MX2011010925A - High fiber nutritional emulsions for blood glucose control. - Google Patents

High fiber nutritional emulsions for blood glucose control.

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Publication number
MX2011010925A
MX2011010925A MX2011010925A MX2011010925A MX2011010925A MX 2011010925 A MX2011010925 A MX 2011010925A MX 2011010925 A MX2011010925 A MX 2011010925A MX 2011010925 A MX2011010925 A MX 2011010925A MX 2011010925 A MX2011010925 A MX 2011010925A
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oil
aqueous emulsion
emulsion
emulsions
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MX2011010925A
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Spanish (es)
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Vikkie A Mustad
Neile K Edens
Joseph E Walton
David R Wolf
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Abbott Lab
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23DEDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
    • A23D7/00Edible oil or fat compositions containing an aqueous phase, e.g. margarines
    • A23D7/005Edible oil or fat compositions containing an aqueous phase, e.g. margarines characterised by ingredients other than fatty acid triglycerides
    • A23D7/0053Compositions other than spreads
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16Inorganic salts, minerals or trace elements
    • A23L33/165Complexes or chelates
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • A23L33/19Dairy proteins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

Disclosed are nutritional aqueous emulsions having high fiber content. These emulsions comprise fat, protein, and carbohydrate, including (a) from 1.75% to about 4.0% by weight of a diacylglycerol oil; (b) from about 0.5% to about 9.0% by weight of a milk protein concentrate; (c) from about 2.0% to about 9.0% by weight of fiber; and (d) fructose and from about 0.15% by weight of leucrose in a weight ratio of fructose to leucrose of at least 2:1, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20°C. These high fiber emulsions provide beneficial features, including one or more of stability, desirable hedonics, rheology, and product performance, including a blunted glycemic response profile and or minimal or no gastrointestinal intolerance.

Description

EM U LSION IS N UTRITION ALES WITH A HIGH CONTENT FI BRAS TO CONTROL THE G LUCOSE IN THE BLOOD This application is referred to the Provisional US Patent Application 61/169030, which was filed on April 14, 2009, and priority is claimed over them.
Field of invention The present invention relates to nutritional emulsions having a low viscosity and a high concentration of fibers.
Background of the invention There are several types of milk-based or protein-based emulsions that are suitable for oral administration in humans, so that they serve as the sole source of nutrition or as a source of supplementary nutrition. These emulsions are typically manufactured as oil-in-water emulsions comprising fats, proteins, carbohydrates, vitamins and minerals. Examples of these emulsions include the nutritional liquid ENSURE® and the GLUCERNA® beverage, which are available from Abbott Laboratories, Columbus, Ohio, US.
Many of these nutritional emulsions are manufactured with the addition of fibers, with the purpose of obtaining various additional benefits. It is believed that, by appropriate fiber intake, it is possible to reduce the risk of developing numerous conditions, which They include heart failure, diabetes, diverticular diseases and constipation. Fibers are often formulated in the form of nutritional emulsions to help reduce the glycemic index of an emulsion containing carbohydrates, which can be beneficial for many individuals, including diabetics and individuals who are interested in the benefits that can be obtained with a more modulated glycemic response.
Taking into account the various benefits that can be obtained with a diet with a high fiber content, it is often recommended that children and adults consume at least 20 grams of fiber per day through the diet. In fact, the more calories an individual consumes per day, the more fiber is necessary for the diet to be healthy. For example, between adolescents and men, 30-35 grams of fiber per day, or more, may be necessary, depending on the specific intake.
Although it has been indicated that there is a need for relatively high fiber content in most diets, the average American consumes only about 1.5 grams of fiber per day, even though various foods already contain additional fiber. Accordingly, there is a need for nutritional products, such as protein-based emulsions or milk emulsions, which are manufactured with a relatively high concentration of fiber, so as to better meet the nutritional needs of the typical consumer.
However, when nutritional emulsions are formulated with higher concentrations of fibers, various problems often arise, some of which are typical of matrices that are based on emulsions. A high fiber content may deteriorate the stability of the emulsion, may bring with it the need to use high processing temperatures, may reduce gastrointestinal tolerance and may cause undesirable sensations, such as poor mouthfeel, gritty texture, changes in the taste and so on.
Consequently, there is a need for nutritional emulsions that contain a higher concentration of fiber, that have a relatively low viscosity, that is, that are drinkable, and that also lack some or all of the negative characteristics that have historically been associated with emulsions with a high fiber content.
BRIEF DESCRIPTION OF THE INVENTION In a first embodiment, the nutritional emulsions comprise fats, proteins and carbohydrates and include (a) between about 1.75% and about 4.0% by weight of a diacylglycerol oil, (b) between about 0.5% and about 9.0% by weight of a milk protein concentrate, (c) between about 2.0% and about 9.0% by weight of fibers and (d) fructose and a minimum of about 0.1% of leucose, with a weight ratio between fructose and leucrose of at least 2: 1, where the emulsions have a lower viscosity than approximately 300 cps.
In a second embodiment, nutritional emulsions comprise between about 5% and about 40% by weight of carbohydrates, between about 2% and about 30% by weight of fats and between about 0.5% and about 15% by weight of proteins , wherein the emulsions include (a) between about 1.75% and about 4.0% by weight of a diacylglycerol oil, (b) between about 0.5% and about 9.0% by weight of a protein concentrate. of milk, (c) between about 2.0% and about 9.0% by weight of fiber, (d) fructose and between about 0.1% of leucrose, with a weight ratio between fructose and leucrose of at least 2: 1, and (e) between about 0.0020% and about 0.0001 0% chromium picolinate, relative to the weight of the emulsion, wherein the aqueous emulsions have a viscosity of less than about 300 centipoise a 20 ° C.
These nutritional compositions are water-in-water aqueous emulsions which, despite having a high fiber content, exhibit desirable physical and chemical stability under various conditions and exhibit favorable sensory, theological and performance properties, encompassing a modulated profile in the glycemic response and / or minimal or no gastrointestinal intolerance. Emulsions are especially useful when they are provided in a container that has a plastic inner surface in contact with the nutritional emulsion, in contrast to a metal surface, glass or a material other than plastic BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a graph of study I showing fasting plasma insulin concentrations (mmol / l) after 0, 14 and 28 days in Zucker fa / fa rats fed diets comprising the formulations A1, A2 and A3.
Figure 2 is a graph of study I where the differences in insulin sensitivity are illustrated, which were determined with an assessment of insulin tolerance (the changes in blood glucose are detailed at defined times after the administration) in Zucker fa / fa rats that were fed formulations A1, A2 and A3.
Figure 3 is a graph of study I showing glycated hemoglobin (%) after 0 and 28 days, in Zucker fa / fa rats that were fed diets comprising formulations A1, A2 and A3. The change in glycated hemoglobin between day 0 and day 28 is shown in the upper section of each bar.
Figure 4 is a graph of study II showing fasting plasma insulin concentrations (pmol / l) after 0, 14 and 28 days in Zucker fa / fa rats fed the diet of the patient. study or with the diet of the study in combination with the formulation A1, which was consumed voluntarily. In the graph, it can be seen that the voluntary intake of formulation A1 resulted in an attenuation in the increase in plasma insulin that had been observed in the control group (*: p <0.05).
Figure 5 is a graph of study II showing blood glucose levels (mg / dl) after 0, 30, 60, 90 and 120 minutes after insulin injection in Zucker rats. Fa that were fed the study diet or study diet in combination with formulation A1, which was consumed voluntarily (p <0.05).
