Funding for this research was provided by:
Joint Programming Initiative A healthy diet for a healthy life
Received: 8 August 2019
Accepted: 11 October 2019
First Online: 9 December 2019
Ethics approval and consent to participate
: The Tuscany Regional Ethics Committee of the University Hospital of Careggi, Florence has reviewed and approved the study protocol (SPE, #12390). The study will be conducted in accordance with the Declaration of Helsinki and the Data Protection Act. Trial personnel will obtain informed consent from all participants prior to inclusion. All patients must agree to participate voluntarily and will be free to withdraw from the study at any time. Ethics Committee approval included the trial protocol, information sheet and consent form, questionnaires, interviews, any other written information that will be provided to the participants, and any advertisements that will be used during the study. The trial was registered at the clinical trial registration (ClinicalTrials.gov, NCT03416777, on 3 May 2018) in accordance with the International Committee of Medical Journal Editors (ICMJE) requirements. Given the nature of the study, post-trial provisions are not required.
: Results from this study will be presented in publications and meetings but will not contain any identifying information. Consent for publication as well as sample storage for future research will be obtained from participants in the study.
: The authors declare that they have no competing interests.