2.1. Study Design and Participants
ICH
POLYGENIC HYPERCHOLESTEROLEMIA, CHOLESTEROLEMIA
DESCO (Diet and plant sterols in the control of cholesterolemia) is a randomized, double-blind, placebo-controlled, two-way crossover clinical study that involved a sample of Italian free-living individuals with polygenic hypercholesterolemia, who were recruited from the Lipid Clinic of the S. Orsola Malpighi University Hospital, Bologna, Italy.Participants were required to be aged between 20 and 65 years, with moderately high levels of plasma cholesterol (total cholesterol (TC) > 200 mg/dL and <240 mg/dL and/or LDL-C > 130 mg/dL and <160 mg/dL) and an estimated 10-year cardiovascular risk <5% according to the SCORE (Systematic COronary Risk Evaluation) risk charts for countries at moderate risk [Enrolled subjects were asked to follow their habitual diet for 2 weeks before randomization and during the study, and to avoid consumption of other supplements or functional foods containing substances with effects on cholesterol (red yeast rice, berberine, beta-glucan, etc.). At baseline and on the day of crossover, the study participants received adequate doses of either phytosterols or placebo to complete one of two 3-week treatment sequences. The crossover to the second treatment was preceded by a 2-week washout period.Before and after each treatment sequence, participants were evaluated for clinical status, and via the execution of a physical examination and laboratory and hemodynamic analyses.The study timeline is described in detail in The study fully complied with the ethical guidelines of the Declaration of Helsinki and with The International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (GCP). The study protocol was approved by the Ethical Committee of the University of Bologna and registered in 