Figure 6 is a graph of study II showing the glycated hemoglobin (%) in Zucker rats on days 0 and 28 of a study where the rats were fed the study diet or the study diet in combination with the formulation A1, which was consumed voluntarily. The change in glycated hemoglobin between day 0 and day 28 of the study is shown in the upper section of each bar. Voluntary consumption of formulation A1 resulted in an attenuation in the increase in plasma insulin that had been observed in the group that had not been administered the A1 formulation.
Figure 7 is a graph of study III showing the total food intake (in kcal) in Zucker fa / fa rats that were fed a control diet or a semi-purified diet (the study diet), suggesting that the rats They preferred the study diet because it was more pleasant.
Figure 8 is a graph of the I I I study illustrating the cumulative food intake (in kcal) in Zucker fa / fa rats that were fed the study diet alone or with the study diet in combination with the A1 formulation. In the graphs, it can be observed that the rats preferred to decrease the consumption of the preferred, pleasant study diet, to compensate the calories they had consumed through the formulation A1 (p <0.05).
Detailed description of the invention Nutritional emulsions with a high fiber content may comprise various combinations of diacylglycerol oils, fibers, fructose and leucrose, concentrates of milk proteins and glycerin, as well as other optional or alternative components. The essential characteristics of nutritional emulsions are described below, as well as some of the various optional variations.
The term "nutritional emulsion", as used herein, and unless otherwise specified, refers to an aqueous emulsion which is suitable for oral administration in a human being, comprising fats, proteins and carbohydrates. .
The terms "fats" and "oils", as used herein, and unless otherwise specified, are synonymous and refer to lipid materials that are derived from plants or animals or that are processed from them .
The term "high fiber content", as used herein, and unless otherwise specified, refers to a fiber concentration of between about 1.5% and about 9%, more typically from about 2.3% and about 9%, relative to the weight of a nutritional emulsion.
The term "sensory properties", as used herein, and unless otherwise specified, may refer to any of the following properties of nutritional emulsions: aroma, mouthfeel, texture, taste and color or physical appearance.
The term "rheology", as used herein, may refer to the desirable viscoelastic properties of a nutritional emulsion, including those under various conditions, which may encompass storage at a higher or lower temperature to reflect, among others. characteristics, improved stability of emulsion or suspension of nutritional emulsions.
The term "performance", as used herein, and unless otherwise specified, may refer to the desirable benefits that the packaged nutritional emulsions described herein may present, where these benefits include enhanced gastrointestinal tolerance, a modulated glycemic response, desirably, at various times and under certain circumstances, increased insulin sensitivity, modulated glycemic response to a food, and a desirable interaction with the package.
Unless otherwise specified, all viscosity values that are provided herein are obtained using a Brookfield vise-meter (model DV-I I +), with a spindle number 62, at room temperature (20 ° C) or at the specified temperature. The viscosity is measured by operating the viscometer at the highest possible speed, in order to obtain a reading at the appropriate scale. The values that are determined for the viscosity represent the ratio between the stress due to the agitation and the speed of agitation, expressed in dynes second / cm2, or poise, or more typically in centipoise (cps), that is, in hundredths of poise .
Unless otherwise specified, all percentages, parts and proportions provided herein are expressed in relation to the total weight of the composition. These weights are applied to the mentioned ingredients in their active forms, so they do not cover the solvents or by-products that may be included in the commercially available materials, unless otherwise specified.
In the present, any reference to a singular feature or feature must include a plural reference, and vice versa, unless otherwise specified.
Additionally, unless otherwise specified, it should be possible to implement any combination of the method or processing steps described herein, in any order.
In various embodiments, the nutritional emulsions may be substantially free of any of the specific ingredients described herein, with the proviso that the remaining nutritional emulsion exhibits all of the essential limitations described herein. In this context, the term "substantially free" denotes that the composition comprises an amount less than the functional amount of the ingredient in question, typically less than about 1.0%, such as less than about 0.5% or less than about 0. , 1%, which also covers zero percent by weight of the ingredient in question.
In various embodiments, nutritional emulsions may have any of the essential characteristics or may comprise any of the ingredients described herein, or may consist or consist essentially of them. They may also include additional features or ingredients, including those described herein and those which are known to be useful in nutritional emulsions.
The numerical ranges, as used herein, should cover any value and subset of intermediate values, which may be described specifically or not. Additionally, these numerical ranges have to be interpreted as support for those claims that are related to any value or subset of values in them. For example, a range of between 1 and 10 has to cover a range of between 2 and 8, a range of between 3 and 7, a range of between 5 and 6, a range of between 1 and 9, a range of 3 , 6 and 4.6, a range between 3, 5 and 9.9 and similar.
Product form Nutritional emulsions are aqueous systems that can They are classified as oil-in-water, water-in-oil or complex emulsions, although the most typical emulsions are oil-in-water emulsions having a continuous aqueous phase and a discontinuous oil phase. The water content varies between the emulsions, but more typically ranges from about 70% to about 90%, and even more typically ranges from about 75% to about 85%, relative to the weight of the emulsions.
A nutritional emulsion may have a viscosity that is suitable for drinking at room temperature or when cooled. Thus, the emulsions may have a viscosity, measured at room temperature (20 ° C), which is less than about 300 cps, which is typically between about 10 cps and about 1 60 cps, and which more typically is between about 20 cps and approximately 70 cps.
Nutritional emulsions can be formulated with appropriate types and amounts of nutrients, with the purpose of providing an exclusive, primary or supplemental source of nutrition, or in such a way as to provide a specialized nutritional emulsion, that can be used in individuals suffering from certain diseases or conditions. , such as diabetes or other conditions characterized by an abnormal tolerance to glucose.
These nutritional emulsions may also have a density greater than about 1.055 g / ml, which includes a density between 1.06 g / ml and 1.08 g / ml.
Nutritional emulsions can be packaged through retort sterilization or aseptically in a glass, plastic, metal or other suitable container. However, it was found to be advantageous to formulate them in a plastic container or a material other than metal or glass, having an inner plastic surface in contact with the emulsions representing the majority of the inner area of the container or the container. These containers are particularly useful when used with emulsions and subjected to retort sterilization and packaging.
Diacilglycerol The nutritional emulsions may comprise a diacylglycerol oil, which is as defined herein. The concentration of this diacylglycerol oil varies from at least about 1%, which ranges from about 1.75% to about 4%, from about 1, 8% to about 3% or from about 1. , 9% and approximately 2.7%, inclusive, in relation to the weight of the emulsion.
The term "diacylglycerol oil" is known in the art. As used herein, it refers to a processed oil comprising between about 60% and about 1000% by weight of a diglyceride, which ranges from about 70% to about 85%. The diacylglycerol oil may represent between about 10% and about 1 00% of the fat in the emulsion, relative to the weight of the emulsion, which ranges from about 40% to about 80% or from about 50% and approximately 70% Diacylglycerol oils are well known in the art of nutrition, and typically comprise a mixture of monoglycerides, diglycerides and triglycerides, where the diglycerides represent the majority of the glycerol esters present. The oils are typically processed vegetable oils, which may be soybean or cocoa oils comprising about 80% by weight of diglycerides and about 20% by weight of other glycerol esters, ie, triglycerides and monoglycerides. The diglycerides may be able to coat esters of C 1 6-24 fatty acids, which includes the esters of C 1 6-20 fatty acids, more typically the esters of oleic, linoleic and / or linolenic acid. A non-limiting example of a diacylglycerol oil suitable for use herein is Enova® oil, which is available from Kao Health and Nutrition, Itasca, Illinois, US.
