December 26, 1995

Medical Officer, Epidemiology Branch, Division of Market
Studies (HFS-728)

Review of Study Entitled "Measurement of Selected
Fecal Parameters in Subjects Consuming Increasing
Levels Of Olestra" (FAP 3997, Volume 280)

Helen Thorsheim, Ph.D., Consumer Safety Officer,
Office of Premarket Approval, (HFS-216)

Through: Raymond E. Schucker, Ph.D., Director,
Division of Market Studies

Study Objectives: The purposes of this study were to quantitate the frequency, duration, and intensity of pre- defined GI symptoms as a function of dietary level of olestra, and to quantitate selected fecal parameters that might change in response to changes in olestra intake.

Study Design: The study consisted of two phases. A screening phase was conducted to identify subjects who reported GI symptoms in response to olestra consumption. This was followed by the study phase during which the identified subjects were given increasing dietary levels of olestra and GI symptoms were recorded and fecal measurements were made.

Screening Phase

This was a four-week, cross-over design with two treatment groups, 0 and 20 g/d olestra. The olestra substituted for 20 g of triglyceride in the three daily meals. Roughly one- third of the daily dose was provided in each meal.

Fifty-two adult subjects who had reported GI symptoms in previous product acceptance or olestra clinical studies were acclimated to the study procedures during a three-day baseline period in which they were given placebo meals. They were then divided into two groups and given placebo meals or meals which provided 20 g/d olestra for five days. After a seven-day washout period, the subjects were again given placebo meals (containing triglycerides) for three days, and then crossed- over to olestra or placebo meals for five days. After the second treatment period, the subjects were monitored for a four-day washout period.

The subjects were fed one of four meal sizes, based on four average body weights: 50, 65, 80, and 95 kg. The meals provided 30 kcal of energy per kg of body weight. The olestra was incorporated into the meals in french fries, ice cream,