A Phase 3 interventional study of Aged garlic extract and Coenzyme Q10 in Coronary Atherosclerosis, Coronary Artery Calcification and Coronary Stenosis, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed at 1 site in United States. Open to male participants aged 35 Years to 84 Years. Per ClinicalTrials.gov, last updated 2015-03-12.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Phase 3, Interventional, and Prevention
Statement of Problem
According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque progression. However is certainly not the only factor in evaluating for progression of coronary artery disease (CAD), and other factors must play a role. Garlic therapy has been shown to retard atherosclerosis independently.
Specific Aims:
Inclusion Criteria
Exclusion Criteria
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater.
Secondary Change in blood values and endothelial function over 6 and 12 months:
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center is the lead sponsor of 67 studies on the registry; 1 is open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
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Exclusion Criteria:
AGE (1200 mg) and CoQ10 (120 mg) This is a combination of aged garlic extract and co-enzyme Q10
Dietary Supplement: Aged garlic extract and Coenzyme Q10
placebo pills will be given
AGE (1200 mg) and CoQ10 (120 mg)
Also known as: Kyolic formula 110
Rate of Change in Total Coronary Calcium Scores by Computed Tomography
progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.
Time frame: 1 year
1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH
Time frame: 1 year
65 patients were recruited
| Milestone | Aged Garlic Extract and Coenzyme Q10 | Placebo |
|---|---|---|
| Started | 32 | 33 |
| Completed | 28 | 28 |
| Not completed | 4 | 5 |
progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.
| Agatston score change | Aged Garlic Extract and Coenzyme Q10 | Placebo |
|---|---|---|
| Rate of Change in Total Coronary Calcium Scores by Computed Tomography | 32 ± 6 | 58 ± 8 |
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aged Garlic Extract and Coenzyme Q10 | — | 0/32 (0%) | 0/32 (0%) |
| Placebo | — | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Aged Garlic Extract and Coenzyme Q10 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 33 | 65 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Aged Garlic Extract and Coenzyme Q10 | Placebo | Total |
|---|---|---|---|
| Mean | 55 ± 6 | 55 ± 6 | 55 ± 6 |
| Sex: Female, Male(Participants) | Aged Garlic Extract and Coenzyme Q10 | Placebo | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 17 | 17 | 34 |
| Region of Enrollment(participants) | Aged Garlic Extract and Coenzyme Q10 | Placebo | Total |
|---|---|---|---|
| United States | 32 | 33 | 65 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center