Cases and Studies of Security & Regulation in Lottery & Gambling
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- Article] Randomized, double-blind, placebo-controlled, food allergy challenge to olestra snacks
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DocNo of ILP: 6429
Doc. Type: Article
Title: Randomized, double-blind, placebo-controlled, food allergy challenge to olestra snacks
Authors: Burks, AW; Christie, L; Althage, KA; Kesler, JM; Allgood, GS
Full Name of Authors: Burks, AW; Christie, L; Althage, KA; Kesler, JM; Allgood, GS
Keywords by Author: allergy; olestra; Olean; food additive
Keywords Plus: ASPARTAME
Abstract: 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 allergy-type symptoms (e.g., rash, itching, edema, hives, dyspnea). 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 hypersensitivity to olestra's postmarketing surveillance program, 14 men and women traveled to the Arkansas Children'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 potato chips and regular fat-containing potato chips. The dose of potato 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 allergic reaction 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 hypersensitivity after consuming the regular-fat, placebo potato chips. The results of this study confirm that olestra is unlikely to have an allergenic potential. (C) 2001 Academic Press.
Cate of OECD: Health sciences
Year of Publication: 2001
Business Area: gamble
Detail Business: gamble
Country: USA
Study Area:
Name of Journal: REGULATORY TOXICOLOGY AND PHARMACOLOGY
Language: English
Country of Authors: Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72205 USA; Procter & Gamble Nutr Sci Inst, Cincinnati, OH 45224 USA
Press Adress: Burks, AW (reprint author), Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72205 USA.
Email Address:
Citaion:
Funding:
Lists of Citation: Allgood GS, 2001, REGUL TOXICOL PHARM, V33, P224, DOI 10.1006/rtph.2001.1460; BOCK SA, 1988, J ALLERGY CLIN IMMUN, V82, P986; BUTCHKO HH, 1994, NUTR TOXICOLOGY, P235; *FDA, 1996, FED REGISTER, V61, P3118; GARRIGA MM, 1991, J ALLERGY CLIN IMMUN, V87, P821, DOI 10.1016/0091-6749(91)90128-B; GEHA R, 1993, J ALLERGY CLIN IMMUN, V92, P513, DOI 10.1016/0091-6749(93)90075-Q; Sampson HA, 1997, JAMA-J AM MED ASSOC, V278, P1888, DOI 10.1001/jama.278.22.1888; Slough CL, 2001, REGUL TOXICOL PHARM, V33, P218, DOI 10.1006/rtph.2001.1461
Number of Citaion: 8
Publication: ACADEMIC PRESS INC
City of Publication: SAN DIEGO
Address of Publication: 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA
ISSN: 0273-2300
29-Character Source Abbreviation: REGUL TOXICOL PHARM
ISO Source Abbreviation: Regul. Toxicol. Pharmacol.
Volume: 34
Version: 2
Start of File: 178
End of File: 181
DOI: 10.1006/rtph.2001.1488
Number of Pages: 4
Web of Science Category: Medicine, Legal; Pharmacology & Pharmacy; Toxicology
Subject Category: Legal Medicine; Pharmacology & Pharmacy; Toxicology
Document Delivery Number: 486XV
Unique Article Identifier: WOS:000171843500007
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