Although nutritional emulsions can comprise any natural oil, most of which contain a minor amount of diacylglycerol esters (diglycerides), these natural oils do not contain sufficient relative amounts of diglycerides to form the diacylglycerol oil component of the emulsions in the I presented.
Nutritional emulsions can also comprise lecithin in combination with diacylglycerol oil. The concentration of the lecithin can vary from at least about 0.1%, which ranges from about 0.16% to about 0.5%, relative to the weight of the emulsion.
It is possible to replace the diacylglycerol component and still maintain the physical stability of the formulations described herein if a mixture of oil comprising between 30 and 50% of safflower oil with a high oleic acid content is used, 20 and 40% canola oil, between 1 5 and 35% soybean oil and between 1 and 10% lecithin, relative to the weight of the mixture, which can include a mixture 40/30/25/5 of the respective oils. The replacement mixture can be used as a diacylglycerol component, in an identical concentration relative to the weight of the finished nutritional emulsion described herein.
Fiber Nutritional emulsions comprise fiber at levels that represent at least about 1, 5%, which ranges from about 2.0% to about 9%, from about 2, 1% and about 6% or from about 2.2% to about 4, 3%, relative to the weight of the emulsions. The fiber may represent between about 10% and about 100% of the total weight of the carbohydrates in the emulsions, which ranges from about 1 2% to about 40% or from about 1 5% to about 25%.
The term "fiber", as used herein, refers in general to those components of the nutritional product that are not absorbed by the body and that are not degraded by enzymes in the human digestive tract, which would result in It resulted in several small molecules that could be absorbed. The fiber may encompass any fiber or fiber source suitable for oral administration in a nutritional product, for example, fiber or sources of soluble and / or insoluble fiber, fermentable or non-fermentable, or combinations or variations thereof.
The fiber used herein can be classified as soluble or insoluble on the basis of the ability to be solubilized in a buffer solution with a defined pH. The sources of fiber differ in the amount of soluble and insoluble fiber they contain. As used herein, and unless otherwise specified, the designations of the soluble and insoluble fibers and their concentrations or their amounts, including the total fiber concentrations, are determined using the Association's 991 .43 method. Official Analytical Engineers (AOAC).
Non-limiting examples of fibers or sources of soluble fibers that may be employed in the diets described herein include gum arabic, sodium carboxymethyl cellulose, guar gum, pectin from citrus fruits, pectin with a high content or reduced methoxyl groups, glucans derived from oats or barley, carrageenan and psyllium. There are numerous commercial sources of soluble fiber for the diet. For example, gum arabic, hydrolyzed carboxymethylcellulose, guar gum, pectin and pectin with a high or low content of methoxyl groups are available in TIC Gums, I nc. , of Belcamp, Maryland. Glucans derived from oats or barley are available from Mountain Lake Specialty Ingredient, Inc., of Omaha, Nebraska. Psyllium is available from Meer Corporation, of North Bergen, New Jersey. Carrageenan is available from FMC Corporation, of Philadelphia, Pennsylvania.
Non-limiting examples of fiber or insoluble fiber sources for the diets described herein include the fibers derived from the pericarp of oats, the fibers derived from the pericarp of the pea, the fibers derived from the pericarp of the soybean, the derived fibers of cotyledons of soybeans, fibers derived from beet, cellulose and corn germ. Numerous sources of insoluble dietary fiber are also available. For example, corn germ is available from Quaker Oats, Chicago, Illinois. The fibers derived from the pericarp of oats are available from Canadian Harvest, Cambridge, Minnesota. The fibers derived from the pericarp of ch ร ro ร ro ร ro ร ro are available from Woodstone Foods, Winnipeg, Canada. The fibers derived from the pericarp of soybeans and the fibers derived from the pericarp of oats are available from The Fibrad Group, LaVale, Maryland. The fibers derived from soybean cotyledons are available from Protein Technologies International, of St. Louis, Missouri. Beet-derived fibers are available from Delta Fiber Foods, Minneapolis, Minnesota. Cellulose is available from James River Corp., of Saddle Brook, New Jersey.
The fibers that are employed herein may also include fructo-oligosaccharides (FOS), which encompasses those fructo-oligosaccharides having a degree of polymerization of between 2 and 10, more typically between 3 and 7, inulin, including inulin which presents a degree of polymerization of at least 10, which ranges from about 20 to about 50, and / or glucooligosaccharides (GOS). The FOS, the GOS and / or the inulin may represent between about zero and about 50% of the weight of the fibers in the nutritional emulsion, which ranges from about 5% to about 30% or between about 10% and approximately 20%. As used herein, the fiber content of the FOS can be determined according to the 997.08 method of the Official Association of Analytical Chemists (AOAC). Otherwise, it is assumed that it has a value of approximately 96% of the weight of the FOS.
A commercially available fiber source which is suitable for use herein is Fibersol-2 ™: it is a source of soluble fibers comprising approximately 37% by weight of dietary fiber. It is available from ADM Company, Decatur, Illinois, US.
The nutritional emulsions may also have a weight ratio between fiber and diacylglycerol oil of at least about 1, 20: 1, which ranges from about 1, 23: 1 to about 5: 1 or from about 1, 24: 1 and approximately 1, 8: 1.
Sugar The nutritional emulsions may comprise a relatively low concentration of sugar, which may range from zero to about 2.1%, which ranges from about 0.5% to about 1.8% or between about 0.9% and about 1, 7%, relative to the weight of the emulsion. Thus, the emulsions can also have a relatively high proportion between the fibers and the sugars, ie, greater than about 1: 1, which ranges from about 20: 1 to about 1: 1 or from about 3 : 1 and approximately 1, 4: 1.
In this context, the term "sugar" refers to the total sum of the monosaccharides and the disaccharides in the emulsions.
The ratio between the total carbohydrates and the sugars in the nutritional emulsions can vary from at least about 5: 1, which ranges from about 5.5: 1 to about 20: 1, from about 6: 1 and about 1 0: 1 or between about 7: 1 and about 9: 1.
Nutritional emulsions may also comprise artificial sweeteners, such as saccharin, aspartame, sucralose, neotame, acesulfame potassium or combinations of these. The ratio between artificial sweeteners and sugars can vary from at least about 0.0060: 1, which ranges from about 0.0070: 1 to about 0.0300: 1 or from about 0.0080 : 1 and approximately 0.0095: 1.
The nutritional emulsions may also comprise glycerin as a sweetening agent, which may be used in combination with the sugars (at low concentrations of sugars described herein) and the artificial sweeteners, in the proportions of artificial sweeteners to sugars described in the present.
Concentrated milk proteins Nutritional emulsions may comprise a milk protein concentrate (MPC), which may represent some or all of the proteins in the emulsions. The emulsions may comprise M PC in a concentration of at least about 0.5%, which ranges from about 1% to about 9% or from about 2% to about 6%, relative to the weight of the emulsions .
Concentrates of milk proteins suitable for use herein will include any concentrate that can be used in oral nutritional products. In this context, the term "milk protein concentrate" refers to a product based on bovine milk having a protein content that typically represents between about 40% and about 88% of the milk product, encompassing a range of between about 60% and about 80% or between about 65% and about 75%, by weight of the milk product. Typically, milk protein concentrates also comprise minor amounts of lactose and milk-derived fat.
Glycerin Nutritional emulsions may comprise glycerin in a concentration of between about 2.0% and about 6.0%, which ranges from about 2.1% to about 4.0% or from about 2.2% and approximately 3.0%, relative to the weight of the nutritional emulsion.
