2.2. Inclusion Criteria, Participants, Ethics
DISEASE, RECRUITMENT, CHOLESTEROLEMIA
The subjects were enrolled among high school and university students aged 18–22 years. To this end, we held 20 min meetings with students in each class, during a lesson, in the presence of their teacher, to explain the study design and invite the students to participate. Since this trial was part of a study on semen quality and environmental risk factors in healthy adolescents living in polluted areas in Italy [After filling in a short self-administered screening questionnaire for excluding subjects not suitable to the research, the potential candidates were invited to undergo a urologic visit, including a clinical examination and spermiogram analysis, by a specialist physician, in a Urology and Fertility Unit. At the same time, participants underwent a fasting blood sample for the analysis of some common parameters (glycemia, cholesterolemia, etc.), and measurement of height, weight, and abdominal circumference by two trained nutritionists, using standardized instruments and methods [Upon their recruitment, all subjects filled in three questionnaires on their dietary habits and physical activity, using standardized questionnaires, under the control of a nutritionist. The questionnaires were administered three times: at the enrolment (t0), 4 months (t4), and 8 months after baseline evaluation (t8).All the participants were also interviewed on their medical history and provided a blood sample for the analysis of common parameters, as indicators of possible unrecognized disease: fast glycaemia, protein levels, blood cell counts and characterization, etc. Only those with absence of severe disease and normal blood parameters were included in the study.The study was conducted according to the guidelines of the Declaration of Helsinki. The protocol was approved by the Ethic Committees of Southern Campania (29 November 2017), the coordinating center of the FASt study, and by that of Brescia Province (13 March 2018), and accepted by the Italian National Institute of Health (20 December 2017).All the participants signed an informed consent form. Participation was on a voluntary basis and participants were free to withdraw from the project and revoke their consent to use their data at any time. All the data analyses were carried out in an aggregate and anonymous way. The data were collected and analyzed in accordance with Legislative Decree No. 196 of 30/6/2003 “Personal Data Protection Code” and the new European Data Protection Regulation 2016/679 (EU).The study started with the recruitment and first evaluation of the participants between April 2018 and January 2019 (t0) and ended in November 2019.