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

Phase 2

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Kochujang

• Registration Number: NCT01532375
• Lead Sponsor: Chonbuk National University Hospital

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 Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-13
• Last Update Submitted: 2012-02-13
• Study First Posted: 2012-02-14
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo(32g)	placebo	-
Kochujang(32g)	Kochujang	-

Primary Outcome Measures

Name	Time	Method
Visceral fat	after 12 weeks of consumption

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	after 12 weeks of consumption
Subcutaneous fat	after 12weeks
Triglyceride	after 12week of consumption
Atherosclerosis index	after 12weeks of consumption
Apolipoprotein	after 12weeks of consumption