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Identifying the Anti-Blood-Clotting Compounds in Garlic

Primary Purpose

Arteriosclerosis, Intracranial Arteriosclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
garlic powder added to ambient water
garlic powder added to boiling water
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arteriosclerosis focused on measuring garlic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Silliker, Inc./Plant Bioactives Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Garlic powder in ambient water

garlic powder in boiling water

Arm Description

high allicin

no allicin

Outcomes

Primary Outcome Measures

Percent Platelet Aggregation
percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)

Secondary Outcome Measures

Electrical Impedance in Ohms
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.

Full Information

First Posted
September 12, 2005
Last Updated
December 4, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00200785
Brief Title
Identifying the Anti-Blood-Clotting Compounds in Garlic
Official Title
Identification of the Antiplatelet Compounds of Garlic Ex Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis, Intracranial Arteriosclerosis
Keywords
garlic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Garlic powder in ambient water
Arm Type
Active Comparator
Arm Description
high allicin
Arm Title
garlic powder in boiling water
Arm Type
Experimental
Arm Description
no allicin
Intervention Type
Dietary Supplement
Intervention Name(s)
garlic powder added to ambient water
Other Intervention Name(s)
Global Marketing Assoc., Inc.
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
garlic powder added to boiling water
Other Intervention Name(s)
Global Marketing Assoc., Inc.
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent Platelet Aggregation
Description
percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Electrical Impedance in Ohms
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry D. Lawson, PhD
Organizational Affiliation
Silliker, Inc./Plant Bioactives Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silliker, Inc./Plant Bioactives Research Institute
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States

12. IPD Sharing Statement

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Identifying the Anti-Blood-Clotting Compounds in Garlic

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