title: A Healthy Balance of Plasma Cholesterol by a Novel Annurca Apple-Based Nutraceutical Formulation: Results of a Randomized Trial.
abstract: Cardiovascular diseases are nowadays preferential targets of preventive medicine through a straightforward therapy on lipid profile. However, statins, the first-line lipid-lowering drug therapy, specifically act on low-density lipoprotein cholesterol (LDL-C), having a modest effect on plasma high-density lipoprotein cholesterol (HDL-C) concentrations. Today, a number of novel HDL-targeted therapies are emerging, along with unexpected side effects. Thus, novel and possibly safe substances, able to correct impaired lipid profile in humans, are still in great demand. Herein, based on encouraging clinical data, we formulated a nutraceutical product (AppleMetS®, AMS), based on a polyphenolic extract from Annurca apple, and demonstrated that two capsules a day of AMS, after one month, have a LDL-C lowering outcome equivalent to 40 mg of simvastatin or 10 mg of atorvastatin. Nevertheless, different from statin-based therapy, AMS exerted a notable effect on HDL (+49.2%). Based on the trial results, we can assert that AMS formulation could effectively integrate the current therapeutic arsenal to correct impaired lipid profile in humans. Specifically, AMS may be considered a complementary and/or alternative safe substance suitable for the treatment of mildly hypercholesterolemic subjects who do not present occurrence of atheromatous plaques yet.
authors.affiliation: 1 Department of Pharmacy, University of Naples Federico II , Naples, Italy .
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Tenore
authors.affiliation: 2 Department of Internal Medicine, Hospital Cardarelli , Naples, Italy .
authors.forename: Domenico
authors.initials: D
authors.lastname: Caruso
authors.affiliation: 3 Coop. Samnium Medica , Benevento, Italy .
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Buonomo
authors.affiliation: 2 Department of Internal Medicine, Hospital Cardarelli , Naples, Italy .
authors.forename: Maria
authors.initials: M
authors.lastname: D'Avino
authors.affiliation: 4 Department of Pharmaceutical and Biomedical Sciences, University of Salerno , Salerno, Italy .
authors.forename: Pietro
authors.initials: P
authors.lastname: Campiglia
authors.affiliation: 1 Department of Pharmacy, University of Naples Federico II , Naples, Italy .
authors.forename: Luciana
authors.initials: L
authors.lastname: Marinelli
authors.affiliation: 1 Department of Pharmacy, University of Naples Federico II , Naples, Italy .
authors.forename: Ettore
authors.initials: E
authors.lastname: Novellino
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000097:blood / Q000188:drug therapy*; D002784:Cholesterol / Q000097:blood*; D019587:Dietary Supplements / Q000032:analysis*; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents; D008297:Male; D027845:Malus / Q000737:chemistry*; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000737:chemistry / Q000302:isolation & purification; D055815:Young Adult
chemical_list: D000960:Hypolipidemic Agents; D010936:Plant Extracts; D002784:Cholesterol
keywords: Annurca apple; nutraceutical; plasma cholesterol; polyphenols; randomized controlled clinical trial