Page 2 - Helen Thorsheim, Ph.D.

margarine, and cookies. The subjects were fed all meals during the baseline, treatment, and washout periods under supervision at the clinical site. The stiffness of the olestra was approximately 90 kPa/s.

The frequency, duration, and severity of nine pre-defined GI symptoms were documented daily by the subjects, starting at the beginning of the baseline period and continuing through the final four-day washout period. Diarrhea was defined as "excessive frequency of very loose/watery stools that are extremely difficult or impossible to control." Loose stools were defined as "a bowel movement that is easier to pass than normal, but is not watery and unformed."

At the completion of the screening phase those subjects who reported an increase in the frequency, severity, or duration of GI symptoms during the olestra period, relative to the placebo period, were selected to take part in the study phase. Eighteen subjects met the selection criteria.

Study Phase

This phase was a crossover, placebo-controlled, single-blind (subject) design with three treatment groups, 0, 10, and 20 g/d olestra. Each subject received each treatment for seven days. The treatment periods were separated by seven-day washout periods.

During the treatment periods, the subjects were fed all meals under supervision at the clinical site. The subjects were fed according to their weight, 30, kcal/kg of body weight/day. Portions of food were weighed before the meals and uneaten amounts were weighed after the meal to monitor consumption. The olestra dose was divided among the three daily meals and was incorporated into the meals in french fries, ice cream, margarine, and cookies. The placebo and olestra-containing meals provided the same amount of metabolizable energy. During the treatment periods, the subjects were not allowed to eat any food other than that provided in the test meals. During the washout periods, subjects ate their habitual diets at home.

GI symptoms were ascertained during the treatment periods and the first four days of the washout periods by GI Assessment Records completed daily by the subjects. For each GI symptom episode, the subject recorded the date, the time of day, and the intensity. The intensity scale for GI symptoms was graded as follows: 0 (none); 1 (slight); 2 (mild); 3 (moderate); and