Effects of Garlic Supplements on Drug Metabolism

NCT ID: NCT00122889

Last Updated: 2010-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-03-31

Brief Summary

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This study will determine whether garlic supplements affect the way certain drugs are processed in the body.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Garlic powder with high allicin content

Intervention Type DRUG

Garlic powder with low allicin content

Intervention Type DRUG

Garlic oil

Intervention Type DRUG

Aged garlic

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Danny D. Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT002712-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHCRC-1984.00

Identifier Type: -

Identifier Source: org_study_id

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