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The Effect of Aged Garlic Extract Supplementation on Immune System

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StatusZavršeno
Sponzori
University of Florida
Saradnici
Wakunaga Pharmaceutical Co., Ltd.

Ključne riječi

Sažetak

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.

Opis

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.

Datumi

Posljednja provjera: 10/31/2013
Prvo podneseno: 07/04/2011
Predviđena prijava predata: 07/05/2011
Prvo objavljeno: 07/07/2011
Zadnje ažuriranje poslato: 11/11/2013
Posljednje ažuriranje objavljeno: 11/12/2013
Stvarni datum početka studija: 01/31/2010
Procijenjeni datum primarnog završetka: 04/30/2010
Predviđeni datum završetka studije: 04/30/2010

Stanje ili bolest

Improvement in Immune Cell Function in Healthy Humans

Intervencija / liječenje

Dietary Supplement: Sugar pill

Dietary Supplement: AGE

Faza

-

Grupe ruku

ArmIntervencija / liječenje
Placebo Comparator: Sugar pill
looks like and is given in the same way as the experimental treatment but contains no active ingredient
Dietary Supplement: Sugar pill
2 aged garlic extract capsules taken twice daily
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

Kriteriji prihvatljivosti

Uzrast podoban za studiranje 18 Years To 18 Years
Polovi podobni za studiranjeAll
Prihvaća zdrave volontereDa
Kriterijumi

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

Ishod

Primarne mjere ishoda

1. Physiological modifications to immune cell function [45 days]

The ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo.

Sekundarne mjere ishoda

1. Cold and flu symptoms [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 [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).

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