title: The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.
abstract: BACKGROUND
  Metabolic syndrome is a set of disorders that increases the risk of developing cardiovascular disease. The primary target of treatment of patients with metabolic syndrome is therapeutic lifestyle change. Numerous preclinical study have reported positive effects of chungkookjang in in vivo models of diabetes and obesity, but there is a paucity of controlled clinical trials on variables of metabolic syndrome in obese subjects. Thus, the objective of this trial is to examine the effect of chungkookjang compared to placebo on variables of metabolic syndrome in overweight/obese subjects.
  
  
  METHODS
  This double-blind randomized controlled crossover trial will be conducted on 120 overweight/obese subjects; aged 19-29 years. Subjects will be recruited from the Chonbuk National University, Jeonju, South Korea. Enrolled subjects will be randomly assigned to two groups of equal number; one group received 35 g of chungkookjang (n = 60) and the other group received placebo (n = 60) on a regular daily basis for 12 weeks. After a 12-week washout period, the groups will be crossed over. In addition to anthropometric measures and blood pressure, glucose parameter, lipid profile, adipocytokine, and carnitine assay will be determined at baseline and 12 week. Also, safety will be assessing by measuring total bilirubin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, total protein, albumin, blood urea nitrogen, creatinine, and creatine kinase at baseline and 12 weeks. 24-hour dietary recalls were collected at the baseline and at the end of the trial.
  
  
  CONCLUSIONS
  This trial will evaluate the effects of chungkookjang on variables of metabolic syndrome in overweight/obese subjects. The results of this study may contribute to the reduction of risk factor for metabolic syndrome caused by obesity.
  
  
  BACKGROUND
  Clinical trials NCT01811511.
authors.forename: Hyang-Im
authors.initials: HI
authors.lastname: Back
authors.forename: Ki-Chan
authors.initials: KC
authors.lastname: Ha
authors.forename: Hye-Mi
authors.initials: HM
authors.lastname: Kim
authors.forename: Min-Gul
authors.initials: MG
authors.lastname: Kim
authors.forename: Ok-Kyeong
authors.initials: OK
authors.lastname: Yu
authors.forename: Moon-Sun
authors.initials: MS
authors.lastname: Byun
authors.forename: Do-Youn
authors.initials: DY
authors.lastname: Jeong
authors.forename: Seong-Yeop
authors.initials: SY
authors.lastname: Jeong
authors.affiliation: Clinical Trial Center, Chonbuk National University Hospital, 20 Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk 561-712, Republic of Korea. cha8@jbnu.ac.kr.
authors.forename: Youn-Soo
authors.initials: YS
authors.lastname: Cha
authors.forename: Tae-Sun
authors.initials: TS
authors.lastname: Park
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000378:metabolism*; D008019:Life Style; D008297:Male; D024821:Metabolic Syndrome / Q000178:diet therapy* / Q000378:metabolism; D009765:Obesity / Q000178:diet therapy* / Q000378:metabolism; D050177:Overweight / Q000178:diet therapy* / Q000378:metabolism; D056910:Republic of Korea; D030262:Soybean Proteins / Q000378:metabolism*; D055815:Young Adult
chemical_list: D007529:Isoflavones; D030262:Soybean Proteins; C525760:chungkookjang; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase