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Title:  Carbohydrate system and a method for providing nutrition to a diabetic

United States Patent:  6,774,111

Issued:  August 10, 2004

Inventors:  Wolf; Bryan W. (Johnstown, OH); Zinker; Bradley A. (Vernon Hills, IL); Garleb; Keith A. (Powell, OH); Walton; Joseph E. (Westerville, OH)

Assignee:  Abbott Laboratories (Abbott Park, IL)

Appl. No.:  524716

Filed:  March 14, 2000

Abstract

The two carbohydrate mixture of this invention utilizes a source of fructose in combination with at least one readily digestible glucose polymer source. The addition of the fructose significantly decreases the glycemic response when compared to the digestible glucose polymer alone. Additional components may be added to the simple two component carbohydrate mixture to form a carbohydrate system suitable for incorporation into an enteral nutritional. This carbohydrate system optionally incorporates nonabsorbent carbohydrates, dietary fiber and indigestible oligosaccharides. The present invention is also directed to an enteral nutritional which incorporates the two component carbohydrate mixture and less than 37% of calories from fat. Additionally, the invention is directed to a method of delivering nutrients to a person with diabetes by feeding the enteral nutritional.

SUMMARY OF THE INVENTION

The present invention is directed to a two component carbohydrate mixture that solves a number of problems associated with the prior art complex multi-component carbohydrate systems designed for the diabetic. The two component carbohydrate mixture of this invention utilizes a source of fructose in combination with at least one readily digestible glucose polymers. The use of the fructose in the two component carbohydrate mixture significantly decreases the glycemic response when compared to, the glucose polymer alone. Further, this two component carbohydrate mixture tastes good and possesses physical properties which allow for easy incorporation into liquid, powder, bars and semisolid nutritionals.

Additional components may be added to the two component carbohydrate mixture to form a "carbohydrate system". This carbohydrate system optionally incorporates nonabsorbent carbohydrates, dietary fiber and indigestible oligosaccharides, thereby increasing fecal bulk, modifying the transit time of nutrients through the intestines and providing nutrients to the beneficial microflora of the large intestine which all contribute to a healthy gastrointestinal tract.

The present invention is also directed to a new nutritional product designed for the person with diabetes that solves a number of problems associated with the prior art nutritional formulas. Since the aim of diabetic therapy is to prevent large fluctuations in blood glucose throughout the day, diabetics are advised to select carbohydrate foods that minimize blood glucose level after a meal by emphasizing the complex carbohydrates (starch) over the simple sugars. Complex carbohydrates are the preferred carbohydrate source as they are considered to be digested more slowly and to raise the blood glucose less than simple rapidly absorbed sugars. The prior art teaches that a complex multi-component carbohydrate system should be used. These systems incorporate differing carbohydrate sources that are digested and absorbed at differing rates. While theses systems produce improved blood glucose levels after a meal, they are difficult to incorporate into nutritional formulas.

The nutritional product of this invention utilizes a two component carbohydrate mixture which includes a source of fructose in combination with at least one readily digestible glucose polymers which the inventors have discovered significantly decreases the glycemic response when compared to the glucose polymer alone. Consequently, a nutritional formula may contain a higher percentage of readily absorbed carbohydrate and produce a lower glycemic response than expected. Further, the additional carbohydrate calories may replace fat calories, thereby facilitating the formulation of a nutritional for persons with diabetes containing less than 37% of the calories from fat.

The present invention is also directed, to a method of delivering nutrients to a person with abnormal glucose tolerance by feeding a nutritional which incorporates the two component carbohydrate mixture and less than 37% of calories from fat.

DETAILED DESCRIPTION OF THE INVENTION

One embodiment of the instant invention is a two component carbohydrate mixture which decreases the glycemic response of digestible glucose polymers. The two component carbohydrate mixture comprises a source of fructose and at least one digestible glucose polymer source. Component ranges for the two component carbohydrate system are described in Table 2 on a dry matter basis.

