More specifically, the present invention relates to liquid oral supplements having increased caloric and protein content.

The human body requires energy to perform its vital functions, such as blood circulation, immune processes, respiration processes, etc. Energy can be supplied in the form of calories. Calories are typically supplied by the consumption of food. Calorie sources can be classified into three categories: proteins, fats, and carbohydrates. Proteins can provide the body with support for muscular activity ; fats can provide the body with stored energy ; and carbohydrates can supply the body with immediate energy. Essential vitamins and minerals are necessary to help regulate the processes of the human body.

An individual needs to receive a proper balance of nutrients to sustain health ; otherwise, malnutrition can result in a variety of physical complications. Moreover, it is imperative that the support provided be adapted to the needs of an individual. For example, patients who are ill require increased and specialized nutritional support. An increase in specific nutrients can help the body recover from a particular stress placed upon it.

Nutritional needs can also change with a person's age. For example, elderly individuals show a decrease in the amount of energy their body requires from fat sources.

This is attributed to a decrease in the number of functioning cells an elderly individual has. This is also attributed to a decrease in activity. Accordingly, an elderly individual's nutritional requirements may be different than a young or middle aged individual.

Because at least certain individuals may not receive their required nutritional support from a normal diet, nutritional supplements have been designed to provide nutritional support to individuals. The supplements can be directed towards a particular type of nutritional support. For example, a supplement may provide an individual with additional calories for increased energy. Although these supplements provide a certain

amount of nutritional support, it is in the best interests to provide a composition having increased nutritional value for a specific nutritional requirement.

In the above examples of elderly individuals and ill patients, it is desired to provide nutritional supplements having increased energy as well as increased protein per serving. In this regard, although an elderly individual's energy needs may be reduced, their ability to consume products may also be diminished. For example, they may have difficulty consuming a product due to, e. g., swallowing difficulties. Further, certain disease states or conditions may require restrictions on the diet a patient consumes. For example, renal patients may have fluid restrictive diets.

However, increasing both calories and/or protein in a nutritional supplement can increase the overall viscosity of the supplement. This can make the supplement difficult to consume or administer, and can also diminish the taste of the supplement.

Therefore, a need exists for improved oral supplements, for example, with an increased amount of protein and calories per ml for an elderly individual or ill patient.

SUMMARY OF THE INVENTION The present invention provides a calorically dense liquid oral supplement. In an embodiment, the supplement is designed to help to meet the nutritional needs of elderly individuals as well as patients with certain disease states. The supplement provides an increased amount of calories per ml while providing a sufficiently low viscosity to allow the supplement to be easily consumed orally or be administered by tube feeding or other like manner. In addition, the taste of the supplement is not diminished despite the increase in calories and protein.

To this end, in a first aspect of the present invention, a nutritional product is provided comprising a protein source that provides 14% to 20% of the total caloric content of the product, the protein source comprising caseinate ; and the product having a caloric density of at least 2.25 calories per ml.

In a second aspect, the present invention concerns a method of providing nutritional support comprising the steps of administering to an individual requiring nutritional support the nutritional product according to the present invention.

In a third aspect, the present invention concerns a method of providing nutritional supplement comprising the steps of administering to an individual requiring a nutritional supplement at least 25 ml and less than 100 ml of a the nutritional product according to the present invention.

In a fourth aspect, the present invention concerns the use of the product according to the present invention to provide nutrition to an individual that has or is recovering from a disease state.

In a fifth aspect, the present invention concerns the use of a protein source, a fat source and a carbohydrate source in the manufacture of the nutritional product according to the present invention for providing nutrition to an individual that is malnourished, elderly, in a disease state, and/or recovering from a disease state.

It is, therefore, an advantage of the present invention to provide an improved liquid oral supplement.

Moreover, an advantage of the present invention is to provide a nutritional supplement for an elderly individual.

Furthermore, an advantage of the present invention is to provide a nutritional product for individuals suffering from a disease state or recovering from a disease state.

