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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

NCT ID: NCT01402102

Last Updated: 2012-10-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia

Keywords

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Aged garlic Hyperlipidemic LDL HDL Triglyceride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aged garlic powder

Group Type EXPERIMENTAL

Aged garlic powder

Intervention Type DIETARY_SUPPLEMENT

Aged garlic powder(6.0g/day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DIETARY_SUPPLEMENT

Placebo powder(6.0g/day)

Interventions

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Aged garlic powder

Aged garlic powder(6.0g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo powder

Placebo powder(6.0g/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dal-Sik Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Doul-BGarlic-001

Identifier Type: -

Identifier Source: org_study_id