3.2.3. Procedures
EVENTS, RECRUITMENT
No problems were associated with randomization and blinding by an independent researcher. Nor were any problems found with regard to blood collection or anthropometric measures.Regarding the self-assessment questionnaires, the content of the study-specific initial questionnaire and monitoring questionnaire appear reliable enough to gain all necessary information on potential confounders. However, additional questions were provided regarding any significant life events or changes that the participant believed influenced their mood or stress level. The self-assessment questionnaire collection had a strong influence on ensuring data completeness. The questionnaires were initially distributed in paper and electronic (via e-mail message) form. Unfortunately, several subjects (Stool collection was generally complete, apart from three participants, one of whom lacked samples for both the V1 and V2 time points, and two of them were lost to follow up. In addition, several participants had to receive additional reminders for up to three consecutive days. It was subsequently decided to only give the investigated preparation to subjects that had completed both blood and feces samples collection.Two study investigators were involved in the investigation period (recruitment, enrolment, data collection and entry). Finally, the principal study investigator was responsible for 34 study participants, and the auxiliary study investigator the other 14 subjects. It is planned to enlist further research staff to support the advertising and recruitment processes.No problems were revealed for the analysis.