HealthyEarly Phase 1NCT00874666
Allicin Bioavailability From Garlic Supplements and Garlic Foods
A Early Phase 1 study testing crushed garlic clove and garlic powder tablet in people with Healthy, run by Silliker, Inc. at 1 site in United States.
Trial summary
This study will measure the bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods (raw, cooked, processed) so that supplement manufacturers and clinical investigators know how supplements need to be made and consumed to obtain high bioavailability consumers can know… Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- crushed garlic clove and garlic powder tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2011
- Phase
- Early Phase 1
- 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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in good health (self-judged)
- BMI (body mass index): 19-32 kg/m2
- not planning to move out of the area in the next year
- willing to abstain from consuming garlic and onion and foods that contain them for two days prior to and during each test (diet restrictions)
- able to deliver bags of breath to the research facility five times in two days
- willing to eat whole wheat tuna sandwiches
Who cannot join
- known serious health problems: diabetes, heart disease, active neoplasms, renal or liver disease, hyper- or hypothyroidism, breathing disorders, gastroesophageal reflux disease (GERD), gastrointestinal disease (absorption interference)
- known allergy to garlic or wheat
- tobacco user
- excessive alcohol intake (³2 drinks/day, self-reported)
- unable to speak English well
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allicin Bioavailability of Garlic Products
This study will measure the bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods (raw, cooked, processed) so that
- supplement manufacturers and clinical investigators know how supplements need to be made and consumed to obtain high bioavailability
- consumers can know how garlic can be prepared to obtain any established health benefits of garlic.
Read the detailed description
The bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods is highly questionable and unpredictable from in vitro tests, due to dependence upon alliinase activity under conditions that challenge alliinase activity (heat, gastric acid, intestinal proteases). It is likely that garlic supplement manufacturing procedures and coatings, meal conditions when supplements are consumed (high or low protein), and garlic food preparation conditions (temperature, surface area) will greatly affect allicin bioavailability. Such variability may account for some of the many conflicts seen in clinical trials on cardiovascular disease risk factors.
To resolve these issues, this study will determine the actual bioavailability of allicin from several types of garlic supplements and garlic foods under various conditions. Bioavailability will be determined by measuring the area under the 32-hour curve for breath concentrations of allyl methyl sulfide, the main metabolite allicin.
- Conditions
- Healthy
- Being tested
- crushed garlic clove, garlic powder tablet
- Keywords
- garlic, allicin, allyl methyl sulfide, healthy persons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crushed garlic cloveOther
Also called Allium sativum
1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks
garlic powder tabletDietary supplement
Also called Kwai, Garlique
tablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Positive control with 100% allicin bioavailability Receives: Other: crushed garlic clove |
| 2 | Experimental | garlic powder tablet Receives: Dietary Supplement: garlic powder tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath allyl methyl sulfide
Measured: 1-32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
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.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silliker, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Larry D Lawson, Ph. D., Principal investigator, Silliker, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874666
- Sponsor's protocol ID
- R21AT004236
- Other IDs
- R21AT004236, 1R21AT004236-01
- Status last verified
- Nov 2009
- First submitted
- 1 Apr 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allicin Bioavailability of Garlic Products
- ClinicalTrials.gov ID
- NCT00874666
- Acronym / sponsor ID
- R21AT004236
- Conditions
- Healthy
- Keywords
- garlic, allicin, allyl methyl sulfide, healthy persons
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Silliker, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 2 Apr 2009 (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 measure the bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods (raw, cooked, processed) so that
- supplement manufacturers and clinical investigators know how supplements need to be made and consumed to obtain high bioavailability
- consumers can know how garlic can be prepared to obtain any established health benefits of garlic.
Detailed description
The bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods is highly questionable and unpredictable from in vitro tests, due to dependence upon alliinase activity under conditions that challenge alliinase activity (heat, gastric acid, intestinal proteases). It is likely that garlic supplement manufacturing procedures and coatings, meal conditions when supplements are consumed (high or low protein), and garlic food preparation conditions (temperature, surface area) will greatly affect allicin bioavailability. Such variability may account for some of the many conflicts seen in clinical trials on cardiovascular disease risk factors.
To resolve these issues, this study will determine the actual bioavailability of allicin from several types of garlic supplements and garlic foods under various conditions. Bioavailability will be determined by measuring the area under the 32-hour curve for breath concentrations of allyl methyl sulfide, the main metabolite allicin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: crushed garlic clovePositive control with 100% allicin bioavailability |
| 2 | Experimental | Dietary Supplement: garlic powder tabletgarlic powder tablet |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- in good health (self-judged)
- BMI (body mass index): 19-32 kg/m2
- not planning to move out of the area in the next year
- willing to abstain from consuming garlic and onion and foods that contain them for two days prior to and during each test (diet restrictions)
- able to deliver bags of breath to the research facility five times in two days
Key exclusion criteria (5 listed)
- known serious health problems: diabetes, heart disease, active neoplasms, renal or liver disease, hyper- or hypothyroidism, breathing disorders, gastroesophageal reflux disease (GERD), gastrointestinal disease (absorption interference)
- known allergy to garlic or wheat
- tobacco user
- excessive alcohol intake (³2 drinks/day, self-reported)
- unable to speak English well
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 |
|---|---|---|
| crushed garlic cloveAlso: Allium sativum1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks | Other | 1 |
| garlic powder tabletAlso: Kwai, Garliquetablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks | Dietary supplement | 2 |
Primary outcome
Breath allyl methyl sulfide
Time frame: 1-32 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
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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.
Larry D Lawson, Ph. D. principal investigator
Silliker, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing crushed garlic clove and garlic powder tablet in people with Healthy, run by Silliker, Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 20 Nov 2009. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Breath allyl methyl sulfide (time frame: 1-32 hours). 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 20 Nov 2009.