Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122889
Status:
COMPLETED
Last Update Posted:
2010-01-01
First Post:
2005-07-20
Brief Title:
Effects of Garlic Supplements on Drug Metabolism
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Garlic Metabolism and Cytochrome P450 Modulation
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether garlic supplements affect the way certain drugs are processed in the body
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002712-01 | NIH | None | httpsreporternihgovquickSearchR21AT002712-01 |