Compositions for inhibiting absorption of cholesterol

Abstract

Polyol fatty acid polyesters having at least four fatty acid ester groups are fortified with fat-soluble vitamins and used in pharmaceutical compositions for treating and/or preventing hypercholesterolemia in animals, especially humans, and in low-calorie foods.

What is claimed is: 
     
       1. A composition of matter, comprising: a nonabsorbable, nondigestible polyol fatty acid polyester having at least 4 fatty acid ester groups, wherein the polyol is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups and wherein each fatty acid group has from about 8 to about 22 carbon atoms; .[.and.]. .Iadd.said composition being fortified with .Iaddend.sufficient fat soluble vitamin selected from the group consisting of vitamin A, vitamin D, .Iadd.and .Iaddend.vitamin E, .[.and vitamin K.]., or mixtures thereof, .Iadd.over and above that naturally present in said composition, .Iaddend.to prevent abnormally low levels of any of said fat-soluble vitamins in animals ingesting said composition. 
     
     
       2. A composition according to claim 1 wherein the polyol fatty acid polyester contains no more than 2 free hydroxyl groups. 
     
     
       3. A composition according to claim 2 wherein the fatty acid ester groups contain from about 14 to about 18 carbon atoms. 
     
     
       4. A composition according to claim 3 wherein the polyol is a member selected from the group consisting of erythritol, xylitol, sorbitol, glucose and sucrose. 
     
     
       5. A composition according to claim 4 wherein the polyol is sucrose. 
     
     
       6. A composition according to claim 5 wherein the sucrose fatty acid polyester is a member selected from the group consisting of C 14 , C 16  and C 18  hexa-, hepta-, and octa-esters, and mixtures thereof. 
     
     
       7. A composition according to claim 6 wherein the sucrose fatty acid polyester is a member selected from the group consisting of the hexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof. 
     
     
       8. A composition according to claim 1 which comprises from about 98% to about 99.999% by weight of the non-absorbable, non-digestible polyol fatty acid polyester and from about 0.001% to about 2% by weight of a vitamin selected from the group consisting of vitamin A, vitamin D, vitamin E, .[.vitamin K.]. and mixtures thereof. 
     
     
       9. A pharmaceutical composition in effective unit dosage amounts for inhibiting the absorption of cholesterol without interfering with the body's stores of fat-soluble vitamins, comprising: from about 0.1 gram to about 5 grams of a non-absorbable, non-digestible polyol fatty acid polyester having at least 4 fatty acid ester groups, wherein the polyol is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups and wherein each fatty acid group has from about 8 to about 22 carbon atoms; .[.and.]. .Iadd.said composition being fortified with .Iaddend.sufficient fat-soluble vitamin selected from the group consisting of vitamin A, vitamin D, .Iadd.and .Iaddend.vitamin E, .[.and vitamin K.]. or mixtures thereof, .Iadd.over and above that naturally present in said composition, .Iaddend.to prevent abnormally low levels of any of said fat-soluble vitamins in humans ingesting said composition. 
     
     
       10. A composition according to claim 9 wherein the polyol fatty acid polyester contains no more than 2 free hydroxyl groups. 
     
     
       11. A composition according to claim 10 wherein the fatty acid ester groups contain from about 14 to about 18 carbon atoms. 
     
     
       12. A composition according to claim 11 wherein the polyol is a member selected from the group consisting of erythritol, xylitol, sorbitol, glucose and sucrose. 
     
     
       13. A composition according to claim 12 wherein the polyol is sucrose. 
     
     
       14. A composition according to claim 13 wherein the sucrose fatty acid polyester is a member selected from the group consisting of C 14 , C 16  and C 18  hexa-, hepta-, and octa-esters, and mixtures thereof. 
     
     
       15. A composition according to claim 14 wherein the sucrose fatty acid polyester is a member selected from the group consisting of the hexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof. 
     
     
       16. A low calorie fat-containing food composition comprising non-fat ingredients and fat ingredients wherein from about 10% to about 100% of the total fat ingredients comprise a non-absorbable, non-digestible polyol fatty acid polyester having at least 4 fatty acid ester groups, wherein the polyol is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups and wherein each fatty acid group has from about 8 to about 22 carbon atoms, said food composition being fortified with sufficient fat-soluble vitamin selected from the group consisting of vitamin A, vitamin D .Iadd.and .Iaddend.vitamin E .[.and vitamin K.]., or mixtures thereof, over and above that naturally present in said food composition to prevent abnormally low levels of any of said fat-soluble vitamins in animals ingesting said composition. 
     
     
       17. A composition according to claim 16 wherein the polyol fatty acid polyester contains no more than 2 free hydroxyl groups. 
     
     
       18. A composition according to claim 17 wherein the fatty acid ester groups contain from about 14 to about 18 carbon atoms. 
     
     
       19. A composition according to claim 18 wherein the polyol is a member selected from the group consisting of erythritol, xylitol, sorbitol, glucose and sucrose. 
     
     
       20. A composition according to claim 19 wherein the polyol is sucrose. 
     
     
       21. A composition according to claim 20 wherein the sucrose fatty acid polyester is a member selected from the group consisting of C 14 , C 16  and C 18  hexa-, hepta-, and octa-esters, and mixtures thereof. 
     
     
       22. A composition according to claim 21 wherein the sucrose fatty acid polyester is a member selected from the group consisting of the hexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof. 
     
     
       23. A method for inhibiting the absorption of cholesterol without decreasing the body's stores of fat-soluble vitamins comprising systemically administering to an animal susceptible to or afflicted with hypercholesterolemia successive therapeutically effective doses of a non-absorbable and non-digestible polyol fatty acid polyester having at least 4 fatty acid ester groups, wherein the polyol is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups and wherein each fatty acid group has from about 8 to about 22 carbon atoms and sufficient fat-soluble vitamin .Iadd.selected from the group consisting of vitamin A, vitamin D, and vitamin E, or mixtures thereof, .Iaddend.to prevent abnormally low levels of .Iadd.any of .Iaddend.said .[.vitamin.]. .Iadd.fat-soluble vitamins .Iaddend.from developing in said animal. .Iadd. 
     
     
       24.  The composition of claim 5 wherein said fat-soluble vitamin is vitamin E. .Iaddend. .Iadd.25. The composition of claim 20 wherein said fat-soluble vitamin is vitamin E. .Iaddend. .Iadd.26. The composition of claim 5 wherein said fat-soluble vitamin is vitamin A. .Iaddend. .Iadd.27. The composition of claim 20 wherein said fat-soluble vitamin is vitamin A. .Iaddend. .Iadd.28. The composition of claim 5 wherein said fat-soluble vitamin is vitamin D. .Iaddend. .Iadd.29. The composition of claim 20 wherein said fat-soluble vitamin is vitamin D. .Iaddend.