Effects of Glutathione on Immunity in Individuals Training for a Marathon

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725241
• Other study ID #: 18-100
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: November 2020
• Source: University of North Texas, Denton, TX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Glutathione Supplement
1000 mg/day Glutathione
• Placebo Supplement
Crystalline cellulose

Locations

Country	Name	City	State
United States	University of North Texas	Denton	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of North Texas, Denton, TX	Kirin Holdings Co, Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Erythrocyte Sedimentation Rate (ESR)	ESR will be measured as a marker of systematic inflammation	Evaluated at baseline, week 12 and week 16
Primary	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
Primary	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
Primary	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	Survey based tracking of upper respiratory tract infection symptoms	Tracking of symptoms allows for calculation of % healthy vs % sick days	Continuous for 18 weeks
Secondary	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
Secondary	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
Secondary	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