Effects of Garlic Supplements on Drug Metabolism
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Purpose
This study will determine whether garlic supplements affect the way certain drugs are processed in the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Garlic powder with high allicin content Drug: Garlic powder with low allicin content Drug: Garlic oil Drug: Aged garlic |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Garlic Metabolism and Cytochrome P450 Modulation |
- Blood plasma and urine samples [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Blood plasma and breath samples. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, urine
| Enrollment: | 80 |
| Study Start Date: | July 2005 |
| Study Completion Date: | March 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Healthy volunteers
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
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Danny D. Shen, PhD | Fred Hutchinson Cancer Research Center |
More Information
No publications provided
| Responsible Party: | Danny Shen, PhD, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00122889 History of Changes |
| Other Study ID Numbers: | FHCRC-1984.00, R21 AT002712-01 |
| Study First Received: | July 20, 2005 |
| Last Updated: | December 30, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
Drug Interactions Pharmacokinetics Garlic Complementary Therapies Complementary and Alternative Medicine |
Additional relevant MeSH terms:
|
Allicin Allyl sulfide Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Lipid Regulating Agents Antioxidants Protective Agents Physiological Effects of Drugs Hypoglycemic Agents Free Radical Scavengers Anticarcinogenic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013