The Journal of Nutrition Vol. 127 No. 8 August 1997, pp. 1666S-1685S
Copyright ©1997 by the American Society for Nutritional Sciences

Olestra's Effect on Vitamins D and E in Humans Can Be Offset by Increasing Dietary Levels of These Vitamins

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

One hundred two normal healthy males and females were given 0, 8, 20 or 32 g/d olestra to which had been added graded amounts of vitamins A, D and E for 8 wk in a parallel, double-blind study. The primary purpose of the study was to determine the amounts of vitamins D and E needed to offset the effect of olestra on the availability of these vitamins. Serum concentrations of retinol, carotenoids, 25-hydroxyvitamin D metabolites, -tocopherol, phylloquinone, lipids, ferritin and total iron, iron-binding capacity and hematology parameters, plasma concentrations of des--carboxyprothrombin and prothrombin, and urinary -carboxyglutamic acid (Gla) excretion were measured biweekly. Clinical chemistry and urinalysis parameters, vitamin B₁₂ absorption, and serum 1,25-dihydroxyvitamin D concentration were measured at wk 0 and 8. Serum concentrations of -tocopherol and 25-hydroxyergocalciferol were restored to control concentration by adding 2.1 mg d--tocopheryl acetate and 0.06 µg ergocalciferol per gram of olestra, respectively, to the diet. Olestra reduced serum concentrations of 25-hydroxyergocalciferol, carotenoids and phylloquinone in a dose-responsive manner but did not affect Gla excretion, plasma des--carboxyprothrombin and prothrombin concentrations, overall vitamin D status, vitamin B₁₂ absorption or iron status. Laboratory evaluations showed no olestra-related effects. Subjects in all groups reported mild to moderately severe transient gastrointestinal symptoms. These symptoms did not affect study compliance or the integrity of the data.