The Effect of Aged Garlic Extract Supplementation on Immune System

This study has been completed.
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01390116
First received: July 5, 2011
Last updated: November 12, 2013
Last verified: November 2013

July 5, 2011
November 12, 2013
February 2010
May 2010   (final data collection date for primary outcome measure)
Physiological modifications to immune cell function [ Time Frame: 45 days ] [ Designated as safety issue: No ]
The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.
Same as current
Complete list of historical versions of study NCT01390116 on ClinicalTrials.gov Archive Site
  • Cold and flu symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Cold and flu symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
The Effect of Aged Garlic Extract Supplementation on Immune System
The Effect of Aged Garlic Extract Supplementation on Immune System

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Improvement in Immune Cell Function in Healthy Humans
  • Dietary Supplement: Aged garlic extract
    2 aged garlic extract capsules taken twice daily
    Other Name: AGE
  • Dietary Supplement: AGE
    encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
    Other Name: Kyolic
  • Placebo Comparator: Sugar pill
    looks like and is given in the same way as the experimental treatment but contains no active ingredient
    Intervention: Dietary Supplement: Aged garlic extract
  • Experimental: AGE
    Encapsulated aged garlic extract, 4 capsules per day, 2.56 g/day
    Intervention: Dietary Supplement: AGE
Nantz MP, Rowe CA, Muller CE, Creasy RA, Stanilka JM, Percival SS. Supplementation with aged garlic extract improves both NK and γδ-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01390116
AGE-84403
No
University of Florida
University of Florida
Wakunaga Pharmaceutical Co., Ltd.
Principal Investigator: Susan S Percival, PhD University of Florida
University of Florida
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP