Task | Pre-screening (telephone) | Screening | Test visit 1 (week 0) | Intermediate visit (week 6) | Test visit 2 (week 12) |
---|---|---|---|---|---|
Pre-screening questionnaire | X | ||||
Obtain informed consent | X | ||||
Study eligibility/screening | X | X | |||
Medical history | X | ||||
Height, weight and BMI | X | X | X | X | |
Waist circumference | X | X | |||
Body composition (bioelectrical impedance) | X | X | |||
Spot urine sample (10 ml) for hydration status assessment including osmometry and including dipstick | X | X | |||
24-hour urine collection | X | X | |||
Physical activity questionnaire (IPAQ) | X | X | X | ||
Standardised ‘5-A-Day’ advice | X | X | X | X | |
Group randomisation | X | ||||
FACET (‘5-A-Day’/Lifestyle) Questionnaire | X | X | X | X | |
Blood pressure (standard automated at screening; seated, supine and ambulatory in TV1 and TV2) | X | X | X | ||
Pulse wave analysis | X | X | |||
Carotid intima-media thickness | X | X | |||
12-lead ECG | X | X | |||
and GTN-induced dilatation | X | X | |||
Laser doppler iontophoresis | X | X | |||
Assess continuance criteria | X | X | X | ||
Blood samples | X | X | X | X | |
Assess concomitant medication | X | X | X | X | X |
Test product dispensed | X | X | |||
Compliance assessment | X | X | |||
Tablet count | X | X | |||
Assess adverse reactions | X | X | |||
Empty containers collected | X | X | |||
Collect unused test product | X |