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Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

Primary Purpose

Hyperlipidemia

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Kochujang Pills
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kochujang Pills

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
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).

Secondary Outcome Measures

Changes in Triglyceride
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
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).

Full Information

First Posted
November 23, 2012
Last Updated
November 27, 2012
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01735149
Brief Title
Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kochujang Pills
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Kochujang Pills
Intervention Description
Kochujang Pills (34.5g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (34.5g/day)
Primary Outcome Measure Information:
Title
Changes in Total Cholesterol
Description
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
Description
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Triglyceride
Description
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in HDL-C(High Density Lipoprotein-cholesterol)
Description
HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Kyung Choi, MD
Phone
82-63-250-2537
Email
ekchoi@jbctc.org

12. IPD Sharing Statement

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Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

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