Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

February 8, 2015 updated by: Tae Sun Park, Chonbuk National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Obesity Research Center of Chonbuk National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chungkookjang
Chungkookjang(35g/day)
Dietary supplement: Placebo
Other Names:
  • Placebo(35g/day)
Dietary supplement: Chungkookjang
Other Names:
  • Chungkookjang(35g/day)
PLACEBO_COMPARATOR: Placebo
Placebo(35g/day)
Dietary supplement: Placebo
Other Names:
  • Placebo(35g/day)
Dietary supplement: Chungkookjang
Other Names:
  • Chungkookjang(35g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Percent Body Fat
Time Frame: 12 weeks
Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Change in Body Fat Mass
Time Frame: 12 weeks
Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glucose
Time Frame: 12 weeks
Glucose was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Cholesterol
Time Frame: 12 weeks
Cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (ESTIMATE)

March 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 8, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORC-MS-CKJA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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