Trial record 5 of 5 for:    Garlic | NCCAM

Effects of Garlic Supplements on Drug Metabolism

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00122889
First received: July 20, 2005
Last updated: December 30, 2009
Last verified: December 2009
  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 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Garlic Metabolism and Cytochrome P450 Modulation

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Blood plasma and urine samples [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood plasma and breath samples. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, urine


Enrollment: 80
Study Start Date: July 2005
Study Completion Date: March 2009
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122889

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Danny D. Shen, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Danny Shen, PhD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00122889     History of Changes
Other Study ID Numbers: FHCRC-1984.00, R21 AT002712-01
Study First Received: July 20, 2005
Last Updated: December 30, 2009
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
Drug Interactions
Pharmacokinetics
Garlic
Complementary Therapies
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Allicin
Allyl sulfide
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs
Hypoglycemic Agents
Free Radical Scavengers
Anticarcinogenic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014