The Effect of Aged Garlic Extract Supplementation on Immune System
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
| Zuletzt überprüft: | 10/31/2013 |
| Zuerst eingereicht: | 07/04/2011 |
| Geschätzte Einschreibung eingereicht: | 07/05/2011 |
| Zuerst veröffentlicht: | 07/07/2011 |
| Letztes eingereichtes Update: | 11/11/2013 |
| Letztes Update veröffentlicht: | 11/12/2013 |
| Tatsächliches Startdatum der Studie: | 01/31/2010 |
| Geschätztes primäres Abschlussdatum: | 04/30/2010 |
| Voraussichtliches Abschlussdatum der Studie: | 04/30/2010 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: Sugar pill
Dietary Supplement: AGE
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| 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 |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 |
Ergebnis
Primäre Ergebnismaße
1. Physiological modifications to immune cell function [45 days]
Sekundäre Ergebnismaße
1. Cold and flu symptoms [90 days]
2. Cold and flu symptoms [90 days]
