Effects of Glutathione on Immunity in Individuals Training for a Marathon

Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo Supplement; Dietary supplement: Glutathione Supplement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Denton, Texas, United States, 76201
      • University of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intervention: Dietary Supplement: Placebo supplement	Dietary supplement: Placebo Supplement; Crystalline cellulose; Other Names: Placebo
Experimental: Experimental: Glutathione; Intervention: Dietary Supplement: Glutathione supplement	Dietary supplement: Glutathione Supplement; 1000 mg/day Glutathione; Other Names: L-Glutathione reduced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Complete Blood Count (CBC)	CBC will be drawn and white blood cell count will be evaluated as an indicator of infection.	Evaluated at baseline, week 12 and week 16
Change in Erythrocyte Sedimentation Rate (ESR)	ESR will be measured as a marker of systematic inflammation	Evaluated at baseline, week 12 and week 16
Change in mucosal immunity	Salivary Immunoglobulin concentrations will be tracked as a marker of the bodies ability to mount a first line defense against viruses and other pathogens	Evaluated at baseline, week 12 and week 16
Change in T-cell population	Shifts in the T-cell concentration and population phenotypes will be tracked as a marker for readiness to fight infection	Evaluated at baseline, week 12 and week 16
Change in T-cell response to Group A Streptococci Antigen	Measurements will provide insight regarding the in vitro capacity of the body to respond to the most common virus causing URTI	Evaluated at baseline, week 12 and week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey based tracking of upper respiratory tract infection symptoms	Tracking of symptoms allows for calculation of % healthy vs % sick days	Continuous for 18 weeks
Incident specific tracking of upper respiratory tract infections (URTI)	Incidence tracking of URTI allows for evaluation of comparative number, severity and recovery time from URTI	Continuous for 18 weeks
Changes in Thiobarbituric acid reactive substances (TBARs)	TBARs are a direct index of the state of lipid peroxidation which is a marker of oxidative stress	Evaluated at baseline, week 12 and week 16
Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood	The ratio of reduced glutathione to oxidized glutathione will be analyzed as a marker of oxidative stress and antioxidant capacity	Evaluated at baseline, week 12 and week 16

Collaborators and Investigators

• Sponsor: University of North Texas, Denton, TX
• Collaborators: Kirin Holdings Company, Limited
• Investigators: Principal Investigator: Brian K McFarlin, PhD, University of North Texas, Denton, TX

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No