2.2. Study Design and Conduct
impaired fasting glucose
EVENTS, MAY
This study followed a double-blind, randomised, placebo-controlled design with three parallel arms (The investigators completed a subject screening log to document each individual screened for this study regardless of enrolment. This screening log also aimed at avoiding selection bias. Each individual was assigned to one of the three test products in randomised order. Individuals were supposed to appear for four visits in total during the study.Visit 0 (screening visit) and the start of the first intervention scheduled for visit 1 (intervention 1) were supposed to take place within ca. 2 weeks to provide actual lab parameters (e.g., impaired fasting glucose). The subsequent visits, V2 and V3, followed visit 1 after 6 weeks and 12 weeks, respectively.Study participants were supposed to appear after a 12 h overnight fasting period at all visits except V2. They were provided with a diary at V0, were advised to keep it until the end of the study and were asked to fill in the diary every day with regards to product consumption, concomitant medication and events with potential significance for the study. They were required to bring the diary back to the study site at every visit for inspection.This monocentre trial was conducted at CRC Clinical Research Center Kiel/Germany between June 2021 (first patient, first visit) and May 2022 (last patient, last visit).