2.3. Participants and Study Design
The present study has been registered at ClinicalTrials.gov (identifier: NCT04876261). The protocol was approved by the Ethics Commission of State Medical Association of Rheinland-Pfalz (Mainz, Germany). The clinical study was conducted as set out in the Declaration of Helsinki by daacro GmbH & CO at the Science Park Trier (Trier, Germany). Written informed consent was obtained from all participants.Volunteers meeting the inclusion and exclusion criteria (The study design was randomized, single-blind, single-dose, three-way cross-over. Twelve healthy male volunteers ingested, after an overnight fast of at least 10 hr, different concentrations of olive phenolics through the respective IP administered with 200 mL of water. Water intake was allowed ad libitum, and a controlled basal diet was administered 2 h after intake.One volunteer dropped out of the study after the completion of the first intervention period (IP-2) and was subsequently replaced. Considering the data from this subject the sample size for the IP-2 group is 13.