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The Effect of Aged Garlic Extract Supplementation on Immune System

NCT ID: NCT01390116

Last Updated: 2013-11-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to determine whether consuming capsules of aged garlic extract is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu symptoms.

Detailed Description

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A non-therapeutic intervention study is described. The Aged Garlic Extract (AGE) supplement (and placebo) intervention occurs over a total of 90 days between mid-January to March. The CDC indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm ). Blood is taken at baseline and at 45 days, 2 hours after they have taken their capsule. Capsule consumption will continue for a total of 90 days in order to continue monitoring cold and flu symptoms. Subjects will be given a diary to keep a record of their cold and flu symptoms. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured in autologous serum for 24 hours or cultured in autologous serum for 10 days. Freshly isolated cells will be used for glutathione analysis, for protection against induced DNA strand breaks, and for γδ T cell and NK cell numbers. The supernatant of 24 hour cultures will be used for cytokine determination, specifically, interferon-g, tumor necrosis factor-a and IL-12. Cells cultured for 10 days will be used to determine the rate of proliferation. If cells have been primed by AGE, we expect the AGE cells to proliferate to a greater extent and have greater cytokine secretion compared to placebo.

If AGE enhances the function of one or both of these cell types (NK or γδ T cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the supplement.

Conditions

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Improvement in Immune Cell Function in Healthy Humans

Keywords

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gamma delta T cell natural killer cell proliferation cytokine secretion Improvement in immune cell function in healthy humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugar pill

looks like and is given in the same way as the experimental treatment but contains no active ingredient

Group Type PLACEBO_COMPARATOR

Aged garlic extract

Intervention Type DIETARY_SUPPLEMENT

2 aged garlic extract capsules taken twice daily

AGE

Encapsulated aged garlic extract, 4 capsules per day, 2.56 g/day

Group Type EXPERIMENTAL

AGE

Intervention Type DIETARY_SUPPLEMENT

encapsulated aged garlic extract, 4 capsules per day, 2.56g/day

Interventions

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Aged garlic extract

2 aged garlic extract capsules taken twice daily

Intervention Type DIETARY_SUPPLEMENT

AGE

encapsulated aged garlic extract, 4 capsules per day, 2.56g/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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AGE Kyolic

Eligibility Criteria

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Inclusion Criteria

* Healthy male or non-pregnant female
* Between the ages of 21 and 50
* BMI between 18 and 35

Exclusion Criteria

* High blood pressure defined as 140/90
* Ongoing or chronic illness or infection
* On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
* Taking dietary supplements other than those with "normal" levels of vitamins and minerals
* Consumes more than 2 glasses of alcoholic beverages per day
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wakunaga Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan S Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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449 Food Science and Human Nutrition Department

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Percival SS. Aged Garlic Extract Modifies Human Immunity. J Nutr. 2016 Feb;146(2):433S-436S. doi: 10.3945/jn.115.210427. Epub 2016 Jan 13.

Reference Type DERIVED
PMID: 26764332 (View on PubMed)

Nantz MP, Rowe CA, Muller CE, Creasy RA, Stanilka JM, Percival SS. Supplementation with aged garlic extract improves both NK and gammadelta-T cell function and reduces the severity of cold and flu symptoms: a randomized, double-blind, placebo-controlled nutrition intervention. Clin Nutr. 2012 Jun;31(3):337-44. doi: 10.1016/j.clnu.2011.11.019. Epub 2012 Jan 24.

Reference Type DERIVED
PMID: 22280901 (View on PubMed)

Other Identifiers

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AGE-84403

Identifier Type: -

Identifier Source: org_study_id