Clinical trial NCT03725241: Effects of Glutathione on Immunity in Individuals Training for a Marathon
Official title: Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
Collaborators: name: Kirin Holdings Company, Limited
First posted: 2018-10-31
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Complete Blood Count (CBC)
timeFrame: Evaluated at baseline, week 12 and week 16
measure: Change in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Evaluated at baseline, week 12 and week 16
measure: Change in mucosal immunity
timeFrame: Evaluated at baseline, week 12 and week 16
measure: Change in T-cell population
timeFrame: Evaluated at baseline, week 12 and week 16
measure: Change in T-cell response to Group A Streptococci Antigen
timeFrame: Evaluated at baseline, week 12 and week 16
Secondary outcomes:
measure: Survey based tracking of upper respiratory tract infection symptoms
timeFrame: Continuous for 18 weeks
measure: Incident specific tracking of upper respiratory tract infections (URTI)
timeFrame: Continuous for 18 weeks
measure: Changes in Thiobarbituric acid reactive substances (TBARs)
timeFrame: Evaluated at baseline, week 12 and week 16
measure: Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood
timeFrame: Evaluated at baseline, week 12 and week 16
Other outcomes:
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
affiliation: University of North Texas, Denton, TX
name: Brian K McFarlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: