This trial is active, not recruiting.

Condition improvement in immune cell function in elderly humans
Treatments setria glutathione supplement, crystalline cellulose
Sponsor University of Florida
Collaborator Kyowa Hakko Bio Co., Ltd.
Start date October 2015
End date June 2016
Trial size 124 participants
Trial identifier NCT02438956, IRB201500236


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 the duration of the study. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
(Placebo Comparator)
looks like and is given in the same way as the experimental treatment but contains no active ingredient
crystalline cellulose Placebo
500 mg/day capsule taken in the morning for 120 days.
500 mg/day Setria glutathione supplement
setria glutathione supplement Setria
500 mg/day capsule taken in the morning for 120 days.

Primary Outcomes

Severity and frequency of Cold / Flu symptoms
time frame: 120 days

Secondary Outcomes

Improvement of immune cell function
time frame: 120 days

Eligibility Criteria

Male or female participants from 50 years up to 75 years old.

Inclusion Criteria: - generally healthy - must have had at least one cold during the previous year - age 50-75 - must discontinue other dietary supplement use Exclusion Criteria: - on arthritis medication - on hypertension medication - severe allergies - compromised immune system - high cholesterol, heart failure, angina, etc. - diagnoses of diabetes or metabolic syndrome

Additional Information

Official title 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
Principal investigator Susan S Percival, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by University of Florida.