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

This study has been completed.
Sponsor:
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01532375
First received: February 10, 2012
Last updated: February 13, 2012
Last verified: February 2012

February 10, 2012
February 13, 2012
October 2009
March 2010   (final data collection date for primary outcome measure)
Visceral fat [ Time Frame: after 12 weeks of consumption ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01532375 on ClinicalTrials.gov Archive Site
  • Body Mass Index [ Time Frame: after 12 weeks of consumption ] [ Designated as safety issue: Yes ]
  • Subcutaneous fat [ Time Frame: after 12weeks ] [ Designated as safety issue: Yes ]
  • Triglyceride [ Time Frame: after 12week of consumption ] [ Designated as safety issue: Yes ]
  • Atherosclerosis index [ Time Frame: after 12weeks of consumption ] [ Designated as safety issue: Yes ]
  • Apolipoprotein [ Time Frame: after 12weeks of consumption ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults
Kochujang Decreases Visceral Fat and Improves Lipids Profiles

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Overweight
  • Dietary Supplement: Kochujang
    Kochujang (32g/day) for 12weeks.
  • Dietary Supplement: placebo
    placebo(32g/day) for 12weeks
  • Experimental: Kochujang(32g)
    Intervention: Dietary Supplement: Kochujang
  • Placebo Comparator: placebo(32g)
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01532375
CUH_2008_AT_4
Yes
Not Provided
Chonbuk National University Hospital
Not Provided
Study Chair: Soo-Wan Chae, Ph.D, MD Chonbuk National University Hospital
Chonbuk National University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP