Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults

Tracking Information
First Submitted Date ICMJE	February 10, 2012
First Posted Date ICMJE	February 14, 2012
Last Update Posted Date	February 14, 2012
Study Start Date ICMJE	October 2009
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 13, 2012)	Visceral fat [ Time Frame: after 12 weeks of consumption ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: February 13, 2012)	Body Mass Index [ Time Frame: after 12 weeks of consumption ]; Subcutaneous fat [ Time Frame: after 12weeks ]; Triglyceride [ Time Frame: after 12week of consumption ]; Atherosclerosis index [ Time Frame: after 12weeks of consumption ]; Apolipoprotein [ Time Frame: after 12weeks of consumption ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults
Official Title ICMJE	Kochujang Decreases Visceral Fat and Improves Lipids Profiles
Brief Summary	With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be potentially effective in preventing and treating obesity and cardiovascular risks if proven in humans. However, human trial still have not been reported with KCJ supplementation. In the present study, we investigated the hypothesis that KCJ supplementation can be decrease the body fat and improve blood lipid profiles in overweight adults.
Detailed Description	The aim of this study was to evaluate the efficacy of KCJ supplementation on anthropometric parameters, visceral fat/subcutaneous fat, and blood lipid profiles in overweight subjects. Sixty overweight subjects with BMI >25 kg/m2 and waist-hip-ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly assigned to either KCJ supplement (n=30, 32 g/day) or placebo (n=30, 32 g/day) group for 12 weeks.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Overweight
Intervention ICMJE	Dietary Supplement: Kochujang Kochujang (32g/day) for 12weeks.; Dietary Supplement: placebo placebo(32g/day) for 12weeks
Study Arms	Experimental: Kochujang(32g) Intervention: Dietary Supplement: Kochujang; Placebo Comparator: placebo(32g) Intervention: Dietary Supplement: placebo
Publications *	Cha YS, Kim SR, Yang JA, Back HI, Kim MG, Jung SJ, Song WO, Chae SW. Kochujang, fermented soybean-based red pepper paste, decreases visceral fat and improves blood lipid profiles in overweight adults. Nutr Metab (Lond). 2013 Feb 26;10(1):24. doi: 10.1186/1743-7075-10-24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 13, 2012)	60
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2010
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: BMI >25kg/m2 and 2)Waist-Hip Ratio (WHR): WHR> 0.90(male), WHR>0.85(female) Exclusion Criteria: lipid metabolic disorders; >10% changes in body weight in the past 3 months; Cardiovascular disease such as arrhythmia, heart failure, myocardial infarction, and wearing pacemaker; Allergy or hypersensitivity to any of the ingredients in the test products - History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery; Participation in other clinical trials within the past 2 months; Abnormal hepatic liver function, renal disease such as acute chronic renal failure, nephrotic syndrome; Use of anti-psychosis drug therapy within 2 months; Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study; History of alcohol or substance abuse; Pregnancy or breastfeeding
Sex/Gender	Sexes Eligible for Study: All
Ages	19 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01532375
Other Study ID Numbers ICMJE	CUH_2008_AT_4
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Chonbuk National University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Soo-Wan Chae, Ph.D, MD Chonbuk National University Hospital
PRS Account	Chonbuk National University Hospital
Verification Date	February 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP