Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865370
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: Kochujang Pills Dietary Supplement: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kochujang Pills Dietary Supplement: Kochujang Pills
Kochujang Pills (34.5g/day)

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (34.5g/day)




Primary Outcome Measures :
  1. Changes in Total Cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) [ Time Frame: 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 :
  1. Changes in Triglyceride [ Time Frame: 12 weeks ]
    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in HDL-C(High Density Lipoprotein-cholesterol) [ Time Frame: 12 weeks ]
    HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865370


Locations
Layout table for location information
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01865370     History of Changes
Other Study ID Numbers: ISFSP-HL-KOCHUJANG
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases