Nutritional compositions in various forms

Abstract: The invention provides a method and composition for providing nutrition to long-term care patients in different forms. In particular, a composition is utilized that can be administered in a solid, semi-solid or liquid form. Irrespective of the form selected, the composition includes a protein source including from approximately 14% to 25% of the caloric distribution of the composition and a carbohydrate source including from approximately 40% to 75% of the caloric distribution of the composition.

Description: This invention relates generally to compositions and uses for the treatment and nutritional support of patients. More specifically, the invention relates to providing nutrition to a patient in a variety of compositional forms. Patients suffering from a loss of nutrients require adequate nutritional support. The lack of adequate nutritional support can result in malnutrition associated complications, such as prolonged negative nitrogen balance and depletion of somatic and visceral protein levels. Thus, the goal of nutritional support is to maintain body mass, provide nitrogen and energy in adequate amounts to support healing, meet metabolic demands characterized by the degree of stress, and support immune function. A traditional form of nutritional support is administering whole protein liquid feedings to the patient Whole protein feedings are offered as a dietary supplement that typically can be consumed as partial or total meal replacements in hospitals, nursing homes and by home patients. Dietary supplements are generally useful for patients who are able to eat spontaneously but, for various reasons, do not consume enough nutrients. For instance, dietary supplements are often utilized in nursing homes as well as hospitals to treat elderly patients suffering from or at risk for protein-calorie malnutrition due to illness or age. EP 0614616 (Clintec Nutrition Company) discloses a ready-to-use nutritional composition comprising a protein source comprising 6 to 16% of the caloric content of the composition and a carbohydrate source comprising 66 to 88% of the caloric content of the composition. EP 0655245 (Free Radical Science Inc) discloses a nutritional composition comprising 15-30% of the calories from cystein-rich protein, 45-70% of the calories from carbohydrates and vitamin/mineral mixture exceeding US RDA values in 1000 or 2000 calories of product. EP 0486425 (Sandoz Nutrition Ltd) discloses liquid oral nutritional formulations comprising from 40 to 90% of the calories as carbohydrates, from 5 to 25% of the calories as protein. EP 0721742 (Clintec Nutrition Company) discloses a composition comprising a carbohydrate source (156g per 1200 calories), vitamins, minerals and a protein source which provides at least 16% of the calories of the composition. Dietary supplements are also useful for patients who do not absorb adequate nutrition from a routine diet. For instance, individuals who have high energy needs, fluid restriction or fat malabsorption can benefit from the use of dietary supplements. For persons who have an isolated deficiency, supplements can increase the total quantity of carbohydrate, fat or protein consumed. The use of complete oral formulas as dietary supplements for patients who are deficient in their intake of protein, carbohydrate and/or fat is frequently a temporary measure. The temporary nature of such dietary supplements often stems from the patient's resistance to continually ingest such formulas over time as opposed to the continued need for the supplements. The great majority of medical food supplements are liquids intended for consumption at room or refrigerated temperatures. Variety with these products currently means different flavors of the same form. However, research on sensory-specific satiety shows that consumption of foods and nutritional supplements with an almost identical hedonic profile, regardless of flavor differentiation, results in a sense of satiety and boredom. As a result, a progressive drop in compliance of the use of the supplements arises. Moreover, some carry-over satiety that affects the intake of other food as well as a lower caloric intake/day arises. Moreover, in addition to taste variety, the nutritional supplement must also contain a nutritionally complete profile of needed nutrients to provide the required nutritional support. An assortment of meal supplements and snacks exist on the market, such as many weight loss and sports supplements. However, these supplements tend to stress low fat or high protein without providing nutritional balance and completeness in the form of the full component of vitamins and minerals. Patients