Following approval of the fat replacer olestra for use in preparing savory snacks, Procter _ Gamble implemented a postmarketing surveillance program to monitor marketplace introduction. Three and one-half percent of all health effects reported by consumers to the surveillance toll-free number were @entity566 -type symptoms (e.g., @entity1910 , itching, @entity4 , @entity110 , @entity1353 ). Because of these reports, we investigated whether olestra or some component of olestra snacks was a likely allergen in some subset of the population. A single center, randomized, double-blind, placebo-controlled, within-subject crossover food challenge study was conducted to confirm or refute the allergenicity of olestra snacks. Of the 65 subjects who reported symptoms consistent with immediate @entity56 to olestra's postmarketing surveillance program, 14 @entity1 and @entity1 traveled to the Arkansas @entity1 's Hospital Research Institute to participate in this study. Each subject underwent a standard skin prick test at the beginning of the study, to help determine what component, if any, of the olestra product was allergenic. Following the skin prick test, subjects ate in random order, olestra-containing @entity415 chips and regular fat-containing @entity415 chips. The dose of @entity415 chips consumed at each challenge was at least the amount alleged to have caused the symptoms that prompted the consumer to phone the postmarketing surveillance toll-free number. No subject experienced an @entity56 after consuming the olestra-containing chips. Nor did any subject elicit a positive response to olestra following the skin prick testing. Two subjects had positive reactions consistent with immediate @entity56 after consuming the regular-fat, placebo @entity415 chips. The results of this study confirm that olestra is unlikely to have an allergenic potential.

Randomized, double-blind, placebo-controlled, food XXXX challenge to olestra snacks.

@entity1 :: ('9606', 'Species') :: ['men', 'women', 'Children'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity1353 :: ('MESH:D004417', 'Disease') :: ['dyspnea'] @entity566 :: ('MESH:D006967', 'Disease') :: ['allergy'] @entity4 :: ('MESH:D004487', 'Disease') :: ['edema'] @entity415 :: ('4113', 'Species') :: ['potato'] @entity56 :: ('MESH:D004342', 'Disease') :: ['allergic reaction', 'hypersensitivity'] @entity110 :: ('MESH:D014581', 'Disease') :: ['hives']
@entity566 :: (MESH:D006967,Disease) :: ['allergy']
