{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T20:28:50Z","timestamp":1782160130509,"version":"3.54.5"},"reference-count":47,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2017,7,12]],"date-time":"2017-07-12T00:00:00Z","timestamp":1499817600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Increased non high-density lipoprotein (HDL)\/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels \u2265160 mg\/dL. 39 subjects (age 52 \u00b1 11 years; 54% females; body mass index 27 \u00b1 4 kg\/m2) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical\/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin\/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (\u221230 \u00b1 20 mg\/dL; p = 0.012), LDL cholesterol (\u221231 \u00b1 18 mg\/dL, p = 0.011) and apolipoprotein (Apo) B (\u221214 \u00b1 12 mg\/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.<\/jats:p>","DOI":"10.3390\/ijms18071498","type":"journal-article","created":{"date-parts":[[2017,7,12]],"date-time":"2017-07-12T10:36:12Z","timestamp":1499855772000},"page":"1498","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":53,"title":["Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study"],"prefix":"10.3390","volume":"18","author":[{"given":"Valentina","family":"Spigoni","sequence":"first","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2350-1222","authenticated-orcid":false,"given":"Raffaella","family":"Aldigeri","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Antonini","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Micheli","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Fantuzzi","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Fratter","sequence":"additional","affiliation":[{"name":"Nutraceutical Research and Innovation Technology, Labomar Research, Istrana, 31036 Treviso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Pellizzato","sequence":"additional","affiliation":[{"name":"Nutraceutical Formulation, Labomar Research, Istrana, 31036 Treviso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Derlindati","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Zavaroni","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"},{"name":"Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Bonadonna","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"},{"name":"Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8666-4849","authenticated-orcid":false,"given":"Alessandra","family":"Dei Cas","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy"},{"name":"Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2017,7,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1016\/S0140-6736(04)17018-9","article-title":"Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): Case-control study","volume":"364","author":"Yusuf","year":"2004","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"112","DOI":"10.1016\/S0140-6736(10)60834-3","article-title":"Risk factors for ischaemic and intracerebral haemorrhagic stroke in 22 countries (the INTERSTROKE study): A case-control study","volume":"376","author":"Xavier","year":"2010","journal-title":"Lancet"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1267","DOI":"10.1016\/S0140-6736(05)67394-1","article-title":"Cholesterol Treatment Trialists\u2019 (CTT) Collaborators. 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