Gastrointestinal Symptoms in 3181 Volunteers Ingesting Snack Foods Containing Olestra or Triglycerides for 6 Weeks

A Randomized, Placebo-Controlled Trial

16 February 1999 | Volume 130 Issue 4 Part 1 | Pages 253-261

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 regular snacks in the home.

Design: 6-week, double-blind, randomized, parallel, placebo-controlled trial.

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 regular 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 (difference, 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 proportion of participants who reported individual gastrointestinal symptoms; however, more controls reported nausea (8.4% compared with 5.7%; difference, –2.7 percentage points [CI, –4.9 to –0.4 percentage points]; P = 0.02). The only 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 compared with 2.8 symptom days; difference, 0.9 symptom-days [CI, 0.1 to 1.8 symptom-days]; P = 0.04). The groups did not differ in the impact of symptoms on daily activities.

Conclusions: Clinically meaningful or bothersome gastrointestinal effects are not associated with unregulated consumption of olestra corn and potato chips in the home.

Author and Article Information

From University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Procter & Gamble Co., Cincinnati, Ohio.

Note: Dr. Sandler is a consultant to Procter & Gamble Co. The terms of this arrangement are being managed by the University of North Carolina at Chapel Hill in accordance with its conflict of interest policies. Ms. Royer is an editorial consultant to Procter & Gamble.

Acknowledgments: The authors acknowledge Hill Top Research, Inc., Cincinnati, Ohio, for conducting the study.

Grant Support: By Procter & Gamble Co., Cincinnati, Ohio.

Requests for Reprints: Robert S. Sandler, MD, MPH, CB#7080, 326 Burnett-Womack Building, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080; e-mail, rsandler{at}med.unc.edu.

Current Author Addresses: Dr. Sandler: CB#7080, 326 Burnett-Womack Building, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080.

Drs. Zorich, Filloon, and Miday; Mr. Lietz; Mr. Brock; and Ms. Wiseman: Regulatory and Clinical Development, Food and Beverage Division, The Procter & Gamble Company, Winton Hill Technical Center, 6071 Center Hill Avenue, Cincinnati, OH 45224.

Ms. Royer: 1 Deer Run Road, Ithaca, NY 14850.