Identifying the Anti-Blood-Clotting Compounds in Garlic

• 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: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by: National Center for Complementary and Integrative Health (NCCIH)

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 20, 2005
• Results First Submitted Date: April 23, 2009
• Results First Posted Date: January 11, 2010
• Last Update Posted Date: January 11, 2010
• Study Start Date: March 2006
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 12, 2005)

• cardiovascular disease
• cerebrovascular disease

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Identifying the Anti-Blood-Clotting Compounds in Garlic
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Arteriosclerosis
• Intracranial Arteriosclerosis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2009): 9
• Original Enrollment (submitted: September 12, 2005): 8
• Actual Study Completion Date: September 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00200785
• Other Study ID Numbers: R21AT001512-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Larry D. Lawson principal investigator, Silliker, Inc./Plant Bioactives Research Institute, Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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