Objectives　We conducted two randomized double-blind placebo-controlled trials to evaluate the safety of long term and excess intake of the tablet containing hot water extract of Salacia chinensis.
Methods　The subjects were healthy or borderline diabetes with fasted blood glucose level of 100-125 mg/dL, and they were divided into the test group or the placebo group in each trial. One tablet of the test food contained more than 0.221 mg neokotalanol. In long term intake study, 42 subjects were given 3 tablets per day for 12 weeks. In excess intake study, 41 subjects were given 15 tablets per day for 4 weeks.
Results　There were no adverse effects in clinical parameters observed in both trials.
Conclusion　These results suggested the safety of long term and excess intake of the tablet containing Salacia chinensis extract.