Nutraceutical Combinations in Hypercholesterolemia: Evidence from Randomized, Placebo-Controlled Clinical Trials

Anna Rita Bonfigli,Olga Protic,Roberto Antonicelli

doi:10.3390/nu13093128

Abstract

There is an increasing number of nutraceutical combinations (NCs) on the market for hypercholesterolemia, although clinical trials to verify their safety and efficacy are scarce. We selected fourteen randomized, placebo-controlled clinical trials (RCTs) on different lipid-lowering NCs in hypercholesterolemic subjects. We described each compound′s mechanism of action and efficacy in the mixtures and summarized the clinical trials settings and NCs safety and efficacy results. Almost all NCs resulted efficient against hypercholesterolemia; only one reported no changes. Interestingly, red yeast rice (RYR) was present in eleven mixtures. It is not clear whether the lipid-lowering efficacy of these combinations derives mainly from the RYR component monacolin K “natural statin” single effect. Up to now, few RCTs have verified the efficacy of every single compound vs. NCs to evaluate possible additive or synergistic effects, probably due to the complexity and the high resources request. In conclusion, to manage the arising nutraceutical tide against hypercholesterolemia, it could be helpful to increase the number and robustness of clinical studies to verify the efficacy and safety of the new NCs.

Highlights

Cardiovascular diseases (CVDs) remain the leading cause of death worldwide [1].Atherosclerotic plaque formation is an inflammatory process in the endothelial vessel wall associated with retained low-density lipoprotein (LDL) [2,3]
The results demonstrated that doses from 1200 mg/day to 4800 mg/day of red yeast rice (RYR) (4.8 mg to 24 mg of Monacolin K) reduced LDL-cholesterol on average by 1.02 mmol/L compared with placebo after 2–24 months of its use
The results showed that Coenzyme Q10 (CoQ10) significantly decreased total-cholesterol (standard mean differences (SMD): −1.07, 95% confidence interval (CI): −1.94, −0.21, p = 0.01)

Summary

Introduction

Cardiovascular diseases (CVDs) remain the leading cause of death worldwide [1]. Atherosclerotic plaque formation is an inflammatory process in the endothelial vessel wall associated with retained low-density lipoprotein (LDL) [2,3]. In a meta-analysis with five clinical trial studies, investigated the effects of curcumin on blood lipid levels and showed no significant changes [86] Another clinical study showed that a curcumin extract capsule of 630 mg taken thrice daily for 12 weeks reduces LDL cholesterol (from 121 ± 37 to 107 ± 25 mg/dL, p < 0.05) [87]. After 12 weeks, the mean ± SEM changes from baseline in total cholesterol were −11.3 ± 0.9% (p = 0.01) and for LDL cholesterol −16.4 ± 1.1% (p = 0.01), respectively, in the tea extract group [100] Another trial investigated the effects of a green tea supplement containing 1315 mg of catechins on serum lipids in postmenopausal women.

Study Design in the Selected Clinical Trials

Findings

Discussion