A nutraceutical formulation based on Annurca apple polyphenolic extract is effective on intestinal cholesterol absorption: A randomised, placebo-controlled, crossover study

• Published in: PharmaNutrition 2018-09, Vol.6 (3), p.85-94
• Main Authors: Tenore, Gian Carlo, Carotenuto, Alfonso, Caruso, Domenico, Buonomo, Giuseppe, D’Avino, Maria, Brancaccio, Diego, Ciampaglia, Roberto, Maisto, Maria, Schisano, Connie, Novellino, Ettore
• Format: Article
• Language: English
• Subjects: Annurca apple; Dyslipidemia; Fecal cholesterol; Nutraceutical
• ISSN: 2213-4344; 2213-4344
• DOI: 10.1016/j.phanu.2018.05.001

[Display omitted] •AMD is a nutraceutical product formulated by using Annurca polyphenolic extract.•AMD was able to decrease the intestinal micellar solubility of cholesterol in vitro.•NMR data indicated dimeric procyanidins as main responsible for AMD in vitro effects.•AMD was administered to healthy subjects.•AMD increased fecal cholesterol excretion (+ 35%) respect to placebo. Complementary and/or alternative safe substances, able to correct impaired lipid profile in humans, are still in great demand. The objective of the present work was to evaluate the in vitro and clinical effects of a novel nutraceutical product (AMD), formulated with Annurca apple polyphenolic extracts, on the intestinal cholesterol micellar solubility. AMD was able to decrease in vitro cholesterol micellar solubility by about 85.7%, while Nuclear Magnetic Resonance experiments allowed to hypothesize dimeric procyanidins as potential responsible compounds for this effect. Then, a randomised, double blind, single centre, placebo-controlled, crossover study, was designed to evaluate the effect of AMD on the fecal cholesterol excretion. Clinical data indicated that fecal cholesterol excretion was significantly increased (about +35%) in the AMD period compared with placebo period (P