Results: Study phase: Incidence of diarrhea and loose stools

Of the 47 subjects who completed the screening phase, 18 were selected to participate in the study phase. Two subjects withdrew prior to start of treatment, and one subject withdrew after the first treatment period (20 g/d olestra); none of the withdrawals was due to medical reasons. Therefore, 15 subjects completed the placebo arm of the study phase and the olestra 10 g/d arm, and 16 subjects completed the olestra 20 g/d arm of the study.

Figure 1 (attached) summarizes the number of study subjects who reported diarrhea or loose stools, by olestra dose. There was a steady increase in the number of subjects who reported diarrhea with increasing dose of olestra consumed. Three (20%) subjects reported diarrhea while eating 0 g/d olestra; 6 (40% while eating 10 g/d olestra; and 11 (69%) while eating 20 g/d olestra. The difference in incidence of reported diarrhea during placebo and 20 g/d olestra treatment was statistically significant (p=0.004, Mantel-Haenzel chi square test). There was also an increase in the number of subjects reporting loose stools with increasing olestra dose, but this increase did not reach statistical significance (p=0.08 comparing placebo vs. 20 g/d olestra).

Figure 2 summarizes the number of diarrheal or loose stool episodes, by olestra dose consumed. There was a steady increase in the number of diarrheal bowel movements with increasing olestra dose eaten: 5 episodes of diarrhea among subjects while eating 0 g/d olestra; 14 episodes of diarrhea among subjects whole eating 10 g/d olestra; and 40 episodes of diarrhea among subjects while eating 20 g/d olestra. The mean number of diarrheal bowel movements per subject reporting diarrhea during the study phase increased steadily with increasing olestra dose consumed; 1.7 diarrheal bowel movements per subject reporting diarrhea during placebo treatment [5 episodes of diarrhea among 3 subjects]; 2.3 diarrheal bowel movements per subject reporting diarrhea during 10 g/d olestra treatment [14 episodes of diarrhea among 6 subjects]; and 3.6 diarrheal bowel movements per subject reporting diarrhea during 20 g/d olestra treatment [40 episodes of diarrhea among 11 subjects]. The number of subjects experiencing diarrhea as reportedly "severe" increased with increasing doses of olestra consumed: none of the three subjects who experienced diarrhea while eating placebo reported the diarrhea as "severe"; two of the six subjects who experienced diarrhea while eating 10 g/d olestra reported the diarrhea as "severe"; and six of the 11 subjects who experienced diarrhea while eating 20 g/d olestra reported the diarrhea as "severe". The number of episodes of loose stools also increased with increasing amounts of olestra consumed.