consuming such products fail to obtain the required nutrients needed for adequate nutritional support. Therefore, a need exists for a complete nutritional supplement that can be offered in a variety of forms and flavors. In order to provide the same nutritional value irrespective of the form or flavor, such a nutritional supplement should preferably provide a nutritionally consistent profile irrespective of the form selected. Moreover, to increase patient compliance, the composition should be provided in a variety of tastes, forms, smells and temperatures, resulting in a family of products that are nutritionally interchangeable. Accordingly, in one aspect, this invention provides a nutritional package for providing nutrition to an extended care patient comprising a nutritional composition for enteral administration and being in at least two forms selected from solid, semi-solid, and liquid forms, wherein each form has a substantially equivalent profile, the nutritional composition comprising a protein source and a carbohydrate source, the protein source comprising from approximately 14% to 25% of the caloric distribution of the composition and the carbohydrate source comprising from approximately 40% to 75% of the caloric distribution of the composition. In a second aspect, this invention provides the use of a protein source and a carbohydrate source in the preparation of a nutritional composition for providing nutrition to an extended care patient, wherein the composition comprises a first form selected from solid, semi-solid, and liquid; and a second form selected from solid, semi-solid, and liquid, the second form being different from the first form, and wherein each form has a substantially equivalent profile, the protein source comprising from approximately 14% to 25% of the caloric distribution of the composition and the carbohydrate source comprising from approximately 40% to 75% of the caloric distribution of the composition. In a third aspect, this invention provides the use of a nutritional composition in at least two different forms selected from solid, semi-solid and liquid in the preparation of a nutritional package for providing nutrition to an extended care patient, wherein each form has a substantially equivalent profile, and wherein the composition includes a protein source which comprises from approximately14% to 25% of the caloric distribution of the composition and a carbohydrate source comprising from approximately 40% to 75% of the caloric distribution of the composition. Irrespective of the form, the composition provides nutritionally consistent profiles, promoting the interchangeability of the various forms. More preferably, in each form, the composition provides substantially equivalent nutritional profiles. Further, the carbohydrate source preferably provides approximately 40% to 53% of the total caloric content. The composition may include a fat source comprising up to about 45% of the caloric distribution of the composition. Preferably, the fat source provides from about 30% to 45% of the total caloric distribution. In an embodiment the composition includes approximately 14% of the caloric distribution from a protein source, approximately 33% of the caloric distribution from a fat source, and approximately 53% of the caloric distribution from a carbohydrate source. The patient may be enterally administered or provided with a first effective amount of the nutritional composition in a first form selected from solid; semi-solid; and liquid and then enterally administered or provided with a second effective amount of the nutritional composition in a second form selected from solid; semi-solid; and liquid; the first and second forms being different. For example, the patient may be administered or provided with a first amount of the composition in at least the liquid form and a second amount in a form different than the liquid form. Likewise, the patient may be administered or provided with a first amount of the composition in at least either a solid or semi-solid form and a second amount in a different form. Preferably the composition further comprises at least 1/2000 of the U.S. RDA of vitamins and minerals per calorie of the composition regardless of its compositional form. The solid form may be selected from a bar; a cookie; a bread; and cereal. The liquid form may be selected from a drink; a soup; a juice; and a coffee drink. Preferably the long term care patient is an elderly patient. An advantage of the invention is that it provides a nutritional composition that can be administered in a variety of forms. Additionally, the composition may offer a variety of flavors, textures, aromas, temperatures, colors, sizes