Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01735149
Other study ID # SRCM-HL-KOCHUJANG
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received November 23, 2012
Last updated November 27, 2012
Start date November 2012
Est. completion date June 2013

Study information

Verified date November 2012
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Kochujang Pills
Kochujang Pills (34.5g/day)
Placebo
Placebo (34.5g/day)

Locations

Country Name City State
Korea, Republic of Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Jeonju Jeollabuk-do

Sponsors (1)

Lead Sponsor Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02927184 - Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Phase 2
Completed NCT04640012 - Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects Phase 1
Completed NCT03213288 - Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status N/A
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02979704 - A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia Phase 2/Phase 3
Completed NCT02569814 - A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin Phase 1
Completed NCT02428998 - Safety for 24 Weeks Intake of Korean Red Ginseng in Adults N/A
Completed NCT02280590 - Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia Phase 4
Completed NCT01678183 - Financial Incentives for Medication Adherence N/A
Completed NCT01694446 - Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose N/A
Completed NCT01426412 - A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol Phase 1
Completed NCT01131832 - Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols Phase 4
Completed NCT00758303 - A Study to Evaluate the Lipid Regulating Effects of TRIA-662 Phase 2/Phase 3
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00408824 - Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study) N/A
Completed NCT00362206 - Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin Phase 3
Terminated NCT00299169 - Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes Phase 4
Completed NCT00414986 - Using Learning Teams for Reflective Adaptation for Diabetes and Depression N/A
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A