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Identifying the Anti-Blood-Clotting Compounds in Garlic

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00200785
First received: September 12, 2005
Last updated: December 4, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Percent Platelet Aggregation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200785

Locations
United States, Utah
Silliker, Inc./Plant Bioactives Research Institute
Orem, Utah, United States, 84058
Sponsors and Collaborators
Investigators
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
Atherosclerosis
Intracranial Arteriosclerosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014