The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol
1 Healthcare Claims & Management Incorporation, 758 Baekie-daero, Deokin-gu, Jeonju, Jeonbuk 561-832, Republic of Korea
2 Department of Medical Nutrition Therapy, Chonbuk National University Medical School, 567 Baekje-daero, Deokjin-gu, Jeonju, Jeonbuk 561-756, Republic of Korea
3 Clinical Trial Center, Chonbuk National University Hospital, 20 Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk 561-712, Republic of Korea
4 Department of Food Science and Human Nutrition, Chonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju, Jeonbuk 561-756, Republic of Korea
5 Obesity Research Center, Chonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju, Jeonbuk 561-756, Republic of Korea
6 Sunchang Research Center for Fermentation Microbes, 61-27 Minsongmaeul-gil, Sunchang-eup, Sunchang, Jeonbuk 595-804, Republic of Korea
7 Department of Endocrinology and Metabolism, Chonuk National University, Medical School, 20 Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk 561-712, Republic of Korea
BMC Complementary and Alternative Medicine 2013, 13:297 doi:10.1186/1472-6882-13-297Published: 31 October 2013
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.
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.
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.
Clinical trials NCT01811511.