Skip to main content

Table 2 Detailed study procedures in the sustained consumption study (0 mL/day, 3-week intervention periods)

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

 

Study Period

Visit (V) number

WO, washout period

IP, Intervention period

Enrollment

V1

(WO)

V2

(IP 1)

V3

(WO)

V4

(IP 2)

V5

(WO)

V6

(IP 3)

V7

(Close out)

Time Point, week

(Week range)

Up to -12

0

(0–2)

2

(2–5)

5

(5–7)

7

(7–10)

10

(10–12)

12

(12–15)

15

Screening routine laboratory analyses

X

       

Demographic/ habits information-taking

X

       

Informed consent form

X

       

Randomization & allocation

X

       

Treatment distribution

 

X

 

X

 

X

  

Blood and 24 h-urine collection at fasting

 

X

X

X

X

X

X

X

Assessments

General outcomes

  General medical questionnaire

 

X

X

X

X

X

X

X

  Alcohol consumption questionnaire

 

X

 

X

 

X

 

X

  3-day dietary record

 

X

 

X

 

X

 

X

  Minnesota Leisure Time Physical Activity questionnaire

 

X

     

X

  Blood pressure and anthropometric

 

X

X

X

X

X

X

X

  Visual Analogue Scale

   

X

 

X

 

X

  Monitoring adverse effects

   

X

 

X

 

X

  Compliance check (containers)

   

X

 

X

 

X

Primary outcomes

  Plasma Lipid profile

 

X

X

X

X

X

X

X

  Plasma Lipid and DNA oxidation

 

X

X

X

X

X

X

X

  Plasma Inflammation markers

 

X

X

X

X

X

X

X

Secondary outcomes

  Plasma Antioxidant vitamins

 

X

X

X

X

X

X

X

  Plasma fatty acids

 

X

X

X

X

X

X

X

  Serum Endothelin

 

X

X

X

X

X

X

X

  Ex vivo cell immune response

 

X

 

X

 

X

 

X

Compliance markers

  Urinary tyrosol and hydroxytyrosol

 

X

X

X

X

X

X

X

  Plasma Triterpenes

 

X

X

X

X

X

X

X