Hyperlipidemia Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do |
Lead Sponsor | Collaborator |
---|---|
Chonbuk National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
Primary | 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 | Yes |
Secondary | Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
Secondary | 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). | 12 weeks | Yes |
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