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Completed

NCT Number: NCT01390116

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

449 Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aged Garlic Extract

Dietary Supplement

2 aged garlic extract capsules taken twice daily

Other names: AGE

AGE

Dietary Supplement

encapsulated aged garlic extract, 4 capsules per day, 2.56g/day

Other names: Kyolic

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2011
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.