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Completed

NCT Number: NCT03725241

Effects of Glutathione on Immunity in Individuals Training for a Marathon

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Texas

Denton, Texas, 76201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glutathione Supplement

Dietary Supplement

1000 mg/day Glutathione

Other names: L-Glutathione reduced

Placebo supplement

Dietary Supplement

Crystalline cellulose

Other names: Placebo

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Survey based tracking of upper respiratory tract infection symptoms

    Time frame: Continuous for 18 weeks

    Tracking of symptoms allows for calculation of % healthy vs % sick days

  2. Incident specific tracking of upper respiratory tract infections (URTI)

    Time frame: Continuous for 18 weeks

    Incidence tracking of URTI allows for evaluation of comparative number, severity and recovery time from URTI

  3. Changes in Thiobarbituric acid reactive substances (TBARs)

    Time frame: 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

  4. Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of North Texas, Denton, TX

Other

Collaborators

  • Kirin Holdings Company, Limited

Registry information

Official study title

Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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