title: Efficacy and tolerability of a combined lipid-lowering nutraceutical on cholesterolemia, hs-CRP level and endothelial function in moderately hypercholesterolemic subjects.
abstract: Our aim was to test, by a double-blind, placebo-controlled randomized clinical trial, whether a short-term treatment with a combined lipid-lowering nutraceutical could improve endothelial function in a cohort of moderately hypercholesterolemic subjects. Thus, 80 healthy, moderately hypercholesterolemic subjects were consecutively enrolled and, after 4 weeks of stabilization diet, they were randomized to either the tested lipid-lowering nutraceutical or placebo for 8 weeks. At the beginning and end of treatment a complete lipid pattern, safety parameters, hs-CRP and endothelial function were measured. When compared to placebo, during nutraceutical treatment patients experienced a more favorable percentage change in total cholesterol (TC vs baseline: -17.9%; TC vs placebo: -5.6%), LDL-cholesterol (LDL-C vs baseline: -23.3%; LDL-C vs placebo: -2.8%), hs-CRP (hs-CRP vs baseline: -2.4%; hs-CRP vs placebo: -1.5%), and endothelial function (pulse volume displacement vs baseline: +17%; pulse volume displacement vs placebo treatment: -3.3%). No significant difference was observed in respect to effects on triglycerides, HDL-cholesterol and safety parameters. On the basis of our data, the tested lipid-lowering nutraceutical seems to significantly improve endothelial function in moderately hypercholesterolemic subjects. These results have to be confirmed on larger patient samples and over longer periods.
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
authors.forename: A F
authors.initials: AF
authors.lastname: Cicero
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Colletti
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Rosticci
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Grandi
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Borghi
mesh_terms: D000328:Adult; D002097:C-Reactive Protein / Q000032:analysis*; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004730:Endothelium, Vascular / Q000502:physiology*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D000960:Hypolipidemic Agents; D002097:C-Reactive Protein