Gastrointestinal symptoms in 3181 volunteers ingesting snack foods containing olestra or triglycerides - A 6-week randomized, placebo-controlled trial

Background: Olestra is a nonabsorbable, energy-free fat substitute. Because it is not absorbed, it may cause digestive symptoms when consumed in large amounts. Objective: To compare the frequency and impact of gastrointestinal symptoms in adults and children who freely consume snacks containing olestra or reg ular snacks in the home. Design: 6-week, double-blind, randomized, parallel, placebo-controlled tria l. Setting: General community. Participants: 3181 volunteers 2 to 89 years of age. Intervention: Households received identical packages labeled as containing olestra corn or potato chips. These packages contained either olestra or re gular chips (control). Measurement: Gastrointestinal symptoms and their impact on daily activities were reported in a daily record. Results: At least one gastrointestinal symptom was reported by 619 of 1620 (38.2%) persons in the olestra group and 576 of 1561 (36.9%) controls (diff erence, 1.3 percentage points [95% CI, -3.6 to 6.2 percentage points]; P = 0.60). In general, the groups did not differ significantly in the proportio n of participants who reported individual gastrointestinal symptoms; howeve r, more controls reported nausea (8.4% compared with 5.7%; difference, -2.7 percentage points [Cl, -4.9 to -0.4 percentage points]; P = 0.02). The onl y difference between groups for the mean numbers of days on which symptoms were reported was that participants in the olestra group had 1 more symptom -day of more frequent bowel movements than did controls (3.7 symptom-days c ompared with 2.8 symptom days; difference, 0.9 symptom-days [Cl, 0.1 to 1.8 symptom-days]; P = 0.04). The groups did not differ in the impact of sympt oms on daily activities. Conclusions: Clinically meaningful or bothersome gastrointestinal effects a re not associated with unregulated consumption of olestra corn and potato c hips in the home.