                             TABLE 2
      Carbohydrate mixture ranges (wt/wt % of carbohydrate)
                           Target     Preferred  More Preferred
        Component         (wt/wt %)   (wt/wt %)     (wt/wt %)
        fructose             5-50        5-30         10-25
        digestible glucose     50-95       70-95         75-90
        polymer

The preferred ranges may also be described as the ratio of digestible glucose polymer to fructose. The preferred range is from about 19:1 to 1:1 of digestible glucose polymer to fructose, more preferably from about 19:1 to 2.3:1, digestible glucose polymer to fructose, most preferably from about 9:1 to 3:1 digestible glucose polymer to fructose.

A component of the two component carbohydrate mixture of the invention is digestible glucose polymer. Any digestible glucose polymer suitable for human consumption may be utilized in the instant invention. Examples of typical digestible glucose polymer sources include corn syrup, corn syrup solids, rice syrup, glucose oligomers such as maltose and the sugar alcohols such as maltitol. As indicated in Table 2, the typical amount of digestible glucose polymer in the two component carbohydrate mixture is from about 50 wt/wt% to about 95 wt/wt% of the two component carbohydrate mixture, preferably from about 70 wt/wt% to about 95 wt/wt% of the two component carbohydrate mixture, more preferably from about 75 wt/wt% to about 90 wt/wt% of the two component carbohydrate mixture.

Glucose (dextrose) is found naturally in grains, fruits and honey. More typically, commercially available glucose is produced by complete hydrolysis of starch. During the hydrolysis process, digestible glucose polymers are generated as constituents of corn syrup. The amounts of glucose and glucose polymers in corn syrup can vary as described in Table 3 below.

                             TABLE 3
             Carbohydrate profile of several sources*
                                   corn    corn    corn
                liquid  corn syrup  syrup   syrup   syrup
    % dry basis dextrose   DE 63    DE 43   DE 36   DE 45  maltose
    fructose       0.1      0        0       0       0       0
    dextrose      99       36       19      14       9       4
    maltose        0.6     31       14      11      43      65
    maltotriose    0.2     13       12      10      18      15
    higher         0.1     20       55      65      30      16
    saccharides
    *Data from Cargill, Minneapolis, Minnesota product information sheets

Any reference in this application to a quantity of digestible glucose polymer should be understood as referring to the actual amount of digestible glucose polymer in the carbohydrate source. One skilled in the art can readily calculate how much of a carbohydrate source should be added to the nutritional product in order to deliver the desired amount of digestible glucose polymer.

Maltose is a disaccharide which is comprised of two D-glucose units chemically linked together. Maltose is also produced by the hydrolysis of starch and a typical composition is listed in Table 3. Maltitol is the sugar alcohol of maltose produced by the hydrogenation of one of the glucose units of maltose.

Typically, the digestible glucose polymers of the instant invention are partially hydrolyzed starches. For example, the production of partially hydrolyzed corn starch typically begins with a corn starch slurry that is hydrolyzed with food grade acids and/or enzymes. The resulting syrup is refined by filtering and carbon treatment. The hydrolysis is controlled to achieve the desired endpoint. The partially hydrolyzed corn starch is classified according to its dextrose equivalence (DE) which represents the degree of hydrolysis. As described in Table 3, the corn 'syrup may be enriched in a particular constituent. These partially hydrolyzed starches are usually rapidly digested (some chemical modifications may decrease their digestibility resulting in nonabsorbent carbohydrates which are discussed later).

Commercial sources for the digestible glucose polymers are readily available and known to one practicing the art. For example, corn syrup solids are available from Cerestar USA, Inc in Hammond, Ind. Rice based syrups are available from California Natural Products in Lathrop, Calif. Maltose and corn syrup are available from Cargil in Minneapolis, Minn. Maltitol powder is available from Roquette America, Inc., Keokuk, Iowa. Maltitol syrup from AlGroup Lonza, Fair Lawn, N.J.

