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Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735149
First Posted: November 28, 2012
Last Update Posted: November 29, 2012
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.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  Purpose
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 Intervention Phase
Hyperlipidemia Dietary Supplement: Kochujang Pills Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

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

  • 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).


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kochujang Pills Dietary Supplement: Kochujang Pills
Kochujang Pills (34.5g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (34.5g/day)

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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): NCT01735149


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Eun-Kyung Choi, MD    82-63-250-2537    ekchoi@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01735149     History of Changes
Other Study ID Numbers: SRCM-HL-KOCHUJANG
First Submitted: November 23, 2012
First Posted: November 28, 2012
Last Update Posted: November 29, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases