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The Effect of Aged Garlic Extract Supplementation on Immune System

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EstadoTerminado
Patrocinadores
University of Florida
Colaboradores
Wakunaga Pharmaceutical Co., Ltd.

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez: 10/31/2013
Primero enviado: 07/04/2011
Inscripción estimada enviada: 07/05/2011
Publicado por primera vez: 07/07/2011
Última actualización enviada: 11/11/2013
Última actualización publicada: 11/12/2013
Fecha de inicio real del estudio: 01/31/2010
Fecha estimada de finalización primaria: 04/30/2010
Fecha estimada de finalización del estudio: 04/30/2010

Condición o enfermedad

Improvement in Immune Cell Function in Healthy Humans

Intervención / tratamiento

Dietary Supplement: Sugar pill

Dietary Supplement: AGE

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
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

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

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

Salir

Medidas de resultado primarias

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.

Medidas de resultado secundarias

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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