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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged garlic powder | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aged garlic powder | Dietary Supplement | Aged garlic powder(6.0g/day) |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dal-Sik Kim, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
The criteria were an age from 20 to 80 years, a BMI(Body Mass Index)>23 kg/m^2, an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 130 and 220 mg/dL. Subjects were excluded if they had heart disease, liver or kidney disease, irregular lifestyle habits, or if they took medication and functional foods known to affect lipid metabolism
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aged Garlic Powder | Oral intake Aged garlic powder(6.0g/day) for 12weeks. |
| FG001 | Placebo | Oral intake placebo(6.0g/day) for 12weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo powder |
| Dietary Supplement |
Placebo powder(6.0g/day) |
|
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aged Garlic Powder | Oral intake Aged garlic powder(6.0g/day) for 12weeks. |
| BG001 | Placebo | Oral intake placebo(6.0g/day) for 12weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
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| Secondary | 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). | PP analysis | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
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| Secondary | Changes in Triglycerides | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | PP analysis | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
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| Secondary | Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
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| Secondary | Changes in Apo-A1(Apolipoprotein A1) | Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | g/L | 12 weeks |
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| Secondary | Changes in Apo-B(Apolipoprotein B) | Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | g/L | 12 weeks |
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| Secondary | Changes in FFA(Free Fatty Acid) | FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | µEq/L | 12 weeks |
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aged Garlic Powder | Oral intake Aged garlic powder(6.0g/day) for 12weeks. | 0 | 0 | 0 | 0 | ||
| EG001 | Placebo | Oral intake placebo(6.0g/day) for 12weeks | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dal-Sik Kim | Clinical trial center for Functional Food in Chonbuk Nat'l University Hospital | 82-63-250-1793 | dskim@chonbuk.ac.kr |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| >=65 years |
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| Male |
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