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Allicin Bioavailability From Garlic Supplements and Garlic Foods

Sponsor
Silliker, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00874666
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
12
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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 how garlic can be prepared to obtain any established health benefits of garlic.

Condition or Disease Intervention/Treatment Phase
  • Other: crushed garlic clove
  • Dietary Supplement: garlic powder tablet
 Early Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Allicin Bioavailability of Garlic Products
Study Start Date :
Apr 1, 2009
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Positive control with 100% allicin bioavailability

Other: crushed garlic clove
1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks
Other Names:
  • Allium sativum

    		•
    Experimental: 2

    garlic powder tablet

    Dietary Supplement: 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:
  • Kwai, Garlique

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Breath allyl methyl sulfide [1-32 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Silliker, Inc. Orem Utah United States 84058

    Sponsors and Collaborators

    • Silliker, Inc.
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Larry D Lawson, Ph. D., Silliker, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00874666
    Other Study ID Numbers:
    • R21AT004236
    • R21AT004236
    • 1R21AT004236-01
    First Posted:
    Apr 2, 2009
    Last Update Posted:
    Nov 20, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    garlic
    allicin
    allyl methyl sulfide
    healthy persons

    Study Results

    No Results Posted as of Nov 20, 2009