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)

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Arteriosclerosis; Intracranial Arteriosclerosis
• Interventions: Dietary Supplement: garlic powder added to ambient water; Dietary Supplement: garlic powder added to boiling water
• Enrollment: 9

Participant Flow

Recruitment Details	healthy participants were recruited in Utah county, Utah, in early 2006
Pre-assignment Details

Arm/Group Title	Garlic Powder: High Allicin	Garlic Powder: No Allicin
Arm/Group Description	garlic powder in ambient water	garlic powder in boiling water
Period Title: First Intervention
Started	9	6
Completed	9	6
Not Completed	0	0
Period Title: Washout Period of 1 Week
Started	9	6
Completed	9	6
Not Completed	0	0
Period Title: Second Intervention
Started	9	6
Completed	9	6
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Garlic Powder: High Allicin	Garlic Powder: No Allicin	Total
Arm/Group Description		garlic powder in ambient water	garlic powder in boiling water	Total of all reporting groups
Overall Number of Baseline Participants		9	6	15
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	6 participants	15 participants
	<=18 years	0 0.0%	0 0.0%	0.0
	Between 18 and 65 years	9 100.0%	6 100.0%	15.0
	>=65 years	0 0.0%	0 0.0%	0.0
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants	6 participants	15 participants
		32.2 (13.7)	36.5 (15.1)	32.2 (13.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	6 participants	15 participants
	Female	4 44.4%	3 50.0%	7.0
	Male	5 55.6%	3 50.0%	8.0
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	9 participants	6 participants	15 participants
		9	6	15
electrical impedance (ohms) at 0 weeks [1]; Mean (Standard Deviation); Unit of measure: Ohms
	Number Analyzed	9 participants	6 participants	15 participants
		12.7 (1.2)	15.0 (1.6)	13.9 (1.4)
		[1] Measure Description: collagen-induced platelet aggregation in whole blood (WB)
percent platelet aggregation at 0 weeks [1]; Mean (Standard Deviation); Unit of measure: Percent platelet aggregation
	Number Analyzed	9 participants	6 participants	15 participants
		76.0 (1.6)	71.8 (5.7)	73.9 (3.7)
		[1] Measure Description: collagen-induced aggregation in platelet-rich plasma (PRP)

Outcome Measures

1. Primary Outcome

Title	Percent Platelet Aggregation
Description	percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Garlic Powder: High Allicin	Garlic Powder: No Allicin
Arm/Group Description:	garlic powder in ambient water	garlic powder in boiling water
Overall Number of Participants Analyzed	9	6
Mean (Standard Deviation); Unit of Measure: percent platelet aggregation
	71.4 (4.3)	72.5 (5.5)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Nine persons participated in the "high allicin" test. Six of the same persons participated in the "no allicin" test.

Arm/Group Title	Garlic Powder: High Allicin	Garlic Powder: No Allicin
Arm/Group Description:	garlic powder in ambient water	garlic powder in boiling water
Overall Number of Participants Analyzed	9	6
Mean (Standard Deviation); Unit of Measure: ohms
	13.8 (1.5)	15.0 (1.5)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Garlic Powder: High Allicin	Garlic Powder: No Allicin
Arm/Group Description	garlic powder in ambient water	garlic powder in boiling water
All-Cause Mortality
	Garlic Powder: High Allicin	Garlic Powder: No Allicin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Garlic Powder: High Allicin	Garlic Powder: No Allicin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Garlic Powder: High Allicin	Garlic Powder: No Allicin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/6 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Larry D. Lawson
• Organization: Silliker, Inc./Plant Bioactives Research Institute, Inc.
• Phone: 801-226-3041
• EMail: larry.lawson@silliker.com

• 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 Submitted: September 12, 2005
• First Posted: September 20, 2005
• Results First Submitted: April 23, 2009
• Results First Posted: January 11, 2010
• Last Update Posted: January 11, 2010