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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865370
• Other study ID #: ISFSP-HL-KOCHUJANG
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 27, 2013
• Last updated: May 27, 2013
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• 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: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: February 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

• Hyperlipidemia
• Hyperlipidemias

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