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Randomized, double-blind, placebo-controlled, consumer rechallenge test of Olean salted snacks
N L Zorich1, D Biedermann, K A Riccardi
1Department of Medical Affairs, OLEAN, Procter & Gamble Company, Cincinnati, Ohio 45224, USA.
Regulatory Toxicology and Pharmacology : RTP
|November 14, 1997
Summary
Olestra (a zero-calorie fat substitute) did not cause more gastrointestinal issues than regular fat in a study. Even individuals who previously reported symptoms found no difference when consuming Olestra chips.
Area of Science:
- Food Science
- Gastroenterology
- Clinical Nutrition
Background:
- Olestra is a non-digestible, zero-calorie fat substitute used in snacks.
- Anecdotal reports suggest Olestra may cause gastrointestinal (GI) symptoms.
- Previous symptom attribution to Olestra necessitates further investigation.
Purpose of the Study:
- To objectively assess GI symptom occurrence after Olestra consumption.
- To compare Olestra chips against conventional triglyceride chips.
- To evaluate symptoms in individuals with prior self-reported Olestra intolerance.
Main Methods:
- Randomized, double-blind, placebo-controlled, within-subject crossover rechallenge study.
- 57 subjects consumed 2 oz of Olestra or triglyceride chips weekly.
- GI symptoms were monitored via telephone interviews 3-5 days post-consumption.
Main Results:
- No significant difference in the frequency of GI symptoms (cramping, diarrhea, loose stools) between Olestra and triglyceride chips.
- Severity of reported GI symptoms was similar for both chip types.
- Olestra consumption was not more likely to cause GI symptoms than triglyceride snacks.
Conclusions:
- Consumption of 2 oz Olestra chips is not more likely to cause GI symptoms than triglyceride snacks.
- Individuals reporting Olestra intolerance may have misattributed symptoms.
- The study suggests Olestra is well-tolerated, even by sensitive individuals.