Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedMay 30, 2013
May 1, 2013
3 months
May 27, 2013
May 27, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
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).
12 weeks
Secondary Outcomes (2)
Changes in Triglyceride
12 weeks
Changes in HDL-C(High Density Lipoprotein-cholesterol)
12 weeks
Study Arms (2)
Kochujang Pills
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
Related Publications (1)
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.
PMID: 24961447DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
May 27, 2013
First Posted
May 30, 2013
Study Start
November 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
May 30, 2013
Record last verified: 2013-05