Suitable glycerin sources include any glycerin product suitable for an oral nutritional product.
Fructose and leucrose The nutritional emulsions may comprise a combination of fructose and leucrose, wherein the leucose represents at least about 0.1% of the weight of the nutritional emulsion, which ranges from about 0.1% to about 1.0%. or between about 0.30% and about 0.40%, by weight of the nutritional emulsion wherein the weight ratio between fructose and leucrose is at least about 1.5: 1, encompassing a range of between about 2: 1 and about 20: 1 or between about 2.8: 1 and about 8: 1.
Fructose and leucose can be added individually or in combination with the nutritional emulsion. A commercial source of such a combination is available from Cargill Sweetener Solutions, Minneapolis, Minnesota, US: it is Cargill Sucromalt SM05 syrup, which includes approximately 37% fructose, 13% leucrose, 48% saccharides and 2% of other disaccharides, based on dry weight.
Chromium picolinate The nutritional emulsions may comprise chromium picolinate in a concentration appropriate for oral administration. The concentration may vary from at least about 0.002%, which ranges from about 0.0020% to about 0.00010%, from about 0.0010% to about 0.00040% or from about 0 , 00090% and approximately 0.00060%, in relation to the weight of the emulsion.
Chromium picolinate can be included in the nutritional emulsions described herein to contribute to the control of blood glucose, in combination with the other nutrients described herein.
Macronutrients Nutritional emulsions include fats, proteins and carbohydrates. In general, it is possible in the present to use any source of fats, proteins and carbohydrates known and / or appropriate for an oral nutritional product, provided that the nutrients are compatible with the other ingredients of the formulation.
Although the concentrations or total amounts of fats, proteins and carbohydrates can vary based on the nutritional needs of the intended user, their values are typically within the ranges mentioned, which encompasses the other ingredients of fats, proteins and / or essential carbohydrates that are described herein.
Very normally, the concentration of carbohydrates varies between about 5% and about 40%, which ranges from about 7% to about 30%, including between about 10% and about 25%, relative to the weight of the emulsion nutritional The concentration of fats very usually varies between about 2% and about 30%, which ranges from about 3% to about 15% or between about 5% and about 10%, relative to the weight of the nutritional emulsion. The concentration of the proteins very normally varies between about 0.5% and about 30%, which ranges from about 1% to about 15% or between about 2% and about 10%, relative to the weight of the protein. nutritional emulsion.
Non-limiting examples of fats or fat sources appropriate for the nutritional emulsions described herein include diacylglycerol oil, which is as described herein, lecithin, which is as described herein, coconut oil, fractionated coconut oil, soybean oil, corn oil, olive oil, safflower oil, safflower oil with a high content of oleic acid, MCT oil (chain triglycerides medium), sunflower oil, sunflower oil with a high content of oleic acid, palm oil, palm kernel oil, palm olein, canola oil, marine oils, seed oil of cotton and combinations of these.
Non-limiting examples of carbohydrates or carbohydrate sources suitable for the nutritional emulsions described herein may include maltodextrin, hydrolyzed or modified starch, or corn starch, glucose polymers, corn syrup, solids of corn syrup, carbohydrates derived from rice, glucose, fructose, lactose, corn syrup with high fructose content, honey, alcohols derived from sugars (for example, maltitol, erythritol and sorbitol) and combinations thereof.
Non-limiting examples of proteins or protein sources suitable for nutritional emulsions include proteins or hydrolysed, partially hydrolyzed or non-hydrolyzed protein sources, which may have any known or appropriate origin, such as milk (e.g. casein, whey), animals (for example, meat, fish), cereals (for example, rice, corn), plants (for example, soybeans) or combinations of these. Non-limiting examples of proteins include milk protein isolates, milk protein concentrates, as described herein, casein isolates, whey proteins, caseinates, whole milk vaccine, partial or completely skim milk, protein isolates from soy, protein concentrates from soybeans and the like.
Optional ingredients The nutritional emulsion may also comprise other optional ingredients that may modify the physical, chemical or sensory or processing characteristics of the products, which may also serve as additional pharmaceutical or nutritional components when administered to the desired population. Many of these optional ingredients are known or suitable for use in other nutritional products, and may also be used in the nutritional emulsions described herein, provided they are safe, are effective for oral administration and are compatible. with the essential and optional ingredients in the product in question.
Non-limiting examples of optional ingredients include preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients, which may be as described herein, dyes, flavors, thickening agents , stabilizers (for example, carrageenan, avicel), sterols, phytosterols, turmeric, lubricants and the like.
Nutritional emulsions can also comprise vitamins or related nutrients. Non-limiting examples include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B1 2, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, its salts, its derivatives and the combinations that comprise them.
The nutritional emulsion may also comprise minerals. Non-limiting examples include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride and combinations of these.
Manufacturing method The nutritional emulsions may be manufactured according to any conventional or known method with which nutritional emulsions may be made, more typically, with any conventional or known method with which aqueous or milk-based nutritional emulsions may be made.
In an appropriate conventional manufacturing process, two or more separate suspensions are prepared, one of which is an aqueous suspension that is substantially free of fat. The one or more additional suspensions may include proteins in a suspension of fats / oils (eg, proteins, fats, emulsifiers, surfactants, etc.), proteins in an aqueous suspension (eg, proteins in water) or an additional suspension of carbohydrates and minerals. Eventually, the various suspensions are combined in a mixing tank. They are subjected to processing at an ultra high temperature, they are homogenized, they are add vitamins, minerals or other optional ingredients and dilute them in water to the appropriate extent.
Manufacturing processes may also include packaging the resulting nutritional emulsion into an appropriate container, which may be made, for example, of metal, glass or plastic, and which may be closed numerous times. The method may also include exposing the packaged nutritional emulsion to a retort sterilization process to produce a sterile packaged nutritional emulsion. Retort sterilization is a process known to those skilled in the art, and typically comprises a treatment at an elevated temperature. The nutritional emulsion can also be packaged aseptically instead of subjected to retort sterilization.
The processes for manufacturing the nutritional emulsions are not critical and can be practiced in ways different from those described herein, without departing from the spirit and scope of the invention. Therefore, the present embodiments are to be interpreted in an illustrative and non-restrictive manner, and all changes and equivalents must be within the scope of the present invention.
Surprisingly, it was found that certain combinations of components such as those described herein can provide unexpected benefits for nutritional emulsions having a high fiber content. One or more of these unexpected benefits may be the result of a synergistic combination of two or more of the components that are describe in the present. The combination of the one or more specific components that are described herein may result in improved and unexpected characteristics in emulsions having a high fiber content, as compared to conventional nutritional emulsions. In one embodiment, the combination of components in the emulsions having a high fiber content can result in an improved glycemic response combined with a higher caloric content. In another embodiment, the combination of components in the emulsion with a high fiber content can result in a very stable emulsion having a high fiber content and which can be manufactured with more desirable processes, at lower processing temperatures, despite of said high fiber content. In yet another embodiment of the emulsion with a high fiber content, an emulsion can be obtained which exhibits improved sensory properties and improved gastrointestinal tolerance, as well as a high fiber content, a higher calorie count and a moderate glycemic response.
