Improvement in Immune Cell Function in Elderly Humans Clinical Trial
Official title:
Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.
The long term goal of this investigation is to understand how food components improve immune
function, both in its ability to respond to pathogens and its ability to turn off when the
response is no longer needed. The goal of this application is to examine mechanisms by which
glutathione improves immune cells after consumption. The central hypothesis is that
glutathione improves redox status within the cell, thereby improving cell function and
increasing the number of healthy days experienced by the participants.
After obtaining informed consent, human participants will receive 500 mg/day of Setria®
Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils
and serum will be obtained from blood draws before and after the 120 days. A daily diary of
illness will be kept by each participant and will record any incidence of illness, the
number of symptoms per incidence, and the number of days in which symptoms are present. This
study is powered on the basis that over 120 days, the glutathione-supplemented group would
experience 3% more healthy days compared to the placebo group. The analysis indicated 60
people per group. Timeline should be between mid-January to May because the Center for
Disease Control and Prevention indicates that this is the cold and flu season
(http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02438956 -
Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo
|
N/A |