GSH Supplementation on Cold/Flu Symptoms in Older Healthy Adults

NCT ID: NCT02316925

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-05-31

Brief 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.

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. 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.

Conditions

Improvement in Immune Cell Function in Elderly Humans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Crystalline Cellulose

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

Group Type: PLACEBO_COMPARATOR

Crystalline Cellulose

Intervention Type: DIETARY_SUPPLEMENT

500 mg/day capsule taken in the morning

Glutathione supplement

500 mg/day Setria glutathione supplement

Group Type: EXPERIMENTAL

Setria glutathione supplement

Intervention Type: DIETARY_SUPPLEMENT

500 mg/day capsule taken in the morning

Interventions

Setria glutathione supplement

500 mg/day capsule taken in the morning

Intervention Type: DIETARY_SUPPLEMENT

Crystalline Cellulose

500 mg/day capsule taken in the morning

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Setria; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan S Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

IRB201400950

Identifier Type: -

Identifier Source: org_study_id