Back to resultsEfficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chungkookjang
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Obesity Research Center of Chonbuk National University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chungkookjang
Placebo
Arm Description
Chungkookjang(35g/day)
Placebo(35g/day)
Outcomes
Primary Outcome Measures
Change in Body Fat Mass
Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat
Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).
Secondary Outcome Measures
Change in Glucose
Glucose was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Cholesterol
Cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Full Information
NCT ID
NCT01811511
First Posted
March 12, 2013
Last Updated
February 8, 2015
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01811511
Brief Title
Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chungkookjang
Arm Type
Experimental
Arm Description
Chungkookjang(35g/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo(35g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Chungkookjang
Other Intervention Name(s)
Chungkookjang(35g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo(35g/day)
Primary Outcome Measure Information:
Title
Change in Body Fat Mass
Description
Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Percent Body Fat
Description
Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Glucose
Description
Glucose was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Cholesterol
Description
Cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Obesity Research Center of Chonbuk National University
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27302672
Citation
Byun MS, Yu OK, Cha YS, Park TS. Korean traditional Chungkookjang improves body composition, lipid profiles and atherogenic indices in overweight/obese subjects: a double-blind, randomized, crossover, placebo-controlled clinical trial. Eur J Clin Nutr. 2016 Oct;70(10):1116-1122. doi: 10.1038/ejcn.2016.77. Epub 2016 Jun 15.
Results Reference
derived
PubMed Identifier
24171779
Citation
Back HI, Ha KC, Kim HM, Kim MG, Yu OK, Byun MS, Jeong DY, Jeong SY, Cha YS, Park TS. The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol. BMC Complement Altern Med. 2013 Oct 31;13:297. doi: 10.1186/1472-6882-13-297.
Results Reference
derived
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Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
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