The second component of the two component carbohydrate mixture of the instant invention is source of fructose. Any fructose source suitable for human consumption may be utilized in the instant invention. Examples of typical fructose sources include sucrose, high fructose corn syrup and liquid and powder fructose. As indicated in Table 2, the typical amount of fructose in the two component carbohydrate mixture is from about 5 wt/wt% to about 50 wt/wt% of the two component carbohydrate mixture, preferably from about 5 wt/wt% to about 30 wt/wt% of the two component carbohydrate mixture, more preferably from about 10 wt/wt% to about 25 wt/wt% of the two component carbohydrate mixture.

Fructose is found in fruits and honey. More typically, commercially available fructose is produced by enzymatic conversion of saccharides to fructose. The fructose content of various sources is listed in Table 4 below.

                             TABLE 4
        Carbohydrate profile of several fructose sources*
                                     high fructose
                                      corn syrup
                                     (representative
        % dry basis          fructose   profiles)       honey
        fructose               99.5     42     55       49
        dextrose                0.5     52     41       40
        maltose                 0        3      2        9
        higher saccharides      0        3      2        2
    *Fructose and corn syrup data from Cargill, Minneapolis, Minnesota product
     information sheets, honey values from National Honey Board, San Francisco,
     California

Commercial high fructose corn syrup is available with various levels of fructose. The high fructose corn syrup profiles listed in Table 4 represent two commercially available fructose sources, with fructose at 42% and 55% of the corn syrup, respectively. Any reference in this application to a quantity of fructose should be understood as referring to the actual fructose content within the carbohydrate source. For example, 100 gm of the honey in Table 4 would provide 49 gm of fructose. One skilled in the art can readily calculate how much of a carbohydrate source should be added to the nutritional product in order to deliver the desired amount of fructose.

Commercial sources for fructose are readily available and known to one practicing the art. For example, various high fructose corn syrups are available from Cargil in Minneapolis, Minn. Fructose is available from A.E. Staley in Decatur, Ill.

The present invention is also directed to a carbohydrate system which incorporates dietary fiber, nonabsorbent carbohydrates and indigestible oligosaccharides into the two component carbohydrate mixture described above. Typically for every gram of dietary fiber, nonabsorbent carbohydrate and indigestible oligosaccharide added to the formulation, a gram of the two component carbohydrate mixture is removed. Typically up to about 57 wt/wt% of the simple two component carbohydrate mixture may be replaced with a combination of dietary fiber, nonabsorbent carbohydrates and indigestible oligosaccharides to form a "carbohydrate systems".

The first optional component of the carbohydrate system is dietary fiber which comprises less than or equal to about 17 wt/wt% of the carbohydrate system, preferably less than or equal to about 15 wt/wt% of the carbohydrate system, more preferably less than or equal to about 10 wt/wt% of the carbohydrate system.

Examples of dietary fiber sources of the instant invention typically include gum arabic, carboxymethylcellulose, guar gum, konjac flour, xanthan gum, alginate, gellan gum, gum acacia, citrus pectin, low and high methoxy pectin, modified cellulose, oat and barley glucans, carrageenan, psyllium, soy polysaccharide, oat hull fiber, pea hull fiber, soy hull fiber, soy cotyledon fiber, sugar beet fiber, cellulose, corn bran and hydrolyzed forms of the listed fibers and any combination thereof.

Numerous types of dietary fibers are known and available to one practicing the art. Fibers differ significantly in their chemical composition and physical structure and therefore their physiological functions. The dietary fiber sources utilized in this invention can be characterized by the terms solubility and fermentability. With regard to solubility, fiber can be divided into soluble and insoluble types and fiber sources differ in the amount of soluble and insoluble fiber they contain.

Representative of soluble dietary fiber, sources are gum arabic, sodium carboxymethylcellulose, guar gum, gellan gum, konjac flour, xanthan gum, alginate, citrus pectin, low and high methoxy pectin, oat and barley glucans, carrageenan and psyllium. Numerous commercial sources of soluble dietary fibers are readily available and known to one practicing the art. For example, gum arabic, hydrolyzed carboxymethylcellulose, guar gum, xanthan gum, alginates, pectin and the low and high methoxy pectins are available from TIC Gums, Inc. of Belcamp, Md. The oat and barley glucans are available from Mountain Lake Specialty Ingredients, Inc. of Omaha, Nebr. Psyllium is available from the Meer Corporation of North Bergen, N.J. while the carrageenan and konjac flour are available from FMC Corporation of Philadelphia, Penn.

