2.2. Outcome Measures
SECONDARY, RECRUITMENT
The primary outcome measure was the rate of eligibility per month. The secondary outcome measures were rates of recruitment, enrolment per month, retention, and adherence, as well as capacity and resources to conduct all trial processes, or data completeness.The rate of eligibility was assessed as the number of subjects eligible per month. Furthermore, an eligibility ratio was constructed to show the proportion of subjects who met the eligibility criteria to all those who were assessed for eligibility.The recruitment rate was determined by the number of participants recruited for the first assessment meeting per month. The enrolment rate referred to the eligible participants who successfully enrolled in the study per month. The retention ratio was the proportion of subjects who completed the 60-day intervention period and were finally assessed to enrolled participants. Adherence was assessed as compliance with all study procedures: completing self-rated psychometric and dietary questionnaires on time, and a monitoring questionnaire every 15-days, the self-collection of stool samples, and the following of the inclusion and exclusion criteria, which was dependent on participants’ will. Later in the study, participants were also asked to confirm their regular intake of supplement capsules in the study’s daily medication chart.Regarding feasibility, the capacity of clinicians to recruit and assess participants, the willingness of participants to be randomized, or the resources within the health care system and clinical setting to perform every trial procedure were considered [The tertiary outcome measures included various demographic, diet- and health-related data, and selected clinical and laboratory parameters. Explanations for these outcome measures are provided in the protocol [