Effect of the phaleria macrocarpa extract on proprotein convertase subtilisin/kexin type-9 levels in healthy population

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background Phaleria macrocarpa fruit extract was reported in decreasing the low-density lipoprotein cholesterol (LDL-C) level as well as increasing the high-density lipoprotein cholesterol (HDL-C) level in animal studies. Currently, proprotein convertase subtilisin/kexin type 9 (PCSK-9) has become a novel target for lipid modification, as it enhances the degradation of LDL-C receptors in hepatocytes. However, the effect of Phaleria macrocarpa fruit extract on PCSK-9 levels in humans remains unclear. Purpose To evaluate the effect of Phaleria macrocarpa fruit extract on PCSK9 levels in a healthy population. Method This is a randomised, double-blind, placebo-controlled clinical trial. A total of 40 healthy participants were included and randomised into two treatment groups, consisting of 2 x 500 mg of Phaleria macrocarpa extract (n = 20) and placebo (n = 20). Participants were followed for eight weeks. Clinical and laboratory parameters, including PCSK9 levels, were measured on the baseline and the eighth week. Intention-to-treat analysis was performed with a p-value of <0.05 was considered statistically significant. Results There was no loss-to-follow-up in each treatment group and the analysis was conducted according to the original group. Compared to the placebo group, the baseline features in the Phaleria macrocarpa extract group were not significantly different, except for the PCSK9 levels (21.1 ± 2.5 ng/mL and 23.9 ± 1.0 ng/mL respectively, p=0.000). After eight weeks of administration of the treatment, Phaleria macrocarpa extract failed to show any remarkable effect on the PCSK9 concentration in humans, as the PCSK9 level was not significantly different at the final evaluation compared to the baseline (23.7 ± 1.3 ng/mL and 23.9 ± 1.0 ng/mL respectively, p=0.455).±. Conclusion Phaleria macrocarpa fruit extract did not affect PCSK9 levels in a healthy population after eight weeks of administration.