Agent for use in the case of fructose intolerance

Abstract

The present invention refers to an agent for use in the case of fructose intolerance and any form of impairment and affliction of health and well being which is caused by the administration of fructose or fructose containing foodstuffs or by the release of fructose in the digestive tract of humans or animals from other substances, such as e.g. sucrose. The agent according to the invention comprises 5 -D-fructose dehydrogenase, optionally in combination with invertase and/or maltase and/or glucose isomerase, which enzyme or combination of enzymes is/are used in the medical field for the first time. Preferably the agent is in the form of a pharmaceutical composition which is useful for treatment of fructose intolerance.

1 - 139 . (canceled) 
     
     
         140 . A method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism, the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of 5-D-fructose dehydrogenase. 
     
     
         141 . A method according to  claim 140  wherein said condition is fructose Intolerance that is selected from the group consisting of (a) hereditary fructose intolerance, (b) intestinal fructose intolerance, (c) fructose intolerance that is due to a lack of fructose 1,6-diphosphatase and (d) combinations thereof 
     
     
         142 . A method according to  claim 140 , wherein said 5-D-fructose dehydrogenase is administered prior to said subject's eating, concurrently with said subject's eating or after said subject's eating. 
     
     
         143 . A method according to  claim 140 , wherein said 5-D-fructose dehydrogenase is administered with a second enzyme which cleaves fructose from a more complex sugar. 
     
     
         144 . A method according to  claim 143  wherein said second enzyme is selected from the group consisting of invertase, maltase and combinations thereof. 
     
     
         145 . A method according to  claim 140 , wherein said administration comprises oral administration. 
     
     
         146 . A mammalian ingestible composition of matter selected from a pharmaceutical composition and a dietary supplement, said composition of matter comprising 5-D-fructose dehydrogenase and a carrier or excipient that is acceptable for use in pharmaceutical compositions or foodstuffs. 
     
     
         147 . A composition of matter according to  claim 146  which is in unit dosage form. 
     
     
         148 . A composition of matter according to  claim 147  which is in an orally administrable form. 
     
     
         149 . A composition of matter according to  claim 148  which is in a form selected from (a) the group consisting of a tablet, capsule, gel cap, pellet and dragee, and (b) powder or liquid form which is contained in a single-dose container. 
     
     
         150 . A composition of matter according to  claim 146  wherein said 5-D-fructose dehydrogenase is protected by a coating which is stable at pH below 4. 
     
     
         151 . A composition of matter according to  claim 150  wherein said composition of matter is in unit dosage form and said coating protects the entire dosage unit. 
     
     
         152 . A composition of matter according to  claim 146  wherein said 5-D-fructose dehydrogenase is microencapsulated. 
     
     
         153 . A composition of matter according to  claim 146  wherein said 5-D-fructose dehydrogenase constitutes between 5 and 99.9% by weight of the composition of matter. 
     
     
         154 . A composition of matter according to  claim 147  wherein said unit dosage form contains between 50 and 1 million units of 5-D-fructose dehydrogenase activity. 
     
     
         155 . A composition of matter according to  claim 146  wherein said composition of matter comprises a coating which dissolves at a pH of 5.5 or higher. 
     
     
         156 . A composition of matter according to  claim 146  wherein said 5-D-fructose dehydrogenase is not contained in an inorganic-based sol-gel biocompatible matrix. 
     
     
         157 . A foodstuff which comprises 5-D-fructose dehydrogenase, at least some of said 5-D-fructose dehydrogenase being present in said foodstuff in a form in which said 5-D-fructose dehydrogenase will be released in active form to act on fructose which is present in or released from said foodstuff after ingestion of said foodstuff 
     
     
         158 . A foodstuff according to  claim 157 , wherein said foodstuff is selected from the group consisting of a baked foodstuff, a cooked foodstuff, and a liquid foodstuff 
     
     
         159 . A foodstuff according to  claim 157 , wherein said 5-D-fructose dehydrogenase is not contained in an Inorganic-based sol-gel biocompatible matrix. 
     
     
         160 . A foodstuff according to  claim 159 , wherein said 5-D-fructose dehydrogenase is microencapsulated. 
     
     
         161 . A foodstuff according to  claim 157 , wherein said foodstuff is substantially free of substances which are not approved for oral human ingestion. 
     
     
         162 . A process for preparing a 5-D-fructose dehydrogenase-containing foodstuff, the process comprising adding to a foodstuff 5-D-fructose dehydrogenase in a form in which at least some of said 5-D-fructose dehydrogenase will be released in active form to act on fructose which is present in or released from said foodstuff after said foodstuff is ingested by a subject, whereby to obtain said 5-D-fructose dehydrogenase-containing foodstuff. 
     
     
         163 . A kit comprising 5-D-fructose dehydrogenase and instructions explaining how to use said 5-D-fructose dehydrogenase to diagnose, treat, or reduce the effects of a condition selected from fructose intolerance and/or impaired fructose metabolism. 
     
     
         164 . A foodstuff which comprises 5-D-fructose dehydrogenase, wherein said foodstuff is not a dough. 
     
     
         165 . A foodstuff according to  claim 164  which is in unit dosage form. 
     
     
         166 . The foodstuff according to  claim 164 , wherein said 5-D-fructose dehydrogenase is isolated from a natural, synthetic, and/or recombinant source. 
     
     
         167 . The mammalian ingestible composition of matter according to  claim 146 , wherein said 5-D-fructose dehydrogenase is isolated from a natural, synthetic, and/or recombinant source. 
     
     
         168 . A foodstuff according to  claim 157 , wherein said 5-D-fructose dehydrogenase is isolated from a natural, synthetic, and/or recombinant source. 
     
     
         169 . The kit according to  claim 163 , wherein said 5-D-fructose dehydrogenase is isolated from a natural, synthetic, and/or recombinant source. 
     
     
         170 . A foodstuff according to  claim 165 , wherein said foodstuff is in a form selected from (a) the group consisting of a tablet, capsule, gel cap, pellet and dragee, and (b) powder or liquid form which is contained in a single-dose container. 
     
     
         171 . A composition of matter according to  claim 146 , further comprising a second enzyme which is selected from the group consisting of invertase, maltase and combinations thereof. 
     
     
         172 . A foodstuff according to  claim 157 , further comprising a second enzyme which is selected from the group consisting of invertase, maltase and combinations thereof. 
     
     
         173 . A foodstuff according to  claim 164 , further comprising a second enzyme which is selected from the group consisting of invertase, maltase and combinations thereof.