Abstract:
Improved nutritional formulations based on the total formulation calories, of about 40 to 90% of calories as carbohydrates, about 2 to 30% of calories as protein, about 0 to 35% of calories as fat, and about 0 to 17% of calories as fiber. The formulations may also contain 100% of U.S. RDA of vitamins and minerals. The formulations have a high acid (low pH) content (e.g., pH 3.5-3.9). The formulations may be carbonated or non-carbonated. The formulations are preferably used as an oral nutritional supplement providing about 1.0 calorie/ml.

Description:
This is a continuation of application Ser. No. 07/809,852, filed Dec. 18, 1991, now abandoned, which in turn is a continuation of application Ser. No. 07/608,072, filed Nov. 1, 1990, now abandoned. 
    
    
     This invention relates to improved liquid nutritional formulations. More particularly, it relates to improved liquid oral nutritional supplement formulations. 
     FIELD OF THE INVENTION 
     There are numerous oral nutritional supplements on the market. However, currently all are low acid (high pH) dairy based products; typically vanilla, chocolate or strawberry flavored at present. There are no ready-to-drink nutrition supplements providing alternatives to these &#34;milky tasting products&#34;. The present invention provides liquid oral nutritional formulations which have a juice-like consistency and flavor. 
     SUMMARY OF THE INVENTION 
     The present invention provides improved liquid oral nutritional formulations. The improved formulations are comprised based on the total formulation calories of about 40 to 90% of calories as carbohydrates, about 2 to 30% of calories as protein, about 0 to 35% of calories as fat, and about 0 to 17% of calories as fiber. The formulations may also contain 100% of U.S. RDA of vitamins and minerals. The formulations have a high acid (low pH) content (e.g., pH3.5-3.9). The formulations may be carbonated or non-carbonated. The present formulations are preferably used as an oral nutritional supplement providing about 1.0 calorie/ml. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The carbohydrate source may be sucrose, corn syrup solids, glucose, fructose, maltodextrin or combinations thereof. Sucrose is preferred. When using corn syrup solids or maltodextrin, it is preferred that they be used in combination with either sucrose, glucose or fructose, or combinations of sucrose, glucose or fructose with the corn syrup solids or maltodextrin content of the combination being less than about 40% of the total combination. Also, combinations of corn syrup solids and maltodextrin may be used with either sucrose, glucose, fructose, or combinations of sucrose, glucose or fructose provided that the combination of corn syrup solids and maltodextrin is less than about 40% of the total combination. Concentrations of corn syrup solids, maltodextrin or combinations thereof, are maintained below 40% of the total carbohydrate source to minimize Maillard browning. 
     Artificial sweeteners e.g., saccharin and aspartame, may also be used to enhance the organoleptic quality of the formulations. 
     The amount of carbohydrate may preferably be from about 60% to 85% of total formulation calories. 
     The protein source may be whey protein concentrate (whey), caseinate, soy protein, egg whites or combinations thereof. Whey is preferred because of its good flavor, and solubility at low pH. Caseinate, soy protein and egg white may used in combination with the whey, at a concentration of at least 60% whey. At concentrations above 40%, caseinate and soy protein tend to precipitate and impart a poor taste to the formulations, whereas egg whites at concentrations above 40% tend to gel at processing temperatures. 
     The amount of protein may be preferably from about 5-25% of total formulation calories. 
     The fat source of the formulations may be any fat source or blend of fat sources which provide the desired amount of fat calories. Preferably the fat source should be high in monounsaturated fatty acids. Fat sources may include vegetable oils, e.g., high oleic acid vegetable oils such as sunflower oil, canola oil, and olive oil; safflower oil, cottonseed oil, corn oil or soybean oil, and medium chain triglycerides e.g., C6-C12 triglycerides. High oleic acid sunflower oil is preferred. 
     Marine oils and butter fat may also be used. 
     The fat source may preferably be from about 0 to 25% of the total formulation calories. 
     The fiber source may be guar gum, pectin, soy polysaccharide, gum arabic and the like or combinations thereof. Guar gum and pectin are preferred. The fiber may preferably be from about 0-5% of the total formulation calories. 
     It has been found that during heat processing and storage time a high ion concentration, especially sodium ion and potassium ion, causes gellation of the protein of the formulations. To overcome this problem, the potassium content of the formulations is limited to about 0 to 10 mg per 100 ml (0 to 23.7 mg per 8 oz); and the sodium content of the formulations is limited to about 0 to 30 mg per 100 ml (0 to 71.1 per 8 oz). It will be understood that the sodium and potassium ions are supplied naturally (without added salts) by adjusting the combination of carbohydrates and protein. 
     The presence of reducing sugars and protein (which contain alpha amino acid groups) makes the formulations susceptible to nonenzymatic browning, which causes an undesirable color and unpleasant flavor. This browning effect may be reduced by maintaining the formulations at a low pH of 3.5-3.9. Further reduction in nonenzymatic browning without pH change may be achieved by the addition of cysteine, which inhibits this reaction, or by the use of sucrose, a non reducing sugar, or a combination of both. 
     Acids such as phosphoric acid, citric acid, malic acid, tartaric acid, fumaric acid, adipic acid, lactic acid, or combinations thereof, may be used for pH control. However, the combination of phosphoric acid and citric acid is preferred. A ratio of citric acid to phosphoric acid of 1 to 1.9 preferably 0.77 to 1.0 may be so used for pH control. 
     To inhibit nonenzymatic browning, cysteine may be added in free form from about 0.025 to 0.20% on a weight/weight (w/w) basis, based on the total weight of the liquid formulation. The preferred amount is from about 0.04% to 0.1% (w/w). 
     Free amino acids may be added to the present formulations for nutritional benefits. Supplementation with free amino acids normally imparts a detrimental flavor to nutritional products. However, amino acids such as arginine, cysteine, isoleucine, leucine, valine or combinations thereof may be added to the present formulations without negative flavor impact due to the present low pH system. 
     The amino acids are preferably added from about 0 to 1.0% (w/w) basis, based on the total weight of the liquid formulation. 
     The following Tables I, II and III illustrate preferred nutritional formulations. 
     Table I shows the nutritional profile of formulations with and without fat. Table II lists the actual ingredients of .the nutritional profile of Table I without fat. Table III lists the actual ingredients of the nutritional profile of Table I with fat. 
     
