Evaluation of the short term efficacy and tolerability of a combined nutraceutical with lipid-lowering properties: a randomized clinical trial

Abstract

This is a double-blind, placebo-controlled clinical trial on a combined nutraceutical non containing statin-like substances in 40 patients affected by primary polygenic hypercholesterolemia. After 4 weeks of ATP III life-style improvement, patients were randomized to assume a combined nutraceutical or placebo 1 pill/day for 8 weeks. The tested nutraceutical contained octacosanols, tocotrienols and polymethoxylated flavones (offered by Ca.Di.Group Srl, Rome, Italy). When comparing the combined nutraceutical effect with the one of placebo, we observed that the combined nutraceutical assumption was associated with a significantly higher decrease in total cholesterol (p < 0.001), LDL-cholesterol (p < 0.001), triglycerides (p < 0.001) and non HDL-cholesterol (p < 0.001) than the control group. In the short term, the tested combined nutraceutical is well-tolerated and efficacious in reducing plasma lipid levels in subjects affected by primary polygenic hypercholesterolemia.