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Table 1 A brief study schedule at every visit

From: The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol

  Crossover design
Screening Baseline    Follow up
Visit 1 Visit 2, 5 Visit 3, 6 Visit 4, 7 (Visit 8)
D-28 Week 0 Week 6 Week 12 Week 24
~D-1 D0 D42 D84 D168
Informed consent form     
Demographic information taking 1     
Medical history taking     
Inclusion/exclusion criteria check    
Physician examination 2    
Drinking/smoking taking status 3      
Vital sign measurement
Concomitant drugs check
Anthropometric measures 4  
Glucose parameter 5      
Lipid profile 6      
Adipocytokine 7      
Carnitine assay      
Laboratory test 8      
Study product distribution     
Compliance checking     
Adverse event monitoring  
Diet, physical exercisecounseling 9  
  1. : Item need to be performed during the visit.
  2. 1 Sex, date of birth, age, contact address and phone number.
  3. 2 Include present illness, past history taking.
  4. 3,9Risk factors such as alcohol drinking, smoking, severe exercise and other dietary supplement intake will be managed.
  5. 4 weight, body mass index, body fat mass, percentage body fat, lean body mass, waist circumference, hip circumference, and waist to hip ratio.
  6. 5 fasting glucose, HbA1c, insulin, gamma-glutamyl transferase (GGT).
  7. 6 total cholesterol, triglycerides, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), free fatty acid, apolipoprotein A1 (Apo A1), apolipoprotein B (Apo B), high-sensitivity C-reactive protein (hs-CRP).
  8. 7 leptin, adiponectin, ghrelin.
  9. 8 Blood test (white blood cell [WBC], red blood cell [RBC], hemoglobin, hematocrit, platelets count, total bilirubin [TB], alkaline phosphatase [ALP], alanine transaminase [ALT], aspartate aminotransferase [AST], total protein, albumin, blood urea nitrogen [BUN], creatinine, creatine kinase [CK]), urine test (specific gravity, pH, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, microscopic RBC/WBC).