Clinical trial NCT00122889: Effects of Garlic Supplements on Drug Metabolism
Official title: Garlic Metabolism and Cytochrome P450 Modulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Drug Interactions
Pharmacokinetics
Garlic
Complementary Therapies
Complementary and Alternative Medicine
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood plasma and urine samples
timeFrame: 3 months
Secondary outcomes:
measure: Blood plasma and breath samples.
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Danny D. Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: