Randomized, double-blind, placebo-controlled, consumer rechallenge test of Olean salted snacks.
Olestra is a zero-calorie fat substitute that is neither digested nor absorbed. A randomized, double-blind, placebo-controlled, within-subject, crossover rechallenge study was conducted to compare the occurrence of gastrointestinal symptoms after ingestion of chips made with Olean brand of olestra or conventional triglycerides in subjects who had previously experienced gastrointestinal symptoms they attributed to consuming Olean. A total of 57 male or female subjects received 2 oz of Olean potato chips or triglyceride potato chips at each of four weekly site visits. The occurrence of gastrointestinal effects after product consumption was noted in follow-up telephone interviews 3 to 5 days after each visit. There was no significant difference in the frequency of any gastrointestinal symptoms (abdominal cramping, diarrhea, loose stools) following consumption of Olean chips or triglyceride chips, and the severity of diarrhea, loose stools, and abdominal cramping was similar. We conclude that consumption of a 2-oz serving of Olean chips is no more likely to result in reports of gastrointestinal symptoms than consumption of triglyceride snacks as a part of the usual diet, even in individuals who have claimed intolerance to Olean. The data suggest that subjects who previously experienced symptoms that they attributed to consuming products made with Olean may have mistakenly attributed their symptoms to these products.
Zorich
N L
NL
Department of Medical Affairs, OLEAN, Procter & Gamble Company, Cincinnati, Ohio 45224, USA.
Biedermann
D
D
Riccardi
K A
KA
Bishop
L J
LJ
Filloon
T G
TG
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003085:Colic / Q000139:chemically induced*; D018592:Cross-Over Studies; D003967:Diarrhea / Q000139:chemically induced*; D004041:Dietary Fats / Q000009:adverse effects; D004311:Double-Blind Method; D019358:Fat Substitutes / Q000009:adverse effects*; D005227:Fatty Acids / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D013395:Sucrose / Q000009:adverse effects / Q000031:analogs & derivatives*; D014280:Triglycerides / Q000009:adverse effects
D004041:Dietary Fats; D019358:Fat Substitutes; D005227:Fatty Acids; D014280:Triglycerides; D013395:Sucrose; C013692:sucrose polyester