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 (GSH)

University of Florida

Status: Completed

Conditions: Improvement in Immune Cell Function in Elderly Humans

Treatments: Dietary Supplement: Crystalline Cellulose; Dietary Supplement: Setria glutathione supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02438956

IRB201500236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Crystalline Cellulose

Placebo Comparator group

Description:

looks like and is given in the same way as the experimental treatment but contains no active ingredient

Treatment:

Dietary Supplement: Crystalline Cellulose

Glutathione supplement

Experimental group

Description:

500 mg/day Setria glutathione supplement

Treatment:

Dietary Supplement: Setria glutathione supplement