title: Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial.
abstract: A dietary supplement (AP, Armolipid Plus) that combines red yeast rice extract, policosanol, berberine, folic acid, coenzyme Q10 and asthaxantine can have beneficial effects on cardiovascular disease (CVD) biomarkers. The aim of this study was to assess whether the intake of AP, in combination with dietary recommendations, reduces serum low density lipoprotein cholesterol (LDL-c) concentrations and other CVD biomarkers in patients with hypercholesterolemia. Eligible patients were recruited from the outpatient clinics of six Spanish hospitals Hospital Virgen del Rocío (Sevilla); Hospital San Jorge (Huesca); Hospital San Pedro (Logroño); Hospital Gregorio Marañón (Madrid), Hospital la Fe (Valencia) and Hospital Universitari Sant Joan (Reus) as recruiting and coordinating center. 102 participants (mean age ± SD; 50.91 ± 11.61; 32 men) with low CVD, with mild-to-moderately elevated LDL-c (between 3.35 mmol/L and 4.88 mmol/L) without hypolipemic therapy were randomized in a double-blind, parallel, controlled, multicenter trial commencing January 2012 and ending December 2012. Among the exclusion criteria were any concomitant chronic disease, triglycerides (TG) >3.97 mmol/L, pregnant or lactating, and history of CVD. At 12 weeks, compared to placebo, AP reduced LDL-c by -6.9%, apolipoprotein (Apo) B-100 by -6.6% and total cholesterol/HDL-c ratio by -5.5%, the ApoB/ApoA1 ratio by -8.6%, while increasing ApoA1 by +2.5% (p<0.05). AP consumption was associated with modest mean weight loss of -0.93 kg (95%CI: -1.74 to -0.12; P = 0.02) compared with control group while dietary composition remained unchanged in the AP group. The AP product was well tolerated. In conclusion, AP, combined with dietary recommendations, reduced LDL-c levels as well as total cholesterol/HDL-c and ApoB/ApoA1 ratios, while increasing Apo A1, all of which are improvements in CVD risk indicators. AP is a product which could benefit patients having moderate hyperlipidemia and excess body weight.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01562080.
authors.affiliation: Unitat de Recerca de Lipids i Arteriosclerosi, CIBERDEM, Servei de Medicina Interna, Hospital Universitari de San Joan, IISPV, Facultat de Medicina, Universitat Rovira i Virgili, Reus, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Solà
authors.affiliation: Unitat de Recerca de Lipids i Arteriosclerosi, CIBERDEM, Servei de Medicina Interna, Hospital Universitari de San Joan, IISPV, Facultat de Medicina, Universitat Rovira i Virgili, Reus, Spain.
authors.forename: Rosa-M
authors.initials: RM
authors.lastname: Valls
authors.affiliation: Unidad de Lípidos y Laboratorio de Bioquímica, Hospital Universitario San Jorge, Huesca, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Puzo
authors.affiliation: Departamento de Medicina Interna, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: José-Ramón
authors.initials: JR
authors.lastname: Calabuig
authors.affiliation: Unidad de Lípidos, Servicio de Medicina Interna, Hospital Universitario San Pedro, Logroño, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Brea
authors.affiliation: Unitat de Recerca de Lipids i Arteriosclerosi, CIBERDEM, Servei de Medicina Interna, Hospital Universitari de San Joan, IISPV, Facultat de Medicina, Universitat Rovira i Virgili, Reus, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Pedret
authors.affiliation: Centre Tecnològic de Nutrició i Salut, Reus, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Moriña
authors.affiliation: Unidad de Hipertensión y Lípidos, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Villar
authors.affiliation: Servicio de Medicina Interna, Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Millán
authors.affiliation: Medical Department, Rottapharm S.L., Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Anguera
mesh_terms: D000328:Adult; D001688:Biological Products / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects*; D002318:Cardiovascular Diseases; D004032:Diet; D019587:Dietary Supplements; D005260:Female; D005947:Glucose / Q000378:metabolism; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000378:metabolism*; D007328:Insulin / Q000378:metabolism; D050356:Lipid Metabolism / Q000187:drug effects*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D001688:Biological Products; D015415:Biomarkers; D007328:Insulin; D008055:Lipids; D005947:Glucose
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