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Completed

NCT Number: NCT00122889

Effects of Garlic Supplements on Drug Metabolism

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garlic powder with high allicin content

Drug

Garlic powder with low allicin content

Drug

Garlic oil

Drug

Aged garlic

Drug

Primary outcomes

  1. Blood plasma and urine samples

    Time frame: 3 months

Secondary outcomes

  1. Blood plasma and breath samples.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Garlic Metabolism and Cytochrome P450 Modulation

Important dates

Study start
2005
Study completion
2009
First posted
Jul 22, 2005
Registry last updated
Jan 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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