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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
  Purpose

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.


Condition Intervention Phase
Overweight
Dietary Supplement: Kochujang
Dietary Supplement: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Kochujang Decreases Visceral Fat and Improves Lipids Profiles

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Visceral fat [ Time Frame: after 12 weeks of consumption ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kochujang(32g) Dietary Supplement: Kochujang
Kochujang (32g/day) for 12weeks.
Placebo Comparator: placebo(32g) Dietary Supplement: placebo
placebo(32g/day) for 12weeks

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532375

Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Study Chair: Soo-Wan Chae, Ph.D, MD Chonbuk National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01532375     History of Changes
Other Study ID Numbers: CUH_2008_AT_4
Study First Received: February 10, 2012
Last Updated: February 13, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonbuk National University Hospital:
Kochujang,
visceral fat
population

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014