Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2005-07-31
2009-03-31
Brief Summary
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Detailed Description
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However, little is known about the way garlic supplements may interact with prescription medications when used simultaneously. This study will investigate four commonly used garlic supplements: garlic powder with a low content of allicin (a compound with antibacterial properties), garlic powder with a high allicin content, garlic oil, and aged garlic. The effects of these 4 garlic products on the drug-metabolizing enzyme cytochrome P450 (CYP) and a drug transporter, P-glycoprotein (Pgp) will be examined.
Participants will be randomly assigned to receive one of the four garlic supplements for 4 weeks. Drug probes of CYP and Pgp will be used to assess the in vivo activities of the substances. On the first day of garlic ingestion, blood collection will occur immediately after participants ingest their garlic supplement and 3, 4, and 6 hours after ingestion. Urine collection will occur immediately after participants' first garlic ingestion and 12, 15, and 72 hours after ingestion. Blood and urine collection will determine the concentration of the drug probes in the body, which will indicate changes in CYP and Pgp. Blood and urine tests will be repeated at the end of the study.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Garlic powder with high allicin content
Garlic powder with low allicin content
Garlic oil
Aged garlic
Eligibility Criteria
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Inclusion Criteria
* Able to read and understand English
* MUST LIVE WITHIN THE SEATTLE, WA AREA.
Exclusion Criteria
* History of cardiopulmonary, liver, renal or endocrine disease
* Allergy or sensitivity to any of the drugs that will be used in the probe cocktails or the garlic supplements
* Daily consumption of vegetables with a high allium content, including garlic, shallots, leeks, and chives
* Pregnancy or breastfeeding
18 Years
45 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Danny D. Shen, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1984.00
Identifier Type: -
Identifier Source: org_study_id
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