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Table 1 Study timeline and trial assessments

From: Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial

Assessments

 

Screening (telephone)

X

   

Informed consent (mail)

X

   

IPAQ questionnaire (mail)

X

   

3-day food record (mail)

X

   

Medical questionnaire (mail)

X

   
  

Week 1

Week 6

Week 12

  

Baseline (visit1)

Test (visit 2)

Test (visit 3)

Randomisation

 

X

  

Intervention allocation

 

X

  

Anthropometry measurements

 

X

X

X

Blood sample

 

X

 

X

Food diary

 

X

X

X

Physical activity

 

X

X

X

Biochemical analysis

 

X

 

X

Fasting plasma glucose

 

X

 

X

Fasting plasma insulin

 

X

 

X

HbA1c

 

X

 

X

Fructosamine

 

X

 

X

HOMA IR, HOMA S, HOMA β, QUICKI

 

X

 

X

Total cholesterol

 

X

 

X

Triglycerides

 

X

 

X

HDL-C, LDL-C, Total/HDL-C ratio

 

X

 

X

CRP

 

X

 

X

Whole blood cell count

 

X

 

X

Il-6, Il-1β, adiponectin, leptin

 

X

 

X

Capsule count and log record

  

X

X

Plasma curcumin concentration

   

X

Erythrocyte fatty acids content

 

X

 

X

Adverse event reporting

  

X

X

  1. IPAQ International Physical Activity Questionnaire, HbA1c glycosylated haemoglobin, HOMA IR Homeostatic Model Assessment for Insulin Resistance, HOMA S Insulin sensitivity, HOMA β beta-cell function, QUICKI Quantitative insulin Sensitivity Check Index, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, CRP C-reactive protein, IL-6 interleukin-6, IL-1β interleukin-1 beta