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Allicin Bioavailability From Garlic Supplements and Garlic Foods

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Silliker, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
Silliker, Inc.
ClinicalTrials.gov Identifier:
NCT00874666
First received: April 1, 2009
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Other: crushed garlic clove
Dietary Supplement: garlic powder tablet
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Allicin Bioavailability of Garlic Products

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Silliker, Inc.:

Primary Outcome Measures:
  • Breath allyl methyl sulfide [ Time Frame: 1-32 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Kwai, Garlique

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874666

Locations
United States, Utah
Silliker, Inc.
Orem, Utah, United States, 84058
Sponsors and Collaborators
Silliker, Inc.
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Larry D Lawson, Ph. D. Silliker, Inc.
  More Information

No publications provided

Responsible Party: Larry D. Lawson, principal investigator, Silliker, Inc.
ClinicalTrials.gov Identifier: NCT00874666     History of Changes
Other Study ID Numbers: R21 AT004236, R21AT004236, 1R21 AT004236-01
Study First Received: April 1, 2009
Last Updated: November 18, 2009
Health Authority: United States: Federal Government

Keywords provided by Silliker, Inc.:
garlic
allicin
allyl methyl sulfide
healthy persons

Additional relevant MeSH terms:
Allicin
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

ClinicalTrials.gov processed this record on May 22, 2013