                       TABLE I______________________________________NUTRITIONAL PROFILELIQUID NUTRITIONAL FORMULATION           WITH     WITHOUT           FAT PER  FAT PER           237 ml   237 ml______________________________________PROTEIN     8.8    gCARBO-             g      39.2     36.0HYDRATEFAT                g      5.3      0.0ENERGY             kcal   240      180VITAMIN A   625    IUVITAMIN D   50     IUVITAMIN E   5.7    IUVITAMIN C   37.5   mgFOLIC ACID  50     mcgTHIAMINE    0.38   mgRIBOFLAVIN  0.43   mgNIACIN      5.0    mgPYRIDOXINE  0.5    mg(B.sub.6)CYANOCO-    1.5    mcgBALAMIN (B.sub.12)BIOTIN      37.5   mcgPANTOTHENIC 1.25   mgACIDCALCIUM     135    mgPHOSPHORUS  160    mgIODINE      18.8   mcgIRON        2.25   mgMAGNESIUM   50     mgCOPPER      0.25   mgZINC        3.75   mgVITAMIN K   9.0    mcgCHOLINE     130    mgPOTASSIUM   10     mgSODIUM      35     mgCHLORIDE    220    mgMANGANESE   0.5    mg           CALORIC DISTRIBUTIONPROTEIN           15%        20%CARBO-            65%        80%HYDRATEFAT               20%        0%kcal/ml           1.0        0.76______________________________________ 
    
     
                       TABLE II______________________________________ACTUAL INGREDIENTSLIQUID NUTRITIONAL FORMULATIONWITHOUT FATIngredients      GRAMS/237 ml % Formula______________________________________Deionized Water  203.2        80.4Sucrose          35.64        14.1Whey Protein Concentrate            9.81         3.88Magnesium Gluconate            1.01         0.400Phosphoric Acid (75%)            0.784        0.310Citric Acid      0.455        0.180Calcium Chloride 0.480        0.190Corn Syrup Solids            0.526        0.208Choline Bitartrate            0.306        0.121Flavor/Color orange/yellow            0.265        0.105No. 6Ascorbic Acid    0.095        0.038Cysteine         0.1264       0.050Vitamin E Acetate            0.0296       0.0117Zinc Sulfate     0.01360      0.00538Ferrous Sulfate  0.00841      0.00333Niacinamide      0.00654      0.00259Vitamin A Palmitate            0.00500      0.00198d-Calcium Pantothenate            0.003020     0.001195Cyanocobalamin   0.002480     0.000981Copper Gluconate 0.002230     0.000882Manganese Sulfate            0.002120     0.000840Vitamin K.sub.1  0.001650     0.000653Thiamine Hydrochloride            0.000885     0.000350Pyridoxine Hydrochloride            0.000880     0.000348Vitamin D.sub.3  0.000800     0.000320Riboflavin       0.000556     0.000220Folic Acid       0.000074     0.000029Biotin           0.000058     0.000023Potassium Iodide 0.000032     0.000013            252.8 gm     100.%______________________________________ 
    
