L J Cheskin1, R Miday, N Zorich, T Filloon. 1. Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Md 21224, USA. cheskin@welchink.welch.jhu.edu
Abstract
CONTEXT: Olestra, a nonabsorbable, energy-free fat substitute used in snack foods, has been anecdotally reported to cause gastrointestinal (GI) adverse events, although such effects were not expected based on results from randomized trials, in which it was consumed in typical snack patterns. OBJECTIVE: To determine whether ad libitum consumption of potato chips made with the fat substitute olestra results in a different level of GI symptoms than regular chips made with triglyceride (TG). DESIGN: Randomized, double-blind, parallel, placebo-controlled trial. SETTING: A suburban Chicago, III, multiplex cinema. SUBJECTS: A total of 1123 volunteers aged 13 to 88 years. INTERVENTION: Subjects were given a beverage and an unlabeled, white 369-g (13-oz) bag of potato chips made with olestra or TG during a free movie screening. MAIN OUTCOME MEASURES: Total and specific GI symptoms reported during a telephone interview conducted from 40 hours to 10 days after ingestion; level of potato chip consumption; and satiety level. RESULTS: Of 563 evaluable subjects in the olestra chip group, 89 (15.8%) reported 1 or more GI symptoms, while 93 (17.6%) of the 529 evaluable subjects in the regular TG chip group did so (difference in symptom frequency between olestra and TG, -1.8; 95% confidence interval, -6.2 to 2.7; P=.47). For specific GI symptoms (eg, gas, diarrhea, abdominal cramping), there were no significant differences between olestra and TG chips. Fewer olestra chips were consumed than TG chips (60 vs 77 g [2.1 vs 2.7 oz]; P<.001), with olestra chips receiving lower taste scores (5.6 vs 6.4 on a 9-point scale; P<.001). Consumption levels did not correlate with the rate of symptom reporting in either the olestra or TG group. There was no difference in satiety scores between olestra and TG chips (5.7 vs 5.9 on a 9-point scale; P=.07). CONCLUSIONS: This study demonstrates that ad libitum consumption of olestra potato chips during 1 sitting is not associated with increased incidence or severity of GI symptoms, nor does the amount consumed predict who will report GI effects after short-term consumption of either olestra or TG potato chips.
RCT Entities:
CONTEXT: Olestra, a nonabsorbable, energy-free fat substitute used in snack foods, has been anecdotally reported to cause gastrointestinal (GI) adverse events, although such effects were not expected based on results from randomized trials, in which it was consumed in typical snack patterns. OBJECTIVE: To determine whether ad libitum consumption of potato chips made with the fat substitute olestra results in a different level of GI symptoms than regular chips made with triglyceride (TG). DESIGN: Randomized, double-blind, parallel, placebo-controlled trial. SETTING: A suburban Chicago, III, multiplex cinema. SUBJECTS: A total of 1123 volunteers aged 13 to 88 years. INTERVENTION: Subjects were given a beverage and an unlabeled, white 369-g (13-oz) bag of potato chips made with olestra or TG during a free movie screening. MAIN OUTCOME MEASURES: Total and specific GI symptoms reported during a telephone interview conducted from 40 hours to 10 days after ingestion; level of potato chip consumption; and satiety level. RESULTS: Of 563 evaluable subjects in the olestra chip group, 89 (15.8%) reported 1 or more GI symptoms, while 93 (17.6%) of the 529 evaluable subjects in the regular TG chip group did so (difference in symptom frequency between olestra and TG, -1.8; 95% confidence interval, -6.2 to 2.7; P=.47). For specific GI symptoms (eg, gas, diarrhea, abdominal cramping), there were no significant differences between olestra and TG chips. Fewer olestra chips were consumed than TG chips (60 vs 77 g [2.1 vs 2.7 oz]; P<.001), with olestra chips receiving lower taste scores (5.6 vs 6.4 on a 9-point scale; P<.001). Consumption levels did not correlate with the rate of symptom reporting in either the olestra or TG group. There was no difference in satiety scores between olestra and TG chips (5.7 vs 5.9 on a 9-point scale; P=.07). CONCLUSIONS: This study demonstrates that ad libitum consumption of olestrapotato chips during 1 sitting is not associated with increased incidence or severity of GI symptoms, nor does the amount consumed predict who will report GI effects after short-term consumption of either olestra or TGpotato chips.