GSH Supplementation on Cold/Flu Symptoms in Older Healthy Adults

Improvement in Immune Cell Function in Elderly Humans Clinical Trial

Official title:

Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02316925
• Other study ID #: IRB201400950
• Status: Withdrawn
• Phase: N/A
• First received: December 10, 2014
• Last updated: May 4, 2015
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Improvement in Immune Cell Function in Elderly Humans

Intervention

Dietary Supplement:
• Setria glutathione supplement
500 mg/day capsule taken in the morning
• Crystalline Cellulose
500 mg/day capsule taken in the morning

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Kyowa Hakko Bio Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity and frequency of Cold / Flu symptoms	Participants will record any cold / flu symptoms in log throughout the study duration	120 days	No
Secondary	Improvement of immune cell function	Increased neutrophil respiratory burst; IFN-gamma and other cytokine production measurements; ?d-T cell proliferation in mitogen-stimulated ex vivo culture	120 days	No