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

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 < 0.01). AMD may be regarded as a novel complementary and/or alternative safe remedy with clinical relevance in the primary cardiovascular disease prevention.