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GSH Supplementation on Cold/Flu Symptoms in Older Healthy Adults

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ClinicalTrials.gov Identifier: NCT02316925
Recruitment Status : Withdrawn (This study will never recruit. The protocol was renamed and will be resubmitted.)
First Posted : December 15, 2014
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Kyowa Hakko Bio Co., Ltd.
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Improvement in Immune Cell Function in Elderly Humans Dietary Supplement: Setria glutathione supplement Dietary Supplement: Crystalline Cellulose Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults
Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

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
Other Name: Placebo

Experimental: Glutathione supplement
500 mg/day Setria glutathione supplement
Dietary Supplement: Setria glutathione supplement
500 mg/day capsule taken in the morning
Other Name: Setria




Primary Outcome Measures :
  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 Outcome Measures :
  1. Improvement of immune cell function [ Time Frame: 120 days ]
    Increased neutrophil respiratory burst; IFN-gamma and other cytokine production measurements; γδ-T cell proliferation in mitogen-stimulated ex vivo culture



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316925


Sponsors and Collaborators
University of Florida
Kyowa Hakko Bio Co., Ltd.
Investigators
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Principal Investigator: Susan S Percival, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02316925     History of Changes
Other Study ID Numbers: IRB201400950
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015