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The Effect of Aged Garlic Extract Supplementation on Immune System

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赞助商
University of Florida
合作者
Wakunaga Pharmaceutical Co., Ltd.

关键词

抽象

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.

描述

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.

日期

最后验证: 10/31/2013
首次提交: 07/04/2011
提交的预估入学人数: 07/05/2011
首次发布: 07/07/2011
上次提交的更新: 11/11/2013
最近更新发布: 11/12/2013
实际学习开始日期: 01/31/2010
预计主要完成日期: 04/30/2010
预计完成日期: 04/30/2010

状况或疾病

Improvement in Immune Cell Function in Healthy Humans

干预/治疗

Dietary Supplement: Sugar pill

Dietary Supplement: AGE

-

手臂组

干预/治疗
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

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

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

结果

主要结果指标

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.

次要成果指标

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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