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Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01811511
Enrollment
120
Registered
2013-03-14
Start date
2013-03-31
Completion date
2014-02-28
Last updated
2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Brief summary

The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.

Interventions

DIETARY_SUPPLEMENTChungkookjang
DIETARY_SUPPLEMENTPlacebo

Sponsors

Chonbuk National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females 18-29 years old * BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women) * Able to give informed consent

Exclusion criteria

* Allergic or hypersensitive to any of the ingredients in the test products * The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL * Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg * History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery * History of alcohol or substance abuse * Participation in any other clinical trials within past 2 months * Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Fat Mass12 weeksBody Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat12 weeksPercent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).

Secondary

MeasureTime frameDescription
Change in Glucose12 weeksGlucose was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Cholesterol12 weeksCholesterol was measured in study visit 1(0 week) and visit 3(12 week).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026