Abstract
Objectives To evaluate the effects of licorice flavonoid oil concentrate solution containing 3% glabridin(LFO(3%))on the abdominal total/subcutaneous/visceral fat area, body fat mass, body weight, body mass index(BMI), waist╱hip circumference, and safety parameters in Japanese healthy subjects. Methods In this randomized, double-blind, placebo-controlled trial, participants of both sexes aged 20≤to<65 years with a BMI of≤23.0 to<30.0, were assigned to two groups and received a daily dose of placebo or 300 mg LFO(3%)(9 mg glabridin)for 12 weeks, respectively. Body fat mass was measured by dual-energy X-ray absorptiometry and abdominal total╱subcutaneous╱visceral fat area by computed tomography scan at baseline, 8 and 12 weeks after LFO(3%)ingestion. Body weight, BMI, hematologic╱biochemical analyses, and urinalysis were performed at the same time as the scans, and 4 weeks after ingestion and 4 weeks after cessation of ingestion. Adverse events╱reactions were evaluated on the basis of participantsʼ diaries. Results Of 200 participants(100 per group), 172 were included for the efficacy analysis(placebo n=89, male=39; LFO(3%)n=83, male=38). Ingestion of 300 mg LFO(3%)significantly reduced abdominal total╱visceral fat area, waist circumference, and significantly suppressed the increase in abdominal subcutaneous fat area and body fat mass compared with the placebo group. In addition, 300 mg LFO(3%)significantly decreased fasting blood glucose compared with the placebo group. No clinically relevant adverse events related to the ingestion of 300 mg LFO(3%)were observed. Conclusion LFO(3%)may be useful for the prevention of fat accumulation and hyperglycemia. (UMIN000038570)