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This study will seek to identify the compound(s) in garlic that is (are) responsible for its ability to prevent the formation of blood clots (prevent platelet aggregation) and to determine the maximally effective dose and duration of the benefits. This study will also determine whether "cooked" garlic (garlic powder added to boiling water, no allicin present) is as effective as "fresh" garlic (garlic powder added to ambient water, high allicin present) and, if more than one compound is involved, and whether their combined effects are more significant than the effects of each compound alone.
Published studies indicate that various types of undefined garlic products display antiplatelet activity. However, the compounds responsible for this antiplatelet effect have not been identified.
Acute studies. In acute (one day) studies, healthy participants will consume several doses of "fresh garlic" (garlic powder added to ambient water; up to the equivalent of 12 grams fresh garlic or 52 mg allicin) as a paste in a tuna sandwich. At 0, 2, 4, and 6 hours after consumption, the ability of platelets to aggregate in platelet-rich plasma (PRP) or in whole blood (WB), in response to a drug (collagen, ADP) that stimulates platelet aggregation, will be measured. After establishing the optimum dose and optimum time of the antiplatelet effect for each person, and if the effects are sufficiently strong, the effects of cooked garlic (garlic powder added to boiling water, no allicin present) and seven extracted fractions (oil, protein, fructans, etc.) will be determined, using the fractions at the same dose as their abundance in the established optimum dose of crushed fresh garlic.
Chronic studies. If only weak platelet effects are found for a high acute dose of "fresh" garlic, chronic studies will be conducted. In chronic studies, participants will consume 8.0 grams of "fresh garlic" (2.7 grams garlic powder added to ambient water, allicin content = 35 mg) as a paste in a tuna sandwich every day for four weeks and 8.0 grams of "boiled garlic" (2.7 grams garlic powder added to boiling water) in a sandwich every day for an additional four weeks, after a 1-week washout. The ability of platelets to aggregate in PRP and whole blood will be determined before and every week after garlic consumption begins and after the 1-week washout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Garlic powder in ambient water | Active Comparator | high allicin |
|
| garlic powder in boiling water | Experimental | no allicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| garlic powder added to ambient water | Dietary Supplement | consumed 2.7 grams of garlic powder added to ambient water (equivalent to 8 grams fresh or raw garlic) in a sandwich, once a day for four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Platelet Aggregation | percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Electrical Impedance in Ohms | Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry D. Lawson, PhD | Silliker, Inc./Plant Bioactives Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silliker, Inc./Plant Bioactives Research Institute | Orem | Utah | 84058 | United States |
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healthy participants were recruited in Utah county, Utah, in early 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Garlic Powder: High Allicin | garlic powder in ambient water |
| FG001 | Garlic Powder: No Allicin | garlic powder in boiling water |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of 1 Week |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Garlic Powder: High Allicin | garlic powder in ambient water |
| BG001 | Garlic Powder: No Allicin | garlic powder in boiling water |
| 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 | Percent Platelet Aggregation | percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP) | Posted | Mean | Standard Deviation | percent platelet aggregation | 4 weeks |
|
|
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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 | Garlic Powder: High Allicin | garlic powder in ambient water |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry D. Lawson | Silliker, Inc./Plant Bioactives Research Institute, Inc. | 801-226-3041 | larry.lawson@silliker.com |
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| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
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|
| garlic powder added to boiling water | Dietary Supplement | consumed 2.7 grams of garlic powder added to boiling water (equivalent to 8 grams of cooked garlic) in a sandwich, once a day for four weeks |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| 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 |
|
| electrical impedance (ohms) at 0 weeks | collagen-induced platelet aggregation in whole blood (WB) | Mean | Standard Deviation | ohms |
|
| percent platelet aggregation at 0 weeks | collagen-induced aggregation in platelet-rich plasma (PRP) | Mean | Standard Deviation | percent platelet aggregation |
|
| Participants |
|
|
| Secondary | Electrical Impedance in Ohms | Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation. | Nine persons participated in the "high allicin" test. Six of the same persons participated in the "no allicin" test. | Posted | Mean | Standard Deviation | ohms | 4 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Garlic Powder: No Allicin | garlic powder in boiling water | 0 | 6 | 0 | 6 |
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| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |