Infant formula compositions and nutrition

Abstract

Compositions containing human milk proteins, including the so-called host resistance factors of human milk, prepared by chemically synthesizing the human milk proteins or by genetic engineering techniques for producing recombinant human milk proteins, are useful for supplementing or enhancing the diet of infants, particularly very-low-birth-weight infants. The human milk proteins include the host resistance factors (HRF) found in human milk, such as lactoferrin (LF), lactoperoxidase (LP), lysozyme (LZ), immunoglobulin-A (IgA), alpha-lactalbumin, alpha, beta, kappa-caseins, and others. The compositions may also include components other than the human milk proteins useful for improved infant nutrition. In the utilization of the compositions of this invention, the compositions would be administered to an infant in at least an amount that the infant would receive if fed substantially only fresh human milk. Also, the proportions of the human milk proteins would preferably be present in the compositions in about the proportions these proteins are found in human milk.

What is claimed is:  
     
         1 . A composition containing one or more nutritional, functional or protective human milk proteins or host resistance factors of human milk, said proteins or host resistance factors having been manufactured by chemical synthesis or by genetic engineering techniques for the manufacture of said proteins or host resistance factors as recombinant human milk proteins or as recombinant host resistance factors of human milk.  
     
     
         2 . A composition in accordance with  claim 1  wherein said host resistance factors include secretory immunoglobulin-A, lactoferrin, lactoperoxidase, lysozyme, alpha-lactalbumin and alpha, beta and kappa-casein.  
     
     
         3 . A composition in accordance with  claim 1  wherein said host resistance factors are present in said composition in about the proportions said factors are present in human milk.  
     
     
         4 . A composition in accordance with  claim 3  wherein said composition contains lactoferrin.  
     
     
         5 . A composition in accordance with  claim 4  wherein said composition contains only lactoferrin as the host resistance factor.  
     
     
         6 . A composition in accordance with  claim 3  wherein said composition contains only lysozyme as the host resistance factor.  
     
     
         7 . A composition in accordance with  claim 1  wherein the composition contains one or more other components useful for human infant nutrition but not manufactured by genetic engineering techniques for the production of said other components as recombinant products and wherein said other compositions are not derived from human milk.  
     
     
         8 . A composition in accordance with  claim 3  wherein said composition contains lactoferrin, lactoperoxidase and lysozyme.  
     
     
         9 . A composition in accordance with  claim 1  wherein said composition is a concentrate of said nutritional, functional or protective human milk proteins or host resistance factors of human milk suitable, after dilution in a liquid for infant consumption, such that, when so diluted, said human milk proteins or said host resistance factors can be administered to or fed directly to an infant for consumption.  
     
     
         10 . A composition in accordance with  claim 1  wherein said composition contains said nutritional, functional or protective human milk proteins or host resistance factors at a concentration in the range from about 2 to about 5,000 times the concentration of said human proteins or host resistance factors found in fresh human milk.  
     
     
         11 . A composition in accordance with  claim 1  wherein said composition contains only lactoperoxidase as the host resistance factor.  
     
     
         12 . A composition in accordance with  claim 1  wherein said composition contains only secretory immunoglobulin-A as the host resistance factor.  
     
     
         13 . A composition in accordance with  claim 1  wherein said composition contains only alpha-lactalbumin as the host resistance factor.  
     
     
         14 . A composition in accordance with  claim 1  wherein said composition contains alpha, beta and kappa-casein as the nutritional proteins.  
     
     
         15 . A composition according to  claim 14  wherein said composition contains only alpha-casein as the nutritional protein.  
     
     
         16 . A composition according to  claim 14  wherein said composition contains only beta-casein as the nutritional protein.  
     
     
         17 . The composition according to  claim 14  wherein said composition contains only kappa-casein as the nutritional protein.  
     
