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Effects of Garlic Supplements On Drug Metabolism - Article


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Sodium Bicarbonate Powder

Baking Soda; Citrocarbonate 




Clinical Trial: Effects of Garlic Supplements On Drug Metabolism

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

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 IV

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Cross-Sectional, Convenience Sample, Prospective Study

Official Title: Garlic Metabolism and Cytochrome P450 Modulation

Further Study Details: 

Expected Total Enrollment:  80

Study start: July 2005;  Expected completion: February 2009
Last follow-up: July 2008;  Data entry closure: August 2008

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   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 20 and 32
  • Able to read and understand English

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00122889

Megan Kelton-Rehkopf, MA       mkeltonr@fhcrc.org

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States
Megan Kelton-Rehkopf, MA  206-667-6242    mkeltonr@fhcrc.org 
Danny D. Shen, PhD,  Principal Investigator

Study chairs or principal investigators

Danny D. Shen, PhD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

More Information

Study ID Numbers:  AT002712
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122889
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26

Resources



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November 25, 2009



Page Updated: June 1, 2005
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