Back to resultsEfficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Kochujang Pills
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Males and females 19-55 years old
- Total Cholesterol 200~260 mg/dl or LDL-C 110~190 mg/dl
- Able to give informed consent
Exclusion Criteria:
- Allergic or hypersensitive to any of the ingredients in the test products
- 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
- Pregnant or lactating women etc.
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Kochujang Pills
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Secondary Outcome Measures
Changes in Triglyceride
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Changes in HDL-C(High Density Lipoprotein-cholesterol)
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Full Information
NCT ID
NCT01865370
First Posted
May 27, 2013
Last Updated
May 27, 2013
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01865370
Brief Title
Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (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 human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kochujang Pills
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Kochujang Pills
Intervention Description
Kochujang Pills (34.5g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (34.5g/day)
Primary Outcome Measure Information:
Title
Changes in Total Cholesterol
Description
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
Description
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Triglyceride
Description
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in HDL-C(High Density Lipoprotein-cholesterol)
Description
HDL-C(High Density Lipoprotein-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
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females 19-55 years old
Total Cholesterol 200~260 mg/dl or LDL-C 110~190 mg/dl
Able to give informed consent
Exclusion Criteria:
Allergic or hypersensitive to any of the ingredients in the test products
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
Pregnant or lactating women etc.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24961447
Citation
Lim JH, Jung ES, Choi EK, Jeong DY, Jo SW, Jin JH, Lee JM, Park BH, Chae SW. Supplementation with Aspergillus oryzae-fermented kochujang lowers serum cholesterol in subjects with hyperlipidemia. Clin Nutr. 2015 Jun;34(3):383-7. doi: 10.1016/j.clnu.2014.05.013. Epub 2014 Jun 9.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects
We'll reach out to this number within 24 hrs