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Identifying the Anti-Blood-Clotting Compounds in Garlic

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ClinicalTrials.gov Identifier: NCT00200785
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Arteriosclerosis Intracranial Arteriosclerosis Dietary Supplement: garlic powder added to ambient water Dietary Supplement: garlic powder added to boiling water Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Identification of the Antiplatelet Compounds of Garlic Ex Vivo
Study Start Date : March 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Platelet Aggregation [ Time Frame: 4 weeks ]
    percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)


Secondary Outcome Measures :
  1. Electrical Impedance in Ohms [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200785


Locations
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United States, Utah
Silliker, Inc./Plant Bioactives Research Institute
Orem, Utah, United States, 84058
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Larry D. Lawson, PhD Silliker, Inc./Plant Bioactives Research Institute
More Information
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Responsible Party: Larry D. Lawson principal investigator, Silliker, Inc./Plant Bioactives Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00200785    
Other Study ID Numbers: R21AT001512-01 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: January 11, 2010
Last Verified: December 2009
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
garlic
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases