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 |