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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01402102
First received: July 21, 2011
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hyperlipidemia
Dietary Supplement: Aged garlic powder
Dietary Supplement: Placebo powder
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Aged Garlic Powder on Lipids

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

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

  • Changes in Apo-A1(Apolipoprotein A1) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Apo-B(Apolipoprotein B) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in FFA(Free Fatty Acid) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).


Enrollment: 60
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 21, 2011
Results First Received: July 26, 2012
Last Updated: October 11, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Aged garlic
Hyperlipidemic
LDL
HDL
Triglyceride

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

ClinicalTrials.gov processed this record on September 16, 2014