The novel component blends that are employed in the high fiber content emulsions described herein may include any combination of two, three, four, five or more of the components detailed below, which may contribute individually or in combination (which encompasses a synergistic combination) to the surprising benefits of the high-fiber emulsions described here: a diacylglycerol oil, a milk protein concentrate, Sucromalt, fiber, fructooligosaccharides , insoluble fiber, turmeric, glycerin, chromium picolinate, monounsaturated fatty acids with 16-24 carbon atoms, leucrose and fructose. In other words, it is possible to combine any of these components to obtain the surprising benefits described for emulsions with a high fiber content.
Examples In the examples below, modalities and / or specific characteristics of the nutritional emulsions are illustrated. The examples are provided for illustrative purposes only and are not to be construed as limits to the invention, since various modifications can be made without departing from the spirit and scope of the invention.
Examples 1 -4 In these examples, embodiments of the nutritional emulsions of the present invention are illustrated, whose ingredients are detailed in the table below. The quantities of all the ingredients are expressed in kg for each batch of 1 000 kg of the product, unless otherwise specified. The formulations are aqueous emulsions which are stable during storage.
The formulations are prepared according to conventional methods, which comprise combining the appropriate ingredients to obtain a separate suspension of carbohydrates and minerals, a separate suspension of proteins in water or a separate suspension of proteins in oil. In each individual suspension, the ingredients are mixed at a suitable temperature and with agitation for the selected materials, after which the various suspensions are combined in a tank, subjected to a treatment at an ultra high temperature (UHT) and they are homogenized at approximately 3000 psi. Then add the vitamins, flavorings and other sensitive materials the heat to the homogenized mixture. The resulting mixture is diluted with water as necessary, in order to reach the density (approximately 1.0628 g / ml) and the desired concentrations. The resulting nutritional emulsion is sterilized and packaged in 8 ounce plastic bottles. The selected bottles have a narrow neck that extends 1 -5 cm from the widest portion of the body.
When the compositions described by way of example are packaged, they exhibit desirable characteristics, such as improved chemical or physical stability, desirable sensory properties, favorable rheology, improved viscoelastic properties or improved performance, as described in I presented. The formulations are physically stable when packaged and stored for a period of up to 18 months at a temperature of 20 ° C. With them, a modulated glycemic response and minimal or no gastrointestinal intolerance are obtained, especially when used in diabetic patients or in other individuals who may benefit from a modulated glycemic response.
Ingredient Example 1 Example 2 Example 3 Example 4 Water QS QS QS QS Fibersol-2 ™ 1 52.6 68.6 137.2 205.7 Concentrate of 38.5 38.5 38.5 38.5 milk proteins Sucromalt2 36.4 36.4 36.4 36.4 Glycerin 22.0 22.0 22.0 22.0 Enova ™ Oil 3 18.6 18.6 18.6 18.6 Concentrate of 18 18 18 18 soy proteins MALTRIN® M 1004 10.6 10.6 10.6 10.6 Canola oil 7.8 7.8 7.8 7.8 Fructooligosaccharides 5.0 6.5 13.0 19.6 Esters of sterols 3.2 3.2 3.2 3.2 vegetables Safflower oil 3.1 3.1 3.1 3.1 high content oleic acid Magnesium phosphate 2,4 2,4 2,4 2,4 Flavors 3.3 3.3 3.3 3.3 Potassium Citrate 2.0 2.0 2.0 2.0 Sodium Citrate 2.0 2.0 2.0 2.0 Soy lecithin (with 1.6 1.6 1.6 1.6 5% OB) in oil of soy Potassium chloride 0,900 0,900 0,900 0,900 Calcium Phosphate 0,670 0,670 0,670 0,670 Choline chloride 0.6515 0.6515 0.6515 0.6515 Sodium Chloride 0.650 0.650 0.650 0.650 Ascorbic acid 0.5841 0.5841 0.5841 0.5841 Magnesium Chloride 0.5000 0.5000 0.5000 0.5000 Viscarin SA-3595 0.4500 0.4500 0.4500 0.4500 KOH solution at 0.4181 0.4181 0.4181 0.4181 45% UT / TM / WSV 0.2717 0.2717 0.2717 0.2717 Liquid sucralose (0.1600 0.1600 0.1600 0.1600 25%) Acesulfame of potassium 0.0940 0.0940 0.0940 0.0940 Turmeric concentrate 0.0750 0.0750 0.0750 0.0750 Premix of 0.0651 0.0651 0.0651 0.0651 vitamins D, E and K Vitamin A oil 0.0091 0.0091 0.0091 0.0091 palm 54% Potassium iodide 220 mg 220 mg 220 mg 220 mg Vitamin B12 16 mg 16 mg 16 mg 16 mg (Total fiber) 2.3% 3.0% 6.0% 9.0% 1. Source of soluble fiber with 37% by weight of fibers for the diet; ADM Company, Decatur, Illinois, US 2. Sucromalt SM05: syrup with 37% fructose and 13% leucrose (based on dry weight); Cargill, Minneapolis, MN, US 3. Diacylglycerol oil; Kao Health and Nutrition, Itasca, IL, US 4. Maltodextrin DE 9-12; Grain Processing Corporation, Muscatine, Iowa, USA 5. Carrageenan: FMC Biopolymer, Philadelphia, Pennsylvania, US Examples 5-8 In these examples, embodiments of nutritional emulsions of the present invention are illustrated, whose ingredients are detailed in the table below. The quantities of all the ingredients are expressed in kg for each batch of 1000 kg of the product, unless otherwise specified. The formulations are aqueous emulsions which are stable during storage and which are prepared and packaged according to the process described in Examples 1-4.
Ingredient Example 5 Example 6 Example 7 Example 8 Water QS QS QS QS Fibersol 2 52.6 52.6 52.6 52.6 Concentrate of 38.5 38.5 38.5 38.5 milk proteins Sucromalt 36.4 36.4 36.4 36.4 Glycerin 22.0 22.0 22.0 22.0 Enova ™ Oil 20.0 25.0 30.0 40.0 Concentrate of 18 18 18 18 soy proteins Maltrin M 100 10.6 10.6 10.6 10.6 Canola oil 7.8 7.8 7.8 7.8 Fructooligosaccharides 5.0 5.0 5.0 5.0 Esters of sterols 3.2 3.2 3.2 3.2 vegetables Safflower oil 3.1 3.1 3.1 3.1 with content high acid oleic Magnesium phosphate 2,4 2,4 2,4 2,4 Flavors 3.3 3.3 3.3 3.3 Potassium Citrate 2.0 2.0 2.0 2.0 Sodium Citrate 2.0 2.0 2.0 2.0 Soy lecithin (with 1.6 1.6 1.6 1.6 5% OB) in oil of soy Potassium chloride 0,900 0,900 0,900 0,900 Calcium Phosphate 0,670 0,670 0,670 0,670 Choline chloride 0.6515 0.6515 0.6515 0.6515 Sodium Chloride 0.650 0.650 0.650 0.650 Ascorbic acid 0.5841 0.5841 0.5841 0.5841 Magnesium Chloride 0.5000 0.5000 0.5000 0.5000 Viscarin SA-359 0.4500 0.4500 0.4500 0.4500 KOH solution at 0.4181 0.4181 0.4181 0.4181 45% UTM / TM / WSV 0,2717 0,2717 0,271 7 0,2717 Sucralose liquefied (at 0, 1600 0, 1600 0, 1600 0, 1600 25%) Acesulfame of 0.0940 0.0940 0.0940 0.0940 potassium Turmeric 0, 0750 0.0750 0.0750 0.0750 concentrate Premix of 0.0651 0.0651 0.0651 0.0651 vitamins D, E and K Vitamin A of oil 0,0091 0,0091 0,0091 0,0091 of palm at 54% Potassium iodide 220 mg 220 mg, 220 mg 220 mg Vitamin B 12 16 mg 16 mg 16 mg 16 mg (Total fiber) 2, 3% 2, 3% 2, 3% 2.3% Examples 9-12 In these examples, embodiments of nutritional emulsions of the present invention are illustrated, whose ingredients are detailed in the table below. The quantities of all the ingredients are expressed in kg for each batch of 1 000 kg of the product, unless otherwise specified. The formulations are aqueous emulsions which are stable during storage and which are prepared and packaged according to the process described in Examples 1-4.
