薬理と治療

Abstract

Objective　This study examined the effect of lemon-derived monoglucosyl hesperidin（LGH）on reducing serum uric acid（SUA）in healthy Japanese adults with high SUA levels. Methods　We conducted a randomized, placebo-controlled, double-blind, parallel-group study from December 18, 2018 to October 25, 2019 in 166 healthy Japanese adults aged 20-75 years with high SUA levels（6.1-7.9 mg/dL）. The subjects were randomly assigned to LGH or placebo group（n＝83╱group）using a computerized random number generator. Subjects in each group took either 4 LGH tablets or placebo tablets once daily for 12 weeks. The primary outcome was SUA level; secondary outcomes included urinary uric acid level, urinary creatinine level, urinary uric acid╱creatinine ratio, and subjective symptoms. Results　The final per-protocol set（PPS）efficacy analysis included 78 subjects（68 men and 10 women, 49.1±12.7 years）in the LGH group and 77 subjects（69 men and 8 women, 51.3 ±11.1 years）in the placebo group. In the PPS analysis, a significant decrease in SUA level was confirmed in the LGH group at 12 weeks after study initiation. No adverse events were observed. Conclusions　Our results demonstrate that continuous LGH intake for 12 weeks is effective in lowering the serum uric acid levels in Japanese adults with high SUA levels（6.1-7.9 mg╱dL）. Trial registration　UMIN-CTR: UMIN000035298 Foundation　SAPPORO HOLDINGS LTD.