Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wakunaga Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators will be assessing the effect of Aged Garlic Extract on the coronary arteries. The investigators will enroll patients in a double blind study, where half the patients will receive placebo, and have the patients undergo a series of tests of plaque (CT scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and then repeat the tests and blood work at the end of one year. The investigators will assess if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The investigators will also assess the effect of aged garlic extract on markers of inflammation. Patients will receive free drug, free testing and be compensated, and learn more about their heart and neck arteries. if successful, more patients can use this drug to benefit their health. The harms include the radiation from the CT scan and the medication, which has mild side effects.
The investigators will be assessing the effect of Aged Garlic Extract on the coronary arteries. The investigators will enroll patients in a double blind study, where half the patients will receive placebo, and have the patients undergo a series of tests of plaque (CT scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and then repeat the tests and blood work at the end of one year. The investigators will assess if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The investigators will also assess the effect of aged garlic extract on markers of inflammation. Patients will receive free drug, free testing and be compensated, and learn more about their heart and neck arteries. if successful, more patients can use this drug to benefit their health. The harms include the radiation from the CT scan and the medication, which has mild side effects. The study will perform advanced CT angiography at baseline and follow up along with carotid intimal media thickness testing, to see if plaque is slowed down by Aged Garlic Extract
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar pill | Placebo Comparator | placebo |
|
| Aged Garlic Extract | Active Comparator | 2400 mg of aged garlic extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aged garlic extract | Drug | 2400 mg a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CT Angiography Plaque | we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%. Baseline was time zero, followup CT scan was 1 year. | baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Calcium | Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400 |
Not provided
Inclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Budoff, MD | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26764322 | Derived | Matsumoto S, Nakanishi R, Li D, Alani A, Rezaeian P, Prabhu S, Abraham J, Fahmy MA, Dailing C, Flores F, Hamal S, Broersen A, Kitslaar PH, Budoff MJ. Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study. J Nutr. 2016 Feb;146(2):427S-432S. doi: 10.3945/jn.114.202424. Epub 2016 Jan 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
all 65 participants were recruited
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | placebo placebo: placebo |
| FG001 | Aged Garlic Extract | 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | placebo placebo: placebo patients were randomized to placebo |
| BG001 | Aged Garlic Extract | 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day patients randomized to aged garlic extract |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | CT Angiography Plaque | we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%. Baseline was time zero, followup CT scan was 1 year. | Posted | Mean | Standard Deviation | percent change of low attenuation plaque | baseline to 1 year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | placebo placebo: placebo patients were randomized to placebo No adverse events |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matthew Budoff | Los Angeles Biomedical Research Institute | 310-222-4107 | mbudoff@labiomed.org |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000715552 | kyolic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | placebo |
|
| 1 year |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Coronary Calcium | Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400 | patients undergoing two calcium scores | Posted | Mean | 95% Confidence Interval | agatston units | 1 year |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Aged Garlic Extract | 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events | 0 | 32 | 0 | 32 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |