Allicin Bioavailability From Garlic Supplements and Garlic Foods

NCT ID: NCT00874666

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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

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Healthy

Keywords

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garlic allicin allyl methyl sulfide healthy persons

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Positive control with 100% allicin bioavailability

Group Type ACTIVE_COMPARATOR

crushed garlic clove

Intervention Type OTHER

1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks

2

garlic powder tablet

Group Type EXPERIMENTAL

garlic powder tablet

Intervention Type DIETARY_SUPPLEMENT

tablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks

Interventions

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crushed garlic clove

1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks

Intervention Type OTHER

garlic powder tablet

tablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Allium sativum Kwai, Garlique

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Silliker, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Silliker, Inc.

Principal Investigators

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Larry D Lawson, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Silliker, Inc.

Locations

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Silliker, Inc.

Orem, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT004236

Identifier Type: NIH

Identifier Source: secondary_id

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1R21AT004236-01

Identifier Type: NIH

Identifier Source: secondary_id

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R21AT004236

Identifier Type: NIH

Identifier Source: org_study_id

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