- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00122889
Effects of Garlic Supplements on Drug Metabolism
Garlic Metabolism and Cytochrome P450 Modulation
Study Overview
Status
Conditions
Detailed Description
Garlic supplements, which are often used to lower cholesterol and prevent cancer, are one of the most commonly used herbal products in the United States.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Body mass index (BMI) between 20 and 32
- Able to read and understand English
- MUST LIVE WITHIN THE SEATTLE, WA AREA.
Exclusion Criteria:
- Current use of herbal medicines other than oral contraceptives
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood plasma and urine samples
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood plasma and breath samples.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danny D. Shen, PhD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antioxidants
- Free Radical Scavengers
- Anticarcinogenic Agents
- Allicin
- Allyl sulfide
Other Study ID Numbers
- FHCRC-1984.00
- R21AT002712-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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