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

Study Overview
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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.

Official Title
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Efficacy and Safety of Aged Garlic Powder on Lipids

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Aged garlic powder
* Dietary Supplement: Placebo powder


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aged garlic powder<br> | Dietary Supplement: Aged garlic powder<br>* Aged garlic powder(6.0g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo powder<br>* Placebo powder(6.0g/day)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride