are used as food; the product of Example 1, the SondalisMR Fiber product from Nestlé Clinical Nutrition, and the Fresubin Diabetes product from Fresenius GmbH. In each case 400 ml of the product of Example 1, 400 ml of Sondalis ™ Fiber product and 444 ml of Fresubin Diabetes product are consumed to provide a standard energy intake of 400 kcal. All foods contain comparable amounts of minerals and micronutrients. On the first day of the study in stage 1, 4 volunteers were fed with the product of Example 1 and 4 volunteers were fed with the Sondalis ™ Fiber product. The selection of volunteers for any product is random.

On the second day of stage 1, the products are invested. On the first day of stage 2, four volunteers are fed the product of example 1 and four volunteers are fed the product Fresubin Diabetes. The selection of volunteers for any product is random. On the second day of stage 2, the products are inverted. The results are as follows: The results of area under the curve are as follows: The glycemic responses of the product of Example 1 and the Fresubin Diabetes product are significantly lower than that of Sondalis ™ Fiber; about 30 mmol / 1 and 50 mmol / 1 respectively, after 120 minutes, compared to about 80 mmol / l after 120 minutes. In addition, for the product of Example 1, the blood glucose response is much more flat than that of the Sondalis ™ Fiber product. The maximum change of the product of example 1 is also less than that of the other products. Although the glycemic response of the product of Example 1 is lower than that of the Fresubin Diabetes product, the differences are not significant. Therefore, the product of example 1 is suitable for use with diabetic patients. None of the patients indicated any symptoms of digestive intolerance.

Example 3 The viscosity and flow rate of the composition of Example 1 and of the product sold by Fresenius GmbH under the name Fresubin DFN Plus were determined: The viscosity of each composition was determined at 25 ° C using a Contraves Rheomat according to the manufacturer's instructions . The composition of example 1 is filled in a flexible and sealed bag and connected to a support at a standard height. The product Fresubin DFN Plus, which comes in a Glass container (its original container) is connected to a separate support at the same height. An enteral feeding tube is connected to each container and the time required to deliver 500 ml through the enteral feeding tube is determined. Subsequently an open tank is connected to each support and the composition of example 1 is poured into the tank and the product Fresubin DFN Plus is poured into another. An enteral feeding tube is connected to each reservoir and the time required to deliver 500 ml through the enteral feeding tube is determined.

The results indicate that the composition of Example 1 has a higher flow rate.

Example 4 A ready-to-use nutritional composition is prepared. The nutritional composition includes the following components: The composition has an osmolarity of 190 mOsm / 1. The viscosity is about 0.023 kg / ms and the free flow rate is less than about 70 minutes per 500 ml through standard enteral intubation. Monounsaturated fatty acids provide approximately 29% energy, polyunsaturated fatty acids provide approximately 6% energy, and saturated fatty acids provide approximately 5% energy.

It will be understood that numerous modifications can be made to the specific embodiments described in the foregoing without departing from the scope of the invention, as defined in the claims. It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it relates. Having described the invention as above, property is claimed as contained in the following:

Claims (10)

1. A nutritional composition for diabetic patients, the composition comprises a protein source that provides about 10% to about 20% energy, a lipid source that provides about 30% to about 50% energy, a source of carbohydrates that provides approximately 35% energy. % at about 55% energy, and a fiber mixture including a viscous soluble fiber and inulin, an inulin hydrolyzate, or both.

2. A liquid nutritional composition for diabetic patients, the composition is characterized in that it comprises a protein source, a lipid source, a carbohydrate source and a fiber mixture that includes a viscous soluble fiber and inulin, an inulin hydrolyzate, or both.

3. The nutritional composition according to claim 2, characterized in that it has a viscosity, when measured at room temperature, between 0.015 and 0.03 kg / ms.

4. A powdered nutritional composition for diabetic patients, the composition is characterized in that it comprises a source of protein, a source of lipids and a ---- - 26 - source of carbohydrates, and a mixture of fiber including a viscous soluble fiber and inulin, an inulin hydrolyzate or both, - the powdered nutritional composition is reconstitutable in an aqueous liquid to provide a liquid nutritional composition.

5. The nutritional composition according to any of claims 1 to 4, characterized in that the fiber mixture also includes a source of dietary fiber. 10 insoluble.

6. The nutritional composition according to claim 5, characterized in that the source of insoluble food fiber is pea husk fiber.

7. The nutritional composition according to claim 5 or 6, characterized in that the proportion of soluble fiber, including inulin, with respect to insoluble fiber is from 1: 3 to 3: 1.

8. The nutritional composition according to any of claims 1 to 4, characterized in that the fiber mixture comprises approximately 0.5 g / 100 ml of inulin, approximately 0.5 g / 100 ml of pectin or gum arabic, and about 0.5 g / 100 ml pea husk fiber.

9. The nutritional composition according to any of claims 1 to 8, characterized in that the source of lipids includes monounsaturated fatty acids which provide from about 25% to about 35% of the composition's energy.

10. The nutritional composition according to claim 9, characterized in that the lipid source also includes saturated fatty acids that provide less than 10% of the energy of the composition.