- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402102
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
Status
Completed
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
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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