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Table 1 Study events in five different visits

From: The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure

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

  1. a3 week-days, 1 weekend-day. First filling period after screening visit but before first treatment period. During treatment periods, filling on the 4th week of the treatment
  2. FMD, flow mediated dilatation
  3. NMD, nitrate mediated dilatation