Ingredient Example 9 Example 10 Example 11 Example 12 Water QS QS QS QS Fibersol 2 52.6 52.6 52.6 52.6 Concentrate of 10 30 60 90 proteins of the milk Sucromalt 36.4 36.4 36.4 36.4 Glycerin 22.0 22.0 22.0 22.0 Enova ™ Oil 18.6 18.6 18.6 18.6 Concentrate of 18 18 18 18 soy proteins Maltrin M 100 10.6 10.6 10.6 10.6 Canola oil 7.8 7.8 7.8 7.8 Fructooligosaccharides 5.0 5.0 5.0 5.0 Esters of sterols 3.2 3.2 3.2 3.2 vegetables Safflower oil 3.1 3.1 3.1 3.1 with content high acid oleic Magnesium phosphate 2,4 2,4 2,4 2,4 Flavors 3.3 3.3 3.3 3.3 Potassium Citrate 2.0 2.0 2.0 2.0 Sodium Citrate 2.0 2.0 2.0 2.0 Soy lecithin 1.6 1.6 1.6 1.6 (with 5% OB) in soy oil Potassium chloride 0,900 0,900 0,900 0,900 Calcium Phosphate 0,670 0,670 0,670 0,670 Choline chloride 0.6515 0.6515 0.6515 0.6515 Sodium Chloride 0.650 0.650 0.650 0.650 Ascorbic acid 0.5841 0.5841 0.5841 0.5841 Magnesium Chloride 0.5000 0.5000 0.5000 0.5000 Viscarin SA-359 0.4500 0.4500 0.4500 0.4500 KOH solution at 0.4181 0.4181 0.4181 0.4181 45% UT / TM / WSV 0.2717 0.2717 0.2717 0.2717 Liquid sucralose (0.1600 0.1600 0.1600 0.1600 25%) Acesulfame of 0.0940 0.0940 0.0940 0.0940 potassium Turmeric 0.0750 0.0750 0.0750 0.0750 concentrate Premix of 0.0651 0.0651 0.0651 0.0651 vitamins D, E and K Vitamin A oil 0.0091 0.0091 0.0091 0.0091 palm 54% Potassium iodide 220 mg 220 mg 220 mg 220 mg Vitamin B 12 16 mg 16 mg 1 6 mg 16 mg Total fiber 2.3% 2, 3 2, 3 2.3 Examples 13-16 In these examples, embodiments of nutritional emulsions of the present invention are illustrated, whose ingredients are detailed in the table below. The quantities of all the ingredients are expressed in kg for each batch of 1000 kg of the product, unless otherwise specified. The formulations are aqueous emulsions which are stable during storage and which are prepared and packaged according to the process described in Examples 1-4.
I ngredient Example Example Example Example 1 3 14 1 5 16 Water QS QS QS QS Fibersol 2 52.6 52.6 52.6 52.6 Concentrate 38.5 38, 5 38, 5 38, 5 milk proteins Sucromalt 36.4 36.4 36.4 36.4 Glycerin 25.0 30.0 35.0 40.0 Enova ™ Oil 1 8.6 1 8.6 18.6 18.6 Concentrate of 1 8 1 8 1 8 18 soy proteins Maltrin M 100 10.6 1 0.6 1 0.6 10.6 Canola oil 7.8 7, 8 7.8 7.8 Fructooligosaccharides 5.0 5.0 5.0 5.0 Esters of sterols 3.2 3.2 3.2 3.2 vegetables Safflower oil with 3.1 3.1 3.1 3.1 a high content of oleic acid Magnesium phosphate 2,4 2,4 2,4 2,4 Flavors 3.3 3.3 3.3 3.3 Potassium Citrate 2.0 2.0 2.0 2.0 Sodium Citrate 2.0 2.0 2.0 2.0 Soy lecithin (with 1.6 1.6 1.6 1.6 5% OB) in oil soy Potassium chloride 0,900 0,900 0,900 0,900 Calcium Phosphate 0,670 0,670 0,670 0,670 Choline chloride 0.6515 0.6515 0.6515 0.6515 Sodium Chloride 0.650 0.650 0.650 0.650 Ascorbic acid 0.5841 0.5841 0.5841 0.5841 Magnesium Chloride 0.5000 0.5000 0.5000 0.5000 Viscarin SA-359 0.4500 0.4500 0.4500 0.4500 45% KOH solution 0.4181 0.4181 0.4181 0.4181 UTM / TM / WSV 0.2717 0.2717 0.2717 0.2717 Liquid sucralose (0.1600 0.1600 0.1600 0.1600 25%) Acesulfame de potasio 0, 0940 0,0940 0,0940 0,0940 Turmeric concentrate 0.0750 0.0750 0.0750 0.0750 Vitamin premix 0.0651 0.0651 0, 0651 0.0651 D, E and K Vitamin A oil of 0.0091 0.0091 0.0091 0.0091 palm 54% Potassium iodide 220 mg 220 mg 220 mg 220 mg Vitamin B 12 16 mg 16 mg 16 mg 16 mg Total fiber 2, 3% 2.3 2, 3 2.3 Examples 17-20 In these examples, embodiments of nutritional emulsions of the present invention are illustrated, whose ingredients are detailed in the table below. The quantities of all the ingredients are expressed in kg for each batch of 1 000 kg of the product, unless otherwise specified. The formulations are aqueous emulsions which are stable during storage and which are prepared and packaged according to the process described in Examples 1-4.
Ingredient Example Example Example Example 1 7 1 8 19 20 Water QS QS QS QS Fibersol 2 52.6 52.6 52.6 52.6 Concentrate 38.5 38.5 38.5 38, 5 milk proteins Sucromalt 30 35 40 50 Glycerin 22.0 22.0 22.0 22.0 Enova ™ Oil 18.6 18.6 18.6 18.6 Concentrate of 18 18 18 18 soy proteins Maltrin M 100 10.6 10.6 10.6 10.6 Canola oil 7.8 7.8 7.8 7.8 Fructooligosaccharides 5.0 5.0 5.0 5.0 Esters of sterols 3.2 3.2 3.2 3.2 vegetables Safflower oil 3.1 3.1 3.1 3.1 high content oleic acid Magnesium phosphate 2,4 2,4 2,4 2,4 Flavors 3.3 3.3 3.3 3.3 Potassium Citrate 2.0 2.0 2.0 2.0 Sodium Citrate 2.0 2.0 2.0 2.0 Soy lecithin (with 1.6 1.6 1.6 1.6 5% OB) in oil soy Potassium chloride 0,900 0,900 0,900 0,900 Calcium Phosphate 0,670 0,670 0,670 0,670 Choline chloride 0.655 0.6515 0.6515 0.6515 Sodium Chloride 0.650 0.650 0.650 0.650 Ascorbic acid 0.5841 0.5841 0.5841 0.5841 Magnesium Chloride 0.5000 0.5000 0.5000 0.5000 Viscarin SA-359 0.4500 0.4500 0.4500 0.4500 KOH solution at 0.41 81 0.41 81 0.4181 0.41 81 45% UTM / TM / WSV 0,2717 0,271 7 0,271 7 0,271 7 Liquid sucralose (at 0, 1600 0, 1600 0, 1600 0, 1600 25%) Acesulfame of potassium 0,0940 0, 0940 0,0940 0, 0940 Turmeric concentrate 0.0750 0.0750 0.0750 0.0750 Vitamin premix 0.0651 0.0651 0, 0651 0.0651 D, E and K Vitamin A oil of 0.0091 0.0091 0.0091 0.0091 palm 54% Potassium iodide 220 mg 220 mg 220 mg 220 mg Vitamin B1 2 16 mg 16 mg 16 mg 16 mg Total Fibers 2.3% 2, 3% 2.3% 2.3% Study I In this study, the benefits related to insulin sensitivity were evaluated with one embodiment of the present invention (A1), compared to two separate controls (A2 and A3). Formulation A1 is a balanced nutritional formulation according to the present invention. It is compared to formulations A2 (containing carbohydrates and chromium) and A3 (containing carbohydrates, proteins and chromium), which comprise some components selected from formulation A1 and which do not contain the balanced formulation described in the present invention.
