2.1. Study Design and Participants
flat serrated, polyp, adenomatous polyps, cancer, adenomatous polyp, blood coagulation, Status ≤, colorectal tract, adenomas
HYPERPLASTIC POLYPS, CANCER, ADENOMATOUS POLYP, ADENOMATOUS POLYPS
A randomized, double-blind, placebo-controlled, phase II presurgical trial in patients with adenomatous polyps of the colon was conducted (MiRACol trial). Participants received either anthocyanin plus curcumin or a placebo for 4–6 weeks before undergoing polypectomy. To be eligible for the trial, patients had to be between 18 and 85 years old, have one or more adenomatous polyp in the colorectal tract with a diameter of at least 1 cm, and have an ECOG Performance Status ≤ 1. Patients with hyperplastic polyps, flat serrated adenomas, and cancer diagnosis were excluded from the study, as were those who had taken experimental medications, bilberry-based dietary supplements, or curcumin in the 15 days leading up to enrollment.The duration of the experimental treatment was suited to current standard clinical practice. Polyps larger than 1 cm in diameter are typically removed in a subsequent colonoscopy, following the availability of blood coagulation test results, as a safety precaution. Additionally, the 4-week interval between polyp detection and polypectomy falls within the common waiting period observed in numerous national health system facilities.Participants were recruited from the Department of Gastroenterology at Galliera Hospital in Genoa, Italy, between March 2014 and December 2017. The study registered as NCT01948661, was conducted under the approval of the Liguria Region Ethical Committee and in accordance with the Declaration of Helsinki. All patients provided written informed consent before participating in the trial.