Representative of the insoluble dietary fibers are oat hull fiber, pea hull fiber, soy hull fiber, soy cotyledon fiber, sugar beet fiber, cellulose and corn bran. Numerous sources for the insoluble dietary fibers are readily available and known to one practicing the art. For example, the corn bran is available from Quaker Oats of Chicago, Ill.; oat hull fiber from Canadian Harvest of Cambridge, Minn.; pea hull fiber from Woodstone Foods of Winnipeg, Canada; soy hull fiber and oat hull fiber from The Fibrad Group of LaVale, Md.; soy cotyledon fiber from Protein Technologies International of St. Louis, Mo.; sugar beet fiber from Delta Fiber Foods of Minneapolis, Minn. and cellulose from the James River Corp. of Saddle Brook, N.J.

Dietary fiber can also be divided into fermentable and non-fermentable types. This property of fiber is the capacity to be fermented by the anaerobic bacteria present in the human large bowel. Dietary fibers vary significantly in their fermentability.

Representative of fermentable dietary fiber sources are gum arabic and guar gum. Commercial sources of fermentable dietary fibers are readily available and known to one practicing the art. For example, gum arabic and guar gum are available from TIC Gums, Inc. of Belcamp, Md.

Representative of non-fermentable dietary fiber sources are carboxymethylcellulose (CMC), psyllium, oat hull fiber and corn bran. Numerous commercial sources of non-fermentable dietary fibers are readily available and known to one practicing the art. For example, carboxymethylcellulose is available from TIC Gums, Inc. of Belcamp, Md. The corn bran is available from Quaker Oats of Chicago, Ill. while the oat hull fiber is available from Canadian Harvest of Cambridge, Minn. Psyllium is available from the Meer Corporation of North Bergen, N.J.

The second optional component of the carbohydrate system is nonabsorbent carbohydrates which comprises less than or equal to about 20 wt/wt% of the carbohydrate system, preferably less than or equal to 15 wt/wt% of the carbohydrate system, more preferably less than or equal to about 10 wt/wt% of the carbohydrate system.

Examples of nonabsorbent carbohydrates sources of the instant invention typically include chemically modified starches such as Fibersol 2(E) and inulin.

Nonabsorbent carbohydrates possess many of the characteristics of fibers but are not quantified by the AACC method as total dietary fiber. Chemical modification of starch can ultimately affect its rate and extent of digestion in the small intestine. Partial hydrolysis of starch using acid and heat results in molecular rearrangement of the starch molecule such that alpha and beta-(1,2) and -(1,3) linkages are formed in addition to reconfiguration of existing alpha-(1,4) and -(1,6) bonds in to beta bonds. For example, corn starch treated with hydrochloric acid, amylase and heat produces a low molecular weight indigestible dextrin (distributed by Matsutani Chemical Industry, Hyogo Japan under the product name Fibersol 2(E)) with a'slow rate of fermentation. Therefore, the sat nonabsorbent carbohydrate is more likely to reach the lower part of the large intestine and be utilized by the indigenous microbiota.

Inulin is usually purified from plants such as chicory, Jerusalem artichoke, leek and asparagus. Various procedures for extracting the inulin have been reported. Usually the steps include chopping up the plant, extracting it.

Commercial sources of nonabsorbent carbohydrates are readily available and known to one practicing the art. For example, Fibersol 2(E) is available from Matsutani Chemical Industry, Hyogo Japan while inulin is available from Rhone-Poulenc, Inc, Cranbury, N.J.

The third optional component of the carbohydrate system is indigestible oligosaccharides which comprises less than or equal to about 20 wt/wt% of the carbohydrate system, preferably less than or equal to 15 wt/wt% of the carbohydrate system, more preferably less than or equal to about 10 wt/wt% of the carbohydrate system.

