Effect of puerarin supplementation on cardiovascular disease risk factors: A randomized, double-blind, placebo-controlled, 2-way crossover trial

Background: Cell culture and animal studies suggest puerarin could prevent cardiovascular disease (CVD). However, trials in human are scare, not primarily designed for prevention, and inadequately powered. We assessed the effect of puerarin supplementation on CVD risk factors in men using a crossover trial.Methods: In total, 217 Chinese men aged 18-50 years without a history of CVD were recruited. They were randomized to take a puerarin supplement (90.2 mg daily) or a placebo, followed by a 4-week wash-out period, and then crossed over to the other intervention. An intention-to-treat analysis was used. Differences in primary outcomes (lipid profile such as low-density lipoprotein (LDL) cholesterol) and secondary outcomes (other CVD risk factors such as blood pressure and fasting glucose, and some potential mediating pathways such as testos-terone) between supplementation and placebo within participants were compared using a paired t-test, or a crossover (CROS)-based analysis where a period effect existed. Results: Lipid profile was similar after the puerarin supplementation or placebo (e.g., mean difference in LDL cholesterol:-0.02 mmol/L, 95% confidence interval (CI)-0.09 to-0.06). Conversely, fasting glucose was reduced after the puerarin supplementation (-0.13 mmol/L, 95% CI-0.25 to-0.008). There were no differ-ences in blood pressure, testosterone, high-sensitive C-reactive protein, prothrombin time, liver or renal function.Conclusion: In young-to-middle-aged Chinese men, short-term puerarin supplementation did not improve the primary outcome of lipid profile, but an exploratory analysis suggested that puerarin could be beneficial for one of the secondary outcomes, i.e., fasting glucose.