Ingredient Formula A1 Formula A2 Formula A3 g / 100 g of the g / 100 g of the g / 100 g diet diet the diet Proteins (5.5.5 concentrate milk proteins, protein concentrate of soy) Carbohydrate mixture 12.7 11.1 11.1 (Sucromalt, glycerol, Fibersol II) with a total fiber content of approximately 2.6-5.2 Chromium picolinate 0.7 mg / 100 g 0.7 mg / 100 g 0.7 mg / 100 9 Oil DAG 0.197 Canola oil 0.82 Ascorbic acid 0.028 Maltrin M100 1,059 Magnesium chloride 0.075 Sodium chloride 0.05 Potassium chloride 0.09 Potassium citrate 0.2 Potassium hydroxide 0.041 Four. Five% Sodium Citrate 0.2 Hill Chloride 0.065 Calcium triphosphate 0, 1 Magnesium phosphate 0.25 dibasic Safflower oil with a 0.329 high acid content oleic Carragenina Viscarin SA 0.04 359 Vitamins D, E, K 0.006 FOS powder 0.5 Premix of 0, 027 UTM / TM / WSV Fluid lecithin 0, 164 Caloric density 0,837 0, 31 21 0, 5 To prepare the study, 32 male Zucker fa / fa rats (9 weeks old and 5 days old, with a body weight of 0.423 kg at the beginning of the study) were classified into three groups (n = 1 0-1 1), Paired in groups of similar body weight. Rats can be fed ad libitum with a semipurified diet in the form of pellets (the "study diet") that mimics a conventional low-quality American diet, since presents a high content of saturated fats and carbohydrates prone to increase blood glucose. In addition, rats have access to one of the three liquid supplements, A1, A2 or A3. The formulation A1 is a form of a balanced nutritional emulsion according to the present invention. The formulation A2 is a solution comprising the functional carbohydrates and the chromium picolinate of the formulation A1. Formulation A3 is a solution comprising functional carbohydrates, chromium and proteins of formulation A1. The A2 and A3 solutions are prepared in such a way that the rats consume the functional carbohydrate levels (Fibersol, Sucromalt and glycerol) (2.83 kcal / g bouquet) and the proteins (the milk protein concentrate and the milk concentrate). soy proteins, 3.46 kcal / gram) found in formulation A1.
Blood samples are taken after an overnight fast to analyze glucose, insulin and glycated hemoglobin after 0, 14 and 28 days of feeding with the study diet, with or without additional components. Insulin tolerance is measured just before feeding the rats with the study diet and after 28 days of feeding. To determine insulin tolerance, rats are fasted overnight and injected with regular insulin (1 U / kg body weight, Humulin®, Eli Lilly Company). Blood samples are taken from the apex of the tail 30, 60, 90 and 1 20 minutes after injecting the insulin. At the end of the test, they are given access to the food again.
The supplementary compositions do not affect the fasting blood glucose concentration during the 28-day feeding period. Surprisingly, formulations A3 and A2 result in an increase in plasma insulin, compared to formulation A1 (see Fig. 1; p < 0.01 on day 14 for formulation A2 compared to formulation A1). Formulation A3 results in a significant worsening in insulin sensitivity as compared to formulation A1 (see Figure 2). Through the administration of the supplementary formulation A2, the glycated hemoglobin is increased by 0.9% between day 0 and day 28. The increase obtained with the formulation A1 is only 0.2% (figure 3) .
Based on the previous evaluation, it can be established that the voluntary consumption of the functional ingredients of formulation A1 (Fibersol, Sucromalt, glycerol, chromium picolinate, milk protein concentrate and soy protein concentrate) as a result, a surprising worsening in insulin sensitivity and in metabolic control, compared with the voluntary consumption of the complete formula A1. Accordingly, it can be established that the beneficial effect of formula A1 can not be assigned to an individual component, so it must reside in the complete balanced formulation described here.
Study I I A study is carried out where the sensitivity to insulin and glycated hemoglobin is evaluated with a modality of this invention.
To prepare the study, twenty male Zucker fa / fa rats (9 weeks old, with a body weight of 0.36 kg at the beginning of the study) are classified into two groups of 10. The animals in the groups have a body weight. Similary. The rats are fed the "diet of the study", which is a semipurified diet in the form of pellets that mimics a conventional American diet of low quality, since it has a high content of saturated fats and carbohydrates prone to increase blood glucose, such such as sucrose and maltodextrin. The rats are fed the study diet alone ("without additional components") or in combination with formula A1, which was previously described.
Blood samples are taken after an overnight fast to analyze glucose, insulin and glycated hemoglobin after 0, 14 and 28 days of feeding with the study diet, with or without additional components. Insulin tolerance is measured just before feeding the rats with the study diet and after 14 days of feeding. The rats are fasted overnight (16 hours) and blood samples are taken from the apex of the tail at time zero. Immediately afterwards, the rats are injected with regular insulin (1 U / kg of body weight, Humulin®, Eli Lilly Company). Blood samples are taken from the apex of the tail 30, 60, 90 and 120 minutes after injecting the insulin. At the end of the test, they are given access to the food again.
When the formulation A1 is added, the concentration of glucose in the blood. Surprisingly, the voluntary intake of the A1 formulation resulted in a lower concentration of insulin in the plasma (see Fig. 4) and improved insulin tolerance (see Fig. 5). The concentration of glycated hemoglobin increases 2.1% during the study (figure 6), but the voluntary consumption of Viking 2 during only four weeks results in a surprising limitation in this increase, which is only 0.6%. The rats in these experiments are not forced to consume Viking 2. They are merely given access to the formula and to the diet rich in fats and sugars, which is more enjoyable. Surprisingly, these pre-diabetic rats voluntarily consume an amount of the A1 formulation that is sufficient to improve their insulin sensitivity, which was determined through the concentration of insulin in the plasma and the tolerance to insulin. Furthermore, it is surprising that the voluntary intake of the A1 formulation by the prediabetic rats for four weeks resulted in a marked limitation in the glycated hemoglobin that had been induced by the study diet, which had a high content of fats and sucrose. .
Study III A study is carried out where the effects of satiety of an embodiment of the present invention are evaluated.
