Identifying the Anti-Blood-Clotting Compounds in Garlic
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Arteriosclerosis Intracranial Arteriosclerosis |
Dietary Supplement: garlic powder added to ambient water Dietary Supplement: garlic powder added to boiling water |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Identification of the Antiplatelet Compounds of Garlic Ex Vivo |
- Percent Platelet Aggregation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Electrical Impedance in Ohms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Garlic powder in ambient water
high allicin
|
Dietary Supplement: garlic powder added to ambient water
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
Other Name: Global Marketing Assoc., Inc.
|
|
Experimental: garlic powder in boiling water
no allicin
|
Dietary Supplement: garlic powder added to boiling water
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
Other Name: Global Marketing Assoc., Inc.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Body mass index of 19 to 30 kg/m2
- Plans to remain in the study area for the next year
- Willingness to abstain from nonsteroidal anti-inflammatory drugs (NSAID drugs for 1 week prior to each study test
- Willingness to abstain from consuming garlic and significant amounts of onion, chocolate, or purple grape juice for 3 days prior to each study test
- Willingness to participate in all study tests
Exclusion Criteria:
- Pregnancy or breast-feeding
- Serious medical condition
- Allergy to garlic or wheat
- Tobacco use
- Excessive alcohol consumption
- Under psychiatric care
Contacts and Locations| United States, Utah | |
| Silliker, Inc./Plant Bioactives Research Institute | |
| Orem, Utah, United States, 84058 | |
| Principal Investigator: | Larry D. Lawson, PhD | Silliker, Inc./Plant Bioactives Research Institute |
More Information
No publications provided
| Responsible Party: | Larry D. Lawson principal investigator, Silliker, Inc./Plant Bioactives Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT00200785 History of Changes |
| Other Study ID Numbers: | R21 AT001512-01 |
| Study First Received: | September 12, 2005 |
| Results First Received: | April 23, 2009 |
| Last Updated: | December 4, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
garlic |
Additional relevant MeSH terms:
|
Arteriosclerosis Intracranial Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013