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

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

Tracking Information

• First Submitted Date: February 10, 2012
• First Posted Date: February 14, 2012
• Last Update Posted Date: February 14, 2012
• Study Start Date: October 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 13, 2012): Visceral fat [ Time Frame: after 12 weeks of consumption ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Overweight

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2012): 60
• Original Actual Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01532375
• Other Study ID Numbers: 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: Chonbuk National University Hospital
• Collaborators: Not Provided

Investigators

• Study Chair: Soo-Wan Chae, Ph.D, MD; Chonbuk National University Hospital

• PRS Account: Chonbuk National University Hospital
• Verification Date: February 2012