Study event | Screening visit | Visits 1 and 3 (first visit of both periods) | Visits 2 and 4 (last visit of both periods) |
---|---|---|---|
Informed consent | x | ||
Baseline characteristics | x | ||
Blood pressure, heart rate | x | x | x |
Electrocardiogram | x | ||
Physical examination | x | ||
Laboratory determinations: | |||
Haematology | x | x | |
Clinical chemistry | x | x | |
Diet diary filling for 4 daysa | x | ||
Start of study product intake | x | ||
Study product intake | x | x | |
Return of diaries | x | ||
FMD twice, NMD once | x | x | |
Collecting of adverse events | x | x | x |
Concomitant medications | x | x | x |
Blood sampling for epicatechin and biomarker analyses prior to the morning dose and 2 h thereafter | x | x |