Compositions and Methods for the Prevention and Treatment of Metabolic Diseases

Abstract

The present invention is a new method and composition that enhance bone repair, formation, maintenance and slowing of bone resorption. The present invention relates to methods and compositions that enhance collagen formation, tendon health and tendon injury healing, bone maintenance and bone injury healing, and the prevention and treatment of metabolic diseases. The present invention is a part of the therapy to maintain bone health among patients with diabetic bone resorption and others with metabolic disorders. In one embodiment, the composition is a composite of hydroxyapatite and an organic matrix composed of milk pH-dependent serum proteins, i.e., bone morphogenic proteins (BMP), milk serum-derived specific proteins (MSSP), and milk serum derived proteins.

What is claimed is as follows: 
     
         1 . A method of making a nutritional composite material comprising the steps of
 a) providing whey-derived milk minerals in solid form;   b) providing milk-derived basic protein in solution;   c) exposing the milk-derived protein solution of step b. to an ion exchange step to enhance the weight percent milk-derived basic proteins in the solution;   d) removing sodium-based minerals and sodium salts from the milk-derived basic protein solution;   e) purifying the milk-derived solid minerals by mixing the minerals with a solvent and heating the solution;   f) combining the purified milk-derived solid mineral solution of the previous step with the enhanced milk-derived basic protein solution of step d);   g) removing the solvent of the previous step to produce the nutritional composite material.   
     
     
         2 . A method according to  claim 1  in which additional milk-derived protein in solution is treated according to step c. to increase the amount of milk-derived basic protein in solution to be treated according to step d). 
     
     
         3 . A nutritional composite material made according to the process of  claim 1 . 
     
     
         4 . A material made according to  claim 3  which has an x-ray diffraction pattern as shown in  FIG. 18 . 
     
     
         5 . A method according to  claim 1  wherein step d is accomplished using a dialysis step. 
     
     
         6 . A method according to  claim 1  wherein step e) is accomplished by mixing the milk-derived solid minerals with water and heating the mixture. 
     
     
         7 . A method according to  claim 1  wherein steps a) and b) are accomplished by centrifugation of a solution of whey-derived milk minerals. 
     
     
         8 . A method according to  claim 1  wherein step e) is followed by concentrating the purified solid minerals. 
     
     
         9 . A method according to  claim 1  wherein step g) is accomplished by drying.