Effects of Garlic Supplements on Drug Metabolism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00122889|
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : January 1, 2010
|Condition or disease||Intervention/treatment|
|Healthy||Drug: Garlic powder with high allicin content Drug: Garlic powder with low allicin content Drug: Garlic oil Drug: Aged garlic|
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 :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Garlic Metabolism and Cytochrome P450 Modulation|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||March 2009|
- Blood plasma and urine samples [ Time Frame: 3 months ]
- Blood plasma and breath samples. [ Time Frame: 3 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122889
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Danny D. Shen, PhD||Fred Hutchinson Cancer Research Center|