and shapes. Another advantage of the invention is that it stimulates appetite and prevents taste fatigue by providing a variety of suitable nutritional forms. The stimulation of the appetite in turn encourages proper nutrition. Moreover, an advantage of the invention is that it provides a variety of nutritional supplements that all contain nutritionally complete profiles. As a result, the nutritional compositions are interchangeable and all can be utilized as suitable partial or total meal replacements for patients. Yet another advantage of the invention is that it provides a variety of nutritional supplements that contain nutritionally consistent profiles. Since each of the forms has a substantially equivalent profile, the patient or the hospital has the ability to mix and match the various forms in order to encourage patient compliance. The forms are nutritionally interchangeable and modular. Still further, an advantage of the invention is that it provides a solid nutritional supplement that offers the patient a choice of a more natural, food-like product. In addition, the solid nutritional supplement of the invention has the added benefit of being lighter and easier to carry for meal and snack replacement outside normal dining areas. Additional features and advantages of the invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments. Nutritional support of hospitalized as well as non-hospitalized patients requires prevention, recognition and treatment of nutritional depletion that may occur with illness. The goals of nutritional support include stabilizing metabolic state, maintaining body mass, and/or facilitating growth in the presence of disease and gastrointestinal dysfunction. Ensuring proper nutritional support depends on obtaining and maintaining patient compliance. To this end, a never-ending market demand for oral supplements is providing taste variety. Variety stimulates the appetite of the patient and thereby prevents taste fatigue. Stimulation of the appetite in turn encourages proper nutrition. Therefore, to ensure nutritional support of hospitalized as well as non-hospitalized patients, the invention provides a nutritional composition that can be administered in a variety of product forms and flavors. The invention provides a method and nutritional composition for providing nutrition to a long term care patient in a solid, semi-solid or liquid form. Uniquely, each of these forms contains substantially equivalent nutritional profiles. The composition of each form includes a protein source, a carbohydrate source and optionally a fat source. In an embodiment, the composition also provides at least 1/2000 of the U.S. RDA of vitamins and minerals per calorie of the composition regardless of its form. Preferably, the protein source of the invention provides approximately 14% to 25% ofthe caloric distribution ofthe composition. Among others, suitable sources of protein are casein, soy, whey, and pea protein. In a preferred embodiment, the protein source is caseinate. In an embodiment, the protein source comprises approximately 14% of the caloric distribution of the composition. Carbohydrates provide approximately 40% to 75% of the caloric content of the composition. When a fat source is utilized, the carbohydrates, in an embodiment, provide approximately 40% to 53% of the caloric content of the composition. In a preferred embodiment, the carbohydrate source is approximately 53% of the caloric distribution of the composition. A number of carbohydrates can be utilized including maltodextrin, corn syrup solids and sucrose. In addition to simple sugars, the carbohydrate source, in an embodiment, includes a source of dietary fiber. Numerous types of dietary fiber are available. Dietary fiber passes through the small intestine undigested by enzymes and represents a kind of natural and necessary laxative. Suitable sources of dietary fiber, among others, include soy, oat, and gum arabic. When added to the composition, the total fiber contained in the composition is approximately 0 to 14 g/L. The fat source preferably consists of long chain triglycerides (LCT). Preferably, the fat source is approximately 0% to about 45% of the caloric content of the composition. While the composition, in an embodiment is fat-free, the composition containing fat, in another embodiment, comprises from about 30% to 45% of the caloric content of the composition. In a preferred embodiment, the fat source is approximately 33% of the caloric content ofthe composition. Preferably, the fat source is a mixture of long chain triglycerides. Suitable sources of long chain triglycerides are olive oil, corn oil, canola oil, palm kernel oil, sunflower