Examples of indigestible oligosaccharide sources of the instant invention typically include fructooligosaccharides (FOS), xylooligosaccharides(XOS), alpha glucooligosaccharides(GOS), trans galactosyl oligosaccharides(TOS), soybean oligosaccharides, lactosucrose, hydrolyzed inulin and polydextrose.

An indigestible oligosaccharide, such as fructooligosaccharide(FOS), is rapidly and extensively fermented to short chain fatty acids by anaerobic microorganisms that inhabit the large bowel increasing cell proliferation in the proximal colonic epithelial mucosa. Further, FOS is a preferential energy source for most Bifidobcterium species but it is not utilized by potentially pathogenic organisms such as Clostrdium perfingens, C. difficile, or E. coli. Thus, the addition of FOS to the nutritional products of the present invention selects for beneficial bacteria, such as bifidobacteria, but against potential pathogens, such as Clostridium difficile and putrefactive bacteria.

Numerous commercial sources of indigestible oligosaccharides are readily available and known to one practicing the art. For example, FOS is available from Golden Technologies Company of Golden, Colorado and XOS is available from Suntory Limited of Osaka Japan. GOS is available from Solabia, Pantin Cedex, France. TOS is available from Yakult Honsha Co., Tokyo, Japan. Soybean oligosaccharide is available from Calpis Corporation distributed by Ajinomoto U.S.A. Inc., Teaneck, N.J. Hydrolyzed inulin is available from Rhone-Poulenc, Inc, Cranbury, N.J. while polydextrose is available from A.E. Staley in Decatur Ill.

The present invention is also directed to a method of blunting the glycemic response of digestible glucose polymers by feeding the two component carbohydrate mixture or carbohydrate system described above. Research in the area of glucose tolerance tests by Mary Moore et. al. ("Effect of Fructose on the Response of Normal Adults to an Oral Glucose Tolerance Test", A JOURNAL OF THE AMERICAN DIABETES ASSOCIATION, ABSTRACT BOOK 59TH SCIENTIFIC SESSIONS, Jun. 1999, Abstract 1270, p. A291) teaches that glucose tolerance was improved by the addition of fructose to a glucose solution in 8 normal subjects, unchanged in 1 normal subject and worsened in 2 normal subjects. Moore et. al. concluded that, fructose appears most effective in those normal individuals who have the largest glycemic excursions in response to glucose alone. Since glucose metabolism of a diabetic is significantly altered from that of a normal individual, the inventors tested the addition of fructose to a glucose challenge in a diabetic animal model and found a significant reduction in the incremental area under the curve (AUC) for blood glucose of 34% when compared to the control challenge. The inventors were also surprised to discover that supplemental fructose added to a partially hydrolyzed starch challenge significantly reduced the incremental area under the curve (AUC) for blood glucose by 32% when compared to the control challenge. One knowledgeable in the art would not have expected to see reductions in blood glucose levels similar to simple sugars for partially hydrolyzed starch.

As noted above, the present invention is also directed to a nutritional product utilizing the two component carbohydrate mixture or carbohydrate system defined above.

The carbohydrate calories replace the fat calories in the nutritional, thereby facilitating the formulation of a nutritional for persons with diabetes containing less than 37% of the calories from fat, which is a significant advantage over prior art nutritional formulas.

The nutritional products of this invention are designed to be used as a sole source of nutrition or as a supplement in persons with DM. Since the product can be used as a sole source of nutrition it will contain a protein source, a lipid source, a carbohydrate source, vitamins, and minerals in amounts sufficient to maintain a patient's health (i.e., to prevent malnutrition). Such amounts are well known by those skilled in the art and can be readily calculated when preparing such products.

Although not intended to limit the invention in any manner, but to merely serve as a general guideline, the nutritional formulas of this invention will typically provide the caloric distribution described in Table 5.

