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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

449 Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Setria glutathione supplement

Dietary Supplement

500 mg/day capsule taken in the morning for 120 days.

Other names: Setria

Crystalline Cellulose

Dietary Supplement

500 mg/day capsule taken in the morning for 120 days.

Other names: Placebo

Primary outcomes

  1. Severity and frequency of Cold / Flu symptoms

    Time frame: 120 days

    Participants will record any cold / flu symptoms in log throughout the study duration

Secondary outcomes

  1. Improvement of immune cell function

    Time frame: 120 days

    Increased neutrophil respiratory burst; IFN-gamma and other cytokine production measurements; gd-T cell proliferation in mitogen-stimulated ex vivo culture

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Kyowa Hakko Bio Co., Ltd.

Registry information

Acronym: GSH

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 8, 2015
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.