| Summary: | Sergio D’Addato,1 Luciana Scandiani,2 Giuliana Mombelli,3 Francesca Focanti,4 Federica Pelacchi,4 Enrica Salvatori,4 Giorgio Di Loreto,4 Alessandro Comandini,4 Pamela Maffioli,5 Giuseppe Derosa51Medical and Surgical Science Department, S. Orsola Malpighi Hospital, University of Bologna, Bologna, Italy; 2Department of Internal Medicine, Azienda Ospedaliera-Polo Universitario Ospedale Luigi Sacco, Milan, Italy; 3Dyslipidemia Center, Hospital Niguarda Ca’ Granda, Milan, Italy; 4ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy; 5Center of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, ItalyPurpose: To evaluate the ability of the new food supplement, Body Lipid (BL), containing red yeast rice, berberine, coenzyme Q10 and hydroxytyrosol, to lower the LDL-C in patients with mild-to-moderate hypercholesterolemia and to assess the overall safety profile of the product.Methods: In this multicenter, randomized, double-blind, placebo and active comparator (the marketed Armolipid Plus® [AM]) controlled study, 158 hypercholesterolemic patients were randomized following a 4-week dietary run-in period. After 4 weeks of treatment with a daily oral dose of the new food supplement BL, AM or placebo, plus diet, the main outcome was the decrease of LDL-C, total cholesterol (TC), and triglyceride levels.Findings: The absolute changes of LDL-C and TC levels from baseline, at week 4 were: −39.1 mg/dL ±17.76 and −45.9 mg/dL ±21.54, respectively in the BL group; 5.7 mg/dL ±14.98 and 2.4 mg/dL ±18.43, respectively in the placebo group. Results were statistically significant. In terms of mean percentage, BL was shown to be more effective in lowering LDL-C levels as compared to placebo and the active comparator (AM), with a reduction of −26.3%, +4.2%, −18.3%, respectively. Five adverse events (AEs) were reported by five patients after the initiation of the study treatment: two in the BL group (influence and insomnia), two in the AM group (ear pain and rash), and one in the placebo group (back pain). All AEs were mild in intensity, except for back pain (severe). The case of insomnia in the BL group and the case of rash in the AM group were judged as treatment related. The safety review of the laboratory (blood and urine) analyses, vital signs and physical findings did not show any clinical effect of the study products on any of the parameters.Implications: BL showed a good efficacy and safety profile and, for this reason, it can be considered an alternative to pharmacological treatment, for patients with mild-to-moderate hypercholesterolemia. Keywords: lipid profile, red yeast rice, berberine, coenzyme Q10, hydroxytyrosol
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