Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects

Phase 2

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Kochujang Pills; Dietary Supplement: Placebo

• Registration Number: NCT01865370
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Last Update Submitted: 2013-05-27
• Study First Posted: 2013-05-30
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kochujang Pills	Kochujang Pills	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Total Cholesterol	12 weeks	Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)	12 weeks	LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

Name	Time	Method
Changes in Triglyceride	12 weeks	Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Changes in HDL-C(High Density Lipoprotein-cholesterol)	12 weeks	HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of