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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01532375
Other study ID # CUH_2008_AT_4
Secondary ID
Status Completed
Phase Phase 2
First received February 10, 2012
Last updated February 13, 2012
Start date October 2009
Est. completion date March 2010

Study information

Verified date February 2012
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chonbuk National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visceral fat after 12 weeks of consumption
Secondary Body Mass Index after 12 weeks of consumption
Secondary Subcutaneous fat after 12weeks
Secondary Triglyceride after 12week of consumption
Secondary Atherosclerosis index after 12weeks of consumption
Secondary Apolipoprotein after 12weeks of consumption
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