- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874666
Allicin Bioavailability From Garlic Supplements and Garlic Foods
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Utah
-
Orem, Utah, United States, 84058
- Silliker, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Positive control with 100% allicin bioavailability
|
1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks
Other Names:
|
Experimental: 2
garlic powder tablet
|
tablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Breath allyl methyl sulfide
Time Frame: 1-32 hours
|
1-32 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Larry D Lawson, Ph. D., Silliker, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21AT004236 (U.S. NIH Grant/Contract)
- 1R21AT004236-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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