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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

NCT ID: NCT02438956

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Improvement in Immune Cell Function in Elderly Humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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 for 120 days.

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 for 120 days.

Interventions

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Setria glutathione supplement

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

Intervention Type DIETARY_SUPPLEMENT

Crystalline Cellulose

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Setria Placebo

Eligibility Criteria

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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

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Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan S Percival, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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449 Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201500236

Identifier Type: -

Identifier Source: org_study_id