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A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aged garlic powder
Placebo powder
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperlipidemia focused on measuring Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild hypercholesterolemic subjects aged from 20 to 80 years
  • had no received lipid-lowering drugs for at least 3 months prior to the recruitment

Exclusion Criteria:

  • self-reported pregnancy,lactation
  • prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aged garlic powder

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Triglycerides
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-A1(Apolipoprotein A1)
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Apo-B(Apolipoprotein B)
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in FFA(Free Fatty Acid)
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).

Full Information

First Posted
July 21, 2011
Last Updated
October 11, 2012
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01402102
Brief Title
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
Official Title
Efficacy and Safety of Aged Garlic Powder on Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)

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
We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.
Detailed Description
An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aged garlic powder
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Aged garlic powder
Intervention Description
Aged garlic powder(6.0g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder
Intervention Description
Placebo powder(6.0g/day)
Primary Outcome Measure Information:
Title
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)
Description
LDL-C(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 HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
Description
HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Triglycerides
Description
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
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 Apo-A1(Apolipoprotein A1)
Description
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Apo-B(Apolipoprotein B)
Description
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in FFA(Free Fatty Acid)
Description
FFA(free fatty acid) 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
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild hypercholesterolemic subjects aged from 20 to 80 years had no received lipid-lowering drugs for at least 3 months prior to the recruitment Exclusion Criteria: self-reported pregnancy,lactation prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dal-Sik Kim, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
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

12. IPD Sharing Statement

Learn more about this trial

A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia

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