     
         18 . A method of providing an infant with daily nutrition which approximates the nutrition with respect to selected human milk proteins or host resistance factors provided an infant fed substantially only on mother's milk which comprises administering to the infant an amount of liquid containing a composition in accordance with  claim 1 , the content of said liquid with respect to one or more of the selected nutritional, functional or protective human milk proteins or host resistance factors being substantially equivalent to that of a similar amount or volume of fresh human milk.  
     
     
         19 . A method of providing an infant with daily nutrition which approximates the nutrition with respect to selected human milk proteins or host resistance factors provided the infant when fed substantially only on mother's milk which comprises administering to the infant an amount of liquid containing a composition in accordance with  claim 1 , the content of said liquid with respect to one or more of the selected nutritional, functional or protective milk proteins, or host-resistance factors, being equivalent to that the infant would receive when daily fed substantially only on banked or pooled human milk.  
     
     
         20 . A method in accordance with claims  18  or  19  wherein said liquid administered to said infant contains said human milk proteins or host resistance factors at a concentration in the range from about 2 to about 1000 times the concentration said human milk proteins or host resistance factors are found in fresh human milk.  
     
     
         21 . A method of improving the nutritional value of a synthetic infant formula which comprises adding to said formula a composition in accordance with  claim 1 .  
     
     
         22 . A method in accordance with  claim 21  wherein the amount of said composition added to said synthetic infant formula is sufficient such that when the infant formula is administered to an infant for consumption the added nutritional, functional or protective human milk proteins or host resistance factors in said synthetic infant formula are at a concentration substantially the same as the concentration of said human milk proteins and host resistance factors in human milk.  
     
     
         23 . The method of  claim 22  wherein the nutritional, functional and protective value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human lactoferrin.  
     
     
         24 . The method of  claim 23  wherein the nutritional and protective value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human lysozyme.  
     
     
         25 . The method of  claim 24  wherein the nutritional and protective value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human lactoperoxidase.  
     
     
         26 . The method of  claim 25  wherein the nutritional and protective value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human immunoglobulin-A.  
     
     
         27 . The method of  claim 26  wherein the nutritional value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human alpha-lactalbumin.  
     
     
         28 . The method of  claim 27  wherein the nutritional value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human casein.  
     
     
         29 . A method in accordance with  claim 21  wherein the amount of said composition added to said synthetic infant formula is sufficient such that when the infant formula is administered to an infant for consumption the added nutritional, functional or protective human milk proteins or host resistance factors in said synthetic infant formula are at a concentration about substantially the same as the concentration of said human milk proteins and host resistance factors in human milk.  
     
     
         30 . The method of  claim 29  wherein the nutritional, functional and protective value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human lactoferrin.  
     
     
         31 . The method of  claim 29  wherein the nutritional and protective value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human lysozyme.  
     
     
         32 . The method of  claim 29  wherein the nutritional and protective value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human lactoperoxidase.  
     
     
         33 . The method of  claim 29  wherein the nutritional and protective value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human immunoglobulin-A.  
     
     
         34 . The method of  claim 29  wherein the nutritional value of said synthetic infant formula is improved by adding to said synthetic infant formula an effective amount of recombinant human alpha-lactalbumin.  
     
     
         35 . The method of  claim 29  wherein the nutritional value of said synthetic infant formula is further improved by adding to said synthetic infant formula an effective amount of recombinant human casein.  
     
     
         36 . The method of  claim 35  wherein said recombinant human casein is alpha-casein.  
     
     
         37 . The method of  claim 35  wherein said recombinant human casein is beta-casein.  
     
     
         38 . The method of  claim 35  wherein said recombinant human casein is kappa-casein.  
     
     
         39 . A method in accordance with  claim 18  wherein the amount of said composition added is sufficient to bring the concentration of the human milk proteins or host resistance factors in said synthetic formula by the addition of said composition to about the concentration of said human milk proteins or said host resistance factors as found in human milk when said synthetic infant formula is administered to an infant for consumption.