                             TABLE 5
               Nutritional Formula Component Ranges
                          Preferred range   More preferred range
        Component         (% Calories)        (% Calories)
        Protein               10-35              15-25
        Fat                .ltoreq.37            25-30
        Carbohydrate*         25-60              35-55
    *may be the two component carbohydrate mixture or carbohydrate system of
     the instant invention

Additionally, the caloric density is typically from about 0.5 kcal/ml to about 2.0 kcal/ml, preferably from about 0.8 kcal/ml to about 1.2 kcal/ml.

One required component of the nutritional products of this invention is a source of carbohydrates. Either the simple two component carbohydrate mixture or carbohydrate system described above may be incorporated into the nutritional. As stated in Table 5, the carbohydrate component of the nutritional typically provides from about 25% to about 60% of the total calories, more preferably from about 35% to about 55% of the total calories of the nutritional product.

The preferred carbohydrate system for the nutritional typically comprises about 64 wt/wt% of the carbohydrate system as digestible glucose polymers; about 23 wt/wt% of the carbohydrate system as fructose; about 6.5 wt/wt% of the carbohydrate system as nonabsorbent carbohydrates; about 3.5 wt/wt% of the carbohydrate system as indigestible oligosaccharides; and about 3.0 wt/wt% of the carbohydrate system as fiber.

The second component of the nutritional products of this invention is protein. The proteins that may be utilized in the nutritional products of the invention include any proteins suitable for human consumption. Such proteins are well known by those skilled in the art and can be readily selected when preparing such products. Examples of suitable proteins that may be utilized typically include casein, whey, milk protein, soy, pea, rice, corn, hydrolyzed protein and mixtures thereof. As indicated in Table 5, the typical amount of protein in the nutritional product is from about 10% to about 35% of total calories, more preferably from about 15% to about 25% of total calories.

Commercial protein sources are readily available and known to one practicing the art. For example, caseinates, whey, hydrolyzed caseinates; hydrolyzed whey and milk proteins are available from New Zealand Milk Products of Santa Rosa, Calif. Soy and hydrolyzed soy proteins are available from Protein Technologies International of Saint Louis, Mo. Pea protein is available from Feinkost Ingredients Company of Lodi, Ohio. Rice protein is available from California Natural Products of Lathrop, Calif. Corn protein is available from EnerGenetics Inc. of Keokuk, Iowa.

The third component of the nutritional products of this invention is the fat. As noted above, the fat source of this invention will typically provide less than or equal to 37% of the total calories, more preferably from about 25% to about 30% of the total calories. The fat source for the present invention may be any fat source or blend of fat sources which provides the desired levels of saturated (less than 10% kcal), polyunsaturated (up to 10% kcal) and monounsaturated fatty acids (10% to 15% kcal). One skilled in the art can readily calculate how much of a fat source should be added to the nutritional product in order to deliver the desired levels of saturated, polyunsaturated and monounsaturated fatty acids. Examples of food grade fats are well known in the art and typically include soy oil, olive oil, marine oil, sunflower oil, high oleic sunflower oil, safflower oil, high oleic safflower oil, fractionated coconut oil, cottonseed oil, corn oil, canola oil, palm oil, palm kernel oil and mixtures thereof.

Numerous commercial sources for the fats listed above are readily available and known to one practicing the art. For example, soy and canola oils are available from Archer Daniels Midland of Decatur, Ill. Corn, coconut, palm and palm kernel oils are available from Premier Edible Oils Corporation of Portland, Oreg. Fractionated coconut oil is available from Henkel Corporation of LaGrange, Ill. High oleic safflower and high oleic sunflower oils are available from SVO Specialty Products of Eastlake, Ohio. Marine oil is available from Mochida International of Tokyo, Japan. Olive oil is available from Anglia Oils of North Humberside, United Kingdom. Sunflower and cottonseed oils are available from Cargil of Minneapolis, Minn. Safflower oil is available from California Oils Corporation of Richmond, Calif.