Another advantage of the present invention is to provide a liquid oral supplement which provides an increased amount of protein.

Still another advantage of the present invention is to provide a liquid oral supplement which may be easily consumed.

Yet another advantage of the present invention is to provide a liquid oral supplement that provides an increased amount of calories per ml.

Another advantage of the present invention is to provide a liquid oral supplement having a taste acceptable to an individual.

Still another advantage of the present invention is to provide a liquid oral supplement having a low viscosity despite having an increased amount of protein.

Additional features and advantages of the present invention are described in and will be apparent from the detailed description of the presently preferred embodiments.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS The present invention provides a liquid oral supplement and methods of providing nutritional support to individuals. The supplement has an increased amount of caloric content as well as an increased level of protein. The supplement is designed, in a preferred embodiment, to provide nutrition to elderly individuals that may be malnourished, stressed individuals, e. g., those that may have a disease state, as well as patients recovering from a disease. The product despite having an increased caloric content retains a low viscosity such that it may be easily consumed or administered.

Further, the taste of the product remains acceptable despite a high protein level.

In an embodiment of the nutritional product according to the present invention, the protein source further comprises a soy protein isolate.

In a preferred embodiment, the product is a liquid nutritional product.

In an embodiment, the protein source of the product comprises 80 to 102 grams per liter of product. Preferably, the protein source comprises 85 to 95 grams per liter of product. For example, the protein provides 90 grams of protein or less, or at least 90 grams per liter of product.

In an embodiment, the nutritional product includes a prebiotic, such as fructooligosaccharides.

In an embodiment, the product comprises a fat source providing at least 40% of the caloric content. For example, the fat source provides at least 50% of the caloric content of the product. For example, the fat source provides 45 to 60%, preferably 47 to 55% of the caloric content of the product.

In an embodiment, the product comprises a carbohydrate source providing at least 25% of the caloric content. For example, the carbohydrate source provides 27 to 55%, preferably 30 to 40% of the caloric content.

In an embodiment, the product has a viscosity of 100 centipoises or less. For example, the product has a viscosity of 80 to 100 centipoises.

In an embodiment, of the product the caseinate and soy protein isolate is present at a ratio of approximately 75: 25 to about 50: 50.

In an embodiment of the method of providing nutritional support or a nutritional supplement to an individual, the individual is an elderly individual.

In an embodiment, the individual is malnourished.

In an embodiment, the individual has or is recovering from a disease state.

For example, the individual is stressed.

The product is designed to either supplement an individual's diet or provide complete nutritional support. The product includes a protein source, a fat source, a carbohydrate source, and a source of vitamins and minerals.

The protein source provides 14% to 20%, preferably 14% to 18%, more preferably 14 to 17%, even more preferably 15 to 17%, for example at least 15% of the total caloric content of the supplement. In an embodiment, the protein source provides at least 16% of the total caloric content. For example, in an embodiment, 90 grams per liter of protein are provided per serving of product. The high levels of protein are beneficial for patients who may not be physically capable of receiving a large volume of product, for example, fluid restricted patients. Such patients can be given a reduced level of fluid while still receiving a required amount of nutritional support per day.

The protein source can consist of 100% caseinate. Because caseinate may increase the viscosity of the supplement, a blend of caseinate and soy protein isolate may be desired. The isolate may be whole, nicked or hydrolyzed protein. In an embodiment, a caseinate and soy protein isolate blend is used having a ratio of approximately 75: 25 to approximately 50: 50 respectively. For example, in an embodiment, the protein source consists of a blend of caseinate and soy protein isolate in a ratio of 70: 30 respectively.

This embodiment has a viscosity, which is lower than that in which the protein source is 100% caseinate. For example, the viscosity of the 70: 30 blend is approximately 95 centipoises. In an embodiment of the present invention, the protein source consists of a blend of caseinate and soy protein isolate in a ratio of 60: 40 respectively. This embodiment displays a viscosity of approximately 85 centipoises.

