Acute consumption study
This is one of two clinical studies to assess the potential for GI symptoms to occur from eating snacks made with olestra under typical snacking conditions. This placebo-controlled study was a single eating or “acute” consumption study. For perspective nearly 80% of people who called the 800-number on olestra snack packages to report symptoms they attributed to olestra said they had eaten the snacks on only one day.
The study was conducted by Dr. Lawrence Cheskin, who runs the Gastroenterology Clinic and a Weight Management Clinic at Johns Hopkins University. He used a randomized and placebo-controlled design where 1,092 people, aged 13-88, watched a movie at a movie theater. Each had a 13 ounce bag of chips and a 32 ounce beverage. Consumption was measured individually. The question Dr. Cheskin wanted to answer was whether in a single sitting, when people were able to eat as much as they wanted, would there be an increase in GI symptoms compared to the background rate.
Data were collected by telephone recall 2-4 days after the movie. For the people eating olestra chips, 15.9% reported one or more digestive effects, compared to 17.6% eating full-fat chips. For specific digestive effects (e.g., gas, diarrhea, abdominal cramping), there was no significant difference between the olestra and full-fat chips. Consumption levels did not correlate with the rate of digestive effect reporting in either the olestra or the full-fat chip group. The conclusion was that when people ate as much of the olestra chips as they wanted, in a single sitting, they were no more likely to have digestive effects than with full-fat chips.
Results in the Journal of the American Medical Association
- In what may be the first controlled clinical trial of its kind, more than 1,000 people between the ages of 13 and 88 sampled potato chips made with either Olean® or full-fat cooking oil during a first-run movie at a suburban Chicago multiplex cinema in December 1996.
- The chips were either made with Olean fat-free cooking oil or full-fat cooking oil. Participants did not know which type they were eating.
- Olean cooking oil was developed by Procter & Gamble, the makers of Crisco® cooking oil, and approved by the Food and Drug Administration (FDA) for use in snack foods such as potato chips, corn chips and crackers. Because Olean cooking oil is not absorbed by the body, it does not add any calories or dietary fat to snacks.
- The movies were Jingle All the Way, Ransom, Space Jam and the English Patient.
- On January 14, 1998, following a rigorous peer review process, the Journal of the American Medical Association published results from this Olean theater test which measured, for each type chip, how filling it was, the amount eaten, taste preference and any reports of digestive changes.
- The group eating Olean chips reported feeling as full as those eating the full-fat chips. Those eating Olean chips in this setting were satisfied with their snacking experience; that is, they did not feel a need to eat more. Every participant received a large, family-sized (13 ounce) bag of chips and a 32 ounce soft-drink.
- Median individual chip consumption exceeded 2 ounces for each group – 2.1 ounces for the Olean group and 2.7 ounces for the full-fat group. In both groups, the median amounts eaten were more than the typical single-serving snack size bag of chips -- about 1 ounce.
- Average taste preference levels for chips made with Olean or full-fat cooking oil were within a point of each other at 5.6 and 6.4 respectively on a 9 point scale, putting them in the same taste league. The appeal of the Olean chip should make it easier for individuals who are regular chip snackers to lower their fat and calorie intake when they choose Olean chips. In this study, the full-fat chip group ate more than 34 pounds of fat amounting to 120,000 calories. The Olean chip group ate none.
- There were no significant differences in reports of digestive changes between the Olean and full-fat chip groups with 17.6 percent of the full-fat group and 15.8 percent of the Olean group reporting one or more complaints.
- There was also no indication of increasing digestive changes in either group as more chips were eaten. More than a quarter of participants ate more than 4 ounces of chips regardless of type.
- These findings are consistent with those of another controlled clinical study involving consumers who had initially reported digestive changes after eating chips made with Olean cooking oil. Published in the October/November issue of Regulatory Toxicology and Pharmacology, that study found no difference in the level of digestive changes when the consumers ate both Olean and full-fat chips again without knowing the type.
- Test-market consumers reporting digestive changes typically have done so after just one sitting and eating a median of less than 2 ounces of chips – essentially the same conditions under which the Olean cooking oil screen test was conducted.
- The similar levels of digestive changes following the consumption of either type chip require another explanation. The answer appears to lie in the growing body of research indicating that digestive changes are quite common in the general population with up to 40 percent of individuals reporting one or more changes during a one-month period.
- In other findings from this theater test, men ate more chips of either kind than women, while the majority of participants who ate the most chips were teenagers. Not surprisingly, median chip consumption was therefore greatest among those watching Space Jam and lowest for viewers of the English Patient.
- The study’s lead researcher was Lawrence Cheskin, M.D., a gastroenterologist and director of both the Division of Digestive Diseases and the Johns Hopkins Weight Management Center at Hopkins Bayview Hospital in Baltimore, Maryland. Dr. Cheskin is the author of Losing Weight for Good – Developing Your Personal Plan of Action, published by Johns Hopkins University Press in 1997.
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