HealthyNCT00122889
Effects of Garlic Supplements on Drug Metabolism
An observational study of Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This study will determine whether garlic supplements affect the way certain drugs are processed in the body. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Garlic powder with high allicin content, Garlic powder with low allicin content and Garlic oil
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Body mass index (BMI) between 20 and 32
- Able to read and understand English
- MUST LIVE WITHIN THE SEATTLE, WA AREA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Garlic Metabolism and Cytochrome P450 Modulation
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.
- Conditions
- Healthy
- Being tested
- Garlic powder with high allicin content, Garlic powder with low allicin content, Garlic oil, Aged garlic
- Keywords
- Drug Interactions, Pharmacokinetics, Garlic, Complementary Therapies, Complementary and Alternative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic powder with high allicin contentDrug
Garlic powder with low allicin contentDrug
Garlic oilDrug
Aged garlicDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood plasma and urine samples
Measured: 3 months
Secondary outcomes (1)
Blood plasma and breath samples.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJul 2005
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Danny D. Shen, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122889
- Sponsor's protocol ID
- FHCRC-1984.00
- Other IDs
- R21AT002712-01
- Status last verified
- Dec 2009
- First submitted
- 20 Jul 2005
- Last updated
- 1 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Garlic Metabolism and Cytochrome P450 Modulation
- ClinicalTrials.gov ID
- NCT00122889
- Acronym / sponsor ID
- FHCRC-1984.00
- Conditions
- Healthy
- Keywords
- Drug Interactions, Pharmacokinetics, Garlic, Complementary Therapies, Complementary and Alternative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2005
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether garlic supplements affect the way certain drugs are processed in the body.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 20 and 32
- Able to read and understand English
- MUST LIVE WITHIN THE SEATTLE, WA AREA.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic powder with high allicin content | Drug | – |
| Garlic powder with low allicin content | Drug | – |
| Garlic oil | Drug | – |
| Aged garlic | Drug | – |
Primary outcome
Blood plasma and urine samples
Time frame: 3 months
1 secondary outcome
Blood plasma and breath samples.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny D. Shen, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood plasma and urine samples (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2010.