Clinical trial NCT01532375: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Keywords: Kochujang,
visceral fat
population
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Visceral fat
timeFrame: after 12 weeks of consumption
Secondary outcomes:
measure: Body Mass Index
timeFrame: after 12 weeks of consumption
measure: Subcutaneous fat
timeFrame: after 12weeks
measure: Triglyceride
timeFrame: after 12week of consumption
measure: Atherosclerosis index
timeFrame: after 12weeks of consumption
measure: Apolipoprotein
timeFrame: after 12weeks of consumption
Other outcomes:
Locations:
Study officials:
affiliation: Chonbuk National University Hospital
name: Soo-Wan Chae, Ph.D, MD
role: STUDY_CHAIR
References:
citation: 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.