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

Table 1 A brief study schedule at every visit

	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		◯	◯	◯	◯

◯: Item need to be performed during the visit.
¹ Sex, date of birth, age, contact address and phone number.
² Include present illness, past history taking.
^3,9Risk factors such as alcohol drinking, smoking, severe exercise and other dietary supplement intake will be managed.
⁴ weight, body mass index, body fat mass, percentage body fat, lean body mass, waist circumference, hip circumference, and waist to hip ratio.
⁵ fasting glucose, HbA1c, insulin, gamma-glutamyl transferase (GGT).
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).
⁷ leptin, adiponectin, ghrelin.
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).

ISSN: 2662-7671