NCT01532375

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

February 10, 2012

Last Update Submit

February 13, 2012

Conditions

Keywords

Kochujang,visceral fatpopulation

Outcome Measures

Primary Outcomes (1)

  • Visceral fat

    after 12 weeks of consumption

Secondary Outcomes (5)

  • 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

Study Arms (2)

Kochujang(32g)

EXPERIMENTAL
Dietary Supplement: Kochujang

placebo(32g)

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

KochujangDIETARY_SUPPLEMENT

Kochujang (32g/day) for 12weeks.

Kochujang(32g)
placeboDIETARY_SUPPLEMENT

placebo(32g/day) for 12weeks

placebo(32g)

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>25kg/m2 and 2)Waist-Hip Ratio (WHR): WHR\> 0.90(male), WHR\>0.85(female)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Soo-Wan Chae, Ph.D, MD

    Chonbuk National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 14, 2012

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 14, 2012

Record last verified: 2012-02