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

October 11, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital

Efficacy and Safety of Aged Garlic Powder on Lipids

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo powder(6.0g/day)
Experimental: Aged garlic powder
Aged garlic powder(6.0g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)
Time Frame: 12 weeks
LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dal-Sik Kim, MD, Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Doul-BGarlic-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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