Safety evaluation and nutritional composition of a Fraxinus excelsior seed extract, FraxiPure™.

A natural extract obtained from the seeds of Fraxinus excelsior L. (FraxiPure™) has been previously reported to reduce glycemia in animal models and in humans. The objective of this work was to evaluate the safety of FraxiPure™ at in vitro, in vivo and human levels. In addition, nutritional analyses revealed an extract high in carbohydrates, with minor levels of protein, dietary fiber, glucose and sucrose. IC(50) and IC(90) values of 1.447 and 2.530 mg/mL, respectively, after 72 h incubation were calculated using the MTT assay. FraxiPure™ conferred a magnitude of protection of 69.2% against the formation of micronuclei in irradiated human lymphocytes as determined by the micronucleus assay. An LD(50) of greater than 2500 mg/kg was concluded following an acute oral toxicity study in Sprague-Dawley rats. A human safety evaluation in a double-blind, placebo-controlled parallel study of 100 healthy volunteers revealed no significant differences between daily consumption of 1000 mg of FraxiPure™ for 90 days and placebo (maltodextrin) for any of the biochemical or hematological parameters studied. Numbers of adverse events were similar in both groups, and were deemed mild to moderate. These results demonstrate, for the first time, the safety and tolerability of FraxiPure™ for consumption in healthy subjects.