An interventional study of Glutathione Supplement and Placebo Supplement in Healthy, sponsored by University of North Texas, Denton, TX. Completed at 1 site in United States. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by University of North Texas, Denton, TX · Not applicable, Interventional, and Basic science
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.
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.
University of North Texas, Denton, TX is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: Dietary Supplement: Placebo supplement
Dietary Supplement: Placebo Supplement
Intervention: Dietary Supplement: Glutathione supplement
Dietary Supplement: Glutathione Supplement
1000 mg/day Glutathione
Also known as: L-Glutathione reduced
Crystalline cellulose
Also known as: Placebo
Change in Complete Blood Count (CBC)
CBC will be drawn and white blood cell count will be evaluated as an indicator of infection.
Time frame: Evaluated at baseline, week 12 and week 16
Change in Erythrocyte Sedimentation Rate (ESR)
ESR will be measured as a marker of systematic inflammation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Evaluated at baseline, week 12 and week 16
Survey based tracking of upper respiratory tract infection symptoms
Tracking of symptoms allows for calculation of % healthy vs % sick days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Evaluated at baseline, week 12 and week 16
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of North Texas, Denton, TX