The nutritional compositions of the invention desirably contain vitamins and minerals. Vitamins and minerals are understood to be essential in the daily diet. Those skilled in the art appreciate that minimum requirements have been established for certain vitamins and minerals that are known to be necessary for normal physiological function. Practitioners also understand that appropriate additional amounts of vitamin and mineral ingredients need to be provided to nutritional compositions to compensate for some loss during processing and storage of such compositions. Additionally, the practitioner understands that certain micronutrients may have potential benefit for people with diabetes such as chromium, carnitine, taurine and vitamin E and that higher dietary requirements may exist for certain micro nutrients such as ascorbic acid due to higher turnover in people with type 2 diabetes.

An example of the vitamin and mineral system for a complete nutritional formulation used as a sole source of nutrition typically comprises at least 100% of the RDI for the vitamins A, B1, B2, B6, B12, C, D, E, K, beta-carotene, Biotin, Folic Acid, Pantothenic Acid, Niacin, and Choline; the minerals calcium, magnesium, potassium, sodium, phosphorous, and chloride; the trace minerals iron, zinc, manganese, copper, and iodine; the ultra trace minerals chromium, molybdenum, selenium; and the conditionally essential nutrients m-inositol, carnitine and taurine in from about 350 Kcal to about 5600 Kcal.

An example of the vitamin and mineral system for a nutritional formulation used as a nutritional supplement typically comprises at least 25% of the RDI for the vitamins A, B1, B2, B6, B12, C, D, E, K, beta-carotene, Biotin, Folic Acid, Pantothenic Acid, Niacin, and Choline; the minerals calcium, magnesium, potassium, sodium, phosphorous, and chloride; the trace minerals iron, zinc, manganese, copper, and iodine; the ultra trace minerals chromium, molybdenum, selenium; and the conditionally essential nutrients m-inositol, carnitine and taurine in a single serving or from about 50 Kcal to about 800 Kcal.

Artificial sweeteners may also be added to the nutritional formula to enhance the organoleptic quality of the formula. Examples of suitable artificial sweeteners include saccharine, aspartame, acesulfame K and sucralose. The nutritional products of the present invention will also desirably include a flavoring and/or color to provide the nutritional products with an appealing appearance and an acceptable taste for oral consumption. Examples of useful flavorings typically include, for example, strawberry, peach, butter pecan, chocolate, banana, raspberry, orange, blueberry and vanilla.

The nutritional products of this invention can be manufactured using techniques well known to those skilled in the art. While manufacturing variations are certainly well known to those skilled in the nutritional formulation arts, a few of the manufacturing techniques are described in detail in the Examples. Generally speaking an oil and fiber blend is prepared containing all oils, any emulsifier, fiber and the fat soluble vitamins: Three more slurries (carbohydrate and two protein) are prepared separately by mixing the carbohydrate and minerals together and the protein in water. The slurries are then mixed together with the oil blend. The resulting mixture is homogenized, heat processed, standardized with water soluble vitamins, flavored and the liquid terminally sterilized or dried to produce a powder. Alternatively, the homogenized formula may be kept undiluted and filled into appropriate containers as pudding or dried to form powder.

The composition of the invention can be in several physical forms such as liquid enteral nutritional formulas or concentrated-liquid, a semisolid form such as pudding or a solid form such as a powder or nutritional bar.

Claim 1 of 4 Claims

We claim:

1. A nutritional product comprising:

a) about 47% of the total calories of the product as a carbohydrate system, said carbohydrate system further comprises;

i) about 23 wt/wt % of the carbohydrate system is a source of fructose,

ii) about 64 wt/wt % of the carbohydrate system is digestible glucose polymers,

iii) about 6.5 wt/wt % of the carbohydrate system is nonabsorbent carbohydrates,

iv) about 3 wt/wt % of the carbohydrate system is fiber selected from the group consisting of soluble fiber, insoluble fiber, fermentable fiber, non-fermentable fiber and mixtures thereof

v) about 3.5 wt/wt % of the carbohydrate system is indigestible oligosaccharides,

b) a source of fat comprising about 33% of the total calories of the product and

c) a source of protein comprising about 20% of the total calories of the product.



____________________________________________
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