The Effect of Aged Garlic Extract Supplementation on Immune System

Not Applicable

Completed

• Conditions: Improvement in Immune Cell Function in Healthy Humans
• Interventions: Dietary Supplement: Aged garlic extract; Dietary Supplement: AGE

• Registration Number: NCT01390116
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Aged garlic extract	looks like and is given in the same way as the experimental treatment but contains no active ingredient
AGE	AGE	Encapsulated aged garlic extract, 4 capsules per day, 2.56 g/day

Primary Outcome Measures

Name	Time	Method
Physiological modifications to immune cell function	45 days	The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.

Secondary Outcome Measures

Name	Time	Method
Cold and flu symptoms	90 days	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).

Trial Locations

Locations (1)

449 Food Science and Human Nutrition Department; 🇺🇸 Gainesville, Florida, United States