oil, peanut oil, soy lecithin and residual milk fat. The lipid profile containing such long chain triglycerides is designed to have a polyunsaturated fatty acid omega-6 (n-6) to omega-3 (n-3) ratio of approximately 3:1 to 6:1. The proposed ratio of n-6:n-3 is designed to prevent suppression of the immune system caused by excessive n-6 fatty acids. In an embodiment, the omega-6 to omega-3 ratio is approximately 4:1. While the fat source preferably contains only long-chain triglycerides, the fat source may also contain medium chain triglycerides. In an embodiment, the fat source includes up to about 75% medium chain triglycerides. Such medium chain triglycerides are easily absorbed and metabolized in the patient's body. In addition to proper amounts of protein, fat and carbohydrates, most patients receiving dietary supplements have elevated requirements for certain vitamins, minerals and trace elements. To this end, the composition also includes a suitable vitamin and mineral profile. Uniquely, irrespective of the form of the composition utilized, the composition includes, in an embodiment, at least 1/2000 of the U.S. RDA of vitamins and minerals per calorie of the composition. Thus, the various forms can be interchanged for each other without a loss of any key macronutrients or micronutrients. In yet another embodiment, the composition includes a source of betacarotene. Beta-carotene meets a portion of the required vitamin A, thereby meeting micronutrient requirements in a small caloric volume. It is also an important nutrient with anti-oxidant properties. The composition preferably includes approximately 0.5 to 1.5 mg/1000 calories of beta-carotene. In a preferred embodiment, beta-carotene is present in an amount of approximately 1.0 mg/1000 calories. By way of example, and not limitation, an example of a suitable composition that may be used pursuant to the invention is as follows: The composition includes the following ingredients: water; protein: caseinate; carbohydrate: maltodextrin, corn syrup solids, and sucrose; fat: canola oil, corn oil, and soy lecithin; vitamin A; beta-carotene; vitamin D; vitamin E; vitamin K; vitamin C; thiamine (B 1 ); riboflavin (B 2 ); niacin, vitamin B 6 ; folic acid; pantothenic acid; vitamin B 12 ; biotin; choline; taurine; calcium; phosphorus; magnesium; zinc; iron; copper; manganese; iodine; sodium; potassium; chloride; chromium; molybdenum; and selenium. The composition of the invention is a ready-to-use oral supplement. The composition can be provided in a variety of product forms, including solid, semisolid or liquid form. Suitable solid forms that may be utilized are a bar, a cookie, a bread, and cereal. Among others, a suitable semi-solid form is pudding. Whereas, suitable liquid forms that may be used are a shake, soup, juice and coffee drink. In addition to providing variety in the choice of product forms, the invention also provides nutritional supplements in a variety of flavors. Moreover, the product forms of the invention provide variety with respect to aroma, texture, temperature, color, size and shape. Uniquely, irrespective of the form and flavor, the nutritional supplements of the invention contain substantially equivalent nutritional profiles. Naturally, providing the patient with a multitude of suitable nutritional supplements promotes patient compliance as well as versatility. For example, after a patient consumes a standard liquid whole protein feeding in the hospital, such patient may be given another of the suitable nutritional supplement forms (i.e. bar or soup) for use outside of the hospital to assure the patient maintains a proper diet. The composition provided in the various product forms can be used as a supplement or for total nutritional support. The composition is a preferably lactose-free, gluten-free, low in sodium and low in cholesterol. In an embodiment, the composition has a caloric density of approximately 0.75 to 2.0 kcal/ml. The osmolality of the composition ranges from approximately 450 to 750 mOsm depending on the product form of the composition. The composition is non-disease specific. The composition can be utilized to provide adequate nutrition to a multitude of long-term care patients, such as patients suffering from AIDS, malabsorbing conditions, or other chronic diseases. Moreover, the invention is suitable for providing nutrition to elderly patients suffering from or at risk for protein-calorie malnutrition due to illness or age. By way of example, and not limitation, examples of suitable nutritional product forms and corresponding nutrient profiles that may be used invention will now be given. Example 1 - Drink The composition in a liquid shake form has