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
  Purpose

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 Intervention
Improvement in Immune Cell Function in Healthy Humans
Dietary Supplement: Aged garlic extract
Dietary Supplement: AGE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Aged Garlic Extract Supplementation on Immune System

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 120
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390116

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

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01390116     History of Changes
Other Study ID Numbers: AGE-84403
Study First Received: July 5, 2011
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
gamma delta T cell
natural killer cell
proliferation
cytokine secretion
Improvement in immune cell function in healthy humans

ClinicalTrials.gov processed this record on October 23, 2014