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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)

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date  ICMJE April 23, 2009
Results First Posted Date  ICMJE January 11, 2010
Last Update Posted Date January 11, 2010
Study Start Date  ICMJE March 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2009)
Percent Platelet Aggregation [ Time Frame: 4 weeks ]
percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • cardiovascular disease
  • cerebrovascular disease
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2009)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identifying the Anti-Blood-Clotting Compounds in Garlic
Official Title  ICMJE Identification of the Antiplatelet Compounds of Garlic Ex Vivo
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Arteriosclerosis
  • Intracranial Arteriosclerosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Garlic powder in ambient water
    high allicin
    Intervention: Dietary Supplement: garlic powder added to ambient water
  • Experimental: garlic powder in boiling water
    no allicin
    Intervention: Dietary Supplement: garlic powder added to boiling water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2009)
9
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
8
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200785
Other Study ID Numbers  ICMJE R21AT001512-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry D. Lawson principal investigator, Silliker, Inc./Plant Bioactives Research Institute, Inc.
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Larry D. Lawson, PhD Silliker, Inc./Plant Bioactives Research Institute
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP