The Effect of Aged Garlic Extract Supplementation on Immune System

Study Overview
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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.

Official Title
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The Effect of Aged Garlic Extract Supplementation on Immune System

Conditions
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Improvement in Immune Cell Function in Healthy Humans

Intervention / Treatment
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* Dietary Supplement: Aged garlic extract
* Dietary Supplement: AGE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br>looks like and is given in the same way as the experimental treatment but contains no active ingredient | Dietary Supplement: Aged garlic extract<br>* 2 aged garlic extract capsules taken twice daily<br>* Other names: AGE;|
| Experimental: AGE<br>Encapsulated aged garlic extract, 4 capsules per day, 2.56 g/day | Dietary Supplement: AGE<br>* encapsulated aged garlic extract, 4 capsules per day, 2.56g/day<br>* Other names: Kyolic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological modifications to immune cell function | The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo. | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold and flu symptoms | Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, medications prescribed or purchased OTC. | 90 days | 
| Cold and flu symptoms | Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, medications prescribed or purchased Over the Counter (OTC). | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gamma delta T cell, natural killer cell, proliferation, cytokine secretion, Improvement in immune cell function in healthy humans