The Journal of Nutrition Vol. 127 No. 8 August 1997, pp. 1646S-1665S
Copyright ©1997 by the American Society for Nutritional Sciences

Olestra Dose Response on Fat-Soluble and Water-Soluble Nutrients in Humans

The Procter & Gamble Company, Winton Hill Technical Center, Cincinnati, OH 45224 and ^* Chicago Center for Clinical Research, Chicago, IL 60607

Ninety normal healthy adults were given 0, 8, 20 or 32 g/d olestra for 8 wk as part of a diet that provided 1 ± 0.2 of the recommended dietary allowance (RDA) of vitamins A, D, E and K, folate zinc, calcium and iron. In addition, a 20 µg/d supplement of vitamin D was supplied. The diet provided 15% of energy from protein, 35% from fat and 55% from carbohydrate. The purpose of the study was to determine the dose response of olestra on vitamins D, E and K, carotenoids, vitamin B₁₂, folate and zinc. Circulating concentrations of retinol, carotenoids, tocopherols, 25-hydroxy- and 1,25-dihydroxyvitamin D metabolites, phylloquinone, des--carboxyprothrombin, prothrombin, folate and hematological parameters were measured biweekly, as were urine concentrations of zinc and -carboxyglutamic acid (Gla). Clinical chemistry, urinalysis and vitamin B₁₂ absorption were measured at wk 0 and 8. Olestra reduced serum concentrations of carotenoids, -tocopherol, 25-hydroxyergocalciferol and phylloquinone in a dose-responsive manner. Olestra did not affect Gla excretion, plasma des--carboxyprothrombin or prothrombin concentrations, prothrombin time, vitamin B₁₂ absorption, overall vitamin D status or the status of folate or zinc. Laboratory evaluations showed no health-related effects of olestra. Subjects in all groups reported common gastrointestinal symptoms such as loose stools, fecal urgency and flatulence, which were transient and generally mild to moderate in severity. These symptoms did not affect protocol compliance or the ability to measure the potential for olestra to affect nutrient availability.