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

Primary Purpose

Overweight

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kochujang
placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Kochujang,, visceral fat, population

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Kochujang(32g)

    placebo(32g)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Visceral fat

    Secondary Outcome Measures

    Body Mass Index
    Subcutaneous fat
    Triglyceride
    Atherosclerosis index
    Apolipoprotein

    Full Information

    First Posted
    February 10, 2012
    Last Updated
    February 13, 2012
    Sponsor
    Chonbuk National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01532375
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chonbuk National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    Kochujang,, visceral fat, population

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kochujang(32g)
    Arm Type
    Experimental
    Arm Title
    placebo(32g)
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Kochujang
    Intervention Description
    Kochujang (32g/day) for 12weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    placebo(32g/day) for 12weeks
    Primary Outcome Measure Information:
    Title
    Visceral fat
    Time Frame
    after 12 weeks of consumption
    Secondary Outcome Measure Information:
    Title
    Body Mass Index
    Time Frame
    after 12 weeks of consumption
    Title
    Subcutaneous fat
    Time Frame
    after 12weeks
    Title
    Triglyceride
    Time Frame
    after 12week of consumption
    Title
    Atherosclerosis index
    Time Frame
    after 12weeks of consumption
    Title
    Apolipoprotein
    Time Frame
    after 12weeks of consumption

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Soo-Wan Chae, Ph.D, MD
    Organizational Affiliation
    Chonbuk National University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23442518
    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.
    Results Reference
    derived

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

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