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)

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.

Study Overview

• Status: Completed
• Conditions: Improvement in Immune Cell Function in Elderly Humans
• Intervention / Treatment: Dietary supplement: Crystalline Cellulose; Dietary supplement: Setria glutathione supplement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • 449 Food Science and Human Nutrition Department, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Crystalline Cellulose; looks like and is given in the same way as the experimental treatment but contains no active ingredient	Dietary supplement: Crystalline Cellulose; 500 mg/day capsule taken in the morning for 120 days.; Other Names: Placebo
Experimental: Glutathione supplement; 500 mg/day Setria glutathione supplement	Dietary supplement: Setria glutathione supplement; 500 mg/day capsule taken in the morning for 120 days.; Other Names: Setria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity and frequency of Cold / Flu symptoms	Participants will record any cold / flu symptoms in log throughout the study duration	120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of immune cell function	Increased neutrophil respiratory burst; IFN-gamma and other cytokine production measurements; gd-T cell proliferation in mitogen-stimulated ex vivo culture	120 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Kyowa Hakko Bio Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB201500236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No