To prepare the study, forty male Zucker fa / fa rats (9 weeks old, with a body weight of 0.36 kg at beginning of the study) in four groups of 1 0. The animals in the groups have a similar body weight. The rats are fed one of the two possible solid diets. The first is a diet control Harian 201 8 (Harlan-Teklad, Madison, Wl) and the second is the "diet of the study", which is a semipurified diet in the form of pellets that mimics a conventional American diet of low quality, since It has a high content of saturated fats and carbohydrates prone to increase blood glucose, such as sucrose and maltodextrin. The rats are fed the solid diets without additional components (ie, with the control diet or with the study diet) or in combination with formula A1 (liquid), which was previously described.
Experimental diets are provided for 28 days. The solid diets in the form of pellets are administered to the rats in an amount of approximately 50 grams, on top of a wire cage. The non-ingested food is weighed daily. The scattered food is also recorded. The liquid diet (formula Al) is administered by attaching a bottle to the front of the cage. Consumption is measured by weighing the bottles. The old diet is discarded and clean bottles and fresh solid and liquid diets are provided daily. All rats are fed ad libitum with solid and liquid diets.
As expected, diet with the study resulted in an increase in food intake and in body weight, compared to the control diet (p <0.05, see figure 7). Thus, it is shown that the diet of the study, which is characterized by a high content of fat and sucrose, is ingested to a greater extent than the regular diet, so it could be inferred that it was more pleasant for the rats. However, when they were given access to formulation A1, the rats voluntarily consumed approximately 1,000 kcal during the study. Surprisingly, the rats consumed a smaller amount of the study diet, which was more palatable, as compensation for the calories they had consumed through formulation A1 (p <0.05, see figure 8). Accordingly, it can be concluded that formulation A1 is surprisingly pleasant and causes satiety, which is why it motivates rats to reduce the intake of the preferred solid diet.

Claims (24)

  1. REVIVAL NAME IS 1 . An aqueous emulsion characterized in that it comprises fats, proteins and carbohydrates, which includes (a) between about 1.75% and about 4.0% by weight of a diacylglycerol oil, (b) between about 0.5% and about 9.0% by weight of a concentrate of milk proteins, (c) between about 2.0% and about 9.0% by weight of fiber, and (d) fructose and a minimum of about 0.1% of leucrose, with a weight ratio between fructose and leucrose of at least 2: 1, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20 ° C. 2. The aqueous emulsion of claim 1, characterized in that it comprises between about 5% and about 40% by weight of carbohydrates, between about 2% and about 30% by weight of fats and between about 1% and about 15% by weight of proteins . 3. The aqueous emulsion of claim 2, characterized in that it comprises between about 2.0% and about 6% fiber, relative to the weight of the emulsion. 4. The aqueous emulsion of claim 2, characterized in that the fiber represents between approximately 12% and about 40% by weight of the total carbohydrates in the emulsion. 5. The aqueous emulsion of claim 2, characterized in that the fibers include a fructooligosaccharide representing between about 5% and about 50% by weight of the fibers in the emulsion. 6. The aqueous emulsion of claim 2, characterized in that it comprises between about 1, 8% and about 3% diacylglycerol oil, relative to the weight of the emulsion. 7. The aqueous emulsion of claim 2, characterized in that the diacylglycerol oil represents between about 40% and about 80% by weight of the total fats in the emulsion. 8. The aqueous emulsion of claim 2, characterized in that it has a weight ratio between fiber and diacylglycerol oil of between about 1, 20: 1 and about 5: 1. 9. The aqueous emulsion of claim 2, characterized in that it has a viscosity of between about 10 cps and about 160 cps at 20 ° C. 10. The aqueous emulsion of claim 2, characterized in that it also comprises between about 0.1% and about 0.5% by weight of lecithin. eleven . The aqueous emulsion of claim 2, characterized in that it also comprises chromium picolinate. 12. The aqueous emulsion of claim 2, characterized in that it also comprises carrageenan. 3. The aqueous emulsion of claim 2, characterized in that it also comprises a turmeric. 14. An aqueous emulsion characterized in that it comprises between about 5% and about 40% by weight of carbohydrates, between about 2% and about 30% by weight of fats and between about 1% and about 15% by weight of proteins, which includes (a) between about 1.75% and about 4.0% by weight of a diacylglycerol oil, (b) between about 0.5% and about 9.0% by weight of a concentrate of milk proteins, (c) between about 2.0% and about 9.0% by weight of fibers, (d) fructose and a minimum of about 0.1% of leucrose, with a weight ratio between fructose and leucose of at least 2: 1, and (e) between about 0.1 mg% and about 2.0 mg% chromium picolinate, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20 ° C. 5. The aqueous emulsion of claim 2, characterized in that it comprises between about 2% and about 6% fiber, relative to the weight of the emulsion. 16. The aqueous emulsion of claim 2, characterized in that the fiber represents between approximately 12% and about 40% by weight of the carbohydrates in the emulsion. 7. The aqueous emulsion of claim 2, characterized in that the fibers include a fructooligosaccharide, which represents between about 5% and about 50% by weight of the fibers in the emulsion. The aqueous emulsion of claim 2, characterized in that it comprises between about 1, 8% and about 3% diacylglycerol oil, relative to the weight of the emulsion. 9. The aqueous emulsion of claim 2, characterized in that the diacylglycerol oil represents between about 40% and about 80% by weight of the total fats in the emulsion. 20. The aqueous emulsion of claim 2, characterized in that it has a weight ratio between fiber and diacylglycerol oil of between about 1, 20: 1 and about 5: 1. twenty-one . An aqueous emulsion characterized in that it comprises fats, proteins and carbohydrates, which includes (a) between about 1.75% and about 4.0% by weight of an oil blend, wherein the mixture of oils comprises relative to the weight of the oil blend, (i) between 30% and 50% of safflower oil with a high content of oleic acid, (ii) between 20 and 40% cane oil, (iii) between 1 5 and 35% of soybean oil, and (iv) between 1 and 10% of lecithin, (b) between about 0.5% and about 9.0% by weight of a concentrate of milk proteins, (c) between about 2.0% and about 9.0% by weight of fibers, and (d) fructose and at least about 0.1% leucrose, with a weight ratio between fructose and leucrose of at least 2: 1, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20 ° C . 22. The aqueous emulsion of claim 21, characterized in that the mixture of oils comprises 40% of safflower oil with a high content of oleic acid, 30% of canola oil, 25% of soybean oil, and 5% of lecithin, with relation to the weight of the oil mixture. 23. An aqueous emulsion characterized in that it comprises between about 5% and about 40% by weight of carbon carbohydrates, between about 2% and about 30% by weight of fats, and between about 1% and about 15% by weight of proteins, which includes (a) between about 1.75% and about 4.0% by weight of an oil blend, wherein the mixture of oils comprises relative to the weight of the oil blend, (i) between 30% and 50% of safflower oil with a high content of oleic acid, (ii) between 20 and 40% cane oil, (iii) between 1 5 and 35% of soybean oil, and (iv) between 1 and 10% of lecithin, (b) between about 0.5% and about 9.0% by weight of a concentrate of milk proteins, (c) between about 2.0% and about 9.0% by weight of fibers, (d) fructose and at least about 0.1% of leucrose, with a weight ratio between fructose and leucose of at least 2: 1, and (e) between about 0.1 mg% and about 2.0 mg% chromium picolinate, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20 ° C. 24. The aqueous emulsion of claim 23, characterized in that the mixture of oils comprises 40% of safflower oil with a high content of oleic acid, 30% of canola oil, 25% of soybean oil and 5% of lecithin, in relation to to the weight of the oil mixture.
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