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Olean Rechallenge Study

No Difference in Digestive Effect After Eating 2 oz of Chips

A study by Procter & Gamble showed that in consumers who had reported digestive effects, eating 2 oz of fat-free chips made with olestra provides great taste with no difference in digestive effects.

The news comes from a clinical study involving, for the first time, actual consumers of chips made with olestra who have reported digestive effects. Olestra was approved in January 1996 by the Food and Drug Administration (FDA). Appearing in an issue of the journal Regulatory Toxicology and Pharmacology, the study found that eating typical servings of chips made with olestra is no more likely to result in reports of digestive changes than eating full-fat chips.

Consumers participating in the study were from test markets in Eau Claire, Wisconsin, Grand Junction, Colorado, Cedar Rapids, Iowa, and Columbus, Ohio, where snacks made with olestra are being sold in products such as Lay's®, Ruffles®, Pringles®, and Doritos®. Participants were among consumers less than one per 20,000 servings who told Procter & Gamble of digestive changes they thought were associated with eating the olestra chips. Procter & Gamble sells olestra to snack manufacturers under the brand name Olean®. Similar results were subsequently found among consumers in central Indiana where test marketing of olestra-made snacks began after the study report was written.

"We decided that a group of people who reported digestive changes provided the best opportunity to show that what they experienced may have been coincidental; there's nothing standing in the way of their enjoying product made with Olean," said Nora L. Zorich, MD, PhD, primary author of the peer-reviewed study and medical director of the Olean project for Procter & Gamble. Each study participant ate chips on four occasions without knowing which two of the four occasions were made with Olean®. Follow-up calls tracked each participant's status.

"I'm glad I had a chance to see for myself because I liked Olean chips to begin with and now I'm free to choose them with confidence," said Terri Butler, a study participant from Columbus.

Added Butler, "Olean makes a big difference for me because I get to enjoy great tasting chips without getting any fat and only half the calories."

The consumer reports of digestive changes also have been reviewed by an expert physician panel including many of medicine's leading gastroenterologists.

In an article appearing in the same issue of Regulatory Toxicology and Pharmacology, the panel noted that increases in calls to a toll-free number coincided with publicity about olestra in local media which, the reviewers suggested, "may demonstrate the influence of publicity on reporting."

In addition to commenting on test market consumer reports, the expert panel also examined all peer-reviewed olestra studies, either published or, if unpublished, available from the FDA. It concluded that olestra does not change digestive function, although large amounts of olestra can result in digestive effects resembling those typically associated with eating high fiber foods. In the study reviewed by the panel which found these effects, participants ate olestra at breakfast, lunch and dinner in a variety of foods, not just snacks, for 56 days in a row.

"Even under these exaggerated eating circumstances, when digestive changes did occur, they were generally mild and participants remained in the study without changes in their daily routine," said Zorich.

As a condition of participation, members of the panel received written assurance from Procter & Gamble that they could submit their findings for publication regardless of their conclusions. Serving on the panel were physicians with appointments at the following institutions: University of Connecticut Health Center, University of Colorado School of Medicine, Case Western Reserve University School of Medicine, University of Arizona Health Sciences Center, St. Bartholomew's and the Royal London School of Medicine and Dentistry in London, UK, Tufts University School of Medicine, McMaster University, Ontario, University of North Carolina, and Johns Hopkins Bayview Medical Center.

The Olestra Story

Made starting from soybeans or cottonseed, olestra is processed in an improved way that results in a fat-free, calorie-free cooking oil that holds up under high temperatures. Olestra's stability when heated explains why it can be used to fry snacks, giving them satisfying taste and texture like full-fat snacks.

Because olestra is neither digested nor absorbed by the body, it adds no fat or calories. Excess dietary fat is a major factor in obesity, heart disease, diabetes and certain types of cancer. Along with exercise and a balanced diet, olestra is one more tool for a healthier lifestyle.

An innovator in the development of cooking oils since its introduction of Crisco® cooking oil 95 years ago, Procter & Gamble is the maker of Olean brand of olestra cooking oil.

The Nocebo Effect

Recent research points to the power of learned expectation as a serious risk factor in common ailments. People tend to blame commonly occurring problems such as headaches and digestive changes on whatever cause they have been led to expect. The phenomenon has become known as the nocebo effect, the flip-side of the placebo effect. As recently as September, the Journal of Preventative Medicine published a series of articles by scientists at Harvard Medical School, Columbia University and the Centers for Disease Control elaborating on the nocebo effect. "Finding, in a controlled setting, no difference in digestive experiences between 2 oz's of olestra and full-fat chips, following initial reports of digestive changes thought to be related to olestra, may illustrates a nocebo's power," observed Ernst Wynder, M.D., founder and president of the American Health Foundation and editor of the Journal of Preventative Medicine. Research by Dr. Wynder in the 1950s established the connection between smoking and cancer as well as heart disease.