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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

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ClinicalTrials.gov Identifier: NCT01402102
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : October 4, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: Aged garlic powder Dietary Supplement: Placebo powder Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Aged Garlic Powder on Lipids
Study Start Date : July 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aged garlic powder Dietary Supplement: Aged garlic powder
Aged garlic powder(6.0g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo powder
Placebo powder(6.0g/day)



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. Changes in Triglycerides [ Time Frame: 12 weeks ]
    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

  3. Changes in Total Cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  4. 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).

  5. 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).

  6. 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).



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01402102


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Dal-Sik Kim, MD Chonbuk National University Hospital

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01402102     History of Changes
Other Study ID Numbers: Doul-BGarlic-001
First Posted: July 26, 2011    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Aged garlic
Hyperlipidemic
LDL
HDL
Triglyceride

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