Healthy
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTGlutathione Supplement
1000 mg/day Glutathione
DIETARY_SUPPLEMENTPlacebo Supplement
Crystalline cellulose
Sponsors
Kirin Holdings Company, Limited
University of North Texas, Denton, TX
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in T-cell response to Group A Streptococci Antigen | Evaluated at baseline, week 12 and week 16 | Measurements will provide insight regarding the in vitro capacity of the body to respond to the most common virus causing URTI |
| Change in Complete Blood Count (CBC) | Evaluated at baseline, week 12 and week 16 | CBC will be drawn and white blood cell count will be evaluated as an indicator of infection. |
| Change in Erythrocyte Sedimentation Rate (ESR) | Evaluated at baseline, week 12 and week 16 | ESR will be measured as a marker of systematic inflammation |
| Change in mucosal immunity | Evaluated at baseline, week 12 and week 16 | Salivary Immunoglobulin concentrations will be tracked as a marker of the bodies ability to mount a first line defense against viruses and other pathogens |
| Change in T-cell population | Evaluated at baseline, week 12 and week 16 | Shifts in the T-cell concentration and population phenotypes will be tracked as a marker for readiness to fight infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incident specific tracking of upper respiratory tract infections (URTI) | Continuous for 18 weeks | Incidence tracking of URTI allows for evaluation of comparative number, severity and recovery time from URTI |
| Changes in Thiobarbituric acid reactive substances (TBARs) | Evaluated at baseline, week 12 and week 16 | TBARs are a direct index of the state of lipid peroxidation which is a marker of oxidative stress |
| Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood | Evaluated at baseline, week 12 and week 16 | The ratio of reduced glutathione to oxidized glutathione will be analyzed as a marker of oxidative stress and antioxidant capacity |
| Survey based tracking of upper respiratory tract infection symptoms | Continuous for 18 weeks | Tracking of symptoms allows for calculation of % healthy vs % sick days |
Countries
United States
Outcome results
None listed