Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Change in T-cell response to Group A Streptococci Antigen
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Masking Description
Double blind
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
- •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.
Outcomes
Primary Outcomes
Change in T-cell response to Group A Streptococci Antigen
Time Frame: 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 Erythrocyte Sedimentation Rate (ESR)
Time Frame: Evaluated at baseline, week 12 and week 16
ESR will be measured as a marker of systematic inflammation
Change in T-cell population
Time Frame: 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
Change in Complete Blood Count (CBC)
Time Frame: 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 mucosal immunity
Time Frame: 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
Secondary Outcomes
- Survey based tracking of upper respiratory tract infection symptoms(Continuous for 18 weeks)
- Changes in Thiobarbituric acid reactive substances (TBARs)(Evaluated at baseline, week 12 and week 16)
- Incident specific tracking of upper respiratory tract infections (URTI)(Continuous for 18 weeks)
- Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood(Evaluated at baseline, week 12 and week 16)