Improvement in Immune Cell Function in Healthy Humans
Conditions
Keywords
gamma delta T cell, natural killer cell, proliferation, cytokine secretion, Improvement in immune cell function in healthy humans
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAged garlic extract
2 aged garlic extract capsules taken twice daily
DIETARY_SUPPLEMENTAGE
encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
Sponsors
Wakunaga Pharmaceutical Co., Ltd.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed