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Table 2 Schedule of samples and data collection

From: National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial

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