NCT00200785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 11, 2010

Completed
Last Updated

January 11, 2010

Status Verified

December 1, 2009

Enrollment Period

1.5 years

First QC Date

September 12, 2005

Results QC Date

April 23, 2009

Last Update Submit

December 4, 2009

Conditions

ArteriosclerosisIntracranial Arteriosclerosis

Keywords

garlic

Outcome Measures

Primary Outcomes (1)

  • Percent Platelet Aggregation

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

    4 weeks

Secondary Outcomes (1)

  • Electrical Impedance in Ohms

    4 weeks

Study Arms (2)

Garlic powder in ambient water

ACTIVE COMPARATOR

high allicin

Dietary Supplement: garlic powder added to ambient water

garlic powder in boiling water

EXPERIMENTAL

no allicin

Dietary Supplement: garlic powder added to boiling water

Interventions

garlic powder added to ambient waterDIETARY_SUPPLEMENT

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

Also known as: Global Marketing Assoc., Inc.
Garlic powder in ambient water
garlic powder added to boiling waterDIETARY_SUPPLEMENT

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

Also known as: Global Marketing Assoc., Inc.
garlic powder in boiling water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breast-feeding
  • Serious medical condition
  • Allergy to garlic or wheat
  • Tobacco use
  • Excessive alcohol consumption
  • Under psychiatric care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silliker, Inc./Plant Bioactives Research Institute

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

ArteriosclerosisIntracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

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

Study Officials

  • Larry D. Lawson, PhD

    Silliker, Inc./Plant Bioactives Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 11, 2010

Results First Posted

January 11, 2010

Record last verified: 2009-12

Locations

US(1)