an osmolality of approximately 500 to 540 mOsm and a caloric density of about 1.0 kcal/ml. The liquid shake can be offered in vanilla, chocolate or strawberry and provides 100% of the U.S. RDA in 2000 calories. The composition has the following nutrient profile (per 250 calories). In an embodiment, the liquid shake also includes a source of dietary fiber. Nutrient Composition Amount Protein 8.75 g Carbohydrate 33.1 g Fat 9.2 g Cholesterol <1 mg Vitamin A 750 IU Beta-Carotene 0.25 mg Vitamin D 52 IU Vitamin E 5.2 IU Vitamin K 9.4 mcg Vitamin C 26 mg Thiamine (B 1 ) 0.4 mg Riboflavin (B 2 ) 0.45 mg Niacin 5.2 mg Vitamin B 6 0.75 mg Folic Acid 100 mcg Pantothenic Acid 2.6 mg Vitamin B 12 1.5 mcg Biotin 75 mcg Choline 85 mg Taurine 15 mg Calcium 125 mg Phosphorus 125 mg Magnesium 50 mg Zinc 2.6 mg Iron 2.25 mg Copper 0.25 mg Manganese 0.5 mg Iodine 18.75 mcg Sodium 219 mg Potassium 312 mg Chloride 300 mg Chromium 7.5 mcg Molybdenum 22.5 mcg Selenium 7.5 mcg In a preferred embodiment, the protein source is caseinate. The carbohydrate source is a mixture of corn syrup solids and sucrose; whereas, the fat source is a mixture of canola oil, corn oil and lecithin. In an embodiment, the fat source includes 70% from canola oil, 24% from corn oil and 6% from lecithin, with the goal of producing an n6:n3 ratio of between approximately 4:1 to 6:1. Example 2 - Bar The composition may be in a solid bar form. Food bars offer excellent taste as well as variety and convenience over liquids. In an embodiment, the bar delivers 125 calories and half the nutritional content of the liquid form. As a result, for comparison pulposes, two bars are equivalent to 250 ml of the liquid drink form and thus may be replaced for the liquid drink. The solid bar form can be offered in a variety of flavors and provides 100% of the U.S. RDA in 2000 calories. In an embodiment, the bar form has a soft. easy-to-chew texture. The composition has the following nutrient profile (per 125 calories). Nutrient Composition Amount Protein 4.4 g Carbohydrate 16.6 g Fat 4.6 g Cholesterol <1 mg Vitamin A 375 IU Beta-Carotene 0.125 mg Vitamin D 26 IU Vitamin E 2.6 IU Vitamin K 4.7 mcg Vitamin C 13 mg Thiamine (B 1 ) 0.2 mg Riboflavin (B 2 ) 0.25 mg Niacin 2.6 mg Vitamin B 6 0.35 mg Folic Acid 50 mcg Pantothenic Acid 1.3 mg Vitamin B 12 0.75 mcg Biotin 37.5 mcg Choline 42.5 mg Taurine 7.5 mg Calcium 100 mg Phosphorus 100 mg Magnesium 40 mg Zinc 1.3 mg Iron 1.1 mg Copper 0.13 mg Manganese 0.25 mg Iodine 9.5 mcg Sodium 135 mg Potassium 220 mg Chloride 160 mg Chromium 4 mcg Molybdenum 11 mcg Selenium 4 mcg In a preferred embodiment, the protein source is caseinate, whey and soy protein. The carbohydrate source is a mixture of maltodextrin, corn syrup solids and sucrose; whereas, the fat source is a mixture of canola oil, palm kernel oil and lecithin. Example 3 - Soup In yet another form, the composition may be in a soup form. In an embodiment, the composition is a powdered soup that can be mixed with hot water or mixed with cold water and heated. To add variety, the soup can be either of completely uniform texture or contain small food pieces as a means of varying taste and mouth feel. The soup form can be offered in a variety of flavors, such as creamy tomato or chicken. Similar to the other forms, it provides 100% of the U.S. RDA in 2000 calories. The composition of the present invention in a soup form has the following nutrient composition (per 250 calories). Nutrient Composition Amount Protein 8.75 g Carbohydrate 33.1 g Fat 9.2 g Cholesterol <5 mg Vitamin A 750 IU Beta-Carotene 0.25 mg Vitamin D 52 IU Vitamin E 5.2 IU Vitamin K 9.4 mcg Vitamin C 26 mg Thiamine (B 1 ) 0.4 mg Riboflavin (B 2 ) 0.45 mg Niacin 5.2 mg Vitamin B 6 0.75 mg Folic Acid 100 mcg Pantothenic Acid 2.6 mg Vitamin B 12 1.5 mcg Biotin 75 mcg Choline 85 mg Taurine 15 mg Calcium 165 mg Phosphorus 165 mg Magnesium 50 mg Zinc 2.6 mg Iron 2.25 mg Copper 0.25 mg Manganese 0.5 mg Iodine 18.75 mcg Sodium 390-660 mg Potassium 310 mg Chloride 390-660 mg Chromium 7.5 mcg Molybdenum 22.5 mcg Selenium 7.5 mcg Example 4 - Coffee The composition may also be a coffee drink. Since long term care patients, such as elderly patients, often drink decaffeinated coffee, the composition offers not only an appealing liquid supplement, it provides an effective nutritional supplement. In an embodiment, the coffee drink is a powdered product. Preferably, the drink has a decaffeinated coffee base to which protein, carbohydrates, vitamins/minerals and lipid are added. The coffee product has a caloric concentration of approximately 0.75 kcal/ml. The composition in a liquid coffee form has the following nutrient composition (per 125 calories). Nutrient