As noted above, the product includes a fat source. The fat source can consist of medium chain triglycerides (MCT) or long chain triglycerides (LCT). Moreover, the fat source may be any combination of the two types. MCTs are beneficial because they are

easily absorbed and metabolized in a metabolically-stressed patient. Moreover, the use of MCTs will reduce the risk of nutrient malabsorption. LCTs, such as canola or corn oil are preferred because they can reduce immune suppression associated with certain types of fatty acids concentrated in the body.

In an embodiment of the present invention, the fat source provides at least 40% of the caloric content. In a preferred embodiment, the fat source provides the fat source provides 45 to 60%, for example approximately 50% of the total caloric content. The fat source in an embodiment consists of a blend of canola and corn oil.

As noted above, the product includes a carbohydrate source. The carbohydrate source may comprise a variety of components (e. g., sucrose, corn syrup). The carbohydrate source preferably provides at least 25% of the total caloric content. In the preferred embodiment, the carbohydrate source provides approximately 35% of the caloric content.

The supplement can contain a variety of vitamins and minerals. In a preferred embodiment, the supplement provides all necessary vitamins and minerals. For example, the supplement preferably provides 60 mg of zinc per liter which is beneficial for tissue repair in a healing patient. The supplement also provides 250 mg of Vitamin C per liter to aid patients with more severe healing requirements. In addition, the supplement provides 22.5 mg of iron per liter. Iron is essential in maintaining bodily fluids as well as circulatory system functions in an elderly patient. Overall, the supplement preferably includes at least 100% of the United States Recommended Daily Allowance (USRDA) of vitamins and minerals in a one liter portion.

The supplement may be fortified with a prebiotic such as, for example, fructooligosaccharides or inulin. In an embodiment, the supplement provides 24 grams of a prebiotic per liter of product.

As noted above, the product preferably has a high caloric density. Preferably, the product provides at least 2.25 calories per ml. Although the product has a high caloric density, it also has a sufficiently low viscosity to allow it to be consumed by elderly individuals that may have difficulty swallowing products or those that are tube fed.

Preferably, the viscosity of the supplement is 95 centipoises or less. This is ideal for administering the supplement orally because a patient may easily consume a serving

having a low viscosity such as that displayed by the present invention. This is also ideal for servings that are tube fed.

The supplement of the present invention is ideal for individuals requiring nutritional support. A variety of regimens can be used. For example, patients can receive servings in the range of 25 to about 100 ml. For example, a patient receiving 60 ml servings would be given 3 to 4 servings per day to provide complete nutritional support.

However, for alternate embodiments, the number of servings may differ depending on the nutritional needs of the patient.

The supplement may be in liquid or powder form. In a preferred embodiment, the product is provided in a ready to use liquid form and does not require reconstitution or mixing prior to use. The supplement can be tube fed or administered orally. For example, the supplement can be provided in a can, on spike, and hang bag.

By way of example and not limitation, Table 1 sets forth the nutritional data for two embodiments of the present invention.

Table 1 Example No. 1 Example No. 2 60: 40 Casein Soy 60 : 40 + prebiotic cal/ml 2. 25 2. 25 Protein g/liter 90 90 Protein % of cal 16 16 Protein Bend caseinate/Soy Caseinate/Soy Casein: Soy Ratio 60 : 40 60 : 40 Fat g/liter 122. 5 130 Fat % of cal 49 52 Fat Blend Canola, Corn Canola, Corn Carbohydrate g/liter 197 180 Carbohydrate % of cal 35 32 Prebiotic grams-24 Calcium mg/liter 1230 1230 Phosphorus mg/liter 1230 1230 Magnesium mg/liter 433 433 Sodium mg/liter12001200 Potassium m/liter 1733 1733 Chloride mg/liter 1194 1194 Vitamin A IU/liter 7340 7340 Vitamin D IU/liter 489 489 Vitamin E IU/liter 49 49 Vitamin K mcg/liter 87 87 Vitamin C mg/liter 250 250 Thiamine mg/liter 3. 5 3. 5 Riboflavin mg/liter 4.15 4. 15 Niacin mg/liter 48. 7 48. 7 Vitamin B6 mg/liter 6. 9 6. 9 Folic Acid mcg/liter 937 937 Pantothenic Acid mg/liter 24.3 24. 3 Vitamin B12 mcg/liter 14. 4 14. 4 Biotin mcg/liter 693 693 Choline mg/liter 500 500 Taurine mg/liter 158 158 Iron mg/liter 22.5 22. 5 Copper mg/liter 2.6 2. 6 Manganese mg/liter 4.1 4.1 Iodine mcg/liter 181 181 Chromium mcg/liter 50. 2 50. 2 Molybdenum mcg/liter 161 161 Selenium mcg/liter 73.5 73. 5 Zinc mg/liter6060 By way of further example, examples of the product of the present invention are as follows: Example No. 3

