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Safety Evaluation of Red Koji (red yeast rice) in Healthy Adult Volunteers Tomohiro HISANO, Koichi ASANO Central R&D Laboratory, KOBAYASHI Pharmaceutical Co., Ltd. Objective: Red Koji (red yeast rice), which has been shown to reduce serum LDL cholesterol levels, has potential as a material in the development of functional food. The efficacy and safety of fermented food generally depends on the production method (including bacterial strains, bacterial species, and incubation conditions); therefore, it is important to confirm the safety of materials individually. Design: We conducted a randomized, double-blind placebo-controlled clinical study to investigate the safety of red yeast rice (3P-D21) produced by the solid state fermentation of the Monascus pilosus KP1148 strain. Fifty-one healthy volunteers with normal cholesterol levels and borderline and mild hypercholesterolemia were divided into 2 groups: one group given the test food [500 mg of red yeast rice (2.0 mg as monascin)] for 4 weeks, and the other a placebo food. Safety was evaluated using blood and urine analyses, a physical examination, and medical interviews. Results: No adverse events were associated with the intake of the test food in any examinations. Conclusion: These results show that food containing 500 mg of red yeast rice (2.0 mg as monascin) is safe, and red yeast rice produced by the solid state fermentation of the Monascus pilosus KP1148 strain has potential as a material in the development