Proline-rich polypeptide complex for use in treatment of bdnf-dependent disorders

Abstract

The invention relates to the Proline-Rich Polypeptide complex (PRP) derived from the mammalian colostrum for use in the treatment of the disorders and conditions related to the alterations of the Brain-Derived Neurotrophic Factor level as well as modulation thereof, particularly disorders and conditions wherein therapeutic strategy is based on the increasing of the BDNF concentration in blood. The PRP complex is postulated to be used for nutrition of adults, young children/babies and infants to promote and preserve the proper development and function of both immune and nervous system. PRPs may be used for supplementation of modified milk and infant milk formulae to make it closer to breast milk.

What is claimed is: 
     
         1 . The Proline-Rich Polypeptide complex derived from the mammalian colostrum for use in the treatment of the disorders and conditions related to the alterations of the Brain-Derived Neurotrophic Factor level as well as modulation thereof. 
     
     
         2 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended for the treatment of disorders and conditions selected from a group comprising mental disorders, including mood disorders, obsessive-compulsive disorders, major depression; Parkinson's disease; Huntington's disease, Alzheimer's disease; spinocerebellar ataxia; disorders induced by the human immunodeficiency virus (HIV); diabetes mellitus; eating disorders, including anorexia nervosa and bulimia nervosa; obesity and obesity-related disorders; glaucoma; retinal abnormalities; central nervous system demyelinating diseases, including multiple sclerosis; peripheral neuropathy; cerebrovascular diseases, including stroke; migraine and other headache syndromes, cardiovascular diseases and others. 
     
     
         3 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended for the treatment of disorders related to malfunctions of the nervous system or temporary intensive mental activity, depressed mood, memory decline, concentration and memory difficulties, and tiredness. 
     
     
         4 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended to be administered to an individual in the daily dose effective to preserve the neural activity in the brain. 
     
     
         5 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is formulated in the form of pharmaceutical product, nutraceutic, nutritional supplement, food for a special medical purpose, food for particular nutritional uses or dietary supplement. 
     
     
         6 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended for use as a nutritional additive for milk formulae, particularly for infants who had not been breastfed from birth, in order to make it closer to breast milk. 
     
     
         7 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended for use as a nutritional additive for older babies after breastfeeding and/or milk formula feeding and for adults, in order to induce and/or enhance the activity of nervous system and/or to achieve the procognitive effect. 
     
     
         8 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is intended for use as a nutritional additive for pregnant women, in order to increase the BDNF level in the blood of a mother and a baby. 
     
     
         9 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the said Proline-Rich Polypeptide complex is isolated from bovine or any other farm animal colostrum. 
     
     
         10 . The Proline-Rich Polypeptide complex for use according to  claim 9 , wherein the Proline-Rich Polypeptide complex comprises from 16 to 22 percent proline and, optionally, about 18% of acidic amino acids and β-lactoglobulin fraction. 
     
     
         11 . The Proline-Rich Polypeptide complex for use according to  claim 9 , wherein the Proline-Rich Polypeptide complex is free of the β-lactoglobulin fraction. 
     
     
         12 . The Proline-Rich Polypeptide complex for use according to  claim 9 , wherein the Proline-Rich Polypeptide Complex is the whey protein complex isolated from the bovine colostrum comprising cut off fractions of molecular weights below 1 kDa and from 7 to 12.5 percent proline. 
     
     
         13 . The Proline-Rich Polypeptide complex for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is formulated in the form suitable for oral administration. 
     
     
         14 . The Proline-Rich Polypeptide complex for use according to  claim 1  as the sole therapeutically or prophylactically active agent or in combination with any therapeutic agents or dietary supplements. 
     
     
         15 . A composition comprising the Proline-Rich Polypeptide complex isolated from the mammal colostrum for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is formulated in the form of pharmaceutical composition, nutraceutic, nutritional supplement, food for a special medical purpose, food for particular nutritional uses or dietary supplement. 
     
     
         16 . The composition according to  claim 15 , comprising the effective daily dose of the Proline-Rich Polypeptide complex for adults within the range from 50 to 1000 micrograms, preferably from 80 to 160 micrograms. 
     
     
         17 . The Proline-Rich Polypeptide complex isolated from the bovine colostrum for use according to  claim 1 , wherein the Proline-Rich Polypeptide complex is an additive of the modified milk formula or infant nutritional milk formulae, increasing the BDNF level in an infant blood comparable or higher to the level detected in the blood of breastfed baby. 
     
     
         19 . A modified infant milk formulae enriched with the Proline-Rich Polypeptide complex derived from bovine colostrum comprising from 16 to 22 percent proline. 
     
     
         20 . The modified infant milk formulae according to  claim 19  comprising the Proline-Rich Polypeptide complex in an amount that meets the daily infant's requirement for PRPs within the range of 1 to 5 micrograms per 1 kilogram of body weight.