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| Name | Class |
|---|---|
| Kirin Holdings Company, Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intervention: Dietary Supplement: Placebo supplement |
|
| Experimental: Glutathione | Experimental | Intervention: Dietary Supplement: Glutathione supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione Supplement | Dietary Supplement | 1000 mg/day Glutathione |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian K McFarlin, PhD | University of North Texas, Denton, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Texas | Denton | Texas | 76201 | United States |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Double blind
| Placebo Supplement | Dietary Supplement | Crystalline cellulose |
|
|
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 |