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

Ann Intern Med. 1999 Feb 16;130(4 Pt 1):253-61. doi: 10.7326/0003-4819-130-4_part_1-199902160-00002.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain / etiology
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Child
  • Child, Preschool
  • Constipation / etiology
  • Diarrhea / etiology
  • Diet Records
  • Dietary Fats, Unsaturated / adverse effects*
  • Double-Blind Method
  • Fat Substitutes / adverse effects*
  • Fatty Acids / adverse effects*
  • Food*
  • Gastrointestinal Diseases / etiology*
  • Humans
  • Infant
  • Nausea / etiology
  • Placebo Effect
  • Sucrose / adverse effects
  • Sucrose / analogs & derivatives*
  • Triglycerides / adverse effects*


  • Dietary Fats, Unsaturated
  • Fat Substitutes
  • Fatty Acids
  • Triglycerides
  • Sucrose
  • sucrose polyester