Composition Amount Protein 7.8 g Carbohydrate 14.0 g Fat 4.2 g Cholesterol <1 mg Vitamin A 375 IU Beta-Carotene 0.125 mg Vitamin D 26 IU Vitamin E 2.6 IU Vitamin K 4.7 mcg Vitamin C 13 mg Thiamine (B 1 ) 0.2 mg Riboflavin (B 2 ) 0.25 mg Niacin 2.6 mg Vitamin B 6 0.35 mg Folic Acid 50 mcg Pantothenic Acid 1.3 mg Vitamin B 12 0.75 mcg Biotin 37.5 mcg Choline 42.5 mg Taurine 7.5 mg Calcium 100 mg Phosphorus 100 mg Magnesium 40 mg Zinc 1.3 mg Iron 1.1 mg Copper 0.13 mg Manganese 0.25 mg Iodine 9.5 mcg Sodium 135 mg Potassium 220 mg Chloride 160 mg Chromium 4 mcg Molybdenum 11 mcg Selenium 4 mcg Example 5 - Juice The composition may also be in a juice form. The juice form can be offered in characteristic "juice" flavors, colors arid mouth-feel as a means of providing an alternative to the standard milk-like nutritional supplements. Preferably, the composition in a juice form is acidic and has a pH of approximately 3.8. The composition has the following nutrient profile (per 120 calories). Nutrient Composition Amount Protein 7.5 g Carbohydrate 22.5 g Fat 0 g Cholesterol 0 mg Vitamin A 900 IU Vitamin D 60 IU Vitamin E 6 IU Vitamin K 18 mcg Vitamin C 80 mg Thiamine (B 1 ) 0.6 mg Riboflavin (B 2 ) 0.72 mg Niacin 7.2 mg Vitamin B 6 0.84 mg Folic Acid 116 mcg Pantothenic Acid 3.0 mg Vitamin B 12 1.8 mcg Biotin 60 mcg Calcium 50 mg Phosphorus 50 mg Magnesium 20 mg Copper 0.6 mg Manganese 1.2 mg Sodium 30 mg Potassium 100 mg In an embodiment, the protein source of the juice form is a mixture of whey protein hydrolysate and pea protein hydrolysate. The carbohydrate source is a mixture of maltodextrin and sucrose. No fat is incorporated into this form. 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 present invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims: A nutritional package for providing nutrition to an extended care patient comprising a nutritional composition for enteral administration and being in at least two forms selected from solid, semi-solid, and liquid forms, wherein each form has a substantially equivalent profile, the nutritional composition comprising a protein source and a carbohydrate source, the protein source comprising from approximately 14% to 25% of the caloric distribution of the composition and the carbohydrate source comprising from approximately 40% to 75% of the caloric distribution of the composition. The use of a protein source and a carbohydrate source in the preparation of a nutritional composition for providing nutrition to an extended care patient, wherein the composition comprises a first form selected from solid, semi-solid, and liquid; and a second form selected from solid, semi-solid, and liquid, the second form being different from the first form, and wherein each form has a substantially equivalent profile, the protein source comprising from approximately 14% to 25% of the caloric distribution of the composition and the carbohydrate source comprising from approximately 40% to 75% ofthe caloric distribution of the composition. The use of a nutritional composition in at least two different forms selected from solid, semi-solid and liquid in the preparation of a nutritional package for providing nutrition to an extended care patient, wherein each form has a substantially equivalent profile, and wherein the composition includes a protein source which comprises from approximately 14% to 25% of the caloric distribution of the composition and a carbohydrate source comprising from approximately 40% to 75% of the caloric distribution of the composition. The use or package according to any of claims 1 to 3 in which the nutritional composition comprises about 14% of the caloric distribution from the protein source; and about 53% of the caloric distribution from the carbohydrate source. The use or package according to any of claims 1 to 4 in which the nutritional composition provides at least 1/2000 of the U.S. RDA of vitamins and minerals per calorie of the composition. The use or package according to any of claims 1 to 5 in which the nutritional composition further comprises a fat source in an amount up to about 45% of the caloric distribution of the composition. The use or package according to any of claims 1 to 6 in which the patient is an elderly patient. The use or package according to any of claims 1 to 7 in which each form of the nutritional composition provides a substantially consistent nutrient profile.

Inventors: GROTE RANDY, JAMES MIKE, LIN PAUL, MARK DAVID A, SCHMELKIN NANCY, GROTE, RANDY, JAMES, MIKE, LIN, PAUL, MARK, DAVID A., SCHMELKIN, NANCY
Applicants: NESTLE SA, SOCIETE DES PRODUITS NESTLE S.A.
Application year: 1996
Main classification: A23L1
IPC codes: A23J3, A23F5, A23L1, A23L2, A23G3