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

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ClinicalTrials.gov Identifier: NCT01532375
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by:
Chonbuk National University Hospital

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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