Clinical trial NCT01390116: The Effect of Aged Garlic Extract Supplementation on Immune System
Official title: The Effect of Aged Garlic Extract Supplementation on Immune System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement in Immune Cell Function in Healthy Humans
Keywords: gamma delta T cell
natural killer cell
proliferation
cytokine secretion
Improvement in immune cell function in healthy humans
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2011-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Physiological modifications to immune cell function
timeFrame: 45 days
Secondary outcomes:
measure: Cold and flu symptoms
timeFrame: 90 days
measure: Cold and flu symptoms
timeFrame: 90 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: 449 Food Science and Human Nutrition Department
state: Florida
Study officials:
affiliation: University of Florida
name: Susan S Percival, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.