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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