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Effects of Glutathione on Immunity in Individuals Training for a Marathon

NCT ID: NCT03725241

Last Updated: 2020-11-19

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2020-05-01

Brief Summary

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The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model.

Detailed Description

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A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in a randomized, double-blinded, 18 week placebo-controlled trial. Subjects will receive either a placebo or glutathione while participating in a stepwise exercise approach that mixes periods of high and low training volume to train subjects and improve running efficiency. Upper Respiratory Tract Infection-related health conditions will be monitored and assessed throughout the study period. Blood and saliva samples will be collected at baseline, and before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double blind

Study Groups

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Placebo

Intervention: Dietary Supplement: Placebo supplement

Group Type PLACEBO_COMPARATOR

Placebo Supplement

Intervention Type DIETARY_SUPPLEMENT

Crystalline cellulose

Experimental: Glutathione

Intervention: Dietary Supplement: Glutathione supplement

Group Type EXPERIMENTAL

Glutathione Supplement

Intervention Type DIETARY_SUPPLEMENT

1000 mg/day Glutathione

Interventions

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Glutathione Supplement

1000 mg/day Glutathione

Intervention Type DIETARY_SUPPLEMENT

Placebo Supplement

Crystalline cellulose

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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L-Glutathione reduced Placebo

Eligibility Criteria

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Inclusion Criteria

* Generally healthy, male or female.
* Between the ages of 19-45 years.
* Have no medical restrictions and no health conditions that would inhibit participant from marathon run.
* Be willing and able to comfortably abstain from any food supplements.
* Not participating as a subject in another study.

Exclusion Criteria

* BMI \< 20.0 or \> 28.5.
* Current or prior use of tobacco products or other inhaled substance.
* More than a moderate intake of alcohol (\>1 drink per day in women; \>2 drinks per day in men).
* Metabolic or inflammatory disease.
* Excellent fitness based on the American College of Sports Medicine criteria for VO2max based on age and gender.
* Recent weight loss of \>10 pounds in the last 3-months.
* Daily intake of ibuprofen, acetaminophen, aspirin, polyphenol supplements, multivitamins, and/or antioxidant supplements.
* Actively attempting (or planning) to lose or gain weight and/or alter body composition.
* Currently taking cholesterol-lowering medications.
* Currently taking prescription anti-inflammatory medications.
* Currently using mouthwash on a regular basis (\>4 times per week).
* Orthopedic problems that would limit running capacity.
* Currently in very poor or poor fitness.
* Highly aerobic exercise trained.
* Pregnant or planning to become pregnant during the study period.
* Breast feeding
* Currently taking blood pressure medications.
* Contraindications to strenuous exercise.
* Anemic (blood hemoglobin \<10 g/dL and/or hematocrit \<35%).
* Diagnosed with asthma or other lung disease.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kirin Holdings Company, Limited

INDUSTRY

Sponsor Role collaborator

University of North Texas, Denton, TX

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian K McFarlin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Texas, Denton, TX

Locations

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University of North Texas

Denton, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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18-100

Identifier Type: -

Identifier Source: org_study_id