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
|Condition or disease||Intervention/treatment||Phase|
|Improvement in Immune Cell Function in Healthy Humans||Dietary Supplement: Aged garlic extract Dietary Supplement: AGE||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|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|
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
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
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390116
|United States, Florida|
|449 Food Science and Human Nutrition Department|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Susan S Percival, PhD||University of Florida|