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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2012

Last Updated Date

February 13, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01532375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Overweight

Intervention ^ICMJE

Dietary Supplement: Kochujang
Kochujang (32g/day) for 12weeks.
Dietary Supplement: placebo
placebo(32g/day) for 12weeks

Study Arm (s)

Experimental: Kochujang(32g)
Intervention: Dietary Supplement: Kochujang
Placebo Comparator: placebo(32g)
Intervention: Dietary Supplement: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01532375

Other Study ID Numbers ^ICMJE

CUH_2008_AT_4

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Chonbuk National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Soo-Wan Chae, Ph.D, MD

Chonbuk National University Hospital

Information Provided By

Chonbuk National University Hospital

Verification Date

February 2012

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

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