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

► Consumption of 1000mg of FraxiPure™ for 90days was well tolerated by 50 healthy volunteers in a placebo controlled RCT. ► No significant changes in biochemical or hematological parameters were observed between the FraxiPure™ and control groups. ► An acute toxicity study revealed an LD50 of >2500mg/kg for FraxiPure™ in Sprague–Dawley rats. ► FraxiPure™ protected human lymphocytes from the effects of irradiation as determined by the micronucleus assay. ► An IC50 value of 1.447mg/mL was calculated in Vero cell lines using the MTT assay. 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. IC50 and IC90 values of 1.447 and 2.530mg/mL, respectively, after 72h 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 LD50 of greater than 2500mg/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 1000mg of FraxiPure™ for 90days 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.