2.2. Clinical Trial
GROUP B, RECRUITMENT, BLIND
The essay consisted of a randomised, single-blind, single-centre, parallel pilot safety study with healthy individuals. The clinical trial was conducted at the Maimónides Biomedical Research Institute (IMIBIC, Cordoba, Spain) and the Reina Sofía University Hospital (Cordoba, Spain), where the screening, selection, and recruitment of the volunteers who participated in the study were carried out. The study was conducted following the Declaration of Helsinki, and the intervention protocol was approved by the Human Investigation Review Committee of the Reina Sofia University Hospital (number 2519-N-20) according to Institutional and Good Clinical Practice guidelines. All formulations were dispensed by a technician, with the investigator and subjects blinded to the identity of the intervention. Compliance was assessed from the weight of residual powder. All staff members involved in measuring any outcome were blind to the assignments. Healthy subjects were enrolled via public advertising. A total of 73 initial volunteers was contacted among those willing to enter the study and screened, involving a standardised and comprehensive medical history, physical examination, and clinical chemistry analysis before enrolment. Internists conducted the screening, selection, and recruitment processes between July and September 2021. Participants enrolled in the study were randomly assigned (1:1) by a computerised random sequence generator to orally ingest LPG1 capsules (one per day, Group A; here-forward Group A—LPG1) or placebo capsules (one per day, Group B; here-forward Group B—placebo). Capsules were swallowed during breakfast for 30 consecutive days. The participants had no standardised diet; however, ingesting antibiotics, antihistamines, or probiotics (supplements or certain foods such as yogurts, any type of olives, or fermented vegetables) during the study was strictly prohibited. 