     
                       TABLE III______________________________________ACTUAL INGREDIENTSLIQUID NUTRITIONAL FORMULATIONSWITH FAT AND FIBER              Grams/237 mlIngredients        Serving     % Formula______________________________________Deionized Water    195.1       77.2Sucrose            37.7        14.9Whey Protein Concentrate              9.81        3.88Sunflower oil      5.3         2.1Magnesium Gluconate              1.01        0.400Hydrolized guar gum              0.632       0.250Phosphoric Acid (75%)              0.784       0.310Citric Acid        0.455       0.180Emulsifier-polyglycerol ester              0.1264      0.050Calcium Chloride   0.480       0.190Corn Syrup Solids  0.526       0.208Choline Bitartrate 0.306       0.121Flavor/Color orange/yellow No. 6              0.265       0.105Ascorbic Acid      0.095       0.038Cysteine           0.1264      0.050Vitamin E Acetate  0.0296      0.0117Zinc Sulfate       0.01360     0.00538Ferrous Sulfate    0.00841     0.00333Niacinamide        0.00654     0.00259Vitamin A Palmitate              0.00500     0.00198d-Calcium Pantothenate              0.003020    0.001195Cyanocobalamin     0.002480    0.000981Copper Gluconate   0.002230    0.000882Manganese Sulfate  0.002120    0.000840Vitamin K.sub.1    0.001650    0.000653Thiamin Hydrochloride              0.000885    0.000350Pyridoxine Hydrochloride              0.000880    0.000348Vitamin D.sub.3    0.000800    0.000320Riboflavin         0.000556    0.000220Folic Acid         0.000074    0.000029Biotin             0.000058    0.000023Potassium Iodide   0.000032    0.000013              252.8 gm    100.0%______________________________________ 
    
    
    
     EXAMPLE 1 
     Liquid Nutritional Formulation without Fat (8,000 lbs) 
     310.4 lbs. of whey protein concentrate, and 1,128.0 lbs. of sucrose are added to 5,932.0 lbs. of deionized water in a 1000 gallon processing vessel. A solution of 24.8 lbs. of phosphoric acid and 14.4 lbs. of citric acid in 500 lbs. of deionized water are slowly added with agitation to the mixture in the processing vessel. 
     78.0 lbs. of a vitamin/mineral premix, and 4.0 lbs. of cysteine are, then added with agitation to the processing vessel, and allowed to mix thoroughly. 
     The formulation (70°-80° F.) from the processing vessel is pumped through a two-stage Gaulin homogenizer. The second stage pressure is 500 PSI, and the first stage pressure is 2500 PSI. The product flows from the homogenizer to a plate heat exchanger where it is cooled to 40° F. and then pumped to a 2nd 1000 gallon processing vessel. 8.4 lbs. of flavor and color orange/yellow No. 6 are added slowly with agitation to the 2nd vessel. 
     After 10 minutes of mixing, quality control samples are taken for moisture (80.0%), pH (pH 3.8), specific gravity (1.067) and vitamin content (48 mgC/100 gms of solution). 
     The product is sterilized in a Cherry Burrell Unitherm thermo-processor at a minimum processing temperature of 204° F., for 4.33 seconds residence in the hold tube. 
     The product is then cooled to 160° F. and aseptically homogenized in a two-stage homogenizer (pressure settings as above), and aseptically packaged (at 70° F.) in 8 oz. (237 ml) Tetra Brik packages. 
     EXAMPLE 2 
     Liquid Nutritional Formulation with Fat and Fiber (8,000 lbs.) 
     An emulsifier solution of 4 lb. of polyglycerol ester in 100.0 lbs. of (180° F.) deionized water is added to 5326.0 lbs. of deionized water in a 1,000 gallon processing vessel. 20 lbs. of hydrolyzed guar gum, 310.4 lbs. of whey protein concentrate, and 1192.0 lbs. of sucrose are added to the processing vessel and mixed with the emulsifier solution. 168.0 lbs. of high oleic sunflower oil is then added to the processing vessel and the ingredients mixed thoroughly. A solution of 24.8 lbs. of phosphoric acid and 14.4 lbs. of citric acid in 500 lbs. of deionized water are slowly added with agitation to the mixture in the processing vessel. The mixture is then heated to 160°-165° F. 
     62.0 lbs. of a mineral premix, and 4.0 lbs. of cysteine are then added with agitation to the processing vessel, and allowed to mix thoroughly. 
     The formulation (160°-165° F.) from the processing vessel is pumped twice through a two-stage Gaulin homogenizer. The second stage pressure is 500 PSI, and the first stage pressure is 2500 PSI. The product flows from the homogenizer to a plate heat exchanger where it is cooled to 40° F. The mixture is then pumped to a 2nd 1,000 gallon processing vessel. 16.0 lbs. of vitamin premix in 250 lbs. of deionized water are added to the processing vessel. 8.4 lbs. of flavor and color orange/yellow No. 6 are then added slowly with agitation to the 2nd vessel. 
     After 10 minutes of mixing, quality control samples are taken for moisture (78.0%), pH (pH 3.8), specific gravity (1.067) and vitamin C content (48 mgC/100 gms of solution). 
     The product is sterilized in a Cherry Burrell Unitherm thermo-processor at a minimum processing temperature of 204° F., for 4.33 seconds residence in the hold tube. 
     The product is then cooled to 160° F. and aseptically homogenized in a two-stage homogenizer (pressure settings as above), and aseptically packaged (at 70° F.) in 8 oz. (237 ml) Tetra Brik packages.