2.1. Subjects and Ethical Considerations
SECONDARY, INSULIN RESISTANCE, RECRUITMENT
For the present trial, the primary outcome established was a reduction in body weight. Changes in blood lipids, insulin resistance and body fat percentages were established as secondary outcomes. Based on this, the inclusion criteria for the recruitment of volunteers were as follows: men and women between 18 and 60 years old, with a body mass index (BMI) of 25–35 kg/mApproval of the study was obtained from the Clinical Research Ethics Committee of Hospital Universitario Puerta de Hierro, Majadahonda in Madrid (Spain), and the Bioethics Committee of Consejo Superior de Investigaciones Científicas (CSIC). It also followed the guidelines laid down in the Declaration of Helsinki for experiments in humans. Written informed consent was obtained from all volunteers before the start of the study. The study was registered in ClinicalTrials (NCT05009615). 