The uric acid-lowering effect and safety of a fermented barley extract P (FBEP) prepared from barley-shochu distillery by-products were investigated in a randomized, placebo-controlled, parallel-group, double-blinded study. A total of 111 subjects with serum uric acid levels of 6.0-7.9 mg/dl were provided with either a drink containing 2 g/d of FBEP (test group) or a placebo drink. After 12 weeks, the serum uric acid levels changed by -0.21+/-0.56 mg/dl in the test group, showing a significant decrease in comparison to those of the placebo group (+0.02+/-0.54 mg/dl). Additionally, the uric acid clearance in the test group showed a tendency to increase after 12 weeks more than in the placebo group (p=0.054). No abnormalities in the physical and clinical tests were observed, and no adverse diagnostic findings were attributed to the intake of the test meal. These results demonstrated the benefits and safety of the FBEP treatment to subjects with slightly high serum uric acid or mild hyperuricemia.