Ingredient % Water 59. 9328 Frodex 24 D 13. 2000 Corn Oil/Canola Oil Blend 10. 8200 Acid Casein 5. 7750 Sugar 4. 0000 Soy Protein Isolate 3. 9550 Lecithin. 6000 Vanilla Flavor. 2600 Calcium Citrate*4 (H20). 2182 VIT Premix. 1700 Potassium Citrate* 1 (H20). 1373 Calcium Hydroxide. 1120 Magnesium Chloride*6 (H20). 1100 Creamy Mouthfeel Flavor. 1000 Sodium Phosphate Dibasic-Anhydrous. 0955 Potassium Hydroxide. 0850 Potassium Phosphate Dibasic-Anhydrous. 0815 TR Element Premix. 0700 Sodium Chloride. 0611 Sodium Citrate*2 (H20). 0511 Citric Acid. 0500 Magnesium Oxide. 0440 Choline Chloride. 0390 Zinc Sulfate*7 (H20). 0170 Carrageenan. 0105 Antifoam. 0042 Vitamin A. 0008 Total: 100.0000 Example No. 4 Ingredient % Water 59. 8739 Corn Oil/Canola Oil Blend 11. 5200 Frodex 24 D 11. 0000 Acid Casein 5. 8000 Sugar 4. 0000 Soy Protein Isolate 3. 9550 Raftilose P95 1. 7710 Raftiline GR. 7600 Lecithin. 6000 Vanilla Flavor. 2600 Calcium Citrate*4 (H20). 2184 VIT Premix. 1650 Potassium Citrate* 1 (H20). 1417 Calcium Hydroxide. 1120 Magnesium Chloride*6 (H20). 1100 Creamy Mouthfeel Flavor. 1000 Sodium Phosphate Dibasic-Anhydrous. 0943 Potassium Hydroxide. 0820 Potassium Phosphate Dibasic-Anhydrous. 0819 TR Element Premix. 0700 Sodium Chloride. 0634 Sodium Citrate*2 (H20). 0559 Citric Acid. 0500 Magnesium Oxide. 0440 Choline Chloride. 0390 Zinc Sulfate*7 (H20). 0170 Carrageenan. 0105 Antifoam. 0042 Vitamin A. 0008 Total : 100.0000

By way of example and not limitation, an example of a process for making the present invention is as follows.

The product can be created by first hydrating the soy protein isolate in water. The acid casein can then be added to the soy protein slurry. The mixture is then allowed to hydrate. The protein slurry is neutralized by a calcium hydroxide/potassium hydroxide solution to a pH of 6.5-6.8. The resulting solution is then subjected to a heat treatment of 266°F for 5 minutes, followed by flash cooling.

The fat source which may consist of MCTs, corn oil or canola oil singly, or in any combination thereof, is then added into the protein slurry and the mixture is homogenized and cooled. A solution of the carbohydrates, which can be corn syrup solids and sucrose, in addition to carrageenan and monovalent salts is then prepared. The carbohydrate solution is added as well as divalent salts, vitamins, minerals and flavors. The pH of the final mix is adjusted to 6.8-7.1 and the product is thermally processed.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the appended claims.