Allicin Bioavailability From Garlic Supplements and Garlic Foods

NCT00874666 | Unknown Early Phase 1 DMC

• 2 other identifiers: R21AT0042361R21AT004236-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

garlic; allicin; allyl methyl sulfide; healthy persons

Outcome Measures

Primary Outcomes (1)

• Breath allyl methyl sulfide

  1-32 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Positive control with 100% allicin bioavailability

Other: crushed garlic clove

2

EXPERIMENTAL

garlic powder tablet

Dietary Supplement: garlic powder tablet

Interventions

crushed garlic clove OTHER

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

Also known as: Allium sativum

1

garlic powder tablet DIETARY_SUPPLEMENT

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

Also known as: Kwai, Garlique

2

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Silliker, Inc.

Orem, Utah, 84058, United States

Location

Study Officials

• Larry D Lawson, Ph. D.

  Silliker, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 20, 2009

Record last verified: 2009-11

Locations

US (1)