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4 (severe). Total fecal collections were made for the last three days of each treatment period and the daily collections were pooled. To complete the study and have data included in the analyses, a subject had to provide at least one fecal sample for each three-day collection period.
Normal healthy males and females (18 to 60 years of age) were selected for the study from a population of subjects who had reported GI symptoms while consuming olestra in previous product acceptance studies. In addition, to be selected for the study phase, a subject had to report an increased frequency, severity, or duration of GI symptoms while on the 20 g/d olestra treatment, relative to the placebo treatment.
Stools were collected into plastic containers and immediately frozen at -20 degrees C. Sealable plastic bags and an ice chest containing dry ice were provided to the subjects for collection of stools at home. These samples were transferred to -20 degrees C as rapidly as possible. All fecal samples were kept frozen until analyzed.
Fecal samples were initially collected on an individual basis for each bowel movement and several measurements were made (e.g., wt weight, volume, density). Subsequently, all fecal samples from the three-day collection period were pooled (thus diarrheal, loose, and normal stools were pooled) for analyses of the remaining parameters (e.g., water concentration, dry weight, olestra analyses, Na, K, Cl, total and individual bile acids, free fatty acids, triglycerides, and total lipids by the Mayo Medical Laboratories (Rochester, MN). Because the analyses of stool electrolytes were conducted on pooled samples from the three-day collection period, separate daily values for an individual are not available.
More than 99% of the olestra-containing test foods were consumed during both the 10 g/d olestra and 20 g/d olestra treatments.
Results: Screening period
Of the 52 subjects who enrolled in the study, 47 completed the screening phase. None of the five subjects who withdrew did so because of medical reasons. Ten different subjects reported adverse experiences during the screening phase, most commonly GI in nature. Two subjects reported diarrhea during the placebo period; one of these two reported loose stools also. During the olestra consumption period, one subject reported diarrhea and another reported loose stools.