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Table 3 Detailed study procedures in the bioavailability study (30 mL single dose)

From: The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils

Visit (V) number

IP, Intervention period

Enrolment

V2

(IP 1)

V4

(IP 2)

V6

(IP 3)

Time Point, week

Up to -12

2

7

12

Informed consent form

X

   

Randomization & allocation

X

   

Treatment distribution

 

X

X

X

Blood collection at baseline (0 h) and at 30 min, 45 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 24 h after oils ingestion

 

X

X

X

Urine collection at baseline (0 h) and at

0–2 h, 2–4 h, 4–6 h, 6–8 h, 8–10 h, 10–12 h, 12–24 h, after oils ingestion

 

X

X

X

Assessments

Primary outcomes

  Urinary tyrosol and hydroxytyrosol at 0–2 h, 2–4 h, 4–6 h, 6–8 h, 8–10 h, 10–12 h, 12–24 h, after oils ingestion

 

X

X

X

  Plasma Triterpenes at baseline (0 h) and at 30 min, 45 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 24 h after oils ingestion

 

X

X

X

  Endothelial function measurements at baseline (0 h) and at 4 h, and 6 h, after oils ingestion

 

X

X

X

Secondary outcomes

  Plasma gastrointestinal hormones t baseline (0 h) and at 2 h, 4 h, and 6 h, after oils ingestion

 

X

X

X