The Effect of Aged Garlic Extract Supplementation on Immune System

• ClinicalTrials.gov Identifier: NCT01390116
• Recruitment Status: Completed
• First Posted: July 8, 2011
• Last Update Posted: November 13, 2013
• Sponsor: University of Florida
• Collaborator: Wakunaga Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Improvement in Immune Cell Function in Healthy Humans	Dietary Supplement: Aged garlic extract; Dietary Supplement: AGE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of Aged Garlic Extract Supplementation on Immune System
• Study Start Date: February 2010
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Physiological modifications to immune cell function [ Time Frame: 45 days ]
   The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.

Secondary Outcome Measures :

1. Cold and flu symptoms [ Time Frame: 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 OTC.
2. Cold and flu symptoms [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Florida

449 Food Science and Human Nutrition Department

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Wakunaga Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Susan S Percival, PhD; University of Florida

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01390116
• Other Study ID Numbers: AGE-84403
• First Posted: July 8, 2011
• Last Update Posted: November 13, 2013
• Last Verified: November 2013

Keywords provided by University of Florida:

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