Allicin Bioavailability From Garlic Supplements and Garlic Foods

November 18, 2009 updated by: Silliker, Inc.

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

Unknown

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

Interventional

Enrollment (Anticipated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Orem, Utah, United States, 84058
        • Silliker, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Silliker, Inc.

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

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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