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The Effect of Aged Garlic Extract Supplementation on Immune System

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Länken sparas på Urklipp
StatusAvslutad
Sponsorer
University of Florida
Samarbetare
Wakunaga Pharmaceutical Co., Ltd.

Nyckelord

Abstrakt

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.

Beskrivning

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.

Datum

Senast verifierad: 10/31/2013
Först skickat: 07/04/2011
Beräknad anmälan inlämnad: 07/05/2011
Först publicerad: 07/07/2011
Senaste uppdatering skickad: 11/11/2013
Senaste uppdatering publicerad: 11/12/2013
Faktiskt startdatum för studien: 01/31/2010
Uppskattat primärt slutdatum: 04/30/2010
Beräknat slutfört datum: 04/30/2010

Tillstånd eller sjukdom

Improvement in Immune Cell Function in Healthy Humans

Intervention / behandling

Dietary Supplement: Sugar pill

Dietary Supplement: AGE

Fas

-

Armgrupper

ÄrmIntervention / behandling
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

Urvalskriterier

Åldrar berättigade till studier 18 Years Till 18 Years
Kön som är berättigade till studierAll
Accepterar friska volontärerJa
Kriterier

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

Resultat

Primära resultatåtgärder

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.

Sekundära resultatåtgärder

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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