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CompletedNCT00122889Updated Jan 1, 2010

Effects of Garlic Supplements on Drug Metabolism

An observational study in Healthy, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-01.

Sponsored by Fred Hutchinson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Drug Interactions
  • Pharmacokinetics
  • Garlic
  • Complementary Therapies
  • Complementary and Alternative Medicine
03

In context

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • DrugGarlic powder with high allicin content
  • DrugGarlic powder with low allicin content
  • DrugGarlic oil
  • DrugAged garlic
06

What researchers measure

Primary outcomes

  1. Blood plasma and urine samples

    Time frame: 3 months

Secondary outcomes

  1. Blood plasma and breath samples.

    Time frame: 3 months

07

Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00122889
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
First posted
Jul 22, 2005
Start date
Jul 2005
Completion
Mar 2009
Last update
Jan 1, 2010